Pulmonary Rehabilitation in African Countries

NCT07602673 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Chronic Respiratory Conditions

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.

Sponsors & Collaborators

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Igor Rudan · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-11-01
Completion
2027-12-01

Countries

  • Cameroon
  • Nigeria
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602673 on ClinicalTrials.gov