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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)
  1. Derrick Lopez1,
  2. Nola Cecins2,
  3. Joanne Cockram3,
  4. Anna Collins3,
  5. Holly Landers1,4,
  6. Frank Sanfilippo1,
  7. Tom Briffa1,
  8. Fraser Brims1,5,6,7,
  9. Elizabeth Geelhoed8,
  10. Kevin Murray1,
  11. Kirsten Phillips9,
  12. David Preen1 and
  13. Susan Jenkins1,2,7,10
  1. 1School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia
  2. 2Physiotherapy Department, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
  3. 3Community Physiotherapy Services, Perth, Western Australia, Australia
  4. 4Joondalup Health Campus, Joondalup, Western Australia, Australia
  5. 5Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
  6. 6Medical School, Curtin University, Perth, Western Australia, Australia
  7. 7Institute for Respiratory Health, Perth, Western Australia, Australia
  8. 8School of Allied Health, The University of Western Australia, Perth, Western Australia, Australia
  9. 9Lung Foundation Australia, Brisbane, Queensland, Australia
  10. 10School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia
  1. Correspondence to Dr Derrick Lopez; derrick.lopez{at}uwa.edu.au

Abstract

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
  • exercise
  • health economist
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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • 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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