Pulmonary rehabilitation in low-resource settings for people with breathlessness due to lung conditions

Plain English summary of protocol

Background and study aims
Many people with chronic respiratory diseases (CRDs) such as chronic obstructive pulmonary disease, asthma, and post-tuberculosis damage have disabling symptoms, especially breathlessness, which affect their day-to-day activities. Breathlessness is uncomfortable and frightening, so people tend to avoid activities that make breathlessness worse. Then, because they are not doing any exercise, muscles weaken and they become ‘unfit’, which makes activities even harder. This increases anxiety and fear and affects quality of life, and depression is common. Pulmonary rehabilitation (PR) provides a supervised programme of exercise to reverse this vicious circle. PR combines endurance and muscle-strengthening exercises, with education about the causes and treatment of CRDs, and coping with breathlessness. At the end of the PR course, people with CRDs are less breathless and can do more, improving their quality of life. Previously, almost all PR trials have been performed in high-income countries, with well-equipped gyms and usually for people with one disease. In low- and middle-income countries (LMICs) and other low-resource settings, PR Centres often have less equipment and limited access to tests that allow accurate diagnosis of different types of CRD. Another problem is distance; travelling to a Centre 16 times in 8 weeks may be difficult in rural LMICs, so home-based PR may be useful. This trial aims to determine whether PR interventions provided in such settings effectively enhance exercise capacity, improve quality of life and provide efficacy among individuals with CRD when delivered at home versus traditional centre-based PR. Another focus is to ascertain the duration of benefits derived from PR, examining whether improvements are sustained over 6 months. The study further aims to assess the cost implications associated with PR interventions and gather insights from patients, PR therapists, and professionals to understand their perspectives and opinions regarding the PR services offered.

Who can participate?
Symptomatic adults aged 18 years old and over with CRD from four Centres (Bangladesh, India x2, Malaysia)

What does the study involve?
Participants will be allocated by chance to one of three groups:
1. Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre
2. Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone
3. Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR
Outcomes and expected benefits

Before and after the PR programme, exercise capacity, quality of life, breathlessness, anxiety and depression will be assessed to investigate the impact of PR, and again 6-months later to measure whether benefits are maintained. The use of healthcare resources will be measured to assess the cost implications for the health service, and if successful, how can this be rolled out in LMICs and other low-resource settings. Participants will be interviewed to find out what they think of the PR. The therapists will be asked about the practicalities of delivering PR in their Centre and at home and how they overcame any problems. Referring clinicians, health service managers and policymakers will be interviewed to understand how a service might be implemented and sustained in the four different settings.

Stakeholder and community engagement
Two members of the project team are people with CRD and the team will collaborate with community groups in each of the Centres throughout the trial. Proactive stakeholder engagement will ensure the findings influence professionals and policymakers.

What are the possible benefits and risks of participating?
Studies from high-income countries show that PR helps most people with certain lung diseases to feel less breathless, enables them to do more activities and improves their well-being. It is unknown whether PR will help people in low- and middle-income countries though our feasibility studies are encouraging.

The findings from the assessments will mean the PuRe trial will be able to show whether PR is a useful intervention in low- and middle-income countries. If the study shows that it enables people to do more activities and improves their well-being, governments and health services will be encouraged to provide the service. Although PR involves effort, the evidence from high-income countries and the feasibility study is that most people feel the effort is worthwhile because of the benefits. The safety of doing exercise has been tested carefully in high-income countries and there are no concerns even in people with severe breathlessness.

Where is the study run from?
The team includes people with CRD, clinicians, therapists, researchers, statisticians, health economists and health psychologists from the University of Edinburgh and the four Centres.

When is the study starting and how long is it expected to run for?
March 2024 to August 2027

Who is funding the study?
Medical Research Council

Who is the main contact?
Dr Vicky Hammersley, vicky.hammersley@ed.ac.uk

Contact information

Prof Hilary Pinnock
Scientific, Principal Investigator

Usher Institute, Teviot Place, Old Medical School, University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom

ORCID ID	0000-0002-5976-8386
Phone	0131 6509474
Email	hilary.pinnock@ed.ac.uk

Dr Victoria Hammersley
Public

Usher Institute, Teviot Place, Old Medical School, University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom

Phone	+44 (0)131 6509474
Email	vicky.hammersley@ed.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• Algeria
• Bangladesh
• India
• Malaysia

Study participating centres

Sponsor information

Accord (United Kingdom)
University/education

QMRI, 47 Little France Crescent
Edinburgh
EH16 4SA
Scotland
United Kingdom

Phone	+44 (0)131 5361000
Email	enquiries@accord.scot
Website	https://www.accord.scot/
"ROR"	https://ror.org/01x6s1m65

Funders

Funder type

Government

Results and Publications

Editorial Notes

21/01/2025: The ethics approval was added.
05/04/2024: Study's existence confirmed by the Medical Research Council.