Pulmonary rehab for uncontrolled asthma associated with elevated BMI
Research type
Research Study
Full title
A pragmatic, randomised, controlled, trial of the effect of a tailored pulmonary rehabilitation package in uncontrolled asthma associated with elevated body mass index
IRAS ID
213696
Contact name
Douglas C Cowan
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Exercise, a common trigger for symptoms in asthmatics, may be avoided because of associated breathlessness or fear of asthma attack, leading to impaired exercise tolerance and reduced ability to carry out work and normal daily activities. Asthma affects an estimated 120,000 individuals in GGC, a significant proportion of whom are poorly controlled; this puts a high burden on health care resources. Obesity and physical inactivity may be important factors. Pulmonary rehabilitation (a program of care for respiratory patients comprising exercise and education) is standard care in COPD but there is not consistent guidance regarding its role in asthma. It may be particularly beneficial in overweight/obese difficult asthma but is not promoted. We will evaluate the effects of a tailored pulmonary rehabilitation package in this subgroup of asthmatics using a randomised, controlled, partial-cross-over study design.
Summary of Results
In this research study, we set out to evaluate the impact of an 8 week pulmonary rehabilitation program designed specifically for patients with difficult-to-control asthma and elevated body mass index. 95 participants were randomly split into two groups, and allocated to either pulmonary rehabilitation (48) or usual care (47) for 8 weeks; thereafter, those in the usual care group were switched to pulmonary rehabilitation. All participants were followed up to one year. The groups were similar at baseline; 20% were using injectable asthma treatments, 32% were using daily prednisolone tablets, and body mass index was elevated.
To assess the impact of pulmonary rehabilitation compared to usual care, the main endpoint (or measure) we chose was effect on asthma-related quality of life (the “AQLQ questionnaire”) after 8 weeks; no significant difference was found for pulmonary rehabilitation compared to usual care. However, pulmonary rehabilitation was associated with significant improvement in asthma control (as measured by the “ACQ questionnaire”) compared to usual care. There were also significant improvements in favour of pulmonary rehabilitation for exertional breathlessness (the “MRC breathlessness scale”), for exercise tolerance (the “six-minute walk distance”), and for degree of breathless after exercise (the “Borg breathlessness scale”).
In longer-term follow up, a proportion of participants maintained the initial benefits of pulmonary rehabilitation at 1 year, whereas others did not. In addition, some seemed to be ‘late-responders’ and developed benefits further down the line. Those with worse asthma control and asthma quality of life scores at baseline were more likely to benefit from pulmonary rehabilitation.
There was a substantial drop-out rate of 31% for the pulmonary rehabilitation program and this is similar to that found for “real world” pulmonary rehabilitation. Never-the-less, pulmonary rehabilitation was found to be safe, and well-tolerated, with no adverse events.
REC name
West of Scotland REC 1
REC reference
16/WS/0200
Date of REC Opinion
18 Jan 2017
REC opinion
Further Information Favourable Opinion