COPD Rehabilitation Study
Research type
Research Study
Full title
Reducing perioperative risk in chronic obstructive pulmonary disease with pre-operative pulmonary rehabilitation - A feasibility study
IRAS ID
227317
Contact name
Kyle Pattinson
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 0 months, 27 days
Research summary
Summary of Research
This is a feasibility study to help design a trial which tests whether pulmonary rehabilitation (a course of exercise and education) helps reduce complications following surgery in patients with chronic obstructive pulmonary disease (COPD).
It is well known that people with COPD have more complications following surgery, and this research intends to test whether we can reduce that. It is also well known that pulmonary rehabilitation has very powerful effects upon breathlessness and quality of life in people with COPD, and reduces hospitalisations and deaths following exacerbations (flare ups) of COPD. Therefore we would like to see if pulmonary rehabiliation can reduce complications following surgery.
We plan to recruit up to 72 people with COPD who are scheduled for major surgery, half of whom would receive pulmonary rehabilitation (the other half are a control group who would not undertake pulmonary rehabilitation).
The pulmonary rehabilitation would take place along side the normal pulmonary rehabilitation courses run by the NHS (run either in hospitals or community centres, sports halls etc). It is very unlikely that routine pulmonary rehab would be normally offered to this sub set of patients by surgical/anaesthetic teams. If the participant did attend a pulmonary rehab course as clinical management (as opposed to being part of the trial) then they would be excluded from the study.
The study would start approximately 3 to 4 weeks before surgery, and would finish 6 months after surgery. Patients who undergo pulmonary rehabilitation would undertake up to 9 sessions before surgery, the exact number and timing dependend upon time available. In addition to pulmonary rehabilitation, patients would also complete self-report questionnaires at various points during the surgery, a walk test before surgery, and data on surgical recovery would be collected from NHS records.
Summary of Results
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). Methods: We 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). Results: We 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. Conclusions: Although 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.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
17/YH/0220
Date of REC Opinion
17 Jul 2017
REC opinion
Further Information Favourable Opinion