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NOT YET RECRUITING
NCT07602673
NA

Pulmonary Rehabilitation in African Countries

Sponsor: University of Edinburgh

View on ClinicalTrials.gov

Summary

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.

Official title: Respiratory Medicine and Pulmonary Rehabilitation Feasibility Study and Randomised Controlled Trial in Nigeria, South Africa and Cameroon

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-09-01

Completion Date

2027-12-01

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

OTHER

Centre-based Pulmonary Rehabilitation

Pulmonary Rehabilitation for this centre-based arm will take place in a designated hospital/clinic/medical facility and will be supervised by healthcare professionals.

OTHER

Community-based Pulmonary Rehabilitation

Pulmonary Rehabilitation for patients in this arm will take place in the participant's community with regular telehealth/telemedicine supervision.

Locations (3)

Regional Hospital Limbe

Yaoundé, Cameroon

Lagos State University Hospital

Lagos, Lagos, Nigeria

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa