About this trial
Chronic Respiratory Diseases (CRDs) are common disabling conditions worldwide with high prevalence, morbidity and mortality. More than half of the CRD patients live in low- and middle-income countries (LMICs) where resources for identifying the condition, understanding the disease status of individual patients, and overall management are often poor. CRDs in high-income countries (HICs) are dominated by chronic obstructive pulmonary disease (COPD) and asthma, whereas in LMICs, post-tuberculosis (TB) lung disorders, bronchiectasis, and other (often unidentified) respiratory conditions contribute to a significant proportion of CRDs. Pulmonary rehabilitation (PR) is an essential component of evidence-based clinical management guidelines for CRDs, though most of the evidence on PR is disease-specific and generated from HICs. A recent systematic review by the RESPIRE group, with whom we collaborate, revealed that 12 out of 13 studies suggested that PR for patients with CRDs in LMICs was an effective intervention, though the studies were typically at high risk of bias. This highlighted the need for further high-quality large-scale studies in LMICs to assess the enablers and barriers, effectiveness, components, and mode of delivery of PR for CRDs.
In this feasibility study, the investigators will assess the resource infrastructure, optimal components of the PR programme, relevant CRDs eligibility, and model of service delivery for providing PR in Nigeria, South Africa and Cameroon, and then conduct a pilot randomised controlled trial (RCT). The investigators will also assess potential outcomes, including before and after intervention measurement of functional exercise capacity and relevant patient-reported outcomes. In qualitative interviews, the investigators will explore the barriers and enablers and stakeholders' opinions on implementing PR in each country.
The investigators will recruit (Nigeria - 30, South Africa - 30 and Cameroon - 30) clinically eligible patients and provide them with 8 weeks of either a centre- or community-based PR incorporating components derived from global PR guidelines and informed by the prior RESPIRE's systematic review and adapted to be deliverable in a low-resource setting. The investigators will assess the patients at baseline, end of the program (8 weeks) and then at 6 months follow-up to assess sustainability. Moreover, along with the quantitative assessment of outcomes (functional exercise capacity, health-related quality of life, dyspnoea severity and other secondary parameters), the investigators will conduct a qualitative interview with a purposive sample of patients, providers, and other health care professionals, e.g., GPs, pulmonologists, physiotherapists. The investigators will synthesise the findings for conference presentations, peer review publications, and advocate for PR with stakeholders.
Eligibility criteria
Qualifiers
Male and female adults (>= 18 years) with specified clinical diagnosis (typically by detailed clinical history [persistent symptoms for ≥6 months] plus spirometry and/or other available tests, e.g., chest X-ray]
Individuals with CRDs, specifically COPD, asthma or post-tuberculosis lung disorder
Patients with CRDs who have an indication for PR (specifically, these are patients with moderate to severe staged disease who present with reduced exercise/functional capacity, poor quality of life, high disease symptoms, particularly dyspnea) and are medically fit to undergo exercise training (which is to be determined by pre-exercise screening and field tests).
Patients with CRDs attending regular follow-up in the respiratory clinics of the selected centres.
Disqualifiers
Patients with other significant chronic co-morbidities such as heart failure, ischemic heart disease, DM, and confusion/dementia
Pregnant women
Co-morbidity that is a contraindication to PR (e.g., unstable angina, aortic aneurysm, recent myocardial infarction, acute infection, etc.)
Significant cognitive or physical impairment preventing participation in PR
Trial design
Treatments tested in this trial
- Centre-based Pulmonary Rehabilitation
- Community-based Pulmonary Rehabilitation