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.

Community-based pulmonary rehabilitation in a non-healthcare facility is feasible and effective.

Pulmonary rehabilitation programs (PRPs) are most commonly provided in hospital settings which present barriers to attendance such as long distances or travel times. Community-based settings have been used in an attempt to alleviate the travel burden. This study evaluated the feasibility and outcomes of a network of community-based PRPs provided in non-healthcare facilities (CPRPs). The CPRPs were established in five venues and comprised two supervised group sessions each week for 8 weeks. Participant inclusion criteria and guidelines for exercise testing and training were developed to reduce the risk of adverse events. Outcome measures included 6-min walk distance (6MWD) and health-related quality of life (chronic respiratory questionnaire (CRQ)). Respiratory-related hospital admission data were collected in the 12 months prior to and following the program. Two hundred and fifty-one participants (79% with chronic obstructive pulmonary disease: mean ± SD FEV1 49 ± 21%predicted) entered a CPRP of which 166 (66%) completed. Improvements were demonstrated in 6MWD (mean difference (95% CI) 44 m (37-52)) and total CRQ score (0.5 points per item (0.4-0.7)). Fewer participants had a respiratory-related hospital admission following the program (12% vs. 37%, p < 0.0001). Pulmonary rehabilitation is safe, feasible and effective when conducted in community-based non-healthcare facilities.

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.