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
- pulmonary rehabilitation
- health economist
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Contributors DL, NC, HL, FS, EG and SJ conceived the initial study concept, and together with JC and AC, they designed the trial and wrote the protocol with statistical support from KM. DL wrote the first draft of the manuscript and NC, JC, AC, HL, FS and SJ provided early critical feedback. TB, FB, KM, KP and DP reviewed the later iterations and provided input to the study design and protocol.
Funding This project is supported by the WA Department of Health Research Translation Project grant.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval Approval has been received from the ethics committees of South Metropolitan Health Services (RGS645), WA Department of Health (DOH HREC #−2018/11) and The University of Western Australia (RA/4/20/4672). Consent will be obtained in accordance with the Australian National Health and Medical Research Council National Statement on Ethical Conduct of Human Research for the trial and for linkage to health-related administrative data from State and Federal government agencies for a future study to determine long-term outcomes (up to 10 years). The trial will be conducted according to the principles of Good Clinical Practice and Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
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