Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial
Chronic respiratory disease
This is a 3-arm individually randomised implementation trial. Randomisation will be carried out by research staff using a web-based randomisation service managed by the Edinburgh Clinical Trials Unit (ECTU). Participants will be randomised to either Centre-PR, Home-PR or Usual Care in the ratio 1:1:1, as shown below. Patients will be randomly allocated to: • Centre-pulmonary rehabilitation (PR): a programme of exercise and education twice a week for 8 weeks at a PR Centre • Home-pulmonary rehabilitation: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone • Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR Before and after the PR programme patients will be assessed for exercise capacity, quality of life, breathlessness, anxiety and depression, to assess the impact of the intervention, and again 6 months later to measure whether the benefits are maintained. The pulmonary rehabilitation will be delivered by trained therapists. The content of sessions will be defined in a detailed manual and local PR teams trained to deliver sessions in a standardised manner. Internationally recognised standards will be used for the exercise components of PR adapted for delivery in low-resource settings. Education resources (booklets, presentations, video clips etc) will build on those already used in the centres, be standardised for PuRe and adapted locally to ensure cultural and contextual relevance. Sessions will be led by PR-trained therapists, with some content (e.g. psychological support, inhaler technique training, smoking cessation) delivered by other professionals according to the local skill mix. Centre-PR will be delivered in groups (compliant with any social distancing requirements); in single-sex groups where this is culturally appropriate. Sessions will last up to two hours and include exercise components and group educ
1. Adults 18 years old (the age of majority in all the countries). No upper age limit. 2. Assessed by referring physician as having persistent and functionally limiting respiratory symptoms (mMRC 2) after optimisation of pharmacological therapy 3. Resident locally and willing to engage with either Centre-PR or Home-PR schedules if randomised to these groups 4. Willing and able to provide written informed consent
1. People with non-respiratory causes for the symptoms (stable co-morbidity may be included if clinically appropriate) 2. Active TB infection 3. Any condition that would increase risk (e.g. uncontrolled cardiac disease) interfere with PR (e.g. neurological disorders, severe arthritis, dementia), or be inappropriate (very severe frailty, end-of-life) 4. On-going, or completed PR (including other exercise programme) within the previous 18 months 5. Living in the same house as another participant 6. Unwilling or unable to provide informed consent