Process evaluation of a maintenance pulmonary rehabilitation trial for people with chronic obstructive pulmonary disease.

BACKGROUND: The ComEx3 community-based extended maintenance pulmonary rehabilitation (PR) randomised controlled trial (RCT) aimed to determine the optimal strategy for maintaining the benefits of exercise for people with chronic obstructive pulmonary disease (COPD). We conducted a process evaluation of this RCT to determine if the trial was implemented per protocol, and to explore the barriers and facilitators of the trial, and mechanisms of impact. METHODS: This was a mixed methods study consisting of analysis of PR class records, study diaries and interviews of those involved in the trial. We developed a reporting framework from available literature and performed a content analysis. RESULTS: Eleven of the 12 participants in the intervention group attended ≥70% of available classes before the trial was terminated due to the COVID-19 pandemic. Analysis of the study diaries found that adherence to the home exercise program was higher in the intervention than the control group. Analyses of interviews (n = 21) highlighted the complexity of standardising the processes across multiple sites, but revealed behaviour change amongst class physiotherapists who were able to conform with the required processes. Facilitators of participation included the desire to improve function and quality of life, while barriers included illnesses and lack of motivation. Mechanisms of impact included confidence in exercising and benefits from the education sessions. CONCLUSIONS: The ComEx3 RCT was implemented as planned largely due to commitment by the research team and the desire by patients to improve their quality of life by attending a PR program that they are familiar with. Successful implementation of PR RCTs requires good organisational skills, clear and consistent trial documentation, broad understanding of participant needs while being conscious of challenges experienced by people with COPD, and dedication by everyone involved in the RCT. SO WHAT?: This article shows the importance of running a process evaluation alongside an RCT. Although this RCT did not progress to completion, this process evaluation which was guided by a robust framework, will provide guidance for future interventions in this area.

Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study).

INTRODUCTION: Pulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence. METHODS AND ANALYSIS: The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches. ETHICS AND DISSEMINATION: Approval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines. CLINICAL TRIAL REGISTRATION: ANZCTR 12618000933257.

Maintaining exercise capacity and quality of life following pulmonary rehabilitation.

OBJECTIVE: The optimum method for sustaining the benefits gained from pulmonary rehabilitation (PR) has not been determined. In this report the authors describe the 4-year referral and uptake patterns to a hospital-based outpatient PR programme, and the sustained benefits of PR in patients with COPD attending a community-based maintenance exercise programme. METHODS: Entry and exit data were mapped for all patients referred to the PR service over the review period. All eligible patients were offered a community-based maintenance exercise programme upon completion of PR. A total of 21 patients underwent follow-up assessment of functional exercise capacity, quality of life (QOL) and health-care utilization. RESULTS: Over a 4-year period, 467 patients (80% with COPD) were referred to the programme, of whom 230 entered PR. In total, 172 patients completed PR, with attrition (25%) being mostly due to medical problems. Of the 84 patients who elected for the community-based programme, 46 were still attending at follow up and 21 patients with moderate-to-severe COPD (44.9 +/- 12.6 (mean +/- SD) FEV(1)% predicted) were reassessed at 18.4 +/- 11.9 months post PR. Significant improvements (mean change (95% confidence interval)) persisted in 6-min walk distance (41.1 m (15.7-66.5)), distance walked in 20 min (195.1 m (82.3-308)) and in QOL (Chronic Respiratory Disease Questionnaire) (11.0 points (4.4-17.6)) (P < 0.01). The QOL improvements exceeded the minimum clinically important difference. A trend towards a reduction in COPD-related hospital admissions, bed-days and emergency department presentations was observed in the 12 months following PR. Self-reported adherence with the home exercise programme indicated that 67% of patients were exercising at least 3-5 days each week in addition to attending a class. CONCLUSION: For patients with moderate-to-severe COPD, a weekly community-based maintenance exercise class, supervised by a physiotherapist, combined with a home exercise programme is an effective intervention for maintaining improvements following PR.