scholarly journals 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)

2020 ◽  
Vol 7 (1) ◽  
pp. e000548
Author(s):  
Derrick Lopez ◽  
Nola Cecins ◽  
Joanne Cockram ◽  
Anna Collins ◽  
Holly Landers ◽  
...  

IntroductionPulmonary 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 analysisThe 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 disseminationApproval 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 registrationANZCTR 12618000933257

2019 ◽  
Author(s):  
Lucy L Marlow ◽  
Angeline HY Lee ◽  
Emma Hedley ◽  
Michael P Grocott ◽  
Michael C Steiner ◽  
...  

AbstractBackgroundPatients with chronic obstructive pulmonary disease (COPD) are at increased risk of complications and death following surgery. Pulmonary complications are particularly prominent. Pulmonary rehabilitation is a course of physical exercise and education that helps people with COPD manage their condition. Although proven to improve health outcomes in patients with stable COPD, it has never been formally tested as a pre-surgical intervention in patients scheduled for non-cardiothoracic surgery. If a beneficial effect were to be demonstrated, pulmonary rehabilitation for pre-surgical patients with COPD might be rapidly implemented across the National Health Service, as pulmonary rehabilitation courses are already well established across much of the United Kingdom (UK).MethodsWe performed a feasibility study to test study procedures and barriers to identification and recruitment to a randomised controlled trial testing whether pulmonary rehabilitation, delivered before major abdominal surgery in a population of people with COPD, would reduce the incidence of post-operative pulmonary complications. This study was run in two UK centres (Oxford and Newcastle upon Tyne).ResultsWe determined that a full randomised controlled trial would not be feasible, due to failure to identify and recruit participants. We identified an unmet need to identify more effectively patients with COPD earlier in the surgical pathway. Service evaluations suggested that barriers to identification and recruitment would likely be the same across other UK hospitals.ConclusionsAlthough pulmonary rehabilitation is a potentially beneficial intervention to prevent post-operative pulmonary complications, a randomised controlled trial is unlikely to recruit sufficient participants to answer our study question conclusively at the present time, when spirometry is not automatically conducted in all patients planned for surgery. As pulmonary rehabilitation is a recommended treatment for all people with COPD, alternative study methods combined with earlier identification of candidate patients in the surgical pathway should be considered.Trial registrationISRCTN 29696295, http://www.isrctn.com/ISRCTN29696295, registered 31st August 2017


2010 ◽  
Vol 16 (5) ◽  
pp. 253-259 ◽  
Author(s):  
Keir E Lewis ◽  
Joseph A Annandale ◽  
Daniel L Warm ◽  
Claire Hurlin ◽  
Michael J Lewis ◽  
...  

We conducted a six-month randomised controlled trial of home telemonitoring for patients with chronic obstructive pulmonary disease (COPD). A total of 40 stable patients with moderate to severe COPD who had completed pulmonary rehabilitation took part. They were randomised to receive standard care (controls) or standard care plus home telemonitoring (intervention). During the monitoring period, patients in the telemonitoring group recorded their symptoms and physical observations twice daily. The data were transmitted automatically at night via the home telephone line. Nurses could access the data through a website and receive alerting email messages if certain conditions were detected. The patients completed the St George's Respiratory Questionnaire, Hospital Anxiety and Depression and the EuroQoL EQ-5D quality of life scores before and after pulmonary rehabilitation, and then periodically during the trial. There were significant and clinically important improvements in the scores immediately following pulmonary rehabilitation, but thereafter there were no differences in quality of life scores between the groups at any time, or consistently within either group over time. The study showed that telemonitoring was safe but, despite being well used, it was not associated with changes in quality of life in patients who had stable COPD.


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