Journal of Physiotherapy 66 (2020) 19–26 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial Elinaldo da Conceição dos Santos a,b, Juliana de Souza da Silva b, Marcus Titus Trindade de Assis Filho b, Marcela Brito Vidal b, Moisés de Castro Monte c, Adriana Cláudia Lunardi a,d a Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo; b Department of Biological and Health Sciences, Universidade Federal do Amapá; c Department of Physical Therapy, Faculdade de Macapá, Macapá; d Department of Physical Therapy, School of Medicine, Universidade de São Paulo, São Paulo, Brazil KEY WORDS ABSTRACT Pleural effusion Questions: In patients with a collection of fluid in the pleural space, do mobilisation and respiratory Chest drain techniques: shorten the drainage period and length of hospital stay; improve respiratory function and Respiratory care oxygenation; and prevent pulmonary complications? Does the addition of positive airway pressure to this Physical therapy regimen further improve the effects? Design: Randomised controlled trial with three intervention arms, Clinical trial concealed allocation, intention-to-treat analysis and blinded assessment. Participants: One hundred and fifty-six inpatients with a fluid collection in the pleural space and with chest drainage in situ. Intervention: Participants received usual care and were randomly assigned to: a control group that also received sham positive airway pressure (4 cmH2O) only (Con); an experimental group that received incentive spirometry, airway clearance, mobilisation and the same sham positive pressure (Exp1); or an experimental group that received the Exp1 regimen except that the positive airway pressure was 15 cmH2O (Exp2). Treatments were provided three times per day for 7 days. Outcome measures: Days of chest tube drainage, length of hospital stay, pulmonary complications and adverse events were recorded until hospital discharge. Costs in each group were estimated. Results: The Exp2 group had shorter duration of chest tube drainage and length of hospital stay compared with the Exp1 and Con groups. In addition, the Exp2 group had less antibiotic use (18% versus 43% versus 55%) and pneumonia incidence (0% versus 16% versus 20%) compared with the Exp1 and Con groups (all p , 0.01). The groups had similar rates of adverse events (10% versus 2% versus 6%, p . 0.05). Total treatment costs were lower in the Exp2 group than in the Exp1 and Con groups. Conclusions: In patients with a fluid collection in the pleural space, the addition of positive pressure to mobilisation and respiratory techniques decreased the duration of thoracic drainage, length of hospital stay, pulmonary complications, antibiotic use and treatment costs. Registration: ClinicalTrials.gov NCT02246946. [dos Santos EC, da Silva JS, de Assis Filho MTT, Vidal MB, Monte MC, Lunardi AC (2020) Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial. Journal of Physiotherapy 66:19–26] © 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction Depending on its volume and aetiology, excessive pleural fluid can cause dyspnoea and pleuritic pain. The presence of the Pleural effusion is a collection of excessive fluid in the pleural space, intercostal tube causes additional pain, which is not always able to which can have many aetiologies.1 Each year, pleural effusion is diagnosed in approximately 1.5 million people in the USA.2 Among be controlled. Furthermore, various complications can develop people diagnosed with a pleural effusion, mortality at 1 year differs during the period that the intercostal tube is in situ. The most with the aetiology: 25% if from renal failure, 46% if from hepatic failure, 50% if from cardiac failure and more if from malignancy.3 After trauma, common complication is drain blockage, which occurs in about 8% blood (haemothorax) and other fluid may also collect in the pleural of small-bore tubes ( 16 F) and 5% of large-bore tubes ( 20 F).6 space.4 The next most common complications include infection of the pleural fluid collection (empyema), movement of the tube into a Some pleural fluid collections can be managed with aspiration of poor position and injury to internal structures.6 For all these the fluid via an intercostal needle – a procedure known as reasons, facilitating rapid drainage of the pleural fluid collection is thoracentesis.5 However, British Thoracic Society guidelines an important aim of management. recommend the insertion of an intercostal tube attached to a closed drainage system in malignant pleural effusions, empyema, traumatic Lung expansion techniques have been proposed as one group of haemopneumothorax and after thoracic surgery.6 interventions that could be used to hasten the drainage of a pleural fluid collection and thereby reduce the opportunity for complications from the drainage tube.7 A randomised controlled trial involving https://doi.org/10.1016/j.jphys.2019.11.006 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
20 dos Santos et al: Positive pressure for pleural drainage 104 inpatients with pleural effusions with or without an intercostal with a collection of fluid in the pleural space and an intercostal drain drainage tube showed that the addition of breathing exercises and were invited to participate. Inpatients who met the eligibility criteria mobilisation to other usual care reduced the severity of pleural and agreed to participate had the following data collected: personal effusion, as judged by blinded assessment of chest radiographs, and and anthropometric information; history of smoking; cause of the reduced length of stay by a mean of 12 days (95% CI 8 to 16).7 pleural fluid collection; type of drainage; and tomographic confirmation of a pleural fluid collection. All participants continued to Although those results for lung expansion techniques were very receive usual medical and nursing care, and were immediately promising,7 few clinical practice guidelines for pleural effusion have randomised to one of three groups: the control group (Con) received incorporated that evidence,8 presumably because of some limitations. no additional active interventions; the first experimental group Although the trial was generally very rigorous, some participants who (Exp1) received breathing exercises, an airway clearance technique did not complete the allocated intervention were excluded, which is and mobilisation; and the second experimental group (Exp2) contrary to the recommendation to analyse by intention to treat.9 The received the same interventions as Exp1 with the addition of periods authors did not test whether the effects differed between the of CPAP. subgroups managed with or without an intercostal drainage tube. Furthermore, although the substantial effect on length of stay Randomisation was performed by a researcher not involved in suggests that the time spent with the intercostal drainage tube in situ patient selection, evaluation or intervention. The random sequence of was probably also shorter, this was not measured. Perhaps most allocations was computer-generated, with each allocation placed in a importantly, the evidence comes from a single trial7 so an attempt to corresponding sequentially numbered opaque envelope. The replicate the findings is warranted. envelopes were sealed and stored securely where only the researcher responsible for the randomisation had access. This In addition to breathing exercises and mobilisation, another researcher informed only the physiotherapist who administered the intervention that might expand the lungs and promote drainage is interventions of each participant’s random allocation.16 This positive airway pressure, which can be applied non-invasively via a face physiotherapist remained blinded to the assessment information mask. We hypothesised that increasing the intra-pleural pressure being collected on the participants. would promote drainage and reabsorption of the pleural fluid collection, thereby hastening the recovery of respiratory function, The randomly allocated interventions were commenced within 24 permitting earlier removal of the chest drain and shortening the hours of insertion of the drainage system, and were continued three hospital stay. However, the only trial of positive airway pressure for times per day for 7 consecutive days. On the first day of the pleural effusion examined continuous positive airway pressure (CPAP) intervention and after the intervention protocol was completed (on in participants with tuberculous pleural effusions and no drainage the day after the intervention ended), pulmonary function and tubes.10 Therefore, the effects of positive airway pressure in patients peripheral oxygen saturation were reassessed. In cases where the with intercostal tubes for pleural drainage are unknown. drain was removed before completing the intervention protocol period, the reassessments were conducted immediately before the Some indirect evidence suggests that positive airway pressure may drain was removed to homogenise the analyses. Every 24 hours while have additional advantages. It may help to prevent or treat respiratory the chest drain remained in situ, the drainage rate was quantified and complications in patients after thoracic surgery,11 where lung expansion was evaluated by a physician blinded to the end-operative placement of an intercostal drainage tube is routine. For intervention groups. At this assessment, the physician decided example, in patients undergoing lung resection, non-invasive whether the drain should be removed or not. Treatment tolerability ventilation significantly improved gas exchange, spirometry and and adverse events were also recorded for all patients. In addition, length of stay.12 In patients who had already developed patients were evaluated daily for the presence of pulmonary acute hypoxaemic respiratory insufficiency after lung resection, complications and to estimate treatment costs until hospital non-invasive ventilation significantly improved arterial oxygenation discharge. If participants presented any pulmonary complications, and respiratory rate, and significantly reduced reintubation and they received individualised treatment according to their condition. mortality.13 Positive effects have also been noted in other thoracic surgical procedures such as coronary artery bypass grafting14 and Participants resection of lung cancer.15 However, it is important to remember that many of these patients may primarily have pleural gas with some Between December 2014 and February 2017, inpatients with a resolving post-surgical bleeding and oedema in the pleural space, pleural fluid collection at either hospital were approached rather than an extensive pleural fluid collection. Furthermore, the consecutively, advised about the study, screened for eligibility beneficial effects after thoracic surgery may occur via mechanisms (if willing) and invited to participate in the study (if eligible). The that are unrelated to the pleural space, such as more efficient gas inclusion criteria were: being aged 18 years; having a diagnosis of a exchange. Therefore, although these findings are promising, it would fluid collection in the pleural space confirmed by computer be hazardous to extrapolate from these studies to draw conclusions tomography; and having an intercostal thoracic drainage system in about the effects of positive airway pressure in the overall population situ for , 24 hours. Exclusion criteria were drowsiness, restlessness, of patients receiving drainage of fluid via an intercostal tube. treatment refusal, haemodynamic instability, shock (systolic blood pressure , 90 mmHg), facial trauma, ineffective cough, swallowing Therefore, the research questions for this randomised controlled impairment, vomiting, upper gastrointestinal bleeding, acute trial were: myocardial infarction in the past 48 hours, or bullous emphysema.17 1. In patients with a collection of fluid in the pleural space, do Intervention mobilisation and respiratory techniques: shorten the drainage period and length of hospital stay; improve respiratory function Usual nursing and medical care were provided to all participants and oxygenation; and prevent pulmonary complications? in all groups. Where positive airway pressure was provided, the active and sham pressure levels were based on a previous study that tested 2. Does the addition of positive airway pressure to this regimen different values and evaluated the resulting lung expansion via further improve the effects? thoracic computer tomography.18 Method Con group Participants in this group breathed with CPAP of 4 cmH2O Design (sham)18 via an oronasal mask attached to a bedside ventilation unita This study was a randomised controlled trial with concealed for 30 minutes, in order to have a similar intervention period for all allocation, blinded assessors and intention-to-treat analysis. At two groups and guarantee blind assessment (ie, presence of equipment in university-affiliated tertiary hospitals in Macapá, Brazil, inpatients the room and the impression of the mask on the patient’s face).
Research 21 Exp1 group expansion assessed by chest radiograph.19 The decision about the Participants in this group undertook: incentive spirometryb, time of drain removal was made by a physician blinded to the participant’s group. The physician verified the following criteria every performing five sets of 20 repetitions; airway clearance manoeuvres day during the period that drainage was in situ: drainage volume in using a high-frequency oscillatorc, performing five sets of 10 millilitres over 24 hours, and lung expansion assessed by chest repetitions; breathing with CPAP of 4 cmH2O (sham)18 via an oronasal radiograph. mask attached to a bedside ventilation unita for 5 minutes while sitting on a chair; and walking a distance of 100 metres. Secondary outcomes assessed during the treatment period Pulmonary function was evaluated by spirometry following the Exp2 group Participants in this group received all the same interventions as performance and acceptability criteria previously established by the European Respiratory Society and American Thoracic Society.20 those provided to the Exp1 group, except that the CPAP was not a Spirometry assessments were performed prior to the first sham. Participants breathed with CPAP of 15 cmH2O (active)18 via an intervention and at the end of the scheduled intervention protocol oronasal mask attached to a bedside ventilation unita for 30 minutes (Day 8). In cases where the criteria for drain removal were met before while sitting on a chair. the end of the protocol, spirometry was performed immediately before the drain was removed. The spirometry measurements were Outcome measures performed by an assessor blinded to the participant’s group. The variables forced vital capacity (FVC) and forced expiratory volume in Primary outcome 1 second (FEV1) were calculated as a percentage of the predicted The primary outcome was the duration of thoracic drainage, values for the Brazilian population.21 quantified in days until drain removal. The criteria for drain removal were 200 ml fluid drainage in 24 hours and complete lung People admitted and referred for assessment of eligibility (n = 468) Excluded (n = 312) . did not meet inclusion criteria (n = 309) . declined to participate (n = 3) Baseline Measured spirometry and oxygenation Randomised (n = 156) (n = 52) (n = 52) (n = 52) Con group Exp2 group Exp1 group . usual care . usual care . usual care . sham positive airway . mobilisation . mobilisation . respiratory techniques . respiratory techniques pressure (4 cmH₂O) . positive airway . sham positive airway .Loss to follow-up pressure (15 cmH₂O) pressure (4 cmH₂O) discontinued .Loss to follow-up .Loss to follow-up . trial (n = 2) death (n = 1) discharged with death (n = 1) no authorisation (n = 1) Measured spirometry, oxygenation, treatment tolerability (satisfaction and discomfort), and adverse Day 8 events (n = 51) (n = 51) (n = 49) Discharge Measured duration of pleural drainage, length of hospital stay, treatment costs, and antibiotic use (n = 51) (n = 51) (n = 49) Figure 1. Design and flow of participants through the trial. Note that data obtained before loss to follow-up were included in the analysis for some outcomes. Exp2 = experimental group 2, Exp1 = experimental group 1, Con = control group.
22 dos Santos et al: Positive pressure for pleural drainage Peripheral oxygen saturation (SpO2) was assessed daily until (duration of thoracic drainage and length of hospital stay). A signif- completion of the intervention protocol or removal of the thoracic icance level of 5% (p , 0.05) was adopted for all statistical analyses. drain. Measurements were taken by an assessor blinded to the intervention group. Oximetry was performed with the participant Results breathing ambient air (ie, without oxygen supplementation) for at least 10 minutes. Flow of participants, therapists, centres through the study Treatment tolerability was assessed using participant ratings of Four hundred and sixty-eight patients were referred for satisfaction and discomfort on a visual analogue scale ranging from evaluation and selected for possible inclusion in this study. Of these, 0 to 10 points. Participants were requested to report their satisfaction 309 were ineligible and three refused to participate, so 156 patients with their randomly allocated respiratory interventions using scores were included in the study. Figure 1 presents the flowchart of where 0 points indicated complete dissatisfaction and 10 points enrolment and monitoring of the research participants. Although the indicated complete satisfaction with the treatment. Participants were study allowed for an anticipated 15% loss to follow-up based on also instructed to respond about discomfort regarding the randomly existing research,28 a 2% loss to follow-up occurred, with two deaths allocated respiratory interventions received, where 0 points indicated and one unauthorised hospital discharge. no discomfort with the oronasal mask or flow and 10 points indicated unbearable discomfort. Compliance with the study protocol Adverse events were recorded during the positive airway pressure No ineligible participants were randomised. All participants treatment periods based on daily visual evaluation and questioning of commenced on the correctly designated intervention. Treatment was participants. Whenever an adverse event was detected, it was interrupted in three patients who presented clinical complications monitored and reported to the ethics committee. In cases of unrelated to the proposed intervention (hypovolaemia and cardiac confirmed air leaks or aerophagia, the respiratory care session was arrhythmia). No assessors were accidentally unblinded during the interrupted for 24 hours and the participant was re-evaluated the study. Assessors guessed group allocations correctly 17% of the time, next day. which was less than the 33% predicted by chance alone; this suggests that blinding was well preserved. Secondary outcomes assessed until discharge from hospital Length of hospital stay was tallied as the total number of days in Baseline characteristics of the participants hospital. At baseline, all groups were similar with respect to the anthro- Treatment costs were estimated based on established values of pometric and demographic characteristics, as well as to pulmonary function, SpO2 and the variables related to thoracic drainage (Table 1). overnight hospital stay (R$500.00), antibiotic use (R$313.49), physio- therapy session (R$150.00), equipment and accessories for positive Effect of the intervention airway pressure (R$2000.00 divided by the number of participants in the Exp2 group) for the whole length of hospital stay of each participant. Duration of thoracic drainage The total drainage time ranged from 2 to 37 days: 2 to 19 days in Pulmonary complications were assessed by a physician who was blinded to each participant’s group, considering the following the Exp2 group, 2 to 37 days in the Exp1 group and 2 to 16 days in the events: pneumonia (chest radiograph with pulmonary infiltrate Con group. In the Exp2 group, drainage duration was shorter associated with two of the following signs: purulent sputum, compared with that in the other groups (Table 2). Over time, the hyperthermia . 38.8 C, or increase in baseline leucocyte count following approximate probability values for participants remaining . 25%),22 atelectasis (abnormal chest radiograph associated with on thoracic drainage for 7 days were observed: 7% in the Exp2 group, acute respiratory symptoms)23 and hypoxaemia (SpO2 , 85% associated with respiratory symptoms).24 In addition to pulmonary Table 1 complications, the lung entrapment rate was also verified by a Baseline anthropometric and demographic characteristics of the participants (n = 156). physician who was blinded to the intervention groups. Lung entrapment was defined as contralateral displacement of the Variables Exp2 Exp1 Con mediastinum25 verified by chest radiograph or computer tomo- (n = 52) (n = 52) (n = 52) graphy, or reaccumulating pleural effusion within 24 to 72 hours.26 Need for thoracotomy was also recorded until hospital discharge. Gender, n male (%) 46 (88) 45 (87) 46 (88) Age (yr), median (IQR) 32 27 27 Data on antibiotic use were extracted from the medical prescrip- tion records from the inclusion of the participant in the study until BMI (kg/m2), median (IQR) (23 to 38) (23 to 34) (23 to 34) hospital discharge. The type of antibiotic used was not evaluated. 25 25 24 Smoking, n (%) Data analysis FVC (% pred), median (IQR) (22 to 28) (22 to 28) (21 to 27) 24 (46) 27 (52) 25 (48) It was calculated that a sample of 132 participants (43 per group) FEV1 (% pred), median (IQR) 61 57 64 was required, based on the primary outcome of thoracic drainage duration. Two days was nominated as the smallest worthwhile effect, SpO2 (%), median (IQR) (44 to 80) (45 to 72) (51 to 79) anticipating a standard deviation of 3 days,27 and requiring statistical 41 46 46 power of 80% and setting alpha at 5%. Incorporating an allowance for Cause of pleural effusion, n (%) an anticipated 15% loss to follow-up (eg, deaths, refusal to continue trauma (30 to 64) (38 to 60) (39 to 57) participation in the study and hospital transfer),27 resulted in a pneumonia 97 97 97 required sample size of 156 patients (52 per group). neoplasia (96 to 98) (95 to 98) (95 to 98) All analyses were performed by a researcher who was not Type of drainage used, n (%) involved in the study participants’ assessments and interventions. unilateral 48 (92) 50 (96) 48 (92) Statistical analysis was performed following the intent-to-treat bilateral 2 (4) 1 (2) 3 (6) principle.9 The Kruskal-Wallis ANOVA was used to test the 2 (4) 1 (2) 1 (2) continuous variables, namely: FVC, FEV1, SpO2, treatment costs and Pain scale (0 to 10), median (IQR) treatment tolerability, which were not normally distributed. Pairwise 50 (96) 50 (96) 50 (96) chi-squared tests were applied to the categorical variables 2 (4) 2 (4) 2 (4) (pulmonary complications, adverse events and antibiotic use), with 6 7.5 7 between-group comparisons reported as absolute risk reduction (95% CI). Kaplan-Meier survival analysis was used to test the time variables (5 to 8) (5 to 9) (5 to 8) BMI = body mass index, Con = control group (usual care plus sham positive pressure), Exp1 = experimental group 1 (usual care plus mobilisation, respiratory interventions and sham positive pressure), Exp2 = experimental group 2 (usual care plus mobilisation, respiratory interventions and positive pressure), FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity, SpO2 = peripheral oxygen saturation, % pred = percentage predicted.
Research 23 Table 2 Median (IQR) of each group, pairwise differences in ranks, and statistical significance of the pairwise comparisons. Outcome Groups Difference in ranks (p value) Exp2 Exp1 Con Exp2 versus Exp2 versus Exp1 versus (n = 51) (n = 52) (n = 49) Con Exp1 Con Duration of drainage 4 4 5 32.25 23.59 8.66 (d) (3 to 4) (3 to 6) (3.5 to 7) (, 0.05) (, 0.05) (. 0.05) Length of hospital stay (d) 4 5 6 35.89 24.36 11.52 Treatment cost (3 to 4) (3 to 7) (4 to 9.5) (, 0.05) (, 0.05) (. 0.05) (R$) 2671.41 3933.96 4067.45 (2021.41 to 3321.41) (2680.00 to 6528.21) (2440.47 to 6537.69) 24.33 32.64 8.32 (, 0.05) (, 0.05) (. 0.05) Con = control group (usual care plus sham positive pressure), Exp1 = experimental group 1 (usual care plus mobilisation and respiratory interventions and sham positive pressure), Exp2 = experimental group 2 (usual care plus mobilisation and respiratory interventions and sham positive pressure), R$ = Brazilian real. 17% in the Exp1 group and 21% in the Con group; these probabilitiesProbability of remaining on drainage (%)group compared with the Con group (ARR 0.20, 95% CI 0.09 to 0.32) were maintained up to 16 days (Figure 2). and compared with the Exp1 group (ARR 0.16, 95% CI 0.05 to 0.28). No difference was found in the rates of atelectasis and hypoxaemia Length of hospital stay between groups (Table 4). The total length of hospital stay varied from 2 to 46 days, and it Use of antibiotics was also shorter in the Exp2 group when compared with the other The Exp2 group presented less need for antibiotic use compared groups (Table 2). Over time, the approximate probabilities for participants remaining hospitalised for 7 days were as follows: 9% in with the Con and Exp1 groups (Table 4). The ARRs were 0.35 (95% CI the Exp2 group, 23% in the Exp1 group and 31% in the Con group; 0.17 to 0.51) and 0.25 (95% CI 0.08 to 0.41), respectively. these probabilities were maintained up to 33 days (Figure 3). Adverse events Treatment costs All groups showed similar rates of air leaks and aerophagia The estimates of costs ranged from R$1,000.00 to R$29,980.00 per (Table 4). Individual participant data are available in Table 5 on the participant during hospital stay. Comparison between groups showed eAddenda. that the Exp2 group presented a significantly lower cost compared with the other groups (Table 2). Discussion Pulmonary function and oximetry The results show that the combination of intermittent CPAP of 15 These outcomes tended to improve in all groups from baseline until cmH2O and mobilisation and respiratory care reduces the duration of chest drainage, the length of hospital stay, pulmonary complications, Day 8 (Table 3). The interventions compared in this study did not have use of antibiotics, and treatment costs. In addition, the use of CPAP of clear differences in their effects on pulmonary function and oximetry. 15 cmH2O did not produce a higher rate of adverse events or lower tolerability compared with CPAP of 4 cmH2O (without therapeutic Tolerability effect). Despite its other beneficial effects, the addition of CPAP had No inability to tolerate the positive airway pressure was noted in no clear effect on lung function recovery and oxygenation. any participants, so there was 100% adherence during each This study also showed that CPAP of 15 cmH2O added to participant’s period of participation in the trial. Discomfort reported mobilisation and respiratory physiotherapy interventions (Exp2) was by the patients was also similar between groups (Table 3). more effective than mobilisation and respiratory physiotherapy alone (Exp1). The benefits were observed on the same outcomes (duration of Pulmonary complications chest drainage, the length of hospital stay, pulmonary complications, Pulmonary complications were less common in the Exp2 group use of antibiotics, and treatment costs) and had a similar magnitude as in the comparison against the Con group. This suggests that the compared with the Con group (absolute risk reduction (ARR) 0.18, intermittent CPAP was mainly driving the observed benefit. 95% CI 0.06 to 0.31) and compared with the Exp1 group (ARR 0.16, 95% CI 0.04 to 0.28). This effect seemed to arise mainly through a It is important to gauge whether these benefits are large enough reduction in pneumonia. Pneumonia was less common in the Exp2 to be clinically worthwhile. Even without well-established estimates of the smallest worthwhile effect for these comparisons, it seems 100 reasonable to conclude that most of the estimates have confidence intervals that include both trivial and worthwhile effects. For Con example, the estimates of the reductions in complications generally Exp1 and in pneumonia specifically all have confidence intervals around 80 Exp2 the ARRs that span from , 10% to around 30%. The reduction in risk of requiring antibiotics is stronger (ARR 0.35, 95% CI 0.17 to 0.51), so this 60 is arguably a clinically worthwhile benefit in its own right. The clinical utility of the estimated effect on treatment cost is more 40 difficult to interpret because the data were analysed with a test for non-parametric data. However, the difference in medians of R$1,396 20 35 between the Exp2 and Con groups is reassuring, given the other clinical benefits obtained. * Previous studies conducted on participants having open lung 0 resection have shown divergent results from those of this research. 0 5 10 15 20 25 30 Danner et al29 evaluated 21 participants divided into two groups: one Time (days) group received non-invasive ventilation (NIV) with an inspiratory positive airway pressure of 16 cmH2O, whereas the other group Figure 2. Kaplan-Meier curve for duration of thoracic drainage. underwent conventional respiratory physiotherapy without NIV. The *p , 0.001. authors found no between-group difference for duration of chest tube drainage. Similarly, Garutti et al28 and Perrin et al12 assessed the use
24 dos Santos et al: Positive pressure for pleural drainage Probability of remaining in hospital (%) 100 In the Exp2 group, despite the need to purchase positive pressure Con Exp1 equipment and accessories and for physiotherapy assistance three times a day, costs were reduced compared with those in the Con 80 Exp2 group. This finding is consistent with evidence that adequate 60 application of positive airway pressure seems to present good 40 cost-effectiveness in some clinical situations, such as the postoperative period of thoracic surgeries,14 although further 20 * evidence about cost-effectiveness is needed.31 Although more robust 30 35 evidence is still required, the results of the current study indicate that 0 0 5 10 15 20 25 investing in positive pressure equipment and hiring physiotherapists Time (days) can actually reduce costs instead of increasing them. Figure 3. Kaplan-Meier curve for length of hospital stay. The current results show that the addition of CPAP at 15 cmH2O *p , 0.001. reduced the rate of pneumonia and, consequently, the use of antibiotics in non-surgical patients with drained pleural effusions. Zarbock et al32 of NIV with lower inspiratory positive airway pressures (7 to 12 cmH2O) for surgical patients. They also observed no difference in evaluated 468 surgical patients randomly allocated into two groups; duration of chest drainage between intervention and control patients who received CPAP of 10 cmH2O had a lower rate of (conventional treatment) groups. Perhaps the difference detected in pneumonia compared with a no-intervention control group. A Cochrane the present trial occurred due to the combination of two factors: the review15 found no studies that have tested the efficacy of non-invasive absence of surgical trauma and the use of CPAP at high pressure. We positive airway pressure in the prevention of complications after lung believe that respiratory physiotherapy interventions, which included resection and evaluated the use of antibiotics. One recent study of airway clearance techniques and mobilisation, in addition to pulmonary expansion help patients recover more quickly and stay patients undergoing myocardial revascularisation showed no more active during their hospital stay. This increased activity along difference in antibiotic use between patients who received and those with the use of CPAP can accelerate the elimination of excess pleural who did not receive postoperative non-invasive ventilation.33 The cur- fluid, with consequent faster resolution of pleural fluid collection and rent results revive this important aspect in the treatment of patients shorter duration of chest drainage. with chest drainage and reinforce the need for further studies assessing Reduced duration of chest drainage associated with a lower rate of this outcome. It is believed that optimised pulmonary expansion pneumonia in the Exp2 group presumably contributed to the 2-day through positive pressure facilitates blood perfusion34 with possible reduction in the length of hospital stay. A randomised trial30 transport of immune cells facilitating pulmonary defence.22 conducted with surgical patients also showed shorter length of hospital stay for patients receiving CPAP of 10 cmH2O when Despite the effectiveness of the interventions provided to the Exp2 compared with conventional respiratory care. In contrast, a group in this study, patient comfort and adherence to treatment are systematic review showed that non-invasive ventilation did not reduce the length of hospital stay in surgical patients with cancer.15 also important aspects to be considered. In this study, patients in all This difference is most likely associated with the severity of clinical groups reported similar levels of satisfaction and tolerable discomfort in conditions of cancer patients. The shorter length of hospital stay and duration that antibiotics were used resulted in a reduction in the response to the use of CPAP of 4 and 15 cmH2O. Possibly, factors like the estimated treatment costs. use of a padded silicone oronasal mask as the interface and intermittent application facilitated good tolerance even at the higher pressure of 15 cmH2O. In agreement with these results, Stéphan et al assessed tolerability by means of a comfort score in 830 patients, with half of them receiving non-invasive ventilation, and found that 17% reported slight, 29% acceptable and 53% good comfort, with no difference observed when compared with patients only using nasal highflow oxygen.35 In another study conducted on 66 patients undergoing non- invasive ventilation, the rate of intolerability to treatment was 3.5%.36 Regarding adverse events, the rates of air leaks and aerophagia were similar in all groups in the current study. Liao et al37 compared surgical patients who received NIV of 10 cmH2O with patients who underwent usual care, and also found similar rates of air leaks in both groups: 17% versus 11%, respectively. In another trial of patients who underwent lung resection and then random allocation of CPAP of 8.5 cmH2O, no occurrence of air leaks was observed.36 Therefore, all of Table 3 Change scores for pulmonary function and peripheral oxygen saturation, and final scores for discomfort and satisfaction. Median (IQR) for groups and the statistical significance of the Kruskal-Wallis ANOVA. Outcome Groups p value Exp2 Exp1 Con (n = 51) (n = 51) (n = 49) FEV1 (% pred), median (IQR) 15 6 9 0.23 FVC (% pred), median (IQR) (3 to 28) (22 to 17) 0.34 SpO2 (%), median (IQR) (22 to 17) 0.77 Discomfort (0 to 10), median (IQR) 14 22 26 0.37 Satisfaction (0 to 10), median (IQR) (5 to 33) (227 to 8) 0.11 (216 to 9) 0.0 0.0 1.0b (21.0 to 1.0) (0.0 to 2.0) (21.0 to 2.0) 6.5a 7.0a 6.0 (3.8 to 8.0) (4.0 to 7.5) (4.0 to 8.0) 10.0a 10.0a 10.0 (10.0 to 10.0) (9.0 to 10.0) (9.0 to 10.0) Con = control group (usual care plus sham positive pressure), Exp1 = experimental group 1 (usual care plus mobilisation and respiratory interventions and sham positive pressure), Exp2 = experimental group 2 (usual care plus mobilisation and respiratory interventions and positive pressure), FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity, SpO2 = peripheral oxygen saturation. a n = 50 b n = 51
Research 25 Table 4 Number (%) of complications, lung entrapment, thoracotomy, antibiotic use and adverse events, and absolute risk reduction (95% CI) for pairwise comparisons. Outcome Groups Absolute risk reduction (95% CI) Exp2 Exp1 Con Exp2 relative to Exp2 relative to Exp1 relative to (n = 51) (n = 51) (n = 49) Con Exp1 Con Complications, n (%) 1 (2) 9 (18) 10 (20) 0.18 0.16 0.02 pneumonia, n (%) 0 (0) 8 (16) 10 (20) (0.06 to 0.31) (0.04 to 0.28) (20.13 to 0.17) atelectasis, n (%) 1 (2) 2 (4) hypoxaemia, n (%) 0 (0) 0 (0) 0 (0) 0.20 0.16 0.04 3 (6) 7 (14) 0 (0) (0.09 to 0.32) (0.05 to 0.28) (20.11 to 0.19) Lung entrapment, n (%) 3 (6) 5 (10) 8 (16) Thoracotomy, n (%) 9 (18) 22 (43) 7 (14) 20.02 0.02 20.04 Antibiotic use, n (%) 5 (10) 1 (2) 27 (55) (20.10 to 0.05) (20.07 to 0.11) (20.13 to 0.04) Adverse events, n (%) 3 (6)a 0.00 0.00 0.00 (20.07 to 0.07) (20.07 to 0.07) (20.07 to 0.07) 0.10 0.08 0.02 (20.04 to 0.23) (20.04 to 0.20) (20.12 to 0.16) 0.08 0.04 0.04 (20.04 to 0.20) (20.08 to 0.16) (20.09 to 0.17) 0.35 0.25 0.10 (0.17 to 0.51) (0.08 to 0.41) (20.09 to 0.28) 20.04 20.08 0.04 (20.16 to 0.08) (20.19 to 0.22) (20.05 to 0.14) Con = control group (usual care plus sham positive pressure), Exp1 = experimental group 1 (usual care plus mobilisation and respiratory interventions and sham positive pressure), Exp2 = experimental group 2 (usual care plus mobilisation and respiratory interventions and sham positive pressure). a n = 50 these results show that, unlike what many professionals fear in Footnotes: a Müller, Engemed, Brazil. b Respiron, NCS, Mexico. clinical practice, this type of intervention is safe and well tolerated by c Shaker, NCS, Mexico. patients, even with a pressure of 15 cmH2O. eAddenda: Table 5 can be found online at https://doi.org/10.1016/j. Despite the benefits observed in this study, the groups did not mark- jphys.2019.11.006. edly differ in pulmonary function recovery and oxygenation. Most likely, the performance of patients during spirometry was influenced by the high Ethics approval: This project was approved by the Research Ethics level of pain. Furthermore, SpO2 was never outside the normal range. Committee of the Universidade Cidade de São Paulo (process number 793.133). All participants gave written informed consent before data The present study had some limitations. Most participants required collection began. their intercostal drains because of thoracic trauma, so the results may be more generalisable to haemorrhagic pleural effusions and Competing interest: Funders had no role in the execution, haemothoraces rather than other pleural effusions. However, the high analysis, interpretation of data or decision to present the results in adherence of participants to the protocol and the good effect of adding this study and were only involved with funding. No other competing CPAP of 15 cmH2O to more traditional respiratory interventions may interests are declared. indicate that the treatment can be effective in various types of pleural fluid collection. Another limitation concerns the estimation of Sources of support: The present study was funded by the National treatment costs, which was not performed by individualised Council for Scientific and Technological Development (CNPq), project cost-effectiveness analysis. The estimates were determined by the cost number 442709/2014-5. Funding received from the aforementioned of each procedure and based on a chart provided by the hospital. The agency was fundamental in the purchase of equipment to conduct the hospitalisation cost is estimated by the intervention costs added to the interventions proposed in this study. length of hospital stay, but the amount paid to the hospital is the same between 2 and 10 days of hospitalisation.38 Data on the size of the Acknowledgements: We greatly thank the participants and the drainage tubes were not recorded but it is assumed that randomisation clinical staff who were involved in the project. would have produced similar distributions in the three groups. Provenance: Not invited. Peer reviewed. In conclusion, the results of this study indicate that non-invasive Correspondence: Adriana Cláudia Lunardi, Master’s and Doctoral positive airway pressure of 15 cmH2O added to mobilisation and Programs in Physical Therapy, Universidade Cidade de São Paulo, São respiratory care for patients with a collection of fluid in the pleural Paulo, Brazil. Email: [email protected] space reduces the duration of chest drainage, length of hospital stay, pulmonary complications, use of antibiotics and treatment costs. This References type of intervention showed good tolerability by the patients and a low rate of adverse events; therefore, it can be safely integrated into 1. Light RW. Pleural effusions. Med Clin North Am. 2011;95:1055–1070. clinical practice. 2. Light RW. Pleural diseases. 5th ed. Philadelphia, USA: Lippincott Williams & Wilkins; What was already known on this topic: Fluid and/or blood 2007. can accumulate in the pleural space due to a range of conditions. 3. Walker SP, Morley AJ, Stadon L, De Fonseka D, Arnold DT, Medford AR, et al. An intercostal tube attached to a closed drainage system is often used to drain the pleural space. The existing evidence is unclear Nonmalignant pleural effusions: a prospective study of 356 consecutive unselected about whether positive airway pressure applied non-invasively at patients. 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Journal of Physiotherapy 66 (2020) 60 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Appraisal of Clinical Practice Guideline: Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline Date of latest update: 2017. Date of next update: Not specified. Patient group: and harms of arthroscopy, and key practical issues for both clinicians and patients. Patients with degenerative knee disease, including those with or without radio- The main objective of the guideline was to answer the clinical question: What is the graphic evidence of osteoarthritis, mild to severe osteoarthritis, mechanical symp- role of arthroscopic surgery in degenerative knee disease? The guideline makes a toms, acute onset knee pain, and meniscal tears. Intended audience: Patients with strong recommendation against arthroscopic knee surgery in patients with degenerative knee disease and clinicians involved in their management. Additional degenerative knee disease; strong recommendations favouring conservative man- versions: In addition to this rapid recommendation published in the BMJ, a more agement compared with surgery in patients with degenerative knee disease; and detailed version, including decision aids, is available from MAGICapp (www. that further research is unlikely to alter this recommendation. The GRADE approach magicapp.org). Expert working group: The panel included orthopaedic surgeons, was used to rate the quality of evidence. Quality of evidence was rated as high for the a rheumatologist, physiotherapists, a general practitioner, general internists, epi- outcome of pain in the long term (1 to 2 years), and as moderate for the outcome of demiologists, methodologists, and people with lived experience of degenerative function in the long term (1 to 2 years). The guideline concluded that compared with knee disease (including those who had undergone and those who had not under- conservative management there is no important benefit of arthroscopic knee sur- gone arthroscopy). Funded by: This guideline was not funded. Consultation with: gery for the outcomes of pain and function at 1 to 2 years follow-up. Harms asso- No mention of consultation beyond the working group. Approved by: Not specified. ciated with arthroscopic knee surgery were also investigated. Based on the low Location: The guidelines and additional documents are available at: https://www. quality available evidence, the rate of serious harms such as venous thromboem- bmj.com/content/357/bmj.j1982. Description and key recommendations: This bolism and infection were five and two per 1000 people, respectively. clinical practice guideline is presented as a BMJ rapid recommendation. The rec- ommendations are based on two systematic reviews: one assessing the net benefit Provenance: Invited. Not peer reviewed. of knee arthroscopy compared with non-operative care and rate of complications; and the other addressing what level of individual change is considered important to Goris Nazari and Joy MacDermid patients – the minimum important difference. The summary guideline in the BMJ Western University, London, Canada uses infographics to simplify the key results, recommendations, absolute benefits https://doi.org/10.1016/j.jphys.2019.10.007 Appraisal of Clinical Practice Guideline: Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children Date of latest update: September 2018. Date of next update: Not stated. Pa- Each recommendation was assigned a level of confidence in the research (‘high’ tient group: Paediatric athletes who have sustained a mild traumatic brain to ‘very low’), and an indication of how often the recommendation should be injury (sometimes known as concussion). Intended audience: Healthcare followed (‘almost always’ to ‘may sometimes’). A short summary of the evidence professionals involved in the management of paediatric mild traumatic brain follows each set of recommendations. The guideline recommends the use of the injuries. Additional versions: This is the first published version. Expert term ‘mild traumatic brain injury’, as opposed to ‘concussion’ or ‘minor head working group: The Pediatric Mild Traumatic Brain Injury Guideline Work- injury’, in order to remove different interpretations between families, re- group as established by the Centers for Disease Control and Prevention (CDC). searchers and healthcare professionals. Of interest to physiotherapists, the This included a range of clinicians (eg, neurologists, neuropsychologists, ath- guideline does not recommend the use of any imaging modality to diagnose mild letic trainers, physiotherapists and emergency medicine physicians) repre- traumatic brain injury but does recommend using clinical decision rules and, senting various settings (eg, clinical, research, sports and education). Funded potentially, imaging to exclude intracranial injury (eg, subdural haemorrhage). by: The CDC provided complete financial support for the evidence review and The strongest recommendations pertain to the education that patients and to support the working group’s meetings. The CDC authors did not assist with families should receive following an instance of mild traumatic brain injury in the development and preparation of the systematic review that underpinned children. The working group recommend providing education about the warning this guideline. Consultation with: Ad hoc experts were invited to provide signs of more serious injuries, prevention of further injury, expected course of consultation, where necessary, to the workgroup. Approved by: The CDC au- recovery, instructions on monitoring symptoms, and management of mild thors reviewed and approved the present guideline for publication. Location: traumatic brain injury. The additional 22 treatment/management recommen- The guideline and additional documents are available at: https://jamanetwork. dations pertain to cognitive/physical rest, aerobic exercise, psychosocial support, com/journals/jamapediatrics/fullarticle/2698456. Description and key rec- post-traumatic headache treatment, vestibulo-oculomotor dysfunction, sleep, ommendations: This clinical practice guideline was presented as a Journal of cognitive impairment and return to school. the American Medical Association (JAMA) paediatrics special communication. The recommendations are based upon a systematic review that aimed to answer six Provenance: Invited. Not peer reviewed. Prashant Jhala clinical questions. The main objective of the review was to provide the first broad https://doi.org/10.1016/j.jphys.2019.11.003 Macquarie University, Australia evidence-based guideline on the diagnosis and management of mild traumatic brain injury in children aged 18 years. Findings from the review were syn- thesised into 46 recommendations (divided into 19 sets). Eleven recommenda- tions pertained to diagnosis, 12 to prognosis and 23 to treatment/management. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 60 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Appraisal of Clinical Practice Guideline: Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline Date of latest update: 2017. Date of next update: Not specified. Patient group: and harms of arthroscopy, and key practical issues for both clinicians and patients. Patients with degenerative knee disease, including those with or without radio- The main objective of the guideline was to answer the clinical question: What is the graphic evidence of osteoarthritis, mild to severe osteoarthritis, mechanical symp- role of arthroscopic surgery in degenerative knee disease? The guideline makes a toms, acute onset knee pain, and meniscal tears. Intended audience: Patients with strong recommendation against arthroscopic knee surgery in patients with degenerative knee disease and clinicians involved in their management. Additional degenerative knee disease; strong recommendations favouring conservative man- versions: In addition to this rapid recommendation published in the BMJ, a more agement compared with surgery in patients with degenerative knee disease; and detailed version, including decision aids, is available from MAGICapp (www. that further research is unlikely to alter this recommendation. The GRADE approach magicapp.org). Expert working group: The panel included orthopaedic surgeons, was used to rate the quality of evidence. Quality of evidence was rated as high for the a rheumatologist, physiotherapists, a general practitioner, general internists, epi- outcome of pain in the long term (1 to 2 years), and as moderate for the outcome of demiologists, methodologists, and people with lived experience of degenerative function in the long term (1 to 2 years). The guideline concluded that compared with knee disease (including those who had undergone and those who had not under- conservative management there is no important benefit of arthroscopic knee sur- gone arthroscopy). Funded by: This guideline was not funded. Consultation with: gery for the outcomes of pain and function at 1 to 2 years follow-up. Harms asso- No mention of consultation beyond the working group. Approved by: Not specified. ciated with arthroscopic knee surgery were also investigated. Based on the low Location: The guidelines and additional documents are available at: https://www. quality available evidence, the rate of serious harms such as venous thromboem- bmj.com/content/357/bmj.j1982. Description and key recommendations: This bolism and infection were five and two per 1000 people, respectively. clinical practice guideline is presented as a BMJ rapid recommendation. The rec- ommendations are based on two systematic reviews: one assessing the net benefit Provenance: Invited. Not peer reviewed. of knee arthroscopy compared with non-operative care and rate of complications; and the other addressing what level of individual change is considered important to Goris Nazari and Joy MacDermid patients – the minimum important difference. The summary guideline in the BMJ Western University, London, Canada uses infographics to simplify the key results, recommendations, absolute benefits https://doi.org/10.1016/j.jphys.2019.10.007 Appraisal of Clinical Practice Guideline: Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children Date of latest update: September 2018. Date of next update: Not stated. Pa- Each recommendation was assigned a level of confidence in the research (‘high’ tient group: Paediatric athletes who have sustained a mild traumatic brain to ‘very low’), and an indication of how often the recommendation should be injury (sometimes known as concussion). Intended audience: Healthcare followed (‘almost always’ to ‘may sometimes’). A short summary of the evidence professionals involved in the management of paediatric mild traumatic brain follows each set of recommendations. The guideline recommends the use of the injuries. Additional versions: This is the first published version. Expert term ‘mild traumatic brain injury’, as opposed to ‘concussion’ or ‘minor head working group: The Pediatric Mild Traumatic Brain Injury Guideline Work- injury’, in order to remove different interpretations between families, re- group as established by the Centers for Disease Control and Prevention (CDC). searchers and healthcare professionals. Of interest to physiotherapists, the This included a range of clinicians (eg, neurologists, neuropsychologists, ath- guideline does not recommend the use of any imaging modality to diagnose mild letic trainers, physiotherapists and emergency medicine physicians) repre- traumatic brain injury but does recommend using clinical decision rules and, senting various settings (eg, clinical, research, sports and education). Funded potentially, imaging to exclude intracranial injury (eg, subdural haemorrhage). by: The CDC provided complete financial support for the evidence review and The strongest recommendations pertain to the education that patients and to support the working group’s meetings. The CDC authors did not assist with families should receive following an instance of mild traumatic brain injury in the development and preparation of the systematic review that underpinned children. The working group recommend providing education about the warning this guideline. Consultation with: Ad hoc experts were invited to provide signs of more serious injuries, prevention of further injury, expected course of consultation, where necessary, to the workgroup. Approved by: The CDC au- recovery, instructions on monitoring symptoms, and management of mild thors reviewed and approved the present guideline for publication. Location: traumatic brain injury. The additional 22 treatment/management recommen- The guideline and additional documents are available at: https://jamanetwork. dations pertain to cognitive/physical rest, aerobic exercise, psychosocial support, com/journals/jamapediatrics/fullarticle/2698456. Description and key rec- post-traumatic headache treatment, vestibulo-oculomotor dysfunction, sleep, ommendations: This clinical practice guideline was presented as a Journal of cognitive impairment and return to school. the American Medical Association (JAMA) paediatrics special communication. The recommendations are based upon a systematic review that aimed to answer six Provenance: Invited. Not peer reviewed. Prashant Jhala clinical questions. The main objective of the review was to provide the first broad https://doi.org/10.1016/j.jphys.2019.11.003 Macquarie University, Australia evidence-based guideline on the diagnosis and management of mild traumatic brain injury in children aged 18 years. Findings from the review were syn- thesised into 46 recommendations (divided into 19 sets). Eleven recommenda- tions pertained to diagnosis, 12 to prognosis and 23 to treatment/management. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 6 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Call for applications: Journal of Physiotherapy Scientific Editor Applications are invited for the position of Scientific Editor of Journal of Physiotherapy. The appointment is an ongoing 0.6 full-time equivalent position with the Australian Physiotherapy Association (APA). The incumbent is entitled to re-apply. The position of Scientific Editor demands an extremely high level of academic and scholarly expertise, with a track record of excellence in research. The Scientific Editor is responsible for upholding the Journal’s mission (to publish significant research that has important implications for physiotherapy) and vision (to be the pre-eminent international publication of the science and practice of physiotherapy). Responsibilities The Scientific Editor will: manage the peer-review process identify potential reviewers make decisions about the acceptability of manuscripts edit manuscript content closely review copyedited proofs for accuracy respond to enquiries about the suitability of a manuscript for submission deal with correspondence regarding published papers write or solicit editorials solicit expert topical reviews liaise with the Editorial Board and International Advisory Board attend regular Editorial Board teleconferences and a two-day face-to-face meeting annually maintain the Journal’s presence on social media. Selection criteria The knowledge and skills required include: 1. a broad understanding of research methods 2. extensive experience in the publication of research 3. excellent written communication skills 4. a good working knowledge of the physiotherapy profession and an interest in its future. Additionally, to be eligible to apply, applicants must: 5. hold a PhD 6. be a physiotherapist registered in Australia or their country of residence 7. be a financial member of the APA or equivalent WCPT member organisation. Applications To be considered for this position, applicants must submit: a cover letter that addresses the selection criteria and which includes a clear explanation of the impact of any career interruption(s) over the last 5 years a brief (5 pages maximum) CV. Applicants will be assessed against the knowledge and skills listed above and potentially against other criteria. A full position description is available at www.australian.physio/aboutus/workwithus Applications close 28 February 2020 and should be directed to Marko Stechiwskyj at [email protected] Any questions about the Scientific Editor position should be directed to Associate Professor Ilana Ackerman, Chair of the Journal of Physiotherapy Editorial Board, at [email protected] The APA is an equal opportunity employer and encourages applications from people with culturally diverse backgrounds. Aboriginal and Torres Strait Islander people are encouraged to apply. All applicants must have full Australian Working Rights. https://doi.org/10.1016/j.jphys.2019.12.001 1836-9553/
Journal of Physiotherapy 66 (2020) 3–4 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Editorial Chronic obstructive pulmonary disease Tristan Bonnevie a,b, Mark Elkins c,d a ADIR Association, Rouen University Hospital, Rouen, France; b UPRES EA 3830 Haute Normandie Research and Biomedical Innovation, Normandie University, Rouen, France; c Editor, Journal of Physiotherapy; d Centre for Education & Workforce Development, Sydney Local Health District, Sydney, Australia This editorial introduces Journal of Physiotherapy’s second article article collection. The most prevalent reason overall for non- collection online. Each article collection is a collection of papers in a attendance or non-completion was difficulty attending a centre- specific field of research, published in the Journal of Physiotherapy based program, due to difficulties with transport, mobility or cost.7 within the past decade and curated to facilitate access to important findings in that field, highlight trends in research in that field, and The findings of Cox et al and Keating et al presumably explain why provide a scoping perspective on the implications for further so much research has investigated alternatives to the centre-based research. They are collated on the journal’s website (https://www. model, such as telerehabilitation.8 Two systematic reviews evalu- sciencedirect.com/journal/journal-of-physiotherapy/special-issues). ating telerehabilitation programs for people with cardiopulmonary The previous article collection addressed low back pain. The focus of disease concluded that telerehabilitation programs provide similar this article collection is chronic obstructive pulmonary disease improvements in exercise capacity as centre-based programs9 and (COPD). have higher compliance rates.10 Several of the papers in this online article collection have tackled the compex issues that are involved in COPD is the fifth leading cause of death worldwide and its prev- delivering pulmonary rehabilitation outside the centre-based model. alence is increasing gradually.1 The respiratory symptoms are pro- gressive and lead to physical inactivity and muscle wasting, resulting One issue involved in telerehabilitation for people with COPD is in a spiral of worsening dyspnoea and deconditioning.2 This all the need for telecommunication and telemonitoring. Seidman et al11 contributes to its very high global burden. examined whether people attending metropolitan pulmonary reha- bilitation reported that they were prepared to engage with tele- One of the key interventions to interrupt the progressive decon- communication technology and whether they felt they had sufficient ditioning is pulmonary rehabilitation. It has very worthwhile effects, access and skills to use such devices. The responses from those pa- including: reductions in dyspnoea and fatigue; improved emotional tients indicated that physiotherapists who invest in establishing the function and sense of control that individuals have over their con- infrastructure for pulmonary telerehabilitation can expect an ongoing dition; greater exercise capacity; and higher quality of life.3 Despite and growing proportion of candidates who will be willing and able these benefits, many patients who need pulmonary rehabilitation (either immediately or after some training) to use that format. The don’t receive it because of issues such as poor referral rates, limited reported ability of pulmonary rehabilitation attendees to engage with availability of pulmonary rehabilitation programs, difficulty accessing technology adequately was later confirmed objectively in the study existing programs, and patient-related factors.4,5 Of those referred to by Bonnevie et al.12 In a study of over 100 adults with chronic res- pulmonary rehabilitation, up to half will never even attend the pro- piratory disease who were referred to pulmonary rehabilitation, all gram and as much as one-third will not complete the full course of could quickly learn to operate equipment used for remote monitoring rehabilitation.6 of oximetry during home exercise. Almost all of the study participants also considered remote monitoring of oximetry acceptable. Further- One of the most comprehensive reviews of the influences on more, the oximetry data were transmitted with minimal artefact or pulmonary rehabilitation referral and participation is the paper by invalid data. Cox et al6 in this online article collection. Cox et al used the Theo- retical Domains Framework to synthesise the results of 48 studies to Another issue is testing of exercise capacity for people undergoing demonstrate how pulmonary rehabilitation referral, uptake, atten- home-based pulmonary rehabilitation. Where space is limited, dance and completion were influenced by knowledge (eg, referral physiotherapists may be tempted to complete a formal exerise test processes), beliefs (eg, expectations of outcomes), and environment (such as the 6-minute walk test) on a shorter track than might be (eg, travel, waiting time).6 Their findings substantiate the recom- used in hospital-based rehabilitation. However, the study by Beek- mendations in international guidelines to: improve awareness and man et al.13 warns that the results obtained with a shorter track are knowledge of pulmonary rehabilitation among clinicians and pa- not equivalent—raising important caveats about the interpretation of tients; increase patient access to rehabilitation; and ensure the the results and the use of predictive equations that were generated quality of rehabilitation programs.6 using data from tests conducted on a longer track. Although the review by Cox et al6 does an excellent job of iden- Another issue involved in home-based rehabilitation is the exer- tifying the range of barriers to pulmonary rehabilitation, many of the cise modality. Centre-based pulmonary rehabilitation typically uses included studies used convenience or purposive sampling; therefore, exercise equipment, but use of such equipment for home-based it is difficult to infer much about the relative prevalence of those pulmonary rehabilitation introduces expense, storage and transport barriers. One of the included studies that used representative sam- requirements. Therefore, it is important to understand whether pling—and therefore provides robust data on the prevalence of exercise-based rehabilitation can be as effective without the equip- various barriers to attendance and completion of pulmonary reha- ment. In an 8-week randomised trial, Leung et al examined whether a bilitation—is the study by Keating et al,7 which is also in this online prescribed progressive walking training program conducted on flat https://doi.org/10.1016/j.jphys.2019.09.001 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
4 Editorial ground could be as effective as training on a cycle ergometer.14 They COPD.18 Other studies in this online article collection also address found that ground walk training increased endurance walking ca- strategies to improve respiratory mechanics.19,20 pacity more than cycle training, and was similar to cycle training in improving peak walking capacity, peak and endurance cycle capacity In summary, this online article collection includes a range of and quality of life. This study therefore provides evidence for ground important developments in research into physiotherapy management walking as a mode of exercise training in pulmonary rehabilitation of COPD. The study designs address causation,15 treatment,13,18–20 programs generally, as well as for home-based pulmonary rehabili- assessment,12–14 and barriers to traditional pulmonary rehabilita- tation. The greater improvement in endurance walking capacity tion,6,7 remote pulmonary rehabilitation,11,12 and subsequent physical presumably reflects specificity of training. Nevertheless, the result is activity.15–17 Importantly, each paper has clear implications for clin- particularly welcome because walking is a more typical activity of ical physiotherapists, which are identifiable in the paper’s ‘What this daily life than cycling for most people with COPD. This suggests that it study adds’ summary box. might improve both symptoms during the many activities of daily living that involve walking, and self efficacy. Ethics approval: n/a. Competing interest: Nil. Because walking training program is achievable without specific Source of support: Nil. equipment and can be performed in the home environment, it may Acknowledgement: Nil. also help the transition to long-term maintenance of exercise after Provenance: Invited. Not peer reviewed. formal pulmonary rehabilitation ends. The study by Hogg et al shows Correspondence: Mark Elkins, Centre for Education & Workforce that people completing centre-based pulmonary rehabilitation report Development, Sydney Local Health District, Sydney, Australia. Email: that they need ongoing, structured and socially supportive exercise [email protected] opportunities in order to have the self-efficacy to maintain an active lifestyle.15 Indeed, self-efficacy for physical activity and insight into its References benefits are characteristics that physiotherapists might instil in peo- ple with COPD, as recommended in the study by Hartman et al.16 1. Khakban A, et al. Am J Respir Crit Care Med. 2017;195:287–291. 2. Killian KJ, et al. Am Rev Respir Dis. 1992;146:935–940. After pulmonary rehabilitation, sustaining the immediate benefits 3. McCarthy B, et al. Cochrane Database Syst Rev. 2015;2:CD003793. obtained from pulmonary rehabilitation may not be the only purpose 4. Brooks D, et al. Can Respir J. 2007;14:87–92. of maintenance exercise. The analysis of long-term data by McKeough 5. Johnston K, et al. Physiother Can. 2010;62:368–373. et al shows that maintaining physical activity and avoiding prolonged 6. Cox NS, et al. J Physiother. 2017;63:84–93. sedentary periods has a mortality benefit and lowers the odds of 7. Keating A, et al. J Physiother. 2011;57:183–190. developing diabetes.17 This finding generates an important implica- 8. Holland AE. J Physiother. 2017;63:193–195. tion for physiotherapists to not just encourage people with COPD to 9. Chan C, et al. Physiother Can. 2016;68:242–251. adhere to activity recommendations but also seek ways in which 10. Hwang R, et al. J Cardiopulm Rehabil. 2015;35:380–389. sedentary behaviour could be reduced. 11. Seidman Z, et al. J Physiother. 2017;63:175–181. 12. Bonnevie T, et al. J Physiother. 2019;65:28–36. Of course, physiotherapy management of COPD is not limited to 13. Beekman E, et al. J Physiother. 2013;59:169–176. pulmonary rehabilitation. Physiotherapists have much to offer during 14. Leung RWM, et al. J Physiother. 2010;56:105–112. the acute exacerbations that punctuate the clinical course of COPD. 15. Hogg L, et al. J Physiother. 2012;58:189–195. Fortunately for readers of Journal of Physiotherapy, Professor Anne 16. Hartman JE, et al. J Physiother. 2013;59:117–124. Holland’s invited topical review expertly summarises the available 17. McKeough Z, et al. J Physiother. 2018;64:114–120. evidence about physiotherapy management of acute exacerbations of 18. Holland AE. J Physiother. 2014;60:181–188. 19. Padkao T, et al. J Physiother. 2010;56:33–39. 20. Rocha T, et al. J Physiother. 2015;61:182–189.
Journal of Physiotherapy 66 (2020) 58 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Clinimetrics: A core outcome measurement set for low back pain Summary A core outcome set (COS) defines: the core outcome domains, and day; the total score ranges from 0 to 24. NRS is a horizontal line the core outcome measurement instruments.1 It is a minimum agreed ranging from 0 (‘no pain’) to 10 (‘worst imaginable pain’) and asking a patient to rate his/her average LBP intensity over the past week. SF- set of outcomes to be measured in all clinical trials for a given health 12 includes 12 items referring to eight different health domains with a different number response options, and providing physical condition to facilitate comparability of trials’ results and meta- component summary (PCS) and mental component summary (MCS) analyses, and to avoid selective outcome reporting bias.2 A COS for scores. PROMIS-GH-10 also measures eight different health domains, nine of which with 1 to 5 response options and one with a 0 to 10 all clinical trials in adult patients with non-specific low back pain NRS; these items are used to compute PCS and MCS that, like for SF- (LBP) was developed by an international and multidisciplinary group 12, are expressed as T-scores, with higher scores indicating better of researchers, clinicians and patient representatives.3,4 Consensus on health. ODI 2.1a and SF-12 are instruments with a fee, whereas core outcome domains4 and measurement instruments3 was ach- RMDQ-24, NRS and PROMIS-GH-10 can be used entirely free of charge. ieved through two multi-round Delphi surveys. The following The validity of a core outcome set is ensured by different com- patient-reported instruments are recommended: Oswestry Disability ponents, such as clearly defining its scope (in terms of setting, con- dition, population and interventions), involving all relevant Index 2.1a (ODI 2.1a) and 24-item Roland Morris Disability Ques- stakeholders in the consensus process (most importantly: patients), and defining a-priori criteria for consensus and for including/drop- tionnaire (RMDQ-24) for physical functioning; 11-point Numeric ping/adding outcomes in the consensus process.5 All these aspects were covered in the consensus process on core outcomes for LBP.4 Rating Scale (NRS) for pain intensity; Short Form 12 (SF-12) or Meanwhile, the judgement of validity of a core outcome measure- 10-item PROMIS Global Health (PROMIS-GH-10) for HRQoL.3 The ment set lacks consensus-based criteria. fourth core outcome domain (ie, number of deaths) can be covered by a simple statement reporting if any death occurred.4 ODI 2.1a includes 10 items referring to different activities of daily living and other domains (eg, pain intensity, social life) to be scored on a 5-point Likert scale; the total percentage score ranges from 0 to 100. RMDQ-24 includes items referring to different physical functions influenced by LBP that patients can check if relevant to them on that Commentary It could be postulated that a valid core outcome set relies on The use of core sets was shown to improve outcome standardisation measurement instruments with valid, reliable and responsive prop- in clinical trials over time10 and, in this specific case, it can greatly erties, and on meeting pre-established criteria for consensus. The benefit future evidence syntheses for patients with LBP. measurement properties of all recommended instruments in patients with LBP were systematically reviewed in four reviews.6–9 These Provenance: Invited. Not peer reviewed. reviews highlighted evidence in support of these tools but also high quality evidence on a few limitations of the properties of RMDQ-24 Alessandro Chiarottoa,b and Raymond W Osteloa,c (ie, a lack of structural validity and measurement error7,8) and NRS aDepartment of Health Sciences, Amsterdam Movement Sciences (ie. measurement error6). Moreover, a lack of studies in patients with LBP was found on the properties of PROMIS-GH-10.9 These results Research Institute, VU University, Amsterdam were presented to the Delphi participants but they provided ample bDepartment of General Practice, Erasmus MC, University Medical consensus (96%) on endorsing the NRS for pain intensity. No Delphi consensus was reached on endorsing the RMDQ-24 and the two Center, Rotterdam HRQoL instruments.3 Still these three instruments were recom- cDepartment of Epidemiology and Biostatistics, Amsterdam University mended to foster measurement standardisation (ie, SF-12) and to provide free of charge options (ie, RMDQ-24, PROMIS-GH-10). Medical Center (VUmc), Amsterdam, The Netherlands There is a need to fill the evidence gaps on some measurement References properties of the recommended instruments. Additionally, given that the a-priori established consensus on RMDQ-24, SF-12 and PROMIS- 1. Boers M, et al. J Clin Epidemiol. 2014;67:745–753. GH-10 was not met, the perspective of different stakeholders (mainly 2. Williamson PR, et al. Trials. 2012;13:132. patients) on these instruments should be explored in more depth. 3. Chiarotto A, et al. Pain. 2018;159:481–495. With this in mind, a core outcome measurement set for LBP is 4. Chiarotto A, et al. Eur Spine J. 2015;24:1127–1142. available for use as formulated and agreed by an international and 5. Kirkham JJ, et al. PLoS Med. 2017;14:e1002447. multidisciplinary group of researchers, clinicians and patient con- 6. Chiarotto A, et al. J Pain. 2018. sumers.3 Its measurement takes only a few minutes in clinical trials. 7. Chiarotto A, et al. Phys Ther. 2016;96:1620–1637. 8. Chiarotto A, et al. J Clin Epidemiol. 2018;95:73–93. 9. Chiarotto A, et al. J Clin Epidemiol. 2018;102:23–37. 10. Kirkham JJ, et al. BMJ. 2017;357:j2262. https://doi.org/10.1016/j.jphys.2019.07.011 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 59 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Clinimetrics: Physiotherapy Evidence Database (PEDro) Scale Summary Authors have suggested that scores of: , 4 are considered ‘poor’, 4 to 5 are considered ‘fair’, 6 to 8 are considered ‘good’ and 9 to 10 are considered Description: The PEDro scale is a rating scale to assess the methodological ‘excellent’.7,8 It is important to note that the measure of methodological quality quality of clinical trials.1–3 Initially, the PEDro scale was designed to rate the quality of clinical trials indexed on the Physiotherapy Evidence Database produced by the PEDro scale should not be used as a measure of the ‘validity’ of a (PEDro) but is now increasingly being used to rate clinical trials included in study’s conclusions. In addition, the PEDro score should not be used to compare systematic reviews across physiotherapy, health and medical research.4 The PEDro scale was developed from a Delphi List5 – a nine-item list established by the ‘quality’ of clinical trials performed in different areas of therapy, primarily experts – with two additional items related to statistical reporting. In total, the PEDro scale consists of 11 items encompassing external validity (item 1), in- because it is not possible to satisfy all scale items in some areas of physiotherapy ternal validity (items 2 to 9), and statistical reporting (items 10 to 11): practice.3 The PEDro scale is freely available online (https://www.pedro.org.au/ 1. Eligibility criteria and source english/downloads/pedro-scale/) and has been translated into seven languages. 2. Random allocation 3. Concealed allocation A PEDro scale training program is available (AUD50) in both English and Por- 4. Baseline comparability 5. Blinding of participants tuguese to train interested users and potential PEDro raters. 6. Blinding of therapists 7. Blinding of assessors Clinimetric properties: The PEDro score has demonstrated ‘fair’ to 8. Adequate follow-up (. 85%) 9. Intention-to-treat analysis ‘excellent’ inter-rater reliability (intraclass correlation coefficient [ICC] = 0.53 to 10. Between-group statistical comparisons 0.91)1,9,10 for clinical trials of physiotherapy-related interventions, and ‘excel- 11. Reporting of point measures and measures of variability lent’ inter-rater reliability (ICC = 0.80 to 0.89)10,11 for clinical trials of pharma- Items are rated yes or no (1 or 0) according to whether the criterion is clearly cological interventions. The inter-rater reliability for the individual PEDro scale satisfied in the study. A total PEDro score is achieved by adding the ratings of items ranges from ‘fair’ to ‘almost perfect’ (kappa = 0.36 to 1.00)1,9,10,12,13 for items 2 to 11 for a combined total score between 0 to 10. Higher scores indicate superior methodological quality. Independent assessment of each study is clinical trials of physiotherapy-related interventions, and from ‘moderate’ to completed by two raters, with discrepancies resolved via discussion or arbi- ‘almost perfect’ (prevalence and bias adjusted kappa = 0.51 to 1.00)11 in clinical tration from a third rater. The 0 to 10 PEDro score can be considered to meet trials of pharmacological interventions. The inter-rater reliability for both the interval level measurement, allowing comparison of scores between studies.6 PEDro score and individual PEDro scale items has been shown to increase with consensus ratings generated by groups of two or three raters.1 Evidence to support construct validity has been reported for the PEDro scale and the PEDro score,6,11,14 with data supporting the PEDro score to discriminate between high- quality and low-quality clinical trials. Convergent validity is supported for the PEDro score through correlations with other quality rating scales, including: the Jadad scale (0.35) and van Tulder 2003 scale (0.71) for clinical trials of physiotherapy-related interventions,14 and the Cochrane risk of bias summary score (0.61) for clinical trials of pharmacological interventions.11 Commentary Aidan G Cashina,b and James H McAuleya,c aNeuroscience Research Australia, Sydney, Australia Evidence-based practice encourages the integration of high-quality evi- bPrince of Wales Clinical School, Faculty of Medicine, University of New dence when making clinical decisions for patient care. Although randomised clinical trials are considered one of the highest forms of evidence, their South Wales, Sydney, Australia usefulness is impeded when they are of poor methodological quality. Low- cSchool of Medical Sciences, Faculty of Medicine, University of New South quality clinical trials can lead to misleading findings in the original study and in the systematic reviews that combine them. It is therefore important Wales, Sydney, Australia that clinicians are able to distinguish between high-quality and low-quality clinical trials. The PEDro scale is a valid and reliable rating tool to assess References methodological quality and can be readily used to distinguish between high- quality and low-quality clinical trials. 1. Maher CG, et al. Phys Ther. 2003;83:713–721. 2. Moseley AM, et al. Aust J Physiother. 2002;48:43–49. Although developed and well established within physiotherapy research, 3. Sherrington C, et al. Man Ther. 2000;5:223–226. the PEDro scale has demonstrated broader application across wider healthcare 4. Elkins MR, et al. Br J Sports Med. 2013;47:188–189. interventions and is comparable with other methodological quality rating 5. Verhagen AP, et al. J Clin Epidemiol. 1998;51:1235–1241. scales. Through integration of the PEDro scale within the Physiotherapy Evi- 6. de Morton NA. Aust J Physiother. 2009;55:129–133. dence Database, clinicians are able to clearly identify high-quality clinical trials. 7. Foley NC, et al. Top Stroke Rehabil. 2003;10:1–7. Like other methodological quality rating scales, the PEDro scale is influenced by 8. Gonzalez GZ, et al. Arch Phys Med Rehabil. 2018;99:129–136. the quality of reporting in clinical trials. As a result, it is often not possible to 9. Moseley A, et al. Cochrane Colloquium Abstracts; 1999; Rome. Viewed 02 July distinguish between the methodological quality of the clinical trial and the quality of reporting. Finally, it is important to consider both the satisfaction of 2019, from https://abstracts.cochrane.org/1999-rome/reliability-scale-measuring- each item on the PEDro scale alongside the total PEDro score when appraising methodological-quality-clinical-trials the methodological quality of a clinical trial. This is to ensure that the summary 10. Foley NC, et al. Phys Ther. 2006;86:817–824. score does not dilute the influence of items that may be important for some 11. Yamato TP, et al. J Clin Epidemiol. 2017;86:176–181. interventions or outcomes, but not relevant in other situations. 12. Van Peppen RPS, et al. J Rehabil Med. 2006;38:3–9. 13. Brandt C, et al. Man Ther. 2007;12:3–11. Provenance: Invited. Not peer reviewed. 14. Macedo LG, et al. J Clin Epidemiol. 2010;63:920–925. https://doi.org/10.1016/j.jphys.2019.08.005 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 33–38 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Combined aerobic and resistance training improves respiratory and exercise outcomes more than aerobic training in adolescents with idiopathic scoliosis: a randomised trial Vivian Bertoni Xavier a, Osmar Avanzi a, Bruno Derwood Mills Costa de Carvalho a, Vera Lúcia dos Santos Alves a,b a Faculdade de Ciências Médicas da Santa Casa de São Paulo; b Universidade de Mogi das Cruzes, Mogi das Cruzes, São Paulo, Brazil KEY WORDS ABSTRACT Exercise Question: In adolescents with idiopathic scoliosis, does combined aerobic and resistance training improve Exercise test respiratory function, perceived exertion and functional exercise capacity more than aerobic training only? Resistance training Design: Randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat Physical therapy analysis. Participants: Forty adolescents with idiopathic scoliosis and formal indication for surgical Scoliosis correction (spinal curvature 45 deg). Intervention: Both groups undertook three 60-minute training sessions per week for 12 weeks. The experimental group performed combined aerobic and resistance training and the control group performed only aerobic training. Outcome measures: At baseline and upon completion of treatment, participants completed: a 6-minute walk test with Borg scale (0 to 10) rating of exertion, spirometry, maximal respiratory pressures and peak expiratory flow measurement. Results: After 12 weeks of training, the experimental group improved more than the control group on the 6-minute walk test (MD 22 m, 95% CI 4 to 40), with lower perceived exertion at the end of the test (MD –1.2, 95% CI –1.9 to –0.4). The experimental group also improved more than the control group on several respiratory measures, including: FEV1 (MD 270 ml, 95% CI 30 to 510), maximal inspiratory pressure (MD 4 cmH2O, 95% CI 1 to 8) and peak expiratory flow (MD 33 l/minute, 95% CI 7 to 58). Conclusion: In adolescents with idiopathic scoliosis, combined aerobic and resistance training improves functional exercise capacity and several respiratory outcomes more than a similar training regimen with aerobic training only. It is unclear whether the magnitude of the benefits is large enough to be worthwhile. Trial registration: NCT02413788. [Xavier VB, Avanzi O, de Carvalho BDMC, Alves VLS (2020) Combined aerobic and resistance training improves respiratory and exercise outcomes more than aerobic training in adolescents with idiopathic scoliosis: a randomised trial. Journal of Physiotherapy 66:33–38] © 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction still be reduced when compared with the normal range.7,8 However, Adolescent idiopathic scoliosis (AIS), which is also called late-onset the exact causes of respiratory impairment in AIS patients are not yet idiopathic scoliosis, is a lateral curvature of . 10 deg (as measured by completely understood.9 the Cobb angle) that has its onset after 10 years of age.1 It is often accompanied by a variable degree of rotation of the spinal column. A Despite the impact of AIS on exercise capacity and respiratory person with AIS may present with dyspnoea, but even if the patient is function,1,10–12 a program of standardised activity for those who have asymptomatic, respiratory function tests may reveal impairment. In addition to ventilatory restriction, AIS can lead to respiratory muscle a formal indication for surgical correction (ie, spinal curvature 45 weakness and exercise limitation, thereby altering the physiological deg) significantly improves cardiorespiratory and musculoskeletal responses to activities of daily living and resulting in functional conditioning.5,13–19 During exercise, people with scoliosis show disability in many cases.2,3 Lung function testing in these adolescents is typically characterised by decreases in vital capacity and minute appropriate responses in cardiac rate and peripheral vascular resis- ventilation. This is especially true for those whose spinal curvature tance but often have ventilatory limitation.6,12 Despite this, improve- exceeds 45 deg, probably mainly because the deviation reduces chest compliance.1,4–6 Even after corrective surgery, respiratory function can ments in a functional exercise test and some aspects of respiratory function were observed after a sustained period of training in an AIS cohort.13 High scores of perceived exertion have also been reported during exercise.13,16 Although not enough to preclude exercise alto- gether, the increased perception of exertion may contribute to the reduced exercise capacity. The current study hypothesised that this https://doi.org/10.1016/j.jphys.2019.11.012 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
34 Xavier et al: Resistance training in adolescent idiopathic scoliosis limitation might be mitigated by the use of exercise training that for each patient at baseline and maintained throughout the inter- combines aerobic and resistance exercise. vention period.21 The current study aimed to estimate the average effect of a Experimental group combined aerobic and resistance training program compared with a Each exercise session for the experimental group started with 10 program of only aerobic training on respiratory function, perceived exertion and functional exercise capacity in adolescents with idio- minutes of warm-up (stretching exercise and aerobic low-intensity pathic scoliosis who were awaiting surgical treatment. walking) followed by 30 minutes of aerobic exercise on the tread- mill at 60 to 80% of maximum heart rate, followed by 10 minutes of Therefore, the research question for this randomised trial was: resistance training (see below) and 10 minutes of cool-down and relaxation (aerobic exercise with low energy expenditure such as In adolescents with idiopathic scoliosis, does combined aerobic slow walking and a relaxation technique performed in supine lying). and resistance training improve respiratory function, perceived exertion and functional exercise capacity more than aerobic The muscles trained in the resistance training periods were: biceps training only? brachii, triceps brachii, pectoralis (major and minor), latissimus dorsi, quadriceps and triceps surae. See Appendix 1 on the eAddenda for Method details of the exercises that were used. The amount of resistance was initiated as follows. A one-repetition maximum (1RM) test was per- Design formed. The movement was initially performed without load, then the participant performed the same movement using a 0.5 kg anklet or This was a two-arm, parallel group, randomised controlled trial dumbbell (according to the performed test). If there was no with concealed allocation, assessor blinding and intention-to-treat compensatory movement during the entire action, another 0.5 kg was analysis. The study was performed in the Department of Orthopedics added to the anklet or dumbbell, repeatedly. Intervals of 30 seconds of and Traumatology and the Department of Cardiorespiratory Rehabil- rest were inserted between two attempts at the movement. The test itation at Santa Casa de Sao Paulo, São Paulo, Brazil. Adolescents with was stopped when any movement adjustment was observed, and the idiopathic scoliosis were recruited from the hospital’s waiting list for last value, when the activity was completed, was recorded.22 During surgical correction. Eligible and willing participants were randomised the 36 training sessions, resistance training was performed using 60% in a 1:1 ratio to either the experimental intervention (aerobic and of the load achieved in the most recent 1RM test; this test was resistance training) or the control intervention (aerobic training) for 12 repeated weekly.23 weeks. Concealed allocation of the randomisation schedule was achieved using opaque and sealed envelopes containing a computer- Outcome measures generateda random sequence. One physiotherapist applied the exer- cise protocols and supervised all participants throughout their All participants were evaluated before and after the intervention allocated exercise. A different professional measured the outcomes in period by the same assessor, using the tests outlined below. this study. She performed the baseline and post-intervention mea- surements of all participants during her routine physiotherapy service Respiratory function (as she did for all patients under treatment, including those not in the Spirometry was performed in the sitting position using a com- study). She remained unaware of the study protocol and, therefore, unaware of allocation. The nature of the exercises precluded blinding mercial spirometerc and a nose clip. The calculated spirometry of the participants and therapist. measures were forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), the ratio of FEV1/FVC, forced expiratory flow Participants (FEF25/75) and the ratio of FEF25/75/FVC.24 The predicted values were calculated using age, gender and height, according to the equation Participants had to be: 10 to 18 years old, candidates for surgical proposed by Pereira et al.24 correction of AIS spinal curves 45 deg,20 and without any history of pulmonary, cardiovascular, myo-articular or neurological diseases. Maximum respiratory pressures and flow Radiographs of the spine on anterior-posterior and lateral views in the Testing of maximum inspiratory and expiratory pressures and peak standing position were used to assess the spinal curvature using Cobb’s method.20 All the radiographic images were analysed by the same or- expiratory flow was performed as recommended by the Respiratory thopaedic spine surgeon to confirm a Cobb angle 45 deg. Exclusion Muscle Testing Statement,25 with three measurements for every vari- criteria were the known need for urgent or elective surgical interven- able tested and using the greatest value achieved for the analysis. tion of any type during the upcoming planned exercise intervention period, or any history of cognitive and/or physical impairments that 6-minute walk test and perceived exertion would preclude performing the tests of the study’s outcome measures. The 6-minute walk test (6MWT) was performed as a free walk for Intervention 6 minutes, as fast as possible, across a flat 30-m corridor marked out in metres, in accordance with the guidelines of the American Thoracic All participants were scheduled to perform three 60-minute ses- Society.26 The level of effort at the end of the test was rated by the sions of exercise training per week for 12 weeks. The physiotherapist participant on the Borg scale of perceived exertion.27 At the beginning supervised all 36 sessions for each participant. and end of the test, the assessor recorded the participant’s blood pressure in mmHg, heart rate in beats/minute, respiratory rate in Control group breaths/minute and peripheral oxygen saturation (SpO2). The total Each exercise session for the control group started with 10 mi- distance walked was also recorded. nutes of warm-up (stretching exercises and aerobic low-intensity Note that the primary outcome for the study was a cytokine walking) followed by 40 minutes of aerobic exercise on an electric analysis, which will be reported in another publication. treadmill, and then a 10-minute cool-down and relaxation period (aerobic exercise with low energy expenditure such as slow walking Data analysis and a relaxation technique performed in supine lying). On the electric treadmill, the intensity of exercise was kept between 60 and 80% of In the sample size calculation, a smallest worthwhile effect of the maximum heart rate, according to a personal heart rate monitorb. 32 m was nominated,28 a standard deviation of 30 based on data from The maximum heart rate was calculated as 220 minus age (in years) the clinic was anticipated, and a significance level of 5% and study power of 80% were used. This indicated that at least 15 participants were required for each group. To allow for possible loss to follow-up, the total sample size was increased to 40 participants. Baseline characteristics of the participants were summarised with descriptive statistics. Given that the data were normally distributed,
Research 35 Screened via surgical waiting list (n = 63) ..Excluded (n = 23) not eligible (n = 20) time constraints (n = 3) Measured respiratory function, maximal respiratory pressures, expiratory flow, 6-minute walk test and perceived exertion Week 0 Randomised (n = 40) Week 12 (n = 20) (n = 20) .Experimental group Control group aerobic and . aerobic training .. resistance training . 60-minute sessions 60-minute sessions . 3/week x 12 weeks 3/week x 12 weeks Measured respiratory function, maximal respiratory pressures, expiratory flow, 6-minute walk test and perceived exertion (n = 20) (n = 20) Figure 1. Design and flow of participants through the trial. estimates of the treatment effect on each outcome were reported as Effects of the intervention the mean between-group difference with a 95% confidence interval (95% CI). Analyses were conducted according to the principle of Respiratory function intention to treat. Both groups showed improvements in many aspects of respiratory Results function by the end of the training period. Combined training was estimated to be more favourable than aerobic training for several Flow of participants through the study measures of respiratory function, including FEV1, FEF25-75, FEV1/FVC, and FEF25-75/FVC. The result for FVC was unclear, with the confidence Starting in September 2015, 63 consecutive adolescents with interval including estimates that combined training might be more or idiopathic scoliosis on the waiting list for surgery were evaluated for less favourable than aerobic training. The estimates and their 95% eligibility. Among these, 23 were excluded for the reasons described confidence intervals are presented in Table 2. in Figure 1. The 40 remaining adolescents were considered eligible and enrolled in the study, with 20 randomised to each group. Once all Maximum respiratory pressures and flow patients had been allocated in the groups, the treatment protocols Both groups showed improvements in maximal respiratory pres- started. The last evaluation took place in March 2016. sures and flow by the end of the training period. Combined training Compliance with the trial protocol was estimated to be more favourable than aerobic training for maximal inspiratory pressure (MD 4 cmH2O, 95% CI 1 to 8). The effect As the waiting time for surgery is long in the public health system on maximal expiratory pressure was unclear (MD 7 cmH2O, 95% CI –2 in Brazil, none of the participants had to interrupt the exercise to 15). Combined training was estimated to be more favourable than intervention for their surgery and all completed the study protocol. aerobic training for peak expiratory flow (MD 33 l/minute, 95% CI 7 to There was no loss to follow-up. All participants adhered to the three 58). These results are presented in Table 2. training sessions per week. 6-minute walk test and perceived exertion Characteristics of the participants Both groups showed substantial improvement in the 6MWT by Baseline characteristics are presented in Table 1 and in the first the end of the training period. The improvement was estimated to be two columns of data in Tables 2 and 3. There were no important 22 m greater in the combined training group (95% CI 4 to 40) than in between-group differences in the anthropometric or clinical mea- the control group. This better result on the 6MWT was achieved with sures. All study participants presented a single curvature, with a less exertion at the end of the 6MWT, with a mean difference on the thoracic vertex on radiographic evaluation. There was no important Borg scale of –1.2 (95% CI –1.9 to –0.4). It was also achieved with a difference in the gender ratio of the groups, with 18 girls in one group lower respiratory rate at the end of the 6MWT, with a mean differ- and 19 in the other. Similarly, no important between-group differ- ence of –3 breaths/minute (95% CI –4 to –1). The other cardiorespi- ences were observed in their functional capacity or respiratory ratory measures taken at the end of the test did not have estimates function at baseline. that clearly favoured one type of training over the other. These results are presented in Table 3. The exercise training in both groups was well tolerated and there were no adverse events. Individual participant data for all outcomes are presented in Table 4 on the eAddenda.
36 Xavier et al: Resistance training in adolescent idiopathic scoliosis Table 1 the lower limit of the confidence interval included a benefit of 30 ml, Characteristics of participants at baseline. which could be interpreted as a trivial benefit. Similarly, the lower limits of the confidence intervals for FEF25-75, FEV1/FVC and FEF25-75/ Characteristic Exp Con FVC have to be acknowledged as trivial benefits. Even where a (n = 20) (n = 20) ‘minimum clinically important difference’ has been established for these outcomes, such thresholds generally relate to what would make Age (y), mean (SD) 16 (2) 16 (2) training (versus not training) worthwhile. However, both groups Height (cm), mean (SD) 161 (5) 157 (8) spent equal amounts of time training in the present study and the Weight (kg), mean (SD) 54 (8) 54 (8) only extra imposition from the combined training was some simple Body mass index (kg/m2), mean (SD) 20.6 (2.9) 21.9 (2.4) extra equipment and the time taken to determine the 1RM. Therefore, Cobb angle (deg), mean (SD) 71 (17) 70 (15) the effects on respiratory function might be considered as a ‘potential’ FVC (l), mean (SD) 2.95 (0.62) 2.75 (0.58) bonus (ie, combined training can be expected to give greater im- FEV1 (l), mean (SD) 2.45 (0.68) 2.36 (0.59) provements in respiratory function, but the evidence is not precise about how much greater). The benefits for respiratory function seem Con = control group, Exp = experimental group, FVC = forced vital capacity, FEV1 = roughly consistent with other research, although it was FVC that forced expiratory volume in 1 second. improved with aerobic exercise in people with scoliosis.6,12,13,16 However, no other randomised trial has evaluated the impact of Discussion resistance training on respiratory function in AIS. This study estimated that combined aerobic and resistance The extra benefits in respiratory function might be considered training was more beneficial than aerobic training for several out- worthwhile if they contributed to improved exercise capacity, but comes, including most aspects of respiratory function, maximal here the relationships between respiratory function, strength and inspiratory pressure, peak expiratory flow and functional exercise exercise capacity are complex. Swallow et al showed reduced quad- capacity. The greater improvement in functional exercise capacity riceps strength and greater oxidative stress in the muscle in people was achieved with less exertion and a lower respiratory rate. How- with restrictive lung disease due to scoliosis and people with chronic ever, it is crucial to recognise that these favourable estimates came obstructive pulmonary disease (COPD), compared with healthy con- with substantial uncertainty. Another important observation to bear trols.29 The authors state that ‘quadriceps weakness is a feature of in mind when interpreting the results is that both groups showed severe scoliosis; the similarities between patients with scoliosis and substantial improvements in most outcomes over the 12 weeks of the patients with COPD suggest a common etiology to quadriceps study. Although the study did not have a no-intervention control weakness in both conditions’. Those results inspired the current au- group, it is reasonable to expect that such benefits were due to a thors to propose resistance exercises to improve exercise capacity in simple break in the inactivity cycle that is common among adoles- AIS, perhaps via whole body fitness and/or a possible interaction cents with idiopathic scoliosis. It is therefore important to consider between limb and thoracic muscles. For example, the limb whether the additional benefits from combined aerobic and resis- strengthening exercises may have indirectly strengthened (via their tance training are large enough and certain enough (as reflected in stabilising role in the exercises) muscles in the trunk and shoulder the confidence intervals) to warrant recommending it over aerobic girdle,13,22,30,31 which might assist with thoracic expansion. Although training. strength was not tested, the spirometry results might offer proxy indicators of benefits to the respiratory cage. Also, the greater in- Although several aspects of respiratory function were estimated to crease in peak flow with combined training supports the hypothesis improve more in the combined training group than the aerobic of greater conditioning and, consequently, contraction velocity during training group, these estimates all came with confidence intervals the expiratory manoeuvre.3,4,12,25,32 Again, the estimates of greater that included trivial benefits. For example, the mean difference in FEV1 was an extra 270 ml improvement due to using combined training instead of aerobic training. This is arguably worthwhile, but Table 2 Mean (SD) of groups, mean (SD) within-group difference and mean (95% CI) between-group difference for spirometry measures. Outcome Groups Difference within Difference between groups groups Week 0 Week 12 Week 12 minus Week 12 minus Week 0 Week 0 FVC (l), mean (SD) Exp Con Exp Con Exp Con Exp minus Con (n = 20) (n = 20) (n = 20) (n = 20) FVC (% pred), mean (SD) 0.28 0.13 0.15 2.95 2.75 3.23 2.88 (0.36) (0.26) (–0.05 to 0.35) FEV1 (l), mean (SD) (0.62) (0.58) (0.53) (0.47) 9 5 4 FEV1 (% pred), mean (SD) 90 90 99 94 (12) (11) (–3 to 12) (18) (14) (18) (18) 0.38 0.11 FEF25-75 (l/second), mean (SD) 2.45 2.36 2.83 2.47 (0.47) (0.25) 0.27 (0.68) (0.59) (0.51) (0.45) 13 (0.03 to 0.51) FEV1/FVC (%), mean (SD) 83 85 96 89 (16) 4 (22) (19) (18) (20) 0.95 (11) 9 FEV25-75/FVC (%), mean (SD) 2.77 2.72 3.72 2.96 (1.23) 0.24 (0 to 18) (1.30) (0.93) (0.83) (0.69) (0.51) Maximal inspiratory pressure 87 90 96 91 9 0.71 (cmH2O), mean (SD) (13) (11) (6) (8) (13) 1 (0.11 to 1.32) Maximal expiratory pressure 73 79 98 84 25 (5) (cmH2O), mean (SD) (33) (28) (19) (22) (33) 6 8 Peak expiratory flow (l/min), 42 44 49 47 (14) (2 to 14) mean (SD) (10) (12) (9) (8) 7 3 64 67 79 75 (5) (6) 20 (11) (13) (12) (17) 14 8 (3 to 36) 324 333 400 377 (8) (16) (44) (42) (28) (33) 76 44 4 (48) (29) (1 to 8) 7 (–2 to 15) 33 (7 to 58) Small anomalies in subtraction are due to the effects of rounding. Con = control group, Exp = experimental group, FEV1 = forced expiratory volume in 1 second, FEF25-75 = forced expiratory flow at 25 to 75% of the expiratory volume, FVC = forced vital capacity.
Research 37 Table 3 Mean (SD) of groups, mean (SD) within-group difference and mean (95% CI) between-group difference for outcomes measured at the end of the 6-minute walk test. Six-minute walk test Groups Difference within Difference between outcomes groups groups Week 0 Week 12 Week 12 minus Week 12 minus Week 0 Week 0 Exp Con Exp Con Exp Con Exp minus Con (n = 20) (n = 20) (n = 20) (n = 20) Distance (m), mean (SD) 406 406 524 501 118 96 22 (26) (29) (32) (30) (29) (28) (4 to 40) Systolic BP (mmHg), 118 121 118 121 –1 mean (SD) (8) (8) (4) (4) (7) 0 –1 Diastolic BP (mmHg), 80 82 79 82 –1 (6) (–5 to 4) mean (SD) (8) (7) (4) (5) (6) 0 Heart rate (beats/min), 122 122 115 118 –7 (6) –1 mean (SD) (8) (9) (5) (4) (6) –4 (–5 to 3) Respiratory rate 25 25 21 24 –4 (8) (breaths/min), mean (SD) (4) (4) (2) (3) (3) –1 –3 SpO2 (%), mean (SD) 96.7 96.9 97.9 97.8 1.2 (3) (–8 to 2) (1.1) (0.7) (0.8) (0.8) (0.7) 0.9 Exertion on Borg scale 6.0 6.3 3.5 5.0 –2.5 (0.7) –3 (0 to 10), mean (SD) (1.1) (1.2) (0.9) (1.3) (1.2) –1.3 (–4 to –1) (1.1) 0.3 (–0.2 to 0.7) –1.2 (–1.9 to –0.4) Small anomalies in subtraction are due to the effects of rounding. BP = blood pressure, Con = control group, Exp = experimental group, SpO2 = peripheral oxyhaemoglobin saturation measured via pulse oximetry. benefit in maximal inspiratory pressure and peak expiratory flow recommended over aerobic exercise to adolescents with idiopathic come with substantial uncertainty, so the effects may be trivial but scoliosis, with the caveat that the extra benefits obtained may be very perhaps these were contributors to the improved functional exercise small. Given that uncertainty, other issues (eg, a patient may prefer capacity. and be more compliant with aerobic training) should also be taken into consideration in clinical decision-making. On the 6MWT, the estimate of 22 m greater improvement with combined training when compared with aerobic training did not In conclusion, adolescents with idiopathic scoliosis respond more reach the 32-m minimum clinically important difference that was positively to combined aerobic and resistance training than to aerobic used in the sample size calculation. As discussed above, however, that training only. The benefits were evident in several measures of res- threshold may not be relevant when comparing two very similar piratory function, maximal inspiratory pressure, peak expiratory flow training regimens. The lower end of the confidence interval was a and functional exercise capacity. The magnitude of the benefits was benefit of 4 m, which must be considered trivial, and the upper end fairly uncertain, with the estimates for all benefits not excluding the exceeded 32 m. Overall, the study estimated greater improvement in possibility of trivial effects, but some of the estimates included the functional exercise capacity if resistance exercise is incorporated into possibility of arguably worthwhile benefits. an otherwise aerobic training regimen, but how much extra benefit cannot be precisely estimated from the available data. The greater What was already known on this topic: Adolescents with distance on the 6MWT was achieved with a lower respiratory rate idiopathic scoliosis may have respiratory impairment, muscle and less exertion. When these three benefits are combined, perhaps it weakness and exercise limitation. Regular aerobic training im- suggests a worthwhile synergy. proves quality of life in adolescents with idiopathic scoliosis. What this study adds: In adolescents whose idiopathic The results should also be interpreted remembering that partici- scoliosis has progressed enough to warrant surgery, combined pants in the present study were fairly homogeneous: all of them with aerobic and resistance training improves functional exercise ca- high angles of curvature, all with single curvatures with a thoracic pacity more than a similar training regimen with aerobic training vertex and all otherwise healthy. AIS is a three-dimensional defor- only. The greater functional exercise capacity may be contrib- mity, with the degree of progression and prognosis related to the uted to by some of the other benefits, such as respiratory characteristics of the spinal torsion.33,34 Possibly, the respiratory function, maximal respiratory pressure and peak expiratory flow. changes that are seen in AIS are related to this three-dimensional However, it is unclear whether the magnitude of each benefit is torsion.1,3,4,35–37 In contrast, other studies about respiratory impair- trivial or worthwhile. ment in scoliosis usually deal with patients with severe impairment of respiratory function.1,3,4,35 Footnotes: a Java.util, OracleCorporation, Redwood Shores, USA. b RS800, Polar, Kempele, Finland. c Koko spirometer, nSpire Health, Although the effects observed in this study are potentially small, it Longmont, USA. is worth speculating further on their relationships. The increase in lung capacity and volumes may have contributed to the achievement eAddenda: Table 4 and Appendix 1 can be found online at https:// of greater exercise with less increase in respiratory rate. This could be doi.org/10.1016/j.jphys.2019.11.012. physiologically explained by the greater ventilation achieved with the increase in volume, which directly affects the relationship between Ethics approval: This study was previously approved by the local ventilation and perfusion.3,4 Possibly, there was an optimisation of Research Ethics Committee (protocol number 16710613.5.0000.5479). the ventilation perfusion ratio if the oxygen uptake and transport Patients and their legal guardians signed informed consent forms to were optimised with the training. participate in the study and adolescents an assent term. One limitation of the present study is that the long-term effects of Competing interests: Nil. exercise were not measured. Long-lasting benefits for adolescents Sources of support: This paper received funding from the agencies with idiopathic scoliosis have already been demonstrated from aer- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior obic exercise.38 Long-term resistance training has not been examined, (CAPES) and Fundação de Apoio à Pesquisa do Estado de São Paulo but the current results suggest that this should be explored further. (Fapesp). Future studies could adjust for potential confounders in the analysis. Acknowledgements: We thank the participants who were Another limitation of the study is the uncertainty in the estimates of involved in the project. the benefits. Given that the combined training regimen requires only Provenance: Not invited. Peer reviewed. some simple extra equipment and similar time and effort, it could be
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Journal of Physiotherapy 66 (2020) 64 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Recurrence of low back pain is common: a prospective inception cohort study After reading the conclusions of the inception cohort study by da It is unclear what care was provided when the participants com- Silva et al1 about recurrence of low back pain (LBP) and prognostic plained of ‘pain for which healthcare was sought’. Nearly 41% of the factors for recurrence, I wish to raise some concerns. study population opted for healthcare during follow-up, but it is unclear whether the participants (12% by 3 months, 25% by 6 months) It has now been widely accepted that one of the reasons for poor resolved their symptoms during the intervening follow-up periods. recovery of LBP is treating non-specific LBP as a single homogeneous group.2 The authors do not mention the baseline treatments received Although the authors have considered the role of certain factors by the participants (and mention this as a limitation); however, based on literature, they could have added fear avoidance and ex- without knowing the exact nature of the prescribed interventions, pectations about recovery as predictors because they have been no recommendations about the nature of recurrences can be made. found to be significant predictors of disability and work status.5 The authors recruited participants with previous experience of The supplementary findings of the study that exposure to awkward LBP, all of whom had previous LBP lasting for variable durations posture and longer sitting time are prognostic factors of LBP recurrence (Table 3). It may be noted here that having a previous experience of should evoke further debate, considering recent evidence that de- LBP is a risk factor for developing chronic symptoms.3 As the authors nounces the role of mechanical factors for musculoskeletal pain.6,7 claim that the ‘prognosis of people who have had a condition for a long time is likely to be different from those who recently Shankar Ganesh developed the condition’, recruiting participants with a previous Composite Regional Centre for Skill Development, Empowerment, and history of LBP may not avoid bias, despite the participants having recovered at a uniform point of time. Rehabilitation of Persons with Disabilities, Lucknow, India Table 3 also shows that . 21% of the study population belonged to https://doi.org/10.1016/j.jphys.2019.11.005 the subacute stage. This might also explain the high percentage of recurrent LBP rates in this population, as people in the sub-acute stage References are more prone to develop consistent pain.4 Further, it is unknown from the data if any attempts were made to refer the participants to the 1. da Silva T, et al. J Physiother. 2019;65:159–165. interventions that suited them based on specific selection criteria. 2. Hancock M, et al. Phys Ther. 2009;89:698–704. 3. Chou R. BMJ Clin Evid. 2010;2010:1116. The authors could have explained why they did not recruit par- 4. Karjalainen K, et al. Cochrane Database Syst Rev. 2001;3:CD002193. ticipants with first-onset LBP and follow them prospectively using the 5. Fritz JM, et al. Pain. 2001;94:7–15. same design. 6. Lederman E. J Bodyw Mov Ther. 2011;15:131–139. 7. Balagué F, et al. Lancet. 2012;379:482–491. Correspondence: Author response to Ganesh We appreciate Mr Shankar Ganesh’s interest in our publication. generalisable and useful information to clinicians when discussing His comments primarily relate to different research questions than the likelihood of future recurrences with their patients. In addition, the ones we set out to investigate. Many of the comments relate to our design enabled us to explore whether the number of previous treatment for people with back pain, while our study recruited people episodes was associated with increased risk of recurrences, which we who did not have current back pain and followed them to determine were able to confirm. if they had a future recurrence. It is possible that the type of treat- ment received during a previous episode may impact on a future Provenance: Invited. Not peer reviewed. recurrence, but we did not set out to investigate this question. Tatiane da Silvaa, Kathryn Millsb, Benjamin Brownc, One general comment that Mr Ganesh made was the assertion Natasha Pocovib, Tarcisio de Camposb, Christopher Maherd and that recent evidence denounces the role of mechanical factors for musculoskeletal pain. This seems an unjustified comment for a Mark Hancockb number of reasons. First, the citations he provides to support this aMasters and Doctoral Programs in Physical Therapy, view are not to research or to recent publications. Second, the pre- Universidade Cidade de São Paulo, São Paulo, Brazil vailing view for low back pain is that biological, psychological and bDepartment of Health Professions, Macquarie University, Sydney, social factors are all important. Australia Mr Ganesh asks for an explanation of why we did not recruit cDepartment of Chiropractic, Macquarie University, Sydney, Australia people who had experienced only one previous episode of low back pain. Most people presenting to care have experienced multiple dSydney School of Public Health, The University of Sydney, Sydney, previous episodes, so we feel that this sample provides more Australia https://doi.org/10.1016/j.jphys.2019.11.007 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 65 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Practitioners may need to change too if we are to reduce inappropriate imaging Lim et al have conducted a thoroughly comprehensive review of randomised controlled trial, compared patients cared for by chiro- the health information needs of patients with low back pain (LBP).1 practors and medical practitioners. They found that satisfaction was Their results concur with those of an earlier review of patients’ related to the amount of advice given rather than other aspects of care, experiences of health services, in particular the desire for with equal rates of imaging in both groups.4 Care of back pain and sciatica information and need for legitimation.2 tends to focus on intervertebral disc disorder and spinal stenosis, while everything else is often consigned to the non-specific dustbin. More However, their concluding paragraph needs comment: attention should be given by both practitioners and researchers to the causes of back pain and sciatica outside of this narrow focus to conditions This [patients’ need for validation and legitimation by a diagnosis] such as piriformis syndrome. This does not necessarily mean more im- may contribute to the increasing use of inappropriate imaging for aging but attention to symptoms and signs that are otherwise ignored.5 LBP. In order to improve clinical outcomes in LBP, addressing and correcting unhelpful beliefs may better align patients’ expectations Provenance: Invited. Not peer reviewed. with those of healthcare providers. Kevin Hopayian While they qualify the contribution of information needs to University of Nicosia Medical School, Nicosia, Cyprus inappropriate imaging with ‘may’, they give the impression that it is the patients who need to change. We need to be reminded that there is https://doi.org/10.1016/j.jphys.2019.11.016 evidence that professionals may need to change. In an observational study, Deyo and Diel collected questionnaire data before and after References attendance from consecutive patients presenting to a walk-in clinic.3 They found that being given an adequate explanation was positively 1. Lim YZ, et al. J Physiother. 2019;65:124–135. correlated with satisfaction with care and negatively correlated with a 2. Hopayian K, et al. Spine J. 2014;14:1769–1780. desire for imaging. This result was regardless of patients’ prior 3. Deyo RA, et al. Spine. 1986;11:28–30. expectations for imaging at presentation. Hertzman-Miller et al, in a 4. Hertzman-Miller RP, et al. Am J Public Health. 2002;92:1628–1633. 5. Hopayian K, et al. Eur J Orthop Surg Traumatol. 2018;28:155–164. 1836-9553/© 2019 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). Correspondence: Reply to Hopayian We thank Dr Hopayian for his interest and comments regarding leading to patients feeling ‘delegitimised’ and ‘disempowered’.4 Lack of knowledge may also contribute to inconsistent advice from different our publication. clinicians, compounding the problem, and has also been identified as an area of health information need by patients with LBP.4 Our review captured the available data on patients’ perspectives regarding health information needs related to low back pain (LBP). Syn- To address these issues, clinicians require better education regarding the management of LBP along with system-level and thesising patients’ reported needs and barriers to optimal care delivery service-level supports to enable delivery of high-value care for LBP. enables patient-centred changes in service models to be considered. In Provenance: Invited. Not peer reviewed. the example of inappropriate imaging, we agree with Dr Hopayian and Yuan Z Lima, Louisa Choua, Rebecca TM Aua, the existing literature that both patient-related and clinician-related KL Maheeka D Seneviwickramaa, Flavia M Cicuttinia, Andrew factors are important and need to change,1 whilst also considering M Briggsb, Kaye Sullivanc, Donna M Urquharta and Anita E Wlukaa aDepartment of Epidemiology and Preventative Medicine, School of broader organisational-level and system-level factors that influence the Public Health and Preventative Medicine, Monash University, Melbourne choice to undertake imaging.2,3 Patients’ beliefs and expectations, one of bSchool of Physiotherapy and Exercise Science, Curtin University, Perth the factors driving this practice, can be addressed in part by clinician cMonash University Library, Monash University, Melbourne, Australia education. While education alone may shift practice behaviours,2 https://doi.org/10.1016/j.jphys.2019.11.015 empowering clinicians to better explain back pain, coupled with other References practice supports (eg, referral networks, appropriate self-management 1. Slade SC, et al. Clin J Pain. 2016;32:800–816. resources) to reduce the role of imaging, is one of the approaches that 2. Jenkins HJ, et al. CMAJ. 2015;187:401–408. 3. Briggs AM, et al. Pain. 2019;160:1240. we advocate as necessary. The perceived need for imaging (regardless of 4. Lim YZ, et al. J Physiother. 2019;65:124–135. 5. Gnatz SM, et al. Semin Arthritis Rheum. 2012;41:741–744. its appropriateness) to quench the desire for precise accurate LBP diagnosis in this group of patients was highlighted in our study.4 The issue of clinicians’ lack of knowledge regarding high-value LBP care has been identified as a problem internationally.1,5 Many clinicians report being inadequately trained in managing chronic musculoskeletal pain conditions.1,5 This deficiency may be reflected back to the patient, resulting in vague answers and poor explanations of non-specific LBP, 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 64 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Recurrence of low back pain is common: a prospective inception cohort study After reading the conclusions of the inception cohort study by da It is unclear what care was provided when the participants com- Silva et al1 about recurrence of low back pain (LBP) and prognostic plained of ‘pain for which healthcare was sought’. Nearly 41% of the factors for recurrence, I wish to raise some concerns. study population opted for healthcare during follow-up, but it is unclear whether the participants (12% by 3 months, 25% by 6 months) It has now been widely accepted that one of the reasons for poor resolved their symptoms during the intervening follow-up periods. recovery of LBP is treating non-specific LBP as a single homogeneous group.2 The authors do not mention the baseline treatments received Although the authors have considered the role of certain factors by the participants (and mention this as a limitation); however, based on literature, they could have added fear avoidance and ex- without knowing the exact nature of the prescribed interventions, pectations about recovery as predictors because they have been no recommendations about the nature of recurrences can be made. found to be significant predictors of disability and work status.5 The authors recruited participants with previous experience of The supplementary findings of the study that exposure to awkward LBP, all of whom had previous LBP lasting for variable durations posture and longer sitting time are prognostic factors of LBP recurrence (Table 3). It may be noted here that having a previous experience of should evoke further debate, considering recent evidence that de- LBP is a risk factor for developing chronic symptoms.3 As the authors nounces the role of mechanical factors for musculoskeletal pain.6,7 claim that the ‘prognosis of people who have had a condition for a long time is likely to be different from those who recently Shankar Ganesh developed the condition’, recruiting participants with a previous Composite Regional Centre for Skill Development, Empowerment, and history of LBP may not avoid bias, despite the participants having recovered at a uniform point of time. Rehabilitation of Persons with Disabilities, Lucknow, India Table 3 also shows that . 21% of the study population belonged to https://doi.org/10.1016/j.jphys.2019.11.005 the subacute stage. This might also explain the high percentage of recurrent LBP rates in this population, as people in the sub-acute stage References are more prone to develop consistent pain.4 Further, it is unknown from the data if any attempts were made to refer the participants to the 1. da Silva T, et al. J Physiother. 2019;65:159–165. interventions that suited them based on specific selection criteria. 2. Hancock M, et al. Phys Ther. 2009;89:698–704. 3. Chou R. BMJ Clin Evid. 2010;2010:1116. The authors could have explained why they did not recruit par- 4. Karjalainen K, et al. Cochrane Database Syst Rev. 2001;3:CD002193. ticipants with first-onset LBP and follow them prospectively using the 5. Fritz JM, et al. Pain. 2001;94:7–15. same design. 6. Lederman E. J Bodyw Mov Ther. 2011;15:131–139. 7. Balagué F, et al. Lancet. 2012;379:482–491. Correspondence: Author response to Ganesh We appreciate Mr Shankar Ganesh’s interest in our publication. generalisable and useful information to clinicians when discussing His comments primarily relate to different research questions than the likelihood of future recurrences with their patients. In addition, the ones we set out to investigate. Many of the comments relate to our design enabled us to explore whether the number of previous treatment for people with back pain, while our study recruited people episodes was associated with increased risk of recurrences, which we who did not have current back pain and followed them to determine were able to confirm. if they had a future recurrence. It is possible that the type of treat- ment received during a previous episode may impact on a future Provenance: Invited. Not peer reviewed. recurrence, but we did not set out to investigate this question. Tatiane da Silvaa, Kathryn Millsb, Benjamin Brownc, One general comment that Mr Ganesh made was the assertion Natasha Pocovib, Tarcisio de Camposb, Christopher Maherd and that recent evidence denounces the role of mechanical factors for musculoskeletal pain. This seems an unjustified comment for a Mark Hancockb number of reasons. First, the citations he provides to support this aMasters and Doctoral Programs in Physical Therapy, view are not to research or to recent publications. Second, the pre- Universidade Cidade de São Paulo, São Paulo, Brazil vailing view for low back pain is that biological, psychological and bDepartment of Health Professions, Macquarie University, Sydney, social factors are all important. Australia Mr Ganesh asks for an explanation of why we did not recruit cDepartment of Chiropractic, Macquarie University, Sydney, Australia people who had experienced only one previous episode of low back pain. Most people presenting to care have experienced multiple dSydney School of Public Health, The University of Sydney, Sydney, previous episodes, so we feel that this sample provides more Australia https://doi.org/10.1016/j.jphys.2019.11.007 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 65 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Correspondence: Practitioners may need to change too if we are to reduce inappropriate imaging Lim et al have conducted a thoroughly comprehensive review of randomised controlled trial, compared patients cared for by chiro- the health information needs of patients with low back pain (LBP).1 practors and medical practitioners. They found that satisfaction was Their results concur with those of an earlier review of patients’ related to the amount of advice given rather than other aspects of care, experiences of health services, in particular the desire for with equal rates of imaging in both groups.4 Care of back pain and sciatica information and need for legitimation.2 tends to focus on intervertebral disc disorder and spinal stenosis, while everything else is often consigned to the non-specific dustbin. More However, their concluding paragraph needs comment: attention should be given by both practitioners and researchers to the causes of back pain and sciatica outside of this narrow focus to conditions This [patients’ need for validation and legitimation by a diagnosis] such as piriformis syndrome. This does not necessarily mean more im- may contribute to the increasing use of inappropriate imaging for aging but attention to symptoms and signs that are otherwise ignored.5 LBP. In order to improve clinical outcomes in LBP, addressing and correcting unhelpful beliefs may better align patients’ expectations Provenance: Invited. Not peer reviewed. with those of healthcare providers. Kevin Hopayian While they qualify the contribution of information needs to University of Nicosia Medical School, Nicosia, Cyprus inappropriate imaging with ‘may’, they give the impression that it is the patients who need to change. We need to be reminded that there is https://doi.org/10.1016/j.jphys.2019.11.016 evidence that professionals may need to change. In an observational study, Deyo and Diel collected questionnaire data before and after References attendance from consecutive patients presenting to a walk-in clinic.3 They found that being given an adequate explanation was positively 1. Lim YZ, et al. J Physiother. 2019;65:124–135. correlated with satisfaction with care and negatively correlated with a 2. Hopayian K, et al. Spine J. 2014;14:1769–1780. desire for imaging. This result was regardless of patients’ prior 3. Deyo RA, et al. Spine. 1986;11:28–30. expectations for imaging at presentation. Hertzman-Miller et al, in a 4. Hertzman-Miller RP, et al. Am J Public Health. 2002;92:1628–1633. 5. Hopayian K, et al. Eur J Orthop Surg Traumatol. 2018;28:155–164. 1836-9553/© 2019 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). Correspondence: Reply to Hopayian We thank Dr Hopayian for his interest and comments regarding leading to patients feeling ‘delegitimised’ and ‘disempowered’.4 Lack of knowledge may also contribute to inconsistent advice from different our publication. clinicians, compounding the problem, and has also been identified as an area of health information need by patients with LBP.4 Our review captured the available data on patients’ perspectives regarding health information needs related to low back pain (LBP). Syn- To address these issues, clinicians require better education regarding the management of LBP along with system-level and thesising patients’ reported needs and barriers to optimal care delivery service-level supports to enable delivery of high-value care for LBP. enables patient-centred changes in service models to be considered. In Provenance: Invited. Not peer reviewed. the example of inappropriate imaging, we agree with Dr Hopayian and Yuan Z Lima, Louisa Choua, Rebecca TM Aua, the existing literature that both patient-related and clinician-related KL Maheeka D Seneviwickramaa, Flavia M Cicuttinia, Andrew factors are important and need to change,1 whilst also considering M Briggsb, Kaye Sullivanc, Donna M Urquharta and Anita E Wlukaa aDepartment of Epidemiology and Preventative Medicine, School of broader organisational-level and system-level factors that influence the Public Health and Preventative Medicine, Monash University, Melbourne choice to undertake imaging.2,3 Patients’ beliefs and expectations, one of bSchool of Physiotherapy and Exercise Science, Curtin University, Perth the factors driving this practice, can be addressed in part by clinician cMonash University Library, Monash University, Melbourne, Australia education. While education alone may shift practice behaviours,2 https://doi.org/10.1016/j.jphys.2019.11.015 empowering clinicians to better explain back pain, coupled with other References practice supports (eg, referral networks, appropriate self-management 1. Slade SC, et al. Clin J Pain. 2016;32:800–816. resources) to reduce the role of imaging, is one of the approaches that 2. Jenkins HJ, et al. CMAJ. 2015;187:401–408. 3. Briggs AM, et al. Pain. 2019;160:1240. we advocate as necessary. The perceived need for imaging (regardless of 4. Lim YZ, et al. J Physiother. 2019;65:124–135. 5. Gnatz SM, et al. Semin Arthritis Rheum. 2012;41:741–744. its appropriateness) to quench the desire for precise accurate LBP diagnosis in this group of patients was highlighted in our study.4 The issue of clinicians’ lack of knowledge regarding high-value LBP care has been identified as a problem internationally.1,5 Many clinicians report being inadequately trained in managing chronic musculoskeletal pain conditions.1,5 This deficiency may be reflected back to the patient, resulting in vague answers and poor explanations of non-specific LBP, 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 57 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: In people with inoperable lung cancer, home-based rehabilitation provides no benefit over usual care in optimising functional exercise capacity Synopsis Summary of: Edbrooke L, Aranda S, Granger CL, McDonald CF, monthly phone calls from a research team member. During these calls, Krishnasamy M, Mileshkin L, et al. Multidisciplinary home-based participants were not provided with exercise or symptom management rehabilitation in inoperable lung cancer: a randomised controlled advice. Outcome measures: The primary outcome was the change in 6- trial. Thorax 2019;74:787–796. minute walk distance from baseline to Week 9. Secondary outcome measures included health-related quality of life measured via the Question: In people with inoperable lung cancer, is home-based reha- Functional Assessment of Cancer Therapy – Lung scale and symptom bilitation more effective than usual care at improving functional exercise severity measured via the MD Anderson Symptom Inventory – Lung capacity, health-related quality of life and symptoms? Design: Rando- Cancer scale. Results: Sixty-six participants completed the 6-month mised controlled trial with concealed allocation and blinded outcome intervention (33 in each group). On completion of the home-based assessment. Setting: Three tertiary-care hospitals in Melbourne, program, there were no significant between-group differences in 6- Australia. Participants: Inclusion criteria were patients with inoperable minute walk distance (mean difference –25 m, 95% CI –64 to 13), health- non-small cell lung cancer, Eastern Cooperative Oncology Group perfor- related quality of life (total score 3.8, 95% CI –4.5 to 12.1) or symptom mance status 2, and physician-rated life expectancy of . 6 months, and severity (–0.9, 95% CI –2.2 to 0.3). Exploratory analyses demonstrated who commenced treatment 4 weeks prior to recruitment. Exclusion that the intervention group had better health-related quality of life criteria were: patients receiving treatment for other malignancy, those (total score 13, 95% CI 4 to 22) and lower symptom severity (–2.2, 95% CI who had performed 150 minutes per week of moderate physical ac- –3.6 to –0.9) at 6 months. Conclusion: In people with inoperable lung tivity in the past month, and those for whom participation in a land-based cancer, home-based rehabilitation did not improve functional exercise exercise program was prohibited by comorbidities or pelvic or lower limb capacity. However, secondary analyses suggested that this program bony metastases. Randomisation of 92 participants allocated 45 to an may improve patient-reported outcomes at 6 months. intervention group and 47 to a control group. Interventions: Both groups received usual care, which did not involve any routine exercise advice. The Provenance: Invited. Not peer reviewed. intervention group received an 8-week home-based rehabilitation pro- gram that included tailored exercise prescription (aerobic and resistance Vinicius Cavalheri exercises), behaviour change strategies, early treatment initiation to School of Physiotherapy and Exercise Science, Curtin University, Australia manage symptoms, followed by 4 months of monthly contact to review and progress exercise programs. The control group received 6 months of https://doi.org/10.1016/j.jphys.2019.11.010 Commentary If you had an incurable disease, what would your biggest concern changes in patient-reported exploratory secondary outcome mea- be? How would you spend your last weeks or months? You would sures observed at 6 months. probably answer this question as patients with lung cancer did in a previous study.1 On a 20-item scale, patients were asked to rate what In patients with inoperable lung cancer, any improvement (or at they felt as either ‘Important’ or ‘Very Important’ during the trajec- least the prevention of deterioration) in physical and/or mental out- tory of their lung cancer. The top three items that were rated as very comes is of value. Despite not showing any between-group differ- important included: ‘Quality of life’, ‘Maintaining independence’ and ences in primary outcomes, Edbrooke et al reported improvements in ‘Being able to perform normal activities’. Of note, . 60% of the pa- several self-reported secondary outcomes at the 6-month follow-up tients in that study had advanced-stage lung cancer with an expected that favoured the home-based rehabilitation group. This finding survival after diagnosis of 12 to 16 months.2 could indicate that, compared with usual care, a home-based reha- bilitation program can provide patients with a chance of living the This is a similar patient population to that in the study by rest of their lives with better quality, the ability to maintain inde- Edbrooke et al, which indirectly tried to address the top three items pendence and being able to perform normal activities. described above. The aim of the study was to investigate the effec- tiveness of a home-based rehabilitation program in patients with Provenance: Invited. Not peer reviewed. inoperable lung cancer who had recently commenced active treat- Morten Quist ment. Patients were randomised to either a home-based rehabilita- tion program or usual care. The outcomes of the study included Body & Cancer, University Hospital of Copenhagen, Rigshospitalet, Denmark change in functional exercise capacity and patient-reported outcomes such as health-related quality of life. There was no between-group https://doi.org/10.1016/j.jphys.2019.11.009 difference in functional exercise capacity, but there were significant References 1. Gralla RJ, et al. J Thor Oncol. 2014;9:1243–1248. 2. Jakobsen E, et al. Acta Oncol. 2016;55:2–9. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 57 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: In people with inoperable lung cancer, home-based rehabilitation provides no benefit over usual care in optimising functional exercise capacity Synopsis Summary of: Edbrooke L, Aranda S, Granger CL, McDonald CF, monthly phone calls from a research team member. During these calls, Krishnasamy M, Mileshkin L, et al. Multidisciplinary home-based participants were not provided with exercise or symptom management rehabilitation in inoperable lung cancer: a randomised controlled advice. Outcome measures: The primary outcome was the change in 6- trial. Thorax 2019;74:787–796. minute walk distance from baseline to Week 9. Secondary outcome measures included health-related quality of life measured via the Question: In people with inoperable lung cancer, is home-based reha- Functional Assessment of Cancer Therapy – Lung scale and symptom bilitation more effective than usual care at improving functional exercise severity measured via the MD Anderson Symptom Inventory – Lung capacity, health-related quality of life and symptoms? Design: Rando- Cancer scale. Results: Sixty-six participants completed the 6-month mised controlled trial with concealed allocation and blinded outcome intervention (33 in each group). On completion of the home-based assessment. Setting: Three tertiary-care hospitals in Melbourne, program, there were no significant between-group differences in 6- Australia. Participants: Inclusion criteria were patients with inoperable minute walk distance (mean difference –25 m, 95% CI –64 to 13), health- non-small cell lung cancer, Eastern Cooperative Oncology Group perfor- related quality of life (total score 3.8, 95% CI –4.5 to 12.1) or symptom mance status 2, and physician-rated life expectancy of . 6 months, and severity (–0.9, 95% CI –2.2 to 0.3). Exploratory analyses demonstrated who commenced treatment 4 weeks prior to recruitment. Exclusion that the intervention group had better health-related quality of life criteria were: patients receiving treatment for other malignancy, those (total score 13, 95% CI 4 to 22) and lower symptom severity (–2.2, 95% CI who had performed 150 minutes per week of moderate physical ac- –3.6 to –0.9) at 6 months. Conclusion: In people with inoperable lung tivity in the past month, and those for whom participation in a land-based cancer, home-based rehabilitation did not improve functional exercise exercise program was prohibited by comorbidities or pelvic or lower limb capacity. However, secondary analyses suggested that this program bony metastases. Randomisation of 92 participants allocated 45 to an may improve patient-reported outcomes at 6 months. intervention group and 47 to a control group. Interventions: Both groups received usual care, which did not involve any routine exercise advice. The Provenance: Invited. Not peer reviewed. intervention group received an 8-week home-based rehabilitation pro- gram that included tailored exercise prescription (aerobic and resistance Vinicius Cavalheri exercises), behaviour change strategies, early treatment initiation to School of Physiotherapy and Exercise Science, Curtin University, Australia manage symptoms, followed by 4 months of monthly contact to review and progress exercise programs. The control group received 6 months of https://doi.org/10.1016/j.jphys.2019.11.010 Commentary If you had an incurable disease, what would your biggest concern changes in patient-reported exploratory secondary outcome mea- be? How would you spend your last weeks or months? You would sures observed at 6 months. probably answer this question as patients with lung cancer did in a previous study.1 On a 20-item scale, patients were asked to rate what In patients with inoperable lung cancer, any improvement (or at they felt as either ‘Important’ or ‘Very Important’ during the trajec- least the prevention of deterioration) in physical and/or mental out- tory of their lung cancer. The top three items that were rated as very comes is of value. Despite not showing any between-group differ- important included: ‘Quality of life’, ‘Maintaining independence’ and ences in primary outcomes, Edbrooke et al reported improvements in ‘Being able to perform normal activities’. Of note, . 60% of the pa- several self-reported secondary outcomes at the 6-month follow-up tients in that study had advanced-stage lung cancer with an expected that favoured the home-based rehabilitation group. This finding survival after diagnosis of 12 to 16 months.2 could indicate that, compared with usual care, a home-based reha- bilitation program can provide patients with a chance of living the This is a similar patient population to that in the study by rest of their lives with better quality, the ability to maintain inde- Edbrooke et al, which indirectly tried to address the top three items pendence and being able to perform normal activities. described above. The aim of the study was to investigate the effec- tiveness of a home-based rehabilitation program in patients with Provenance: Invited. Not peer reviewed. inoperable lung cancer who had recently commenced active treat- Morten Quist ment. Patients were randomised to either a home-based rehabilita- tion program or usual care. The outcomes of the study included Body & Cancer, University Hospital of Copenhagen, Rigshospitalet, Denmark change in functional exercise capacity and patient-reported outcomes such as health-related quality of life. There was no between-group https://doi.org/10.1016/j.jphys.2019.11.009 difference in functional exercise capacity, but there were significant References 1. Gralla RJ, et al. J Thor Oncol. 2014;9:1243–1248. 2. Jakobsen E, et al. Acta Oncol. 2016;55:2–9. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 55 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Intensive patient education is no more effective than placebo education for reducing pain intensity in patients with acute low back pain Synopsis Summary of: Traeger AC, Lee H, Hübscher M, Skinner IW, Moseley GL, biologic basis and protective nature of back pain; and evaluating Nicholas MK, et al. Effect of intensive patient education vs placebo understanding of new concepts and discussing techniques to pro- patient education on outcomes in patients with acute low back pain. mote recovery. Placebo patient education consisted of two 1-hour A randomized clinical trial. JAMA Neurol. 2019;76:161–169. individual face-to-face sessions and included listening, showing in- terest, and attention of the clinician, but without the education Question: Does intensive patient education improve pain and component. Outcome measures: The primary outcome was mean disability, compared with placebo patient education, in patients with pain intensity during the past week on an 11-point numeric rating acute low back pain receiving recommended first-line care? Design: scale at 3 months after the onset of low back pain. Numerous other Assessor-blinded, randomised placebo-controlled trial. Setting: Phys- self-reported secondary outcomes were included and measured at iotherapy clinics, general practices, and clinic rooms at a research 1 week, and at 3, 6 and 12 months. Results: At 3 months, 194 par- institute in Sydney, Australia. Participants: Patients were included ticipants had completed the primary outcome. There was no difference aged 18 to 75 years and seeking care from general practitioners or in pain intensity at the 3-month follow-up between the patient edu- physiotherapists for acute low back pain with or without referred leg cation group and the placebo patient education group (mean pain. Exclusion criteria were: chronic low back pain for . 3 months, , 3 difference 20.3 points, 95% CI 21.0 to 0.3). There was also no effect of out of 10 on a pain-intensity numeric rating scale over the past week, intervention on pain intensity after 6 and 12 months. A small treatment low risk of pain chronicity, serious spinal pathology, poor English effect in favour of the patient education group was found for disability language understanding, previous spinal surgery, or a mental health at 1 week and 3 months but not 6 or 12 months. Conclusion: Intensive disorder precluding participation. Randomisation of 202 participants patient education was no more effective in improving pain than pla- allocated 101 to the education group and 101 to the placebo education cebo patient education in patients with acute low back pain. group. Interventions: Both groups received recommended first-line care for acute low back pain from their usual practitioner. The pa- Provenance: Invited. Not peer reviewed. tient education group received two 1-hour individual face-to-face patient education sessions from one of two trial clinicians. The ses- Britt Elin Øiestad sions focused on the biopsychosocial nature of pain, using diagrams, Department of Physiotherapy, Oslo Metropolitan University, Norway metaphors and stories. Core concepts included: reframing unhelpful beliefs about low back pain; presenting information about the https://doi.org/10.1016/j.jphys.2019.10.003 Commentary Traeger et al are to be commended for completing this well- delivering the placebo education further supports this notion. A third designed, randomised clinical trial that reported no differences in trial arm would be necessary to differentiate the effects of patient 3-month, 6-month and 12-month pain intensity from receiving bio- education and patient engagement. Third, certain secondary out- psychosocial patient education or placebo education. The authors comes (eg, better pain attitudes and beliefs, lower care seeking at 3 included patients who had acute low back pain and were at higher months, and fewer recurrences at 12 months) showed benefit from risk of developing chronic low back pain and referred by general biopsychosocial patient education. The trial was not designed to practitioners or physiotherapists. The authors appropriately inter- support definitive conclusions regarding these outcomes; however, preted these results as challenging existing clinical guideline rec- they are still important to consider, especially from the patient’s ommendations advocating patient education. On the whole I agree perspective. Nonetheless, the effects observed on secondary out- with the authors’ interpretation of these data, and will highlight comes need to be confirmed in subsequent trials. In the meantime, some areas of personal interest. First is the consideration that the lack given that some information will always be exchanged during a pa- of between-group differences could be attributed to all patients tient encounter, a case can be made for erring on the side of providing receiving guideline-based patient education (ie, advice to stay active, biopsychosocial-focused education. avoid bed rest) regardless of random assignment. The implication of this is that there was no true ‘no education’ condition and readers Provenance: Invited. Not peer reviewed. looking to revise care pathways by removing all forms of patient education would not be faithful to this trial’s design. Second, there is a Steven Z George good chance that placebo education is a viable patient engagement Duke Clinical Research and Department of Orthopaedic Surgery, model without delivering low back pain-related content. Similar methods have been used to develop patient rapport and/or thera- Duke University, Durham, North Carolina, USA peutic alliance. A clinical psychologist training the interventionists https://doi.org/10.1016/j.jphys.2019.10.005 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 55 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Intensive patient education is no more effective than placebo education for reducing pain intensity in patients with acute low back pain Synopsis Summary of: Traeger AC, Lee H, Hübscher M, Skinner IW, Moseley GL, biologic basis and protective nature of back pain; and evaluating Nicholas MK, et al. Effect of intensive patient education vs placebo understanding of new concepts and discussing techniques to pro- patient education on outcomes in patients with acute low back pain. mote recovery. Placebo patient education consisted of two 1-hour A randomized clinical trial. JAMA Neurol. 2019;76:161–169. individual face-to-face sessions and included listening, showing in- terest, and attention of the clinician, but without the education Question: Does intensive patient education improve pain and component. Outcome measures: The primary outcome was mean disability, compared with placebo patient education, in patients with pain intensity during the past week on an 11-point numeric rating acute low back pain receiving recommended first-line care? Design: scale at 3 months after the onset of low back pain. Numerous other Assessor-blinded, randomised placebo-controlled trial. Setting: Phys- self-reported secondary outcomes were included and measured at iotherapy clinics, general practices, and clinic rooms at a research 1 week, and at 3, 6 and 12 months. Results: At 3 months, 194 par- institute in Sydney, Australia. Participants: Patients were included ticipants had completed the primary outcome. There was no difference aged 18 to 75 years and seeking care from general practitioners or in pain intensity at the 3-month follow-up between the patient edu- physiotherapists for acute low back pain with or without referred leg cation group and the placebo patient education group (mean pain. Exclusion criteria were: chronic low back pain for . 3 months, , 3 difference 20.3 points, 95% CI 21.0 to 0.3). There was also no effect of out of 10 on a pain-intensity numeric rating scale over the past week, intervention on pain intensity after 6 and 12 months. A small treatment low risk of pain chronicity, serious spinal pathology, poor English effect in favour of the patient education group was found for disability language understanding, previous spinal surgery, or a mental health at 1 week and 3 months but not 6 or 12 months. Conclusion: Intensive disorder precluding participation. Randomisation of 202 participants patient education was no more effective in improving pain than pla- allocated 101 to the education group and 101 to the placebo education cebo patient education in patients with acute low back pain. group. Interventions: Both groups received recommended first-line care for acute low back pain from their usual practitioner. The pa- Provenance: Invited. Not peer reviewed. tient education group received two 1-hour individual face-to-face patient education sessions from one of two trial clinicians. The ses- Britt Elin Øiestad sions focused on the biopsychosocial nature of pain, using diagrams, Department of Physiotherapy, Oslo Metropolitan University, Norway metaphors and stories. Core concepts included: reframing unhelpful beliefs about low back pain; presenting information about the https://doi.org/10.1016/j.jphys.2019.10.003 Commentary Traeger et al are to be commended for completing this well- delivering the placebo education further supports this notion. A third designed, randomised clinical trial that reported no differences in trial arm would be necessary to differentiate the effects of patient 3-month, 6-month and 12-month pain intensity from receiving bio- education and patient engagement. Third, certain secondary out- psychosocial patient education or placebo education. The authors comes (eg, better pain attitudes and beliefs, lower care seeking at 3 included patients who had acute low back pain and were at higher months, and fewer recurrences at 12 months) showed benefit from risk of developing chronic low back pain and referred by general biopsychosocial patient education. The trial was not designed to practitioners or physiotherapists. The authors appropriately inter- support definitive conclusions regarding these outcomes; however, preted these results as challenging existing clinical guideline rec- they are still important to consider, especially from the patient’s ommendations advocating patient education. On the whole I agree perspective. Nonetheless, the effects observed on secondary out- with the authors’ interpretation of these data, and will highlight comes need to be confirmed in subsequent trials. In the meantime, some areas of personal interest. First is the consideration that the lack given that some information will always be exchanged during a pa- of between-group differences could be attributed to all patients tient encounter, a case can be made for erring on the side of providing receiving guideline-based patient education (ie, advice to stay active, biopsychosocial-focused education. avoid bed rest) regardless of random assignment. The implication of this is that there was no true ‘no education’ condition and readers Provenance: Invited. Not peer reviewed. looking to revise care pathways by removing all forms of patient education would not be faithful to this trial’s design. Second, there is a Steven Z George good chance that placebo education is a viable patient engagement Duke Clinical Research and Department of Orthopaedic Surgery, model without delivering low back pain-related content. Similar methods have been used to develop patient rapport and/or thera- Duke University, Durham, North Carolina, USA peutic alliance. A clinical psychologist training the interventionists https://doi.org/10.1016/j.jphys.2019.10.005 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 54 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Participation-focused therapy for children with cerebral palsy improves perception of leisure-time physical activity goal performance, satisfaction and confidence Synopsis Summary of: Reedman SE, Boyd RN, Trost SG, Elliott C, Sakzewki L. outcome measures collected at 8 and 16 weeks were parent-reported Efficacy of participation-focused therapy on performance of physical barriers to participation, parent-reported community participation fre- activity participation goals and habitual physical activity in children quency and involvement, child-reported quality of life and physical ac- with cerebral palsy: a randomised controlled trial. Arch Phys Med tivity measured with accelerometers. Results: Thirty-two participants Rehab. 2019;100:676–686. completed the study. At the end of 8 weeks, when compared with the control group, the intervention group demonstrated better performance Question: Does participation-focused intervention improve leisure-time on leisure-time physical activity participation goals (MD 3.58, 95% CI 2.19 physical activity goals and habitual physical activity in children with to 4.97), satisfaction (MD 1.87, 95% CI 0.37 to 3.36) and confidence (MD cerebral palsy? Design: Randomised controlled trial with concealed 1.31, 95% CI 0.12 to 2.50) for these goals. At 16 weeks, these differences allocation. Setting: Community based in Australia. Participants: Inclu- were retained. Parents reported fewer barriers/more facilitators to sion criteria were children aged 8 to 12 years, with cerebral palsy and who participation in the intervention group (MD 27, 95% CI 6 to 47) at 8 weeks, were ambulant. Children were excluded if they had an unstable medical which was not retained at 16 weeks. There was no between-group dif- condition, moderate to severe intellectual, communication, hearing and/ ference for other measures at 8 and 16 weeks. Conclusion: In children or visual impairment, or required surgery in the previous 6 months. with cerebral palsy, when compared with usual care, individualised Randomisation of 37 participants allocated 18 to intervention and 19 to a participation-focused therapy improved their perception of wait-list control group. Interventions: Both groups received usual care as performance, satisfaction and confidence with leisure-time physical ac- well as individual face-to-face sessions with a physiotherapist at three tivity. However, the intervention did not have an effect on community time points: baseline (to set goals) and at 8 and 16 weeks (to score goals). participation, quality of life or objective measures of physical activity. In addition, over the first 8 weeks, the intervention group had a further six physiotherapy sessions aimed at enabling the child’s ongoing Provenance: Invited. Not peer reviewed. participation in leisure activities at home, community and/or school. This was tailored to the individual child and family, and based upon their Alicia Spittle baseline goals. Outcome measures: The primary outcomes were per- Department of Physiotherapy, University of Melbourne, Australia formance on leisure-time physical activity participation goals, and Victorian Infant Brain Studies, Murdoch Children’s Research Institute, satisfaction and confidence with these goals measured using a modified Canadian Occupational Performance Measure at 8 weeks. Secondary Australia https://doi.org/10.1016/j.jphys.2019.10.002 Commentary The study by Reedman et al helps us to answer the question: What communication techniques combined with sport-specific training and can we do to increase participation in physical activity by young people context-specific strategies to achieve long-term improvement in self- with cerebral palsy? The one-size-fits-all approach used in most selected leisure-time physical activity goals, satisfaction and confi- studies is unlikely to be effective, given the breadth of family prefer- dence. This program might have greater potential for encouraging ences regarding physical activity programs.1 The highly tailored sustainable physical activity, due to consideration of contextual factors ParticiPAte CP intervention developed in this study enabled children and ensuring alignment between the activities and child’s preferences. with cerebral palsy and their parents to participate in leisure-time Given the research that demonstrates many children with cerebral physical activities that met their needs and preferences. This is in line palsy have low physical activity levels, being moderately active over the with others who advocate for determining what the child wants to do, long-term may be better than short-term physical training alone. including activities the child enjoys participating in.2 This approach resulted in improvement in performance of self-selected leisure-time Provenance: Invited. Not peer reviewed. physical activity goals, satisfaction and confidence at follow-up, but did Olaf Verschuren not translate into improvement in habitual physical activity. These findings are particularly relevant since a recent systematic review Center of Excellence for Rehabilitation Medicine, Utrecht, concluded that physical training did not increase physical activity in The Netherlands children with cerebral palsy, and reported conflicting evidence for the effect of interventions with a behavioural component.3 https://doi.org/10.1016/j.jphys.2019.10.001 Ultimately, we must ask ourselves: Is meeting physical activity References guidelines more important than having fun while being active? The ParticiPAate CP program used behaviour change and 1. Wiart L, et al. Phys Occup Ther Pediatr. 2015;35:73–87. 2. Rosenbaum P, et al. Child: Care, Health Dev. 2011;38:457–463. 3. Bloemen M, et al. Dev Med Child Neurol. 2017;59:1004–1010. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 54 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Participation-focused therapy for children with cerebral palsy improves perception of leisure-time physical activity goal performance, satisfaction and confidence Synopsis Summary of: Reedman SE, Boyd RN, Trost SG, Elliott C, Sakzewki L. outcome measures collected at 8 and 16 weeks were parent-reported Efficacy of participation-focused therapy on performance of physical barriers to participation, parent-reported community participation fre- activity participation goals and habitual physical activity in children quency and involvement, child-reported quality of life and physical ac- with cerebral palsy: a randomised controlled trial. Arch Phys Med tivity measured with accelerometers. Results: Thirty-two participants Rehab. 2019;100:676–686. completed the study. At the end of 8 weeks, when compared with the control group, the intervention group demonstrated better performance Question: Does participation-focused intervention improve leisure-time on leisure-time physical activity participation goals (MD 3.58, 95% CI 2.19 physical activity goals and habitual physical activity in children with to 4.97), satisfaction (MD 1.87, 95% CI 0.37 to 3.36) and confidence (MD cerebral palsy? Design: Randomised controlled trial with concealed 1.31, 95% CI 0.12 to 2.50) for these goals. At 16 weeks, these differences allocation. Setting: Community based in Australia. Participants: Inclu- were retained. Parents reported fewer barriers/more facilitators to sion criteria were children aged 8 to 12 years, with cerebral palsy and who participation in the intervention group (MD 27, 95% CI 6 to 47) at 8 weeks, were ambulant. Children were excluded if they had an unstable medical which was not retained at 16 weeks. There was no between-group dif- condition, moderate to severe intellectual, communication, hearing and/ ference for other measures at 8 and 16 weeks. Conclusion: In children or visual impairment, or required surgery in the previous 6 months. with cerebral palsy, when compared with usual care, individualised Randomisation of 37 participants allocated 18 to intervention and 19 to a participation-focused therapy improved their perception of wait-list control group. Interventions: Both groups received usual care as performance, satisfaction and confidence with leisure-time physical ac- well as individual face-to-face sessions with a physiotherapist at three tivity. However, the intervention did not have an effect on community time points: baseline (to set goals) and at 8 and 16 weeks (to score goals). participation, quality of life or objective measures of physical activity. In addition, over the first 8 weeks, the intervention group had a further six physiotherapy sessions aimed at enabling the child’s ongoing Provenance: Invited. Not peer reviewed. participation in leisure activities at home, community and/or school. This was tailored to the individual child and family, and based upon their Alicia Spittle baseline goals. Outcome measures: The primary outcomes were per- Department of Physiotherapy, University of Melbourne, Australia formance on leisure-time physical activity participation goals, and Victorian Infant Brain Studies, Murdoch Children’s Research Institute, satisfaction and confidence with these goals measured using a modified Canadian Occupational Performance Measure at 8 weeks. Secondary Australia https://doi.org/10.1016/j.jphys.2019.10.002 Commentary The study by Reedman et al helps us to answer the question: What communication techniques combined with sport-specific training and can we do to increase participation in physical activity by young people context-specific strategies to achieve long-term improvement in self- with cerebral palsy? The one-size-fits-all approach used in most selected leisure-time physical activity goals, satisfaction and confi- studies is unlikely to be effective, given the breadth of family prefer- dence. This program might have greater potential for encouraging ences regarding physical activity programs.1 The highly tailored sustainable physical activity, due to consideration of contextual factors ParticiPAte CP intervention developed in this study enabled children and ensuring alignment between the activities and child’s preferences. with cerebral palsy and their parents to participate in leisure-time Given the research that demonstrates many children with cerebral physical activities that met their needs and preferences. This is in line palsy have low physical activity levels, being moderately active over the with others who advocate for determining what the child wants to do, long-term may be better than short-term physical training alone. including activities the child enjoys participating in.2 This approach resulted in improvement in performance of self-selected leisure-time Provenance: Invited. Not peer reviewed. physical activity goals, satisfaction and confidence at follow-up, but did Olaf Verschuren not translate into improvement in habitual physical activity. These findings are particularly relevant since a recent systematic review Center of Excellence for Rehabilitation Medicine, Utrecht, concluded that physical training did not increase physical activity in The Netherlands children with cerebral palsy, and reported conflicting evidence for the effect of interventions with a behavioural component.3 https://doi.org/10.1016/j.jphys.2019.10.001 Ultimately, we must ask ourselves: Is meeting physical activity References guidelines more important than having fun while being active? The ParticiPAate CP program used behaviour change and 1. Wiart L, et al. Phys Occup Ther Pediatr. 2015;35:73–87. 2. Rosenbaum P, et al. Child: Care, Health Dev. 2011;38:457–463. 3. Bloemen M, et al. Dev Med Child Neurol. 2017;59:1004–1010. 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 56 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Task-oriented gait training that focuses on the safe and correct use of a walking aid may reduce falls in people with multiple sclerosis Synopsis Summary of: Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos following the intervention, and the Timed Up and Go, Timed 25-foot CL, Cameron MH. ADSTEP: Preliminary investigation of a multicom- Walk, 2-minute walk test and Four Square Step Test assessed post- ponent walking aid program in people with multiple sclerosis. Arch intervention and at the 3-month follow-up. Secondary outcomes were Phys Med Rehabil. 2018;99:2050–2058. the International Physical Activity Questionnaire short form, and patient-reported walking aid satisfaction, balance confidence, and dis- Question: Does the Assistive Device Selection, Training and Education ease impact on everyday life. Results: All participants completed the Program (ADSTEP) reduce falls and improve physical activity and timed study. There were significantly fewer fallers in ADSTEP (10 of 20) than mobility tests in people with multiple sclerosis? Design: Randomised the control group (16 of 20; number needed to treat (95% CI) = 3.3 (1.7 to controlled trial with concealed allocation and blinded outcome assess- 51.6)) but no between-group differences in number of recurrent fallers ment. Setting: Outpatient multiple sclerosis clinic in the Veterans Affairs and average total number of falls. There was no intervention effect on Portland Health Care System, United States of America. Participants: any of the timed mobility tests or patient-reported outcomes, and little Adults with multiple sclerosis who were currently using a walking aid, effect on physical activity, except for reduced sitting time post- had fallen at least once in the previous year, were relapse-free for 30 intervention and at 3 months. Conclusion: Task-oriented assistive days, and able to walk at least 25 feet. Individuals with previous walking device training for people with multiple sclerosis may reduce falls and aid training, dementia, deafness or blindness were excluded. Random- time spent sitting. A larger, fully powered clinical trial is required to isation of 40 participants allocated 20 to ADSTEP and 20 to the control confirm these preliminary findings. group. Interventions: ADSTEP involved six training sessions provided once a week by a physiotherapist. Training involved an initial assess- [95% CI calculated by the CAP Editor.] ment of walking aid use, safety, acceptability, functionality, and device modification if necessary. Subsequent sessions comprised progressive, Provenance: Invited. Not peer reviewed. task-specific gait training over different surfaces, turning, negotiating doorways, narrow spaces, stairs, and outdoor terrains. Head turning and Prudence Plummer dual-tasking were added as participants progressed. Participants rand- Department of Allied Health Sciences, University of North Carolina omised to the control group received usual medical care. Outcome measures: Primary outcomes were the number of falls in the 3 months at Chapel Hill, USA Commentary https://doi.org/10.1016/j.jphys.2019.10.004 Falls and falls-related injuries are commonly seen by clinicians who constant use of an assistive device, improvements in mobility were treat multiple sclerosis. Therefore, developing intervention strategies still evident after intervention, indicating that even patients with specifically targeting falls in this population should be a priority. greater disability may improve mobility in meaningful ways with Approaches specifically targeting people with greater multiple sclerosis- appropriate intervention. related disability and who are still walking should receive particular attention, as this population is more likely to fall or stop walking due to The absence of improvements in gait mobility measures was fear of falls.1 The authors describe an intervention program combining somewhat curious; however, the authors may not have used tests assistive device training with task-oriented gait training with assistive that sufficiently provoked fatigue to affect gait. Fatigue is highly devices, finding that participants who received this training had fewer prevalent in multiple sclerosis and may impact mobility. The use of falls and spent less time sitting than controls. However, there was no longer tests, such as the 6-minute walk test, may be necessary to between-group difference in mobility scores. illustrate training effects on mobility, as evidence suggests that the presence of fatigue may lead to increased falls risk in this population.2 Two clinically important messages emerged from this study. First, using task-specific programs, as opposed to more generalised Provenance: Invited. Not peer reviewed. programs (eg, aerobic fitness, resistance training), indicates that Herb Karpatkin clinicians working with patients with multiple sclerosis should focus on tailoring treatments to the specific gait problems of the Department of Physical Therapy, Hunter College, New York, USA patient. Multiple sclerosis has a very specific clinical presentation, and clinicians who work with this population should be mindful https://doi.org/10.1016/j.jphys.2019.10.006 that interventions are targeted to their patient’s specific impair- ments and functional limitations. Second, despite the fact that the References participants in this study were fairly disabled and required 1. Gunn HJ, et al. Phys Ther. 2013;93:504–513. 2. Karpatkin HI, et al. Crit Rev Phys Rehabil Med. 2013;25:223-230. 1836-9553/© 2019 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 56 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Appraisal Critically appraised paper: Task-oriented gait training that focuses on the safe and correct use of a walking aid may reduce falls in people with multiple sclerosis Synopsis Summary of: Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos following the intervention, and the Timed Up and Go, Timed 25-foot CL, Cameron MH. ADSTEP: Preliminary investigation of a multicom- Walk, 2-minute walk test and Four Square Step Test assessed post- ponent walking aid program in people with multiple sclerosis. Arch intervention and at the 3-month follow-up. Secondary outcomes were Phys Med Rehabil. 2018;99:2050–2058. the International Physical Activity Questionnaire short form, and patient-reported walking aid satisfaction, balance confidence, and dis- Question: Does the Assistive Device Selection, Training and Education ease impact on everyday life. Results: All participants completed the Program (ADSTEP) reduce falls and improve physical activity and timed study. There were significantly fewer fallers in ADSTEP (10 of 20) than mobility tests in people with multiple sclerosis? Design: Randomised the control group (16 of 20; number needed to treat (95% CI) = 3.3 (1.7 to controlled trial with concealed allocation and blinded outcome assess- 51.6)) but no between-group differences in number of recurrent fallers ment. Setting: Outpatient multiple sclerosis clinic in the Veterans Affairs and average total number of falls. There was no intervention effect on Portland Health Care System, United States of America. Participants: any of the timed mobility tests or patient-reported outcomes, and little Adults with multiple sclerosis who were currently using a walking aid, effect on physical activity, except for reduced sitting time post- had fallen at least once in the previous year, were relapse-free for 30 intervention and at 3 months. Conclusion: Task-oriented assistive days, and able to walk at least 25 feet. Individuals with previous walking device training for people with multiple sclerosis may reduce falls and aid training, dementia, deafness or blindness were excluded. Random- time spent sitting. A larger, fully powered clinical trial is required to isation of 40 participants allocated 20 to ADSTEP and 20 to the control confirm these preliminary findings. group. Interventions: ADSTEP involved six training sessions provided once a week by a physiotherapist. Training involved an initial assess- [95% CI calculated by the CAP Editor.] ment of walking aid use, safety, acceptability, functionality, and device modification if necessary. Subsequent sessions comprised progressive, Provenance: Invited. Not peer reviewed. task-specific gait training over different surfaces, turning, negotiating doorways, narrow spaces, stairs, and outdoor terrains. Head turning and Prudence Plummer dual-tasking were added as participants progressed. Participants rand- Department of Allied Health Sciences, University of North Carolina omised to the control group received usual medical care. Outcome measures: Primary outcomes were the number of falls in the 3 months at Chapel Hill, USA Commentary https://doi.org/10.1016/j.jphys.2019.10.004 Falls and falls-related injuries are commonly seen by clinicians who constant use of an assistive device, improvements in mobility were treat multiple sclerosis. Therefore, developing intervention strategies still evident after intervention, indicating that even patients with specifically targeting falls in this population should be a priority. greater disability may improve mobility in meaningful ways with Approaches specifically targeting people with greater multiple sclerosis- appropriate intervention. related disability and who are still walking should receive particular attention, as this population is more likely to fall or stop walking due to The absence of improvements in gait mobility measures was fear of falls.1 The authors describe an intervention program combining somewhat curious; however, the authors may not have used tests assistive device training with task-oriented gait training with assistive that sufficiently provoked fatigue to affect gait. Fatigue is highly devices, finding that participants who received this training had fewer prevalent in multiple sclerosis and may impact mobility. The use of falls and spent less time sitting than controls. However, there was no longer tests, such as the 6-minute walk test, may be necessary to between-group difference in mobility scores. illustrate training effects on mobility, as evidence suggests that the presence of fatigue may lead to increased falls risk in this population.2 Two clinically important messages emerged from this study. First, using task-specific programs, as opposed to more generalised Provenance: Invited. Not peer reviewed. programs (eg, aerobic fitness, resistance training), indicates that Herb Karpatkin clinicians working with patients with multiple sclerosis should focus on tailoring treatments to the specific gait problems of the Department of Physical Therapy, Hunter College, New York, USA patient. Multiple sclerosis has a very specific clinical presentation, and clinicians who work with this population should be mindful https://doi.org/10.1016/j.jphys.2019.10.006 that interventions are targeted to their patient’s specific impair- ments and functional limitations. Second, despite the fact that the References participants in this study were fairly disabled and required 1. Gunn HJ, et al. Phys Ther. 2013;93:504–513. 2. Karpatkin HI, et al. Crit Rev Phys Rehabil Med. 2013;25:223-230. 1836-9553/© 2019 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Physiotherapy 66 (2020) 7–8 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Erratum Erratum to ‘Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial’ [J Physiother. 2018;64:166–171] Flávia Ignácio Antônio a, Robert D Herbert b, Kari Bø c, Ana Carolina Japur Sá Rosa-e-Silva d, Lúcia Alves Silva Lara d, Maira de Menezes Franco a, Cristine Homsi Jorge Ferreira a a Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil; b Neuroscience Research Australia (NeuRA), Sydney, Australia; c Norwegian School of Sport Sciences Department of Sports Medicine, Oslo and Akershus University Hospital, Department of Obstetrics and Gynecology, Lørenskog, Norway; d Department of Obstetrics and Gynecology, Ribeirão Preto Medical School, Univesity of São Paulo, Ribeirão Preto, Brazil In our randomised trial,1 the column and row headings in all tables were correct. However, two row sub-headings (Using HT and Not using HT) were accidentally transposed by the journal in Tables 1, 3 and 5. The corrected tables are presented below. The data are correct in the rest of the paper, the abstract and the raw data file. The data interpretation and conclusions are also correct. Additionally, Figure 1 had an error in footnote b. The corrected Figure 1 is presented below. It indicates that 17 women were using hormone therapy, not 15 women as was indicated in the printed version. Revised Table 1 Baseline characteristics of participants, and of the subgroups of the 38 participants with hormone therapy and the 61 participants without hormone therapy. Characteristics Participants Con Exp (n = 48) (n = 51) Age (years), mean (SD) All 53.1 (4.4) 52.9 (4.1) BMI (kg/m2), mean (SD) Not using HT 53.6 (4.1) 53.4 (3.4) Using HT 51.9 (4.9) 52.2 (4.9) All 28.3 (4.8) 28.5 (5.4) Not using HT 28.8 (5.1) 28.4 (5.5) Using HT 27.3 (4.1) 28.6 (5.5) Gestations (n), mean (SD) All 2.8 (1.4) 2.7 (1.7) Not using HT 2.7 (1.4) 2.8 (1.4) Using HT 3.1 (1.4) 2.5 (2.1) Caesareans (n), mean (SD) All 0.9 (1.1) 1.0 (0.9) Not using HT 0.8 (1.0) 1.0 (1.0) Using HT 1.1 (1.2) 1.0 (0.9) Vaginal births (n), mean (SD) All 1.6 (1.6) 1.1 (1.4) Not using HT 1.6 (1.5) 1.3 (1.6) Using HT 1.5 (1.7) 1.0 (1.3) HT use, n (%) Yes 17 (35) 21 (41) No 31 (65) 30 (59) BMI = body mass index, HT = hormone therapy. DOI of original article: https://doi.org/10.1016/j.jphys.2018.05.002. Correspondence: Cristine Homsi Jorge Ferreira, Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil. Email: [email protected] https://doi.org/10.1016/j.jphys.2019.11.001 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
8 Ignácio Antônio et al: Pelvic floor training and hormone therapy Revised Table 3 Primary and secondary outcomes by group and subgroup. Outcomes Week 0 Week 12 Participants All Exp Con p All Exp Con pa (n = 88) (n = 47) (n = 41) (n = 88) (n = 47) (n = 41) 0.02 0.001 PFM strength (cmH2O), mean (SD) 38.5 (23.6) 36.1 (20.4) 0.61 41.5 (22.6) 44.7 (24.0) 37.8 (20.5) 0.76 All 37.4 (22.1) 35.7 (24.6) 33.5 (19.5) 0.72 39.2 (23.2) 44.0 (25.5) 33.8 (19.5) 42.6 (22.0) 40.0 (21.8) 0.73 45.0 (21.3) 45.8 (22.2) 44.1 (21.0) 0.02 Not using HT 34.7 (22.1) 0.002 0.83 Using HT 41.4 (21.6) 0.08 Prevalence of UI, n/N (%) 0.43 0.08 All 47/88 (53.4) 21/47 (44.7) 26/41 (63.4) 0.09 42/88 (47.7) 17/47 (36.2) 25/41 (61.0) 11/28 (39.3) 19/25 (76.0) 0.01 26/53 (49.1) 8/28 (28.6) 18/25 (72.0) Not using HT 30/53 (56.6) 10/19 (52.6) 0.74 16/35 (45.7) 9/19 (47.4) 7/16 (43.8) 7/16 (43.8) Using HT 17/35 (48.6) 3.8 (5.0) 0.03 3.7 (4.8) 1.9 (2.9) 3.0 (4.5) 6.4 (6.0) 0.001 3.8 (4.9) 1.3 (2.3) 5.8 (5.7) UI severity (0 to 21), mean (SD) 5.0 (5.5) 7.6 (5.5) 0.76 3.5 (4.7) 2.7 (3.5) 6.7 (5.4) 4.4 (6.4) 4.4 (5.9) All 5.0 (5.6) Not using HT 5.2 (5.5) Using HT 4.7 (5.8) HT = hormone therapy, PFM = pelvic floor muscle, UI = urinary incontinence. a Significance of the between-group comparison (difference in mean change for PFM strength and UI severity, and odds ratio for prevalence of UI) at 12 weeks. Revised Table 5 Effect of pelvic floor muscle training by group and subgroup. Outcome Participants Effect p (95% CI) a interaction b Change in PFM strength (cmH2O) All 4.5 (0.8 to 8.1) 0.018 Not using HT 8.0 (3.4 to 12.6) Using HT –0.9 (–6.5 to 4.8) Prevalence of urinary incontinence All 0.36 (0.14 to 0.94) 0.028 Not using HT 0.16 (0.05 to 0.52) Using HT 1.2 (0.30 to 4.4) Change in severity of urinary incontinence (0 to 21) All –1.4 (–3.0 to 0.2) 0.372 Not using HT –0.8 (–2.9 to 1.3) Using HT –2.3 (–4.9 to 0.2) Con = control group, Exp = experimental group, HT = hormone therapy, PFM = pelvic floor muscle. a For change in PFM strength and severity of urinary incontinence, effects are mean differences between the experimental and control groups. For prevalence of UI, effects are odds ratios. b The p-value for the interaction tests the hypothesis that the effect of PFM training differs in women with and without HT. Women assessed for eligibility (n = 124) Excluded (n = 25) • ineligible (n = 19) • declined to participate (n = 6) Measured pelvic floor muscle strength and urinary incontinence symptoms Week 0 Randomised (n = 99) (n = 51)a (n = 48)b Lost to follow-up Experimental group Control group Lost to follow-up (n = 4)c (n = 7)d • Supervised pelvic floor • no treatment or • illness (n = 3) • illness (n = 5) • lack of time to muscle training twice per instructions to perform • lack of time to week x 12 weeks pelvic floor muscle attend testing training attend testing (n = 1) • Home pelvic floor muscle (n = 2) training five times per week x 12 weeks Measured pelvic floor muscle strength and urinary incontinence symptoms Week 12 (n = 47) (n = 41) Revised Figure 1. Design and flow of participants through the trial. a 21 were using hormone therapy b 17 were using hormone therapy c 2 were using hormone therapy d 1 was using hormone therapy References 1. Ignácio Antônio F, Herbert RD, Bø K, Rosa-e-Silva ACJS, Lara LAS, Franco MdM, et al. Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018;64:166–171.
Journal of Physiotherapy 66 (2020) 1–2 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Editorial Internationalisation of Journal of Physiotherapy Mark R Elkins Editor, Journal of Physiotherapy Ten years ago, this journal changed its name from Australian from authors in 22 countries. In 2019, research manuscripts were Journal of Physiotherapy to Journal of Physiotherapy. This change was received from authors in over 50 countries, as shown in Figure 1. intended to reflect its growing reputation as a major international More than one-third of the research manuscripts submitted in 2019 journal in physiotherapy and rehabilitation.1 Although some may had an author group that was collaborating from across multiple have been disappointed to see ‘Australian’ removed from the title, the countries, with seven countries being the largest collection on one Editorial Board at the time considered that the name change was manuscript. necessary to ensure that the Journal remained at the forefront of the profession. Although having ‘Australian’ in the title might be seen as a It is also interesting to compare the authorship of published mark of quality, given the leadership that Australian physiotherapists content (editorials, research papers and appraisal items) over the have had in the profession internationally, it might also have been same decade. Published items with non-Australian authorship interpreted as ‘local’. One intention behind the name change was to comprised 35% of the journal’s content in 2009 and this increased to encourage more submissions of the very best internationally 53% in 2019. competitive work from overseas authors. Also, international mem- bers were added to the editorial board, starting with two in 2012 and The volume and quality of submissions have also both increased. increasing to four in 2015. This was partly to provide a perspective on Between 2009 and 2019, manuscript submissions increased five-fold. issues that authors might be dealing with in other countries and The amount of data summarised in the published systematic reviews partly to encourage submissions from overseas authors. It is therefore has increased, as shown in Figure 2. The size and quality of the timely to consider whether, during the intervening decade, Journal of published randomised trials have also improved. The median PEDro Physiotherapy has internationalised and whether the volume and scores2 rose quickly from 7 in 2009 to 8 in 2011 and have maintained quality of submissions have improved. this level for the remainder of the decade. The median sample size of the trials has also risen over the decade. The readers of the Journal Submissions of original research papers have certainly become appear to appreciate the improvements in the content, with down- more international. In 2009 — the last year under the title Australian loads also increasing substantially. Journal of Physiotherapy — the Journal received research manuscripts Many other factors would have influenced the changes observed over the past decade. The Journal’s move to an open access model Figure 1. Countries from which authors submitted a research manuscript to Journal of Physiotherapy in 2019. Blue shading shows submitting countries. https://doi.org/10.1016/j.jphys.2019.11.002 1836-9553/© 2019 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
2 Editorial Studies (n)25 from our authors, both international and Australian, that have helped the Journal to achieve these outcomes. We look forward to the 20 continued growth and international positioning of Journal of Physiotherapy. 15 Ethics approval: Nil. 10 Competing interests: The author declares that he has no competing interests. 5 Source(s) of support: Nil. Acknowledgements: Nil. 0 Provenance: Invited. Not peer reviewed. 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Correspondence: Mark R Elkins, Centre for Education & Workforce Year Development, Sydney Local Health District, Australia. Email: [email protected] Figure 2. Median number of studies included in systematic reviews published in Journal of Physiotherapy between 2009 and 2019. References that is free for authors and readers has played an enormous role. 1. Bennell K, Hodges P. J Physiother. 2010;56:5. Nevertheless, if the goal was to internationalise, this seems to have 2. Moseley AM, et al. Physiotherapy. 2015;101:e1043. been achieved. We are very grateful for the wonderful contributions
Journal of Physiotherapy 66 (2020) 5 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Paper of the Year 2019 The Editorial Board of Journal of Physiotherapy is pleased to announce the 2019 Paper of the Year Award. The winning paper is judged by a panel of members of the International Advisory Board who do not have a conflict of interest with any of the papers under consideration. They vote for the paper published in the 2019 calendar year that, in their opinion, has the best combination of scientific merit and application to the clinical practice of physiotherapy. The winning paper is ‘Physiotherapist advice to older inpatients about the importance of staying physically active during hospitalisation reduces sedentary time, increases daily steps and preserves mobility: a randomised trial.’1 The authors are Nayara Alexia Moreno from Uni- versidade Cidade de São Paulo and her colleagues in Brazil. The paper addresses the problem of sedentary behaviour during hospitalisation, with many patients spending long periods resting in bed, regardless of the primary reason for their admission. Low physical activity during hospitalisation can lead to impairment of independence, with losses in muscle strength and functional performance. Older adults have less capacity to fully recover from such losses, which are associated with important outcomes after hospital discharge, including disability and mortality. The new research published in Journal of Physiotherapy examined whether physiotherapists could increase older patients’ activity during a hospital admission by providing them with written and verbal advice about the deleterious effects of hospitalisation and the importance of staying active during hospitalisation. Sixty-eight older people were randomised at admission to receive the physiotherapist’s advice or to receive usual care only. In addition to the amount of physical activity, other outcomes measured included mobility, strength, length of stay, and complications. Accelerometry showed a mean between-group difference of 974 steps/day (95% CI 28 to 1919) in favour of the experimental group. The intervention also increased moderate-intensity physical activity and reduced sedentary time. Experimental group participants were about one- fifth as likely to lose mobility during their hospital admission (two of 33) than control group participants (10 of 35), relative risk 0.21 (95% CI 0.05 to 0.90). Effects of the intervention were unclear regarding muscle strength, length of stay and incidence of complications. Patients reported that the main barriers to remaining active during hospitalisation were dyspnoea, lack of space, and fear of contracting infection. The members of the Editorial Board congratulate Nayara Alexia Moreno and her co-authors on their success. Reference 1. Moreno NA, de Aquino BG, Garcia IF, Tavares LS, Costa LF, Giacomassi IWS, Lunardi AC. Physiotherapist advice to older inpatients about the importance of staying physically active during hospitalisation reduces sedentary time, increases daily steps and preserves mobility: a randomised trial. J Physiother. 2019;65:208–214. https://doi.org/10.1016/j.jphys.2019.11.008 1836-9553/
Journal of Physiotherapy 66 (2020) 27–32 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Perioperative pelvic floor muscle training did not improve outcomes in women undergoing pelvic organ prolapse surgery: a randomised trial Thaiana B Duarte a, Kari Bø b, Luiz Gustavo O Brito c, Sabrina M Bueno a, Thays MR Barcelos a, Marília AP Bonacin a, Cristine HJ Ferreira a a Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil; b Department of Sports Medicine, Norwegian School of Sport Sciences and Department of Obstetrics and Gynecology, University Hospital, Lørenskog, Norway; c Department of Gynecology and Obstetrics, School of Medical Sciences, University of Campinas, Campinas, Brazil KEY WORDS ABSTRACT Pelvic floor muscle training Question: In women undergoing surgery for pelvic organ prolapse (POP), what is the average effect of the Pelvic organ prolapse addition of perioperative pelvic floor muscle training on pelvic organ prolapse symptoms, pelvic floor muscle Urogynaecology strength, quality of life, sexual function and perceived improvement after surgery? Design: Randomised Women’s health controlled trial with concealed allocation, blinded assessors, and intention-to-treat analysis. Participants: Physical therapy Ninety-six women with an indication for POP surgery. Intervention: The experimental group received a 9-week pelvic floor muscle training protocol with four sessions before the surgery and seven sessions after the surgery. The control group received surgery only. Outcome measures: Symptoms were assessed using the Pelvic Floor Distress Inventory (PFDI-20), which is scored from 0 ‘unaffected’ to 300 ‘worst affected’. Secondary outcomes were assessed using vaginal manometry, validated questionnaires and Patient Global Impression of Improvement, which is scored from 1 ‘very much better’ to 7 ‘very much worse’. All partici- pants were evaluated 15 days before surgery, and at Days 40 and 90 after surgery. Results: There was no substantial difference in POP symptoms between the experimental and control groups at Day 40 (31 (SD 24) versus 38 (SD 42), adjusted mean difference 26, 95% CI 225 to 13) or Day 90 (27 (SD 27) versus 33 (SD 33), adjusted mean difference 24, 95% CI 223 to 14). The experimental group perceived marginally greater global improvement than the control group; mean difference 20.4 (95% CI 20.8 to 20.1) at Day 90. However, the estimated effect of additional perioperative pelvic floor muscle training was estimated to be not beneficial enough to be considered worthwhile for any other secondary outcomes. Conclusion: In women undergoing POP surgery, additional perioperative pelvic floor muscle training had negligibly small effects on POP symptoms, pelvic floor muscle strength, quality of life or sexual function. Trial registration: ReBEC, RBR– 29kgz5. [Duarte TB, Bø K, Brito LGO, Bueno SM, Barcelos TMR, Bonacin MAP, Ferreira CHJ (2020) Peri- operative pelvic floor muscle training did not improve outcomes in women undergoing pelvic organ prolapse surgery: a randomised trial. Journal of Physiotherapy 66:27–32] © 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction incontinence surgery at some point in their lives,7,8 and several Pelvic organ prolapse (POP) is a major female health problem with studies show that surgical procedure rates for POP have increased a negative impact on quality of life.1 In a prevalence study among over the years.9 Recent systematic reviews have concluded that women with a mean age of 41 years (SD 14) in Brazil, 52% had evi- PFMT reduces POP symptoms and severity stage10 and PFMT has dence of POP stage I.2 In studies conducted in the USA, the prev- alence of POP stage I was 32% among post-menopausal women3 been shown to: increase pelvic floor muscle (PFM) strength and and 76% among women requiring annual gynaecologic examina- endurance; reduce the levator hiatus area; lift the bladder and tion.4 The prevalence of bulge symptoms of POP is almost 50%.5 The rectal ampulla; increase PFM volume; and reduce PFM length.11 most valid symptom of POP is the sensation of a bulge in the vagina.6 However, the recurrence rate after POP surgery is high, ranging Therapeutic options for POP include surgery and conservative from 10 to 54%.7,12,13 Because of this, it could be assumed that the treatments such as insertion of a pessary or pelvic floor muscle training (PFMT). It is estimated that about 11% of women in the success rate of POP surgery would increase by combining surgery general population will undergo a POP correction and/or urinary with PFMT. To date, few randomised trials have been conducted to evaluate the effect of combining POP surgery and PFMT on POP symptoms14,15 and recent systematic reviews have concluded that there is https://doi.org/10.1016/j.jphys.2019.11.013 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
28 Duarte et al: Pelvic floor muscle training in prolapse surgery insufficient evidence to affirm whether incorporating perioperative The postoperative PFMT commenced at 40 days after surgery. The PFMT improves the benefit obtained from surgical repair of POP.10,16,17 women returned to the same supervised training once a week for 7 weeks, with the same prescription of home training. The primary aim of the present study was to estimate the average effect of adding perioperative PFMT to POP surgery on POP symp- Adherence to the home training protocol was registered in a toms. Secondary aims were to estimate the average effect of adding personal training diary. Supervised training sessions were docu- perioperative PFMT to POP surgery on PFM strength, quality of life, mented by the responsible physiotherapist. Every week the sexual function and global impression of improvement. researcher telephoned all women in the experimental group to remind them to perform the home training and fill in the diary. The Therefore, the research question for this randomised trial was: diaries were collected once a week at the supervised sessions. Completion of 75% of the training sessions was categorised as In women undergoing surgery for pelvic organ prolapse, what is adequate adherence. the average effect of the addition of perioperative pelvic floor muscle training on pelvic organ prolapse symptoms, pelvic floor Outcome measures muscle strength, quality of life, sexual function and perceived improvement after surgery? Primary outcome The primary outcome was POP symptoms measured using the Method Pelvic Floor Distress Inventory-20 (PFDI-20, including its subscales Design POPDI-6, CRADI-8 and UDI-6).21 The possible range of scores for the PFDI-20 is 0 (unaffected) to 300 (worst affected). The PFDI-20 has This was a two-arm, parallel group, assessor-blinded, randomised shown adequate to excellent reliability with an intraclass correlation controlled trial. The study was performed at the Clinics Hospital at coefficient of 0.80 in the total score and 0.76 to 0.79 for the subscales.21 Ribeirão Preto, Brazil, where the participants were recruited. The aim and content of the study were explained to women who appeared Secondary outcomes potentially eligible for the study on initial screening. Assessment of Secondary outcomes were PFM strength, quality of life, sexual eligibility criteria and inclusion of participants in the trial were per- formed by a physiotherapist. Eligible women who were interested in function and the participant’s perception of improvement. PFM participating gave their written consent before enrolment into the strength was measured using a Peritron manometera. The partici- study. Participants were randomised to an experimental intervention pants were asked to perform three maximum contractions. The peak (POP surgery with perioperative PFMT) or a control group (POP surgery value (highest value achieved) of the three contractions was recorded only). A simple randomisation procedure was conducted by an assis- in cmH2O.22 Only contractions with visible inward movement of the tant researcher using a computer-generated random assignment list. perineum were considered valid.23 Several studies have shown good The allocation of the participants was concealed. The assistant to excellent intra-rater reliability using manometry, with the intra- researcher who performed the allocation was not involved with any class correlation coefficient ranging from 0.8 to 0.9 for the maximum other part of the research. Outcome measures were recorded at base- voluntary contraction.24–26 For both groups, at the first assessment, line and at 40 and 90 days after surgery. One physiotherapist, who the physiotherapist performed bi-digital vaginal palpation to instruct remained blinded to group allocation, conducted all the assessments. correct PFM contraction; this was performed before the measure- ment with manometry. Participants Quality of life was measured by the Pelvic Floor Impact All participants were recruited at the Urogynecology Clinic, Hos- Questionnaire-7 (PFIQ-7, including its subscales UIQ-7, CRAIQ-7 and pital das Clínicas, Ribeirão Preto Medical School, University of São POPIQ-7).21 The possible range of scores for the PFIQ-7 is 0 (unaf- Paulo, Brazil. Inclusion criteria were: female; aged between 35 and 80 fected) to 300 (worst affected). Reliability studies have found years; literate; POP symptoms (bulging); surgical indication to un- adequate to excellent reliability in total scores from PFIQ-7, with an dergo anterior, apical and/or posterior repair; and POP stage II, III or intraclass correlation coefficient of 0.84 and a range from 0.48 to 0.94 IV, as evaluated by the Pelvic Organ Prolapse Quantification (POP-Q). for its subscales.21 Exclusion criteria were: previous POP surgery; former participation in PFMT; vaginal or urinary infections; endocrine disorders that may Sexual function was measured by the Pelvic Organ Prolapse/Uri- interfere with sexual function (eg, hyperthyroidism); pregnancy; and nary Incontinence Sexual Questionnaire (PISQ-12).27 The range of use of menopause hormone therapy. scores for the PISQ-12 is 0 (worst affected) to 48 (unaffected). There was adequate and excellent reliability in the score of PISQ-12 with an Intervention intraclass correlation coefficient of 0.7.27 The participants randomised to the experimental group received All the outcome measures described above were obtained at the four sessions of intensive supervised PFMT twice a week for 2 weeks same time points for all participants: 15 days before surgery (base- preoperatively and returned 40 days postoperatively for an additional line); 40 days after surgery (Day 40); and 90 days after surgery (Day seven sessions, giving a total of 11 supervised individual PFMT 90). sessions. The participants’ perception of improvement after their allocated A physiotherapist with 10 years of clinical experience in women’s intervention was assessed by the Patient Global Impression of health and pelvic floor physiotherapy delivered all the individual Improvement (PGI-I),28 which is rated from 1 (very much better) to 7 supervised sessions to the women randomised to the experimental (very much worse). This measure was performed only at Days 40 and group. The PFMT followed principles of a PFMT protocol shown to be 90 postoperatively and was conducted by the same blinded investi- effective for urinary incontinence and POP.18–20 Each session included gator. The PGI-I has excellent reliability at 6 months and 1 year based four sets of 10 repetitions of maximum voluntary contractions with a on Cronbach’s alpha analysis of responses (0.8).28 7-second hold and a 7-second rest period between each contraction. The sets were performed in supine, sitting, kneeling and standing. At Data analysis the end of each set, women were asked to perform five quick con- tractions. In addition, the women were encouraged to perform the A pilot study was conducted with 11 women to determine the same protocol at home at least three times a week. appropriate sample size. The objective of this was to determine the standard deviation of the symptoms of POP based on the PFDI-20 total score. Using the standard deviation of 21.6 obtained from the pilot data and considering a significance level of 1% and a study po- wer of 90%, a minimum of 31 participants was required for each group. To account for possible losses to follow up, it was planned to include a minimum of 40 women per group.
Research 29 Assessed for eligibility (n = 244) Excluded (n = 148) . declined to participate (n = 71) . previous gynaecological surgery (n = 60) . changed the date of surgery (n = 9) . illiterate (n = 8) Measured PFDI-20, POPDI-6, CRADI-8, UDI-6, PPFIQ-7, UIQ-7, CRAIQ-7, POPIQ-7, PISQ-12, and pelvic floor manometry (peak, endurance and mean strength) Baseline Randomised (n = 96) (n = 48) (n = 48) Lost to follow-up .Experimental group . Control group pre -operative pelvic no pelvic floor .(n = 2) floor muscle training .muscle training unable to pelvic organ contact (n = 2) . x 2 weeks prolapse surgery pelvic organ prolapse surgery Day 40 Measured PFDI-20, POPDI-6, CRADI-8, UDI-6, PPFIQ-7, UIQ-7, CRAIQ-7, POPIQ-7, Day 90 PISQ-12, and pelvic floor manometry (peak, endurance and mean strength), and PGI-I (n = 46) (n = 48) .Experimental group . Control group post operative pelvic no pelvic floor floor muscle training muscle training x 7 weeks Measured PFDI-20, POPDI-6, CRADI-8, UDI-6, PPFIQ-7, UIQ-7, CRAIQ-7, POPIQ-7, PISQ-12, pelvic floor manometry (peak, endurance and mean strength), and PGI-I (n = 46) (n = 48) Figure 1. Design and flow of participants through the trial. CRADI-8 = Colorectal-Anal Distress Inventory, CRAIQ-7 = Colorectal-Anal Impact Questionnaire, PFDI-20 = Pelvic Floor Distress Inventory, PFIQ-7 = Pelvic Floor Impact Ques- tionnaire, PGI-I = Patient Global Impression of Improvement, PISQ-12 = Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, POPDI-6 = Pelvic Organ Prolapse Distress Inventory, POPIQ-7 = Pelvic Organ Prolapse Impact Questionnaire, UDI-6 = Urinary Distress Inventory, UIQ-7 = Urinary Impact Questionnaire. An exploratory data analysis was carried out using central and fulfilled the inclusion criteria and were randomised into the experi- dispersion position measurements, with 95% CI of mean/median mental group (n = 48) or the control group (n = 48). In the experimental differences. The sociodemographic variables were described by ab- group, there were two dropouts before the Day 40 assessment. One solute and relative frequencies. Student’s t-tests were used to assess participant in the control group did not attend for measurement on Day differences between the means. Chi-square tests were performed to 40, but did return for the final assessment on Day 90. She is therefore test whether there was a difference between the proportions of re- not shown as lost to follow-up on the flow diagram, but the missing sponses between groups. Day 40 data are indicated in the results tables. A mixed linear regression model was adjusted to assess the effect Compliance with the study protocol of time and groups with regard to the outcomes.29 The models were calculated at the PROC MIXED command at SAS 9.3 statistical pack- All participants remained in their groups according to the original ageb. Repeated measurements over time for each individual were allocation for the duration of their participation in the study. All considered as a random effect in the model. Residual analysis was participants completed the home exercise diaries. In the experi- performed using graphs of normality and dispersion between the mental group, adherence with the intervention was very good, with observed and predicted values. Analyses were conducted according to 93% of participants completing . 75% of the supervised sessions and the principle of intention to treat. 76% reporting that they had performed their home training on 75 to 100% of the days prescribed. At Day 90, participants in the control Results group were asked about home training; none of them reported having performed PFMT. Flow of participants through the study Characteristics of the participants The study recruited and followed the participants from February 2015 to June 2016. The flow of participants is shown in Figure 1. A total Baseline characteristics are presented in Table 1 and in the first of 244 women were assessed for eligibility. Ninety-six participants two columns of data in Tables 2 and 3. There were no important
30 Duarte et al: Pelvic floor muscle training in prolapse surgery Table 1 Exp Con the possibility of stronger effects in either direction. These results are Characteristics of participants at baseline. (n = 48) (n = 48) presented in Table 3. Characteristic 1 (2) 4 (8) Quality of life 14 (29) 13 (27) Both groups showed marked improvement in the PFIQ-7, Age category (y), n (%) 33 (69) 31 (65) 37 to 40 improving from scores around 80 points preoperatively to scores 40 to 60 33 (69) 30 (63) between 9 and 14 points at Days 40 and 90; however, the mean es- . 60 15 (31) 18 (38) timates of the effect of adding PFMT were within 3 points of no effect on Days 40 and 90. The confidence intervals around these estimates Marital status, n (%) 6 (13) 7 (15) were within 25 points either side of no effect (Table 2). Similarly, no with partner 29 (60) 24 (50) clear between-group differences were identified for the subscales without partner 9 (19) 8 (17) related to urinary impact (UIQ-7), colorectal-anal impact (CRAIQ-7) 9 (19) and POP impact (POPIQ-7) (Table 2). Education level (y), n (%) 4 (8) 1 30 (63) Sexual function 2 to 5 31 (65) 18 (38) At Day 40, 39 women answered the PISQ-12: 18 in the experi- 6 to 9 17 (35) . 10 5 (10) 2 (4) mental group and 21 in the control group. They all responded again at 18 (38) 21 (44) Day 90 except one in the experimental group. Although both groups Ethnicity, n (%) showed improvement from baseline at both reassessment points, the Caucasian 1 (6) 1 (5) estimates of the effect of adding PFMT were within 2 points of no other 6 (33) 8 (38) effect for the mean between-group differences. The confidence in- 11 (61) 12 (57) tervals around these estimates were within 8 points either side of no Smoker, n (%) effect (Table 2). Sexually active with a partner, n (%) 13 (27) 12 (25) Sexual activity frequency (n/month), n (%) 22 (46) 24 (50) Global impression of improvement 13 (27) 12 (25) At Day 40, both groups reported average perceived improvement ,1 4.4 (2.4) 4.5 (2.6) 1 to 3 7 (15) scores between 1 point (very much better) and 2 points (much better) 4 2 (4) 35 (73) on the PGI-I scale from 1 to 7. The adjusted mean between-group Body mass index category, n (%) 37 (77) 3.5 (5.5) difference estimated a benefit due to the addition of PFMT of 20.4, normal 3.5 (5.3) 31 (65) but the confidence interval extended as far as no effect (0.0 to 20.8). overweight 24 (50) Similarly, at Day 90, both groups reported average perceived obese 28 (58) improvement scores between 1 and 2 points on the PGI-I scale. The Parity (n), mean (SD) 26 (54) 9 (19) adjusted mean between-group difference again estimated a benefit Instrumental delivery, n (%) 5 (10) 11 (23) due to the addition of PFMT of 20.4 and the confidence interval Episiotomy, n (%) 17 (35) extended almost to no effect (20.1 to 20.8). These results are pre- Highest newborn weight (kg), mean (SD) 21 (44) sented in Table 2. Previous pelvic surgery, n (%) 21 (44) 13 (27) Location of pelvic organ prolapse, n (%) 6 (13) Individual participant data are presented in Table 4 on the anterior vaginal wall 4 (8) 3 (6) eAddenda. posterior vaginal wall 12 (25) 7 (15) anterior and posterior vaginal wall 3 (6) 3 (6) Discussion Pelvic organ prolapse stage, n (%) 2 (4) 0 (0) II anterior or posterior 0 (0) 1 (2) III anterior or posterior IV anterior or posterior II anterior and III posterior III anterior and II posterior IV anterior and II posterior IV anterior and III posterior Con = control group, Exp = experimental group. between-group differences in sociodemographic and other back- The results of the present study did not demonstrate any clear ground variables. At baseline, there were no important between- short-term benefit of combining PFMT with POP surgery on POP group differences for patient-reported outcomes or manometry. symptoms, PFM strength, quality of life or sexual function. Many of these estimates had confidence intervals that were precise enough to Primary outcome indicate that any effect of the intervention would be too small to be worthwhile. The perception of improvement was slightly better on Although both groups improved markedly after surgery, the ana- average for women who received PFMT in addition to surgery, but the lyses of the primary outcome provided estimates that were consistent confidence intervals around these estimates did not exclude the with no important between-group differences due to PFMT. The possibility that the average difference in perceived improvement adjusted between-group difference in the total PFDI-20 score at Day might be trivially small. 40 was MD 26 points (95% CI 225 to 13). The adjusted between- group difference in the total PFDI-20 score at Day 90 was MD 24 Direct comparison with other studies are difficult because they points (95% CI 223 to 14). Moreover, no important between-group differ in design, outcome measures, exercise protocols, addition of differences were apparent on the subscales related to POP symp- lifestyle intervention to PFMT, length of follow-up and surgical pro- toms (POPDI-6), anorectal symptoms (CRADI-8) or urinary symptoms cedures.14,15,30–32 Some studies included patients with diagnoses (UDI-6). These results are presented in Table 2. other than POP, such as stress urinary incontinence, and conducted both POP surgery and stress urinary incontinence surgery at the same Secondary outcomes time,14,30 while other studies included patients undergoing hyster- ectomy in addition to regular POP surgery.15,31 The current results, Pelvic floor muscle strength which suggest no clear benefit from adding PFMT to POP surgery, are The analyses of the manometry data provided mean estimates similar to the results of most of the published randomised trials of adding PFMT to POP surgery.14,15,30,31 McClurg et al32 is the only that the addition of PFMT did not induce any important between- research group reporting a positive effect of perioperative PFMT on group differences in PFM peak strength, mean strength or endur- POP symptoms 12 months after surgery. However, the sample size of ance. The mean between-group differences were all within 1 cmH2O this feasibility study was small and the results must be interpreted of no effect (Table 3). The confidence intervals around these results with caution. were mostly within about 5 cmH2O above or below no effect, although the confidence interval for peak strength did not exclude In the randomised trial by Jarvis et al,30 PFMT appeared to improve quality of life but this may have been due to more attention from the physiotherapist in the training group. In a recent secondary report of the trial by Barber et al,14 Weidner et al33 reported no effect of PFMT
Research 31 Table 2 Mean (SD) of groups and adjusted mean (95% CI) between-group difference for patient-reported outcomes. Outcome Groups Adjusted between-group difference Day 40 Baseline Day 90 Day 40 Day 90 Exp Con Exp Con Exp Con Exp minus Con Exp minus Con (n = 48) (n = 48) (n = 46) (n = 47) (n = 46) (n = 48) PFDI-20 102 123 31 38 27 33 26 24 (0 to 300) (55) (62) (24) (42) (27) (33) (225 to 13) (223 to 14) POPDI-6 40 48 5 9 6 6 24 0 (0 to 100) (20) (24) (7) (16) (9) (13) (29 to 1) (25 to 4) CRADI-8 24 29 13 13 11 11 21 0 (0 to 100) (21) (24) (13) (19) (14) (20) (27 to 6) (28 to 7) UDI-6 39 47 14 16 11 17 22 26 (0 to 100) (27) (29) (16) (22) (15) (21) (210 to 6) (214 to 1) PFIQ-7 82 80 14 13 9 14 3 23 (0 to 300) (71) (75) (30) (31) (23) (25) (219 to 25) (225 to 20) UIQ-7 32 36 6 8 4 8 21 25 (0 to 100) (32) (33) (15) (21) (13) (22) (29 to 6) (212 to 3) CRAIQ-7 11 9 3 2 3 2 0 0 (0 to 100) (19) (23) (7) (9) (11) (9) (23 to 4) (24 to 4) POPIQ-7 39 33 5 3 3 1 2 1 (0 to 100) (35) (33) (14) (11) (13) (5) (23 to 7) (23 to 5) PGI-I 1.3 1.7 1.2 1.6 20.4 20.4 (1 to 7) (0.6) (1.2) (0.4) (1.2) (20.8 to 0.0) (20.8 to 20.1) PISQ-12 29a 28b 33c 32b 37c 35b 1 2 (0 to 48) (9) (9) (10) (9) (11) (8) (25 to 7) (24 to 8) Con = control group, CRADI-8 = Colorectal-Anal Distress Inventory, CRAIQ-7 = Colorectal-Anal Impact Questionnaire, Exp = experimental group, PFDI-20 = Pelvic Floor Distress Inventory, PFIQ-7 = Pelvic Floor Impact Questionnaire, PGI-I = Patient Global Impression of Improvement, PISQ-12 = Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, POPDI-6 = Pelvic Organ Prolapse Distress Inventory, POPIQ-7 = Pelvic Organ Prolapse Impact Questionnaire, UDI-6 = Urinary Distress Inventory, UIQ-7 = Urinary Impact Questionnaire. For all outcomes in this table, lower scores are better, so a negative between-group difference favours the experimental group. a n = 18. b n = 21. c n = 17. added to POP and stress urinary incontinence surgery on health- Lack of improvement of PFM variables is in line with the results of related quality of life, sexual function or body image scale Duarte et al,34 Barber et al14 and Frawley et al,31 whereas Jarvis compared with usual care 24 months after surgery. The current re- et al,30 Pauls et al15 and McClurg et al32 reported improved muscle sults are similar to those of the latter study and the study by Pauls function in the PFMT group. The improvement of PFM strength found et al.15 The only clearly favourable result of the current study was the by Jarvis et al30 and McClurg et al32 was statistically significant, but higher score on the perception of improvement found in the PFMT the improvement was very small, so it is debateable whether the group, but even this result had a confidence interval that still change is of any clinical relevance. McClurg et al,32 who was the only included trivially small benefit. This outcome can be associated with group to find a positive effect of perioperative PFMT, provided only the increased attention given to the training group. Weidner et al33 seven supervised sessions compared with 11 in the present study. did not find any difference in this outcome assessed at 24 months The number of supervised visits was higher in the present study than after the intervention. in other randomised trials in this area. However, it cannot be ruled out that a higher training dosage (frequency, intensity and duration) Some strengths of the present study were: the use of a protocol is needed to show a significant effect of perioperative PFMT on POP using PFMT solely without any additional interventions; apropriate symptoms. Further studies comparing different and longer training statistical power with minimal loss to follow-up; use of a supervised protocols are needed to further clarify this. From an economical and and intensive PFMT regimen; high adherence; blinding of assessors; practical point of view, it could be argued that 11 sessions with a and use of reliable and valid outcome measures. physiotherapist should be enough to show any short-term advantage of POP surgery. The effect of PFMT depends on the dosage of training and adherence, so a possible limitation of the study was the relatively This study had sufficient statistical power to determine whether short duration of the intervention and follow-up periods. Although PFMT provides some additional benefit to POP surgery or not. How- adherence was high, it could be asked whether 11 supervised ses- ever, the majority of the participants had a low socioeconomic status, sions of PFMT is enough to clearly show effects. There was no in- representing a large part of the Brazilian population. This seems to be crease in either PFM mean strength, peak strength or endurance. Table 3 Mean (SD) of groups and adjusted mean (95% CI) between-group difference for manometry. Manometry (cmH2O) Groups Adjusted between-group difference Day 40 Baseline Day 90 Day 40 Day 90 Exp Con Exp Con Exp Con Exp minus Con Exp minus Con (n = 35) (n = 33) (n = 40) (n = 37) (n = 41) (n = 41) Peak 24.8 27.9 27.2 27.7 29.0 28.1 0.2 0.8 Endurance (17.1) (15.4) (19.6) (16.3) (19.0) (18.9) (27.1 to 7.6) (26.4 to 8.1) Mean 5.5 5.3 5.5 5.4 6.3 5.4 0.0 0.8 (4.2) (2.4) (3.3) (2.8) (2.3) (2.3) (21.2 to 1.3) (20.4 to 2.1) 18.8 20.7 20.7 21.0 22.5 22.0 (14.3) (11.6) (15.8) (12.5) (15.7) (14.8) 0.2 20.6 (25.7 to 6.1) (25.2 to 6.5) Con = control group, Exp = experimental group. For all outcomes in this table, higher scores are better, so a positive between-group difference favours the experimental group.
32 Duarte et al: Pelvic floor muscle training in prolapse surgery the first randomised trial including women with this profile, and the 7. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clarck AL. Epidemiology of surgically results may not be generalisable to high-income populations. managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501–506. Although previous trials have had conflicting results, the results of this study support the existing evidence that perioperative PFMT does 8. Fialkow MF, Newton KM, Lentz GM, Weiss NS. Lifetime risk of surgical manage- not add any worthwhile additional short-term benefit to surgery for ment for pelvic organ prolapse or urinary incontinence. Int Urogynecol J Pelvic Floor POP symptoms. Given the evidence that PFMT is effective in reducing Dysfunct. 2008;19:437–440. POP symptoms and improves anatomical POP in POP-Q stages I, II and III, it seems essential that women with POP stage I to III are offered an 9. Jonsson FM, Edenfield AL, Pate V, Visco AG, Weidner AC, Wu JM. Trends in use of evidence-based PFMT protocol as first-line treatment before surgery surgical mesh for pelvic organ prolapse. Am J Obstet Gynecol. 2013;208:70.e1–70.e7. is considered. 10. Li C, Gong Y, Wang B. The efficacy of pelvic floor muscle training for pelvic organ What was already known on this topic: Pelvic organ pro- prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2016;27:981– lapse is common and it impacts quality of life. Therapeutic op- 992. tions include surgery or conservative treatments such as pelvic floor muscle training. The existing evidence about the effect of 11. Brækken IH, Majida M, Engh ME, Bø K. Are pelvic floor muscle thickness and size of adding perioperative pelvic floor muscle training to surgery is levator hiatus associated with pelvic floor muscle strength, endurance and vaginal inconsistent and therefore insufficient to make clinical recom- resting pressure in women with pelvic organ prolapse stages I–III? A cross mendations about its use. sectional 3D Ultrasound Study. Neurourol Urodyn. 2014;33:115–120. What this study adds: In women undergoing surgery for pelvic organ prolapse, the effect of additional perioperative pelvic floor 12. Clarck AL, Gregory T, Edwards R. Epidemiologic evaluation of reoperation for muscle training was estimated to be trivially helpful or harmful surgically treated pelvic organ prolapse and urinary incontinence. Am J Obstet on manometric testing of pelvic floor muscle strength and on Gynecol. 2003;189:1261–1267. relevant quality of life questionnaires. Participants who received the additional pelvic floor muscle training perceived their global 13. Kjøhede P, Norén B, Rydén G. Prediction of genital prolapse after Burch colpo- improvement as marginally higher, although the estimates of this suspension. Acta Obstet Gynecol Scand. 1996;75:849–854. effect showed that the extra improvement may be trivially small. 14. Barber MD, Brubaker L, Burgio KL, Richter H, Nygaard I, Weidner A, et al. Factorial Footnotes: a Cardio-Design, Lara, Victoria, Australia. b SAS Insti- comparision of two transvaginal surgical approaches and of perioperative behav- tute, Cary, NC, USA. ioral therapy for women with apical prolapse: the OPTIMAL randomized trial. JAMA. 2014;311:1023–1034. eAddenda: Table 4 can be found online at https://doi.org/10.1016/j. jphys.2019.11.013. 15. Pauls RN, Crisp CC, Novicki K, Fellner AN, Kleeman SD. Impact of physical therapy on quality of life and function after vaginal reconstrutive surgery. Female Pelvic Med Ethics approval: The Clinics Hospital at Ribeirão Preto Ethics Reconstr Surg. 2013;19:271–277. Committee(s) approved this study (ID 5872/2014). All participants gave written informed consent before data collection began. 16. Zhang FW, Wei F, Wang HL, Pan YQ, Zhen XY, Zhang JX, et al. Does pelvic floor muscle training augment the effect of surgery in women with pelvic organ pro- Competing interests: Nil. lapse? A systematic review of randomized controlled trials. Neurourol Urodyn. Sources of support: This study received a grant from Clinics 2016;35:666–674. Hospital Foundation of the Clinics Hospital at Riberião Preto Medical School. The first author received a scholarship from “Coordination for 17. Hagen S, Stark D. Conservative prevention and management of pelvic organ pro- the improvement of Higher Education Personnel (CAPES)”. The au- lapse in women. Cochrane Database Syst Rev. 2011;12:CD003882. thors received a grant from São Paulo Research Foundation for the visit of Professor Kari Bø to University of São Paulo (17/16262-5). 18. Brækken IH, Majida M, Engh ME, Bø K. Can pelvic floor muscle training reverse Acknowledgements: We thank the participants who were pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded ran- involved in the project. domized, controlled trial. Am J Obstet Gynecol. 2010;203:170.e1–170.e7. Provenance: Not invited. Peer reviewed. Correspondence: Cristine HJ Ferreira, Ribeirão Preto Medical 19. Morkved S, Bø K, Salvesen KA. Pelvic floor muscle training during pregnancy to School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil. prevent urinary incontinence: A single-blind randomized controlled trial. Obstet Email: [email protected] Gynecol. 2003;101:313–319. References 20. Bø K, Hagen RH, Kvarstein B, Jørgensen J, Larsen S. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence. III: Effects of two different 1. Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ degrees of pelvic floor muscle exercise. Neurourol Urodyn. 1990;9:489–502. prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006;194:1455–1461. 21. Arouca MA, Duarte TB, Lott DA, Magnani OS, Noguera AA, Rosa-E-Silva JC, et al. Validation and cultural translation for Brazilian Portuguese version of the Pelvic 2. Horst W, Valle JB, Silva JC, Gascho CLL. Pelvic organ prolapse: prevalence and risk Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20). factors in Brazilian population. Int Urogynecol J. 2017;28:1165–1170. Int Urogynecol J. 2016;27:1097–1106. 3. Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of 22. Ribeiro JD, Guirro EC, Franco MD, Duarte TB, Pomini JM, Ferreira CH. 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Santana GWRM, Aoki T, Auge APF. The portuguese validation of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J. 2012;23:117–121. 28. Srikrishna S, Robinson L, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010;21:523–528. 29. Schall R. Estimation in generalized linear models with random effects. Biometrika. 1991;78:719–727. 30. Jarvis SK, Hallam TK, Lujic S, Abbott JA, Vancaillie TG. Peri-operative physiotherapy improves outcomes for women undergoing incontinence and or prolapse surgery: results of a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2005;45:300– 303. 31. Frawley HC, Phillips BA, Bø K, Galea MP. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2010;29:719–725. 32. McClurg D, Hilton P, Dolan L, Monga A, Hagen S, Frawley H, et al. 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Journal of Physiotherapy 66 (2020) 9–18 j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s Research Physical exercise attenuates cognitive decline and reduces behavioural problems in people with mild cognitive impairment and dementia: a systematic review Chun-Kit Law a, Freddy MH Lam b, Raymond CK Chung a, Marco YC Pang a a Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; b Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong KEY WORDS ABSTRACT Exercise Questions: What is the effect of physical exercise on cognitive decline and behavioural problems in people Dementia with mild cognitive impairment (MCI) or dementia? What is the effect of physical exercise on particular Cognitive dysfunction domains of cognitive function? How do training protocols and patients’ characteristics influence the out- Systematic review comes? Design: Systematic review and meta-analysis of randomised trials. Participants: People with MCI or Meta-analysis dementia as their primary diagnosis. Intervention: Physical exercise. Outcome measures: Cognitive func- tion including global cognition, memory, executive function, reasoning, attention, language, and behavioural problems. Results: Forty-six trials involving 5099 participants were included in this review. Meta-analysis of the data estimated that aerobic exercise reduced the decline in global cognition, with a standardised mean difference (SMD) of 0.44, 95% CI 0.27 to 0.61, I2 = 69%. For individual cognitive functions, meta-analysis estimated that exercise lessened working memory decline (SMD 0.28, 95% CI 0.04 to 0.52, I2 = 40%). The estimated mean effect on reducing the decline in language function was favourable (SMD 0.17), but this estimate had substantial uncertainty (95% CI –0.03 to 0.36, I2 = 67%). The effects of exercise on other cognitive functions were unclear. Exercise also reduced behavioural problems (SMD 0.36, 95% CI 0.07 to 0.64, I2 = 81%). Conclusion: Physical exercise can reduce global cognitive decline and lessen behavioural problems in people with MCI or dementia. Its benefits on cognitive function can be primarily attributed to its effects on working memory. Aerobic exercise at moderate intensity or above and a total training duration of . 24 hours can lead to a more pronounced effect on global cognition. [Law C-K, Lam FMH, Chung RCK, Pang MYC (2020) Physical exercise attenuates cognitive decline and reduces behavioural problems in people with mild cognitive impairment and dementia: a systematic review. Journal of Physiotherapy 66:9–18] © 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction rates throughout the disease progression.24–26 The areas and severity Due to its increasing prevalence, dementia has become a major of cognitive decline also vary greatly among patients. Knowing that public concern in recent years. In 2010, it was estimated that 36 million people were suffering from dementia worldwide. The number exercise improves global cognition is important but insufficient. is anticipated to increase to 115 million by 2050.1 Imaging studies have found that exercise has a particularly potent effect on certain brain regions27 (eg, hippocampus28); this suggests Decline in cognitive functions and behavioural problems are the common and inter-related symptoms of dementia.2–4 Progression of that the effect of exercise could vary across the different cognitive behavioural problems in people with dementia is associated with a higher rate of cognitive decline.5 Cognitive and behavioural problems functions. The effect of exercise on individual cognitive functions has can induce diverse issues such as reduced daily function and inde- pendence, which substantially increase the risk of institutionalisation been widely evaluated in people without cognitive decline or with and caregiver burden.6–14 Effective intervention is needed to reduce mild cognitive impairment (MCI)20,29–31 but limited in people with the deterioration of cognitive functions and behavioural problems in dementia. An existing systematic review19 that included studies of people with cognitive impairment. people with dementia failed to delineate the effect of physical ex- Exercise improves cognition,15–21 but most of the evidence15–18,21 ercise by including trials that adopted multiple interventions32,33 relates to global cognition, which is a summary measure of diverse cognitive functions such as attention, executive function, memory, and no meta-analysis was conducted. The effect of exercise on in- language and reasoning.22,23 These cognitive functions are managed by different areas of the brain and are known to decline at different dividual cognitive functions in people with dementia remains unclear. While it was suggested that exercise can alleviate behavioural problems, the evidence is seldom reviewed.34,35 The most recent reviews16,17 that have attempted to investigate the influence of exercise on behavioural problems did not draw a solid conclusion. https://doi.org/10.1016/j.jphys.2019.11.014 1836-9553/© 2019 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
10 Law et al: Exercise for cognition and behaviour in dementia Therefore, the research questions for this systematic review were: Box 1. Inclusion criteria. 1. What is the effect of physical exercise on cognitive decline and Design behavioural problems in people with mild cognitive impairment Randomised controlled trial (MCI) or dementia? Published in English 2. What is the effect of physical exercise on particular domains of Participants cognitive function? People with mild cognitive impairment (MCI) or dementia as the primary diagnosis 3. How do training protocols and patients’ characteristics influence the outcomes? Intervention Physical exercise Methods Outcome measures Identification and selection of trials Measures of cognitive functions Measures of behavioural problems PubMed, CINAHL, MEDLINE, PsycINFO, and The Cochrane Data- base of Systematic Reviews were searched electronically using terms Comparisons including Alzheimer, dementia, mild cognitive impairment, physical Exercise versus no intervention/placebo exercise, randomized, clinical trial, etc. (see Appendix 1 on the eAd- Exercise plus other intervention versus other intervention denda). Two independent researchers screened the retrieved studies only for eligibility. In cases of disagreement, the senior researcher was consulted for a final decision. The reference lists of all included The level of evidence for each individual outcome measure was studies and related review articles were screened to identify poten- rated by the Grading of Recommendation, Assessment, Development tially eligible studies. Forward searching based on all studies that and Evaluation (GRADE) system.36 Since only randomised trials were were selected in the process mentioned above was conducted using included in the present review, the initial score for each outcome was Science Citation Index. The last search was conducted in September assigned as ‘high quality’ and any condition listed in Box 2 would 2018. The inclusion criteria are presented in Box 1. Exclusion criteria downgrade the quality of evidence by one level. If less than half of the were reports in books, studies in which the effect of physical exercise participants included in the primary meta-analysis were from trials could not be delineated due to the study design, and conference with a PEDro score of 4, the quality of evidence was downgraded by proceedings. two levels. For outcomes that had insufficient studies for meta-analysis (, five trials), the same criteria were administered on the basis of the Assessment of characteristics of studies total number of trials examining those particular outcomes. The quality of evidence was upgraded by one level when a large effect size was Two researchers extracted data independently. From each selected detected or a dose-response relationship was found. study, they extracted the characteristics of the study population, outcome measures and details of the intervention (ie, type, frequency, Results intensity and duration of training). All types of physical exercise – including aerobic exercise, walking exercise and resistance exercise – Flow of studies through the review were included in this review. Physical exercise that could not be classified into these basic categories was grouped into other exercises Electronic searches identified 9635 records. After screening, 144 (eg, Tai Chi, handball training). If a study combined different types of potentially relevant papers were extracted. Thirty-four eligible papers exercise, it was regarded as integrated exercise. Cognitive function were identified and an additional 16 eligible papers were identified was classified into global cognition, memory, executive function, by forward citation tracking. Finally, 46 trials (50 articles)37–86 reasoning, attention and language. Different assessments examining involving a total of 5099 participants were included in this review the same cognitive function were grouped together for analysis. The (Figure 1). Nine papers were excluded from the meta-analyses operational definitions of different types of exercises and cognitive because the necessary information was not available even after functions are presented in Appendix 2 (see eAddenda for Appendix making requests to the original authors.39,46,49,52,56,60,72,79,80 2). The PEDro score, obtained by searching the PEDro website, was used to assess the methodological quality of each selected trial. Characteristics of the included trials Data analysis The mean age of the participants in the included trials ranged from 68 to 86 years and the severity of cognitive impairment varied Meta-analysis was only conducted if an outcome measure was or from MCI to severe dementia (MCI: 14 trials; mild: seven trials; similar outcome measures were adopted in at least five studies. A list of moderate: 19 trials; severe: two trials; not reported: four trials). which outcome measures were categorised as similar is provided in Different types of exercise were adopted (aerobic: 17 trials; inte- Appendix 3 (see eAddenda for Appendix 3). Meta-analysis was per- grated: 15 trials; resistance: three trials; walking: four trials; others: formed using Comprehensive Meta-analysisa, while forest plots of seven trials). Detailed study characteristics are summarised in Table 1. meta-analyses were generated using Review Managerb. A random- The results of the primary meta-analyses and related sensitivity an- effects model was used to combine the results because different alyses are presented Table 2. The quality of the evidence is sum- study designs (eg, exercise protocol, participant characteristics) were marised in Table 3. used across studies. The summarised effect of exercise was denoted by the standardised mean difference (SMD). Egger’s regression asymme- Effect of exercise on cognitive functions try test was used to examine the existence of publication bias. Separate sensitivity analyses were performed for studies that: had good meth- Global cognition odological quality, were conducted in similar patient subgroups, or Assessments for global cognition were reported in 35 adopted similar intervention, as long as five or more studies were available for inclusion. In cases where the information required for trials.37,38,40–44,46,48–57,60,61,64–66,73,75,77–86 Meta-analysis (26 tri- meta-analysis could not be obtained from the original studies, corre- als, 2079 participants) showed that exercise improved global sponding authors were contacted through email. cognition (SMD 0.44, 95% CI 0.27 to 0.61) (Figure 2 and Table 2).37,38,41–43,48,50,51,53–57,60,61,64,66,75,77,80–86 See Figure 3 on the eAddenda for a detailed forest plot. Different sensitivity analyses (Table 2) were conducted and all reported results in favour of exercise. Notably, aerobic exercise might lead to a more potent improvement in global cognition (SMD 0.45, 95%
Research 11 Box 2. Criteria used to downgrade one level of rating in the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system. Risk of bias for outcomes where meta-analysis was possible, less than half of the participants included in the primary analysis Inconsistency were from trials with a PEDro score of 6 Indirectness for outcomes where meta-analysis was not possible, less than half of the participants included for outcome Imprecision Publication bias evaluation were from trials with a PEDro score of 6 for outcomes where meta-analysis was possible, I2 50% in the primary meta-analysis and the meta-analysis that involved only trials with high methodological quality for outcomes where meta-analysis was not possible, mixed results were reported the participants, intervention, comparator intervention, outcome measure or study design did not match between the included studies and the eligibility criteria for this review insufficient studies for meta-analysis the number of subjects included in the primary meta-analysis was , 800 the 95% CI spanned 0 p , 0.1 on the two-tailed Egger’s regression asymmetry test CI 0.15 to 0.76). In particular, aerobic exercise with moderate to exercise had no clear effect on attentional performance and suggested high intensity further augmented this improvement (SMD 0.60, 95% CI 0.21 to 0.98). Sensitivity analyses of studies with par- that any possible effect would be small (SMD 0.04, 95% CI –0.08 to ticipants possessing Mini Mental State Exam (MMSE) baseline 0.15) (Figure 12 and Table 2).38,40–45,48,51,57,64,65,70,85,86 See Figure 13 score of 10 to 20 (SMD 0.54, 95% CI 0.18 to 0.89) and studies adopting exercise with total training duration . 24 hours (SMD on the eAddenda for a detailed forest plot. No clear effect was 0.66, 95% CI 0.32 to 0.99) also resulted in a more prominent effect than the primary meta-analysis. found in sensitivity analyses (Table 2). Memory Language For memory, assessments of delayed memory were reported in 15 Language ability was assessed in 20 trials.38–41,43–46, trials.43–46,48,49,52,56,57,60,65,67,69,74,86 The primary meta-analysis (11 48–51,56,57,60,65,70,72,77,79 The meta-analysis (14 trials, 1593 participants) trials, 1294 participants; SMD 0.15, 95% CI –0.04 to 0.34) (Figure 4 and suggested that exercise might improve language ability moderately, Table 2) and sensitivity analyses did not provide a clear estimate of although the possibility of a trivial harmful effect was not excluded the effect (Table 2).43–45,48,56,57,65,67,70,74,86 See Figure 5 on the eAd- denda for a detailed forest plot. The meta-analysis on recognition (six Records identified by trials, 291 participants) also did not provide a clear estimate of the electronic search (n = 9635) effect (SMD 0.33, 95% CI –0.25 to 0.92) (Figure 6 and Table 2).41,43–45,51,70 See Figure 7 on the eAddenda for a detailed forest Exclusion of duplicates plot. Six trials assessed other memory functions.39,43,51,56,57,68 One (n = 6522) trial showed that exercise could significantly improve associative memory.68 No significant effect of exercise on declarative mem- Records screened by title Excluded after ory,39,43 incidental memory,39,43 short-term memory51 and subjective and abstract (n = 3113) screening (n = 2969) cognitive complaints56,57 was reported. Records assessed in full text Executive function (n = 144) For executive function, meta-analysis (eight trials, 646 partici- Papers excluded after assessment pants) revealed that exercise could significantly improve working of full text (n = 110) memory, although the effect may be small (SMD 0.28, 95% CI 0.04 to • not journal articles (n = 8) 0.52) (Figure 8 and Table 2).38,41,45,48,51,57,64,85 See Figure 9 on the • non-randomised trials (n = 30) eAddenda for a detailed forest plot. Sensitivity analysis (Table 2) of • participants without cognitive high methodological quality trials showed that exercise might improve working memory moderately, but the possibility of a trivial impairment (n = 15) negative effect was not excluded (SMD 0.14, 95% CI –0.03 to 0.30). • target outcome measures not Seventeen trials assessed cognitive flexibility.38–41,46,48, 51,56,57,60,62,64,65,68,70,79,86 The primary analysis (seven trials, 544 par- assessed (n = 17) ticipants; SMD 0.03, 95% CI –0.14 to 0.20) (Figure 10 and Table 2) • effect of exercise not isolated showed no worthwhile effect.38,41,48,51,62,68,79 See Figure 11 on the eAddenda for a detailed forest plot. No worthwhile effect of exercise (n = 40) on cognitive flexibility was found even when sensitivity analyses were conducted (Table 2). Inhibition was not examined among the Papers identified as eligible print & web 4C=FPO included trials in this review. Hence, there was no evidence regarding (n = 34) the effect of exercise on inhibition. Forward tracking of Reasoning references (n = 16) Reasoning was assessed in two trials conducted in community- Papers included in review (n dwelling older people with MCI.46,65 One study46 reported that 6 = 50) months of resistance training could have a small effect on reasoning, while the other study65 showed that a 3-month walking program had Figure 1. Flow of studies through the review. no clear effect. Attention Attention was examined in 20 trials.38–46,48,51,52,56,57,60,64,65,70,85,86 The meta-analysis (15 trials, 1264 participants) demonstrated that
12 Law et al: Exercise for cognition and behaviour in dementia Table 1 Study characteristics. Study Qualitya N Cognitive Study setting Type of exercise Exercise intensity Total training duration (hr) impairmentb Aguiar 201437 Good 34 Mild Other Integratedc NR 27 Aerobic Moderate 16 Arcoverde 201438 Fair 20 Mild Other Aerobic 72 Aerobic High 36 Baker 201039 Good 29 MCI Community Aerobic Low to moderate 18 Aerobic Moderate to high 105 Barnes 201340 Good 126 MCI Community 72 Integratedd Self-paced 15 Bossers 201541 Good 109 Moderate Residential care units Others NR 15 Walking NR 48 Cancela 201642 Good 114 Moderate Residential care units NR 8 Resistance High 48 Christofoletti 200843 Fair 54 Moderate Residential care units Integratedd NR 4 18 Eggermont 2009a44 Good 61 Moderate Residential care units Aerobic Moderate to high 24 Others NR 36 Eggermont 2009b45 Good 97 Moderate Residential care units Resistance NR 45 Resistance NR 120 Fiatarone Singh 201446 Good 100 MCI Community Aerobic NR NR Integratedc High 48 Fleiner 201747 Good 85 Moderate Residential care units Aerobic Low 18 Integratedd 18 Hoffmann 201648 Good 200 Mild Others Integratedc Low to moderate NR Others NR 60 Hokkanen 200849 Fair 29 Moderate Residential care units Others NR 12 Integratedc NR 72 Holthoff 201550 Good 30 Mild Community Integratedc NR 20 Integratedd 36 Hong 201851 Fair 22 NR Others Aerobic Moderate Walking NR 18 Hu 201452 Fair 204 NR Community Others 18 Moderate to high Kemoun 201053 Fair 31 Moderate Residential care units Walking NR 48 Aerobic 48 Kim 201654 Good 33 Moderate Residential care units Aerobic Tailored to participants’ 96 Aerobic capabilities 9 Kwak 200855 Fair 30 Moderate Community Integratedc NR 48 Walking NR NR Lam 201556 Good 555 MCI Community Aerobic 18 Integratedc Moderate to high 18 Lam 201157 Good 389 MCI Community Aerobic Moderate to high 20 Others 20 Lam 201258 Good 389 MCI Community Integratedd NR 30 Integratedd NR 24 Landi 200459 Poor 30 Moderate Residential care units Integratedd Moderate to high 96 Integratedd NR 18 Lautenschlager 200860 Good 170 MCI Community Aerobic NR 48 Aerobic NR NR Lee 201861 Fair 60 NR Residential care units Aerobic High 60 Integratedc High 24 Liu-Ambrose 201662 Good 70 MCI Others Others High 12 Aerobic NR 21 Lowery 201463 Good 131 Moderate Community Aerobic Moderate Others High Lü 201564 Good 45 MCI Community Moderate NR Maki 201265 Good 150 MCI Community Low Miu 200866 Moderate Nagamatsu 201367 Good 85 Moderate Community Low Nagamatsu 201268 Moderate to high Rolland 200769 Good 86 MCI Community Scherder 200570 Sobol 201871 Fair 86 MCI Community Steinberg 200972 Stevens 200673 Good 134 Severe Residential care units Sungkarat 201774 Telenius 2015a75 Fair 43 Severe Residential care units Telenius 2015b76 Toots 201777 Good 52 MCI Others Toulotte 200378 van Uffelen 200879 Fair 27 Moderate Community Varela 201280 Venturelli 201181 Poor 75 NR Residential care units Vreugdenhil 201282 Wei 201483 Good 66 MCI Community Yang 201584 Yoon 201385 Good 163 Moderate Residential care units Zhu 201886 Good 170 Moderate Residential care units Good 186 Moderate Residential care units Poor 20 Moderate Others Good 152 MCI Community Good 48 Mild Residential care units Good 21 Moderate Residential care units Good 40 Mild Community Fair 60 MCI Residential care units Fair 50 Mild Community Fair 20 Moderate Residential care units Good 60 MCI Community NR = not reported, MCI = mild cognitive impairment. a Better methodological quality is indicated by a higher PEDro score (9 to 10: excellent; 6 to 8: good; 4 to 5: fair; , 4: poor). b Cognitive impairment level is classified by average Mini Mental State Exam score of participants (. 24: MCI; 20 to 24: mild; 10 to 20: moderate; , 10: severe). c With aerobic component. d Without aerobic component. (SMD 0.17, 95% CI –0.03 to 0.36) (Figure 14 and Table 2).40,41,43–45, (33%). Reasons for low attendance included behaviour disorders, 48,50,51,56,57,65,70,77,79 See Figure 15 on the eAddenda for a detailed forest plot. disagreement or unwillingness to continue, and acute disease. In Behavioural problems addition, among the 37 trials that reported information about super- Behavioural problems were assessed in 11 trials.42,47,48,50, vision of the intervention, only two of them60,72 reported that partic- 57,59,63,69,72,75,84 The meta-analysis (nine trials, 1172 participants) demonstrated that exercise can reduce behavioural problems but the ipants underwent interventions without supervision. Otherwise, relatively wide confidence intervals indicated that the favourable effect may or may not be worthwhile (SMD 0.36, 95% CI 0.07 to 0.64) interventions were under the supervision of trainers or caregivers. (Figure 16 and Table 2).42,47,48,50,57,63,69,75,84 See Figure 17 on the eAddenda for a detailed forest plot. Data on adverse events were reported in 27 Attendance and adverse events trials.37,38,40–42,46–48,50,52,56–58,60,62–64,67,69,72,74,75,77,79,81,83,86 Nine Attendance to the intervention was reported in 14 trials38,56,64,74,75,79,81,83,86 reported that there were no adverse events. trials.38,41,42,47,48,60,62,65,69,74,77,79,81,86 The attendance rates had a wide Seven trials42,47,57,58,60,63,72 reported adverse events that were regar- range of 33 to 93% and all reported that attendance rates were . 60%, except that one trial67 reported a particularly low attendance rate ded by the original authors as likely unrelated to the intervention. Seven trials37,40,46,48,62,67,69 reported adverse events that were potentially related to the intervention (eg, acute episodes of shortness of breath,67 fall,40,46,62,67 pain,40 dizziness,40,48 hospitalisation,40 ery- thema/itching,37 exacerbations of pre-existing arthritis symptoms,46 musculoskeletal problems,48 faintness,48 and atrial fibrillation48). In addition, the relationship between the intervention and adverse events was not mentioned in four trials.41,50,52,77
Research 13 Table 2 Publication Meta-analysis and sensitivity analysis results for different aspects of cognitive function. bias Outcome Trials (n) Participants (n) SMD 95% CI I2 Yes Yes Exp Con 0.44 0.27 to 0.61 69% Yes 0.29 0.11 to 0.47 68% Yes Global cognition 0.39 0.07 to 0.70 75% Yes 0.33 0.11 to 0.54 8% No primary meta-analysis 26 1011 1068 0.54 0.18 to 0.89 80% Yes 0.45 0.15 to 0.76 71% Yes high quality only 17 852 905 0.43 0.13 to 0.73 73% Yes 0.60 0.21 to 0.98 70% Yes MMSE score . 24 6 396 444 0.23 0.07 to 0.40 35% 0.66 0.32 to 0.99 81% Yes MMSE score 20 to 24 7 205 190 Yes 0.15 –0.04 to 0.34 59% Yes MMSE score 10 to 20 11 370 392 0.10 –0.06 to 0.25 41% No 0.14 –0.10 to 0.38 63% aerobic exercise only 11 352 352 0.16 –0.04 to 0.36 35% No integrated exercise only 9 420 411 0.33 –0.25 to 0.92 82% Yes No aerobic exercisea 7 236 219 0.28 0.04 to 0.52 40% Yes 0.14 –0.03 to 0.30 0% total training time 24 hr 13 514 590 0.30 0.02 to 0.58 48% No Yes total training time . 24 hr 12 477 458 0.03 –0.14 to 0.20 0% No 0.05 –0.13 to 0.23 0% Delayed memory 0.01 –0.16 to 0.19 0% No No primary meta-analysis 11 624 670 0.04 –0.08 to 0.15 0% No 0.05 –0.07 to 0.17 0% No high quality only 9 597 638 0.01 –0.15 to 0.17 0% No 0.11 –0.19 to 0.41 47% No MMSE score . 24 6 428 480 0.12 –0.06 to 0.30 ,1% No 0.05 –0.09 to 0.19 0% total training time 24 hr 7 339 407 20.01 –0.28 to 0.25 42% Yes Yes Recognition 0.17 –0.03 to 0.36 65% No 0.05 –0.11 to 0.21 51% Yes primary meta-analysis 6 141 150 0.00 –0.19 to 0.19 43% Yes 0.33 –0.14 to 0.80 79% Yes Working memory 0.22 0.02 to 0.42 47% 0.08 –0.28 to 0.43 77% No primary meta-analysis 8 292 354 No 0.36 0.07 to 0.64 81% No high quality only 5 261 323 0.35 0.04 to 0.66 83% 0.28 0.10 to 0.46 24% total training time 24 hr 7 270 331 Cognitive flexibility primary meta-analysis 7 289 255 high quality only 5 269 233 aerobic exercise only 6 279 243 Attention primary meta-analysis 15 597 667 high quality only 10 539 604 MMSE score . 24 5 282 347 MMSE score 10 to 20 6 178 195 aerobic exerciser only 6 243 238 total training time 24 hr 10 378 444 total training time . 24 hr 5 219 223 Language primary meta-analysis 14 788 805 high quality only 11 751 761 MMSE score . 24 5 450 471 MMSE score 10 to 20 5 196 204 total training time 24 hr 9 425 490 total training time . 24 hr 5 363 315 Behavioural problems primary meta-analysis 9 560 612 high quality only 8 535 587 total training time 24 hr 6 351 407 SMD = standardised mean difference, MMSE = Mini Mental State Exam. a moderate to high intensity. Discussion There was a moderate level of evidence showing that exercise has minimal effect on cognitive flexibility and attention. The meta- This is the first systematic review to estimate the effect of exercise analyses revealed no favourable effects with relatively low hetero- on individual cognitive functions and behavioural problems geneity across studies. Nonetheless, when the characteristics of the among people with MCI or dementia. In line with previous reviews, trials (n = 7) that examined cognitive flexibility were scrutinised, exercise was estimated to be effective for global cognition.15,17,18,20 those trials were found to be similar in the type of exercise adopted However, it appears to selectively improve particular areas of cogni- (aerobic = 6, resistance = 1) and severity of participants’ cognitive tive function. impairment (baseline MMSE score 20 = 5, baseline MMSE score 10 to 20 = 1, not reported = 1). It remains unclear whether cognitive Among the various cognitive functions that were examined, the flexibility could be improved by other types of exercise or in people results revealed that physical exercise can improve working memory. with more severe dementia. On the other hand, the trials examining Working memory is one of the cognitive functions that shows earlier attention were diverse in trial characteristics. This suggests that ex- decline among all cognitive functions in people with Alzheimer’s ercise in general does not have an effect on attention, regardless of disease,26 and may thus be more sensitive to exercise intervention. the difference in exercise types and characteristics of the participants. There was also very low quality of evidence showing an improvement Although the meta-analysis of delayed memory and recognition also in language function in the exercise group. However, the possibility of yielded non-significant results, the effect of exercise on these cogni- a trivial negative effect could not be excluded. Also, the heterogeneity tion functions was highly uncertain because the heterogeneity across was still moderate to high in all sensitivity analyses. There could be studies was very large. No concrete conclusion could be drawn. Other unidentified factors affecting the participants’ responsiveness to ex- memory-related functions and reasoning were insufficiently studied ercise training on language improvement. Upon scrutinising the in- to draw any conclusion. dividual studies included in the meta-analyses, most studies showed that the intervention group exhibited no improvement, while the This review also demonstrated that exercise significantly reduces control group demonstrated significant cognitive decline during the behavioural problems assessed by the Neuropsychiatric Inventory, study period. Thus, exercise is effective in alleviating cognitive which measures various aspects of behavioural functioning (eg, decline rather than enhancing cognitive functions. apathy, agitation).87 Failure in these aspects of behavioural
14 Law et al: Exercise for cognition and behaviour in dementia Table 3 Grades of Recommendation, Assessment, Development and Evaluation (GRADE) quality of evidence. Outcome Risk of Inconsistency Indirectness Imprecision Publication Effect Plausible Dose- GRADE bias bias size residual response rating confounding gradient Global cognition 0 –1a 0 0 –1b 0 Low Global cognition 0 –1a 0 –1c 0 0 0 0 Moderate (aerobic exercise only) 0 11d Delayed memory 0 0 0 –1e –1b 0 Low Recognition 0 –1a 0 –1e 0 0 0 0 Low Working memory 0 0 –1e –1b 0 0 0 Low Cognitive flexibility 0 0 0 –1e 0 0 0 0 Moderate Reasoning 0 0 0 –1e 0 0 0 0 Low Attention 0 –1f 0 –1e 0 0 0 0 Moderate Language 0 0 0 –1e –1b 0 0 0 Very low Behavioural problem 0 –1a 0 0 0 Moderate Associative memory 21g –1a 0 00 0 0 0 Low Declarative memory 21g 0 0 –1h 0 0 0 0 Low Incidental memory 21g 0 0 –1h 0 0 0 0 Low Short-term memory 21g 0 0 –1h 0 0 0 0 Low 0 0 –1h 0 0 0 a I2 50% in the primary and high methodological quality analysis. b Publication bias is present. c Number of participants included in the analysis is , 800. d Particular training intensity yielded a more prominent effect. e Effect size overlaps 0 in the primary or high methodological quality analysis. f Mixed results reported across trials, and meta-analysis is not possible. g Fewer than half of the participants included for outcome evaluation were from trials with a PEDro score of 6. h Insufficient studies for meta-analysis. Study SMD (95% CI) functioning were found to be related to the defects of certain brain Random regions and neurotransmitter systems.88 Exercise can induce the Aguiar 2014 release of neurotrophic factor and certain neurotransmitters (eg, Arcoverde 2014 norepinephrine, serotonin) and facilitate brain plasticity and the Bossers 2015 balance of the neurotransmitter system,89,90 which may alleviate Cancela 2016 behavioural problems. Christofoletti 2008 Hoffmann 2016 Training duration and type of exercise appeared to be influential Holthoff 2015 training parameters to prompt the favourable effect of exercise on Hong 2018 global cognition. When the training duration of the included trials Kemoun 2010 was divided according to median split (median = 24), the sensitivity Kim 2016 analyses showed that a total training duration . 24 hours resulted in Kwak 2008 a more potent improvement in global cognition when compared with Lam 2015 the primary meta-analysis. Additionally, it was found that aerobic Lam 2011 exercise yielded a more pronounced beneficial effect on global Lee 2018 cognition than the effect seen in the primary analysis that pooled all Liu-Ambrose 2016 exercise types. The effect was further enhanced when only studies Lü 2015 incorporating moderate to high intensity aerobic exercise were Miu 2008 included. Unfortunately, no other types of exercise (eg, resistance Telenius 2015a training) could be singled out for sensitivity analysis. The improve- Toots 2017 ment in cognition through aerobic exercise could be attributed to its Varela 2012 facilitation on adult hippocampal neurogenesis.90,91 The current Venturelli 2011 positive finding agrees with this postulation but the included trials in Vreugdenhil 2012 this review did not aim to examine the neural mechanisms and thus a Wei 2014 causal relationship could not be confirmed.92–95 A similar trend could Yang 2015 not be observed in other outcomes that reported positive findings, Yoon 2015 perhaps due to the insufficient number of trials for sensitivity ana- Zhu 2018 lyses (ie, working memory and behavioural problems). Total Baseline cognitive impairment level is another important factor in determining the treatment outcomes. The sensitivity analysis showed print & web 4C=FPO –4 –3 –2 –1 0 1 2 3 4 that people with more severe cognitive impairment tend to have a better outcome in global cognition with exercise. People with lower Favours con Favours exp MMSE score at baseline also tend to have a steeper cognitive decline rate, and thus any therapeutic effect of exercise may be more Figure 2. Standardised mean difference (95% CI) of the effect of exercise on global apparent.96 This has important clinical implications because people cognition by pooling data from 26 trials (n = 2079). with more severe cognitive deficits can still benefit from exercise. To evaluate the sustainability of the benefits from exercise, six trials included in this review conducted follow-up assessments on global cognition for a period of time (from 4 weeks to 12 months) after the exercise intervention had ceased.41,46,49,50,60,86 Three of the trials reported that the improvement was not sustained when the follow-up assessment was conducted at 12 weeks (ie, 4, 9 and 12 weeks) after the end of the intervention,41,49,50 whereas the other three trials showed that improvement was able to last for an
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