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).
exercise
health economist
pulmonary rehabilitation
Journal
BMJ open respiratory research
ISSN: 2052-4439
Titre abrégé: BMJ Open Respir Res
Pays: England
ID NLM: 101638061
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
16
12
2019
revised:
07
02
2020
accepted:
10
02
2020
entrez:
27
3
2020
pubmed:
27
3
2020
medline:
20
7
2021
Statut:
ppublish
Résumé
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. 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. 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. ANZCTR 12618000933257.
Identifiants
pubmed: 32209643
pii: 7/1/e000548
doi: 10.1136/bmjresp-2019-000548
pmc: PMC7206909
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Int J Chron Obstruct Pulmon Dis. 2018 Jan 10;13:257-273
pubmed: 29391784
BMJ Open. 2017 Nov 17;7(11):e019226
pubmed: 29151055
Chest. 2013 Oct;144(4):1124-1133
pubmed: 23429931
Respirology. 2019 Sep;24(9):909-915
pubmed: 30891887
Control Clin Trials. 1989 Dec;10(4):407-15
pubmed: 2691207
Cochrane Database Syst Rev. 2015 Feb 23;(2):CD003793
pubmed: 25705944
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
Respirology. 2017 May;22(4):800-819
pubmed: 28339144
Eur Respir J. 2009 Sep;34(3):648-54
pubmed: 19720809
Aust Health Rev. 2008 Aug;32(3):415-22
pubmed: 18666869
Eur Respir J. 2014 Dec;44(6):1428-46
pubmed: 25359355
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Eur Respir J. 2014 Oct;44(4):873-84
pubmed: 24993906
Chron Respir Dis. 2017 Feb;14(1):3-10
pubmed: 27315829
Appl Health Econ Health Policy. 2016 Feb;14(1):105-15
pubmed: 26346590
Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64
pubmed: 24127811
Thorax. 1987 Oct;42(10):773-8
pubmed: 3321537
Am J Respir Crit Care Med. 2017 Mar 1;195(5):622-629
pubmed: 27611807
J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):65-9
pubmed: 24983708
Respirology. 2010 Nov;15(8):1157-73
pubmed: 20920127