Pulmonary Rehabilitation in African Countries

NCT07602673 | Not Yet Recruiting DMC

• 2 other identifiers: AC26040NIHR156234
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

COPD; Asthma; Tuberculosis; Chronic Respiratory Diseases; Africa; Nigeria; South Africa; Cameroon; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional Exercise Capacity: 6-minute walk test and clinical status.

  Primary Outcome: Functional Exercise Capacity (6-Minute Walk Distance) * Measure: Distance covered during the 6-minute walk test (6MWT) * Unit of Measure: Meters (m) * Time Frame: Change from baseline to 8 weeks * Description: The primary endpoint is the change in 6-minute walk distance (6MWD), analysed as the mean difference (meters) between baseline and 8 weeks across study arms in patients with chronic respiratory diseases (CRDs).

  8 weeks

Secondary Outcomes (10)

• Health-Related Quality of Life

  8 weeks

• Anxiety Symptoms

  8 weeks

• Depressive Symptoms

  8 weeks

• Dyspnea Severity

  8 weeks

• Disease Impact

  8 weeks

Study Arms (2)

Centre-based Pulmonary Rehabilitation

ACTIVE COMPARATOR

Centre-based PR Programme: Participants in the intervention group will receive 24 supervised centre-based pulmonary rehabilitation. The application of treatments to each patient will be based on his/her pre-PR assessment status. The interventions will include physical exercise training (treadmill walking, stationary cycling, strength training. The participants will also receive group general physical exercise for lower and upper extremities, supervised outdoor walks, balance/flexibility exercises, group educational sessions and group relaxation training (and neuromuscular electrical stimulation, if applicable). For those who have an indication (and if applicable), occupational therapy, dietary intervention, psychosocial counselling, and exacerbation management will be offered.

Other: Centre-based Pulmonary Rehabilitation

Community-based Pulmonary Rehabilitation

ACTIVE COMPARATOR

Community-based PR: Participants in the community-based PR groups will also be prescribed patient-tailored pulmonary rehabilitation. These exercise interventions will be delivered by trained community health extension workers using simple and affordable equipment in the community. The interventions will include endurance exercise training, strength training, physical exercise for lower and upper extremities, supervised outdoor walks, balance/flexibility exercises, group educational sessions and group relaxation training. The trained community extension workers will be supervised by therapists via telerehabilitation. For those who have an indication, occupational therapy, dietary intervention, psychosocial counselling, and exacerbation management will be provided at the community centre by the relevant professionals.

Other: Community-based Pulmonary Rehabilitation

Interventions

Centre-based Pulmonary Rehabilitation OTHER

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

Centre-based Pulmonary Rehabilitation

Community-based Pulmonary Rehabilitation OTHER

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

Community-based Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are willing and able to provide written or oral (audio recorded) informed consent
• All levels (primary, secondary, and tertiary) of healthcare professionals, including doctors, nurses, physiotherapists, respiratory therapists, medical assistants, healthcare administrators, pulmonologists, and other formal practitioners working in primary, secondary, and tertiary care settings, who provide services to patients who may potentially require PR.
• Relevant stakeholders, including policymakers, religious leaders, sports leaders, the pharmaceutical industry, social workers, managers, and hospital/practice owners.
• Willing and able to provide written or oral (audio recorded) informed consent.

You may not qualify if:

• 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
• Active pulmonary tuberculosis vi. Patient with current or recent disease exacerbations
• Non-respiratory cause for symptoms (e.g., breathlessness due to heart failure, anaemia)
• Unable to participate in exercise (e.g., due to severe arthritis or paralysis)
• Undertaken PR within one year.
• Unwilling to participate in the study.
• Unable to give written or oral (audio recorded) informed consent
• Healthcare professionals who are not involved in the care of patients who require PR, e.g., midwives
• Having a conflict of interest that may influence the outcome
• Unable and unwilling to give written or oral (audio recorded) informed consent

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (3)

Regional Hospital Limbe

Yaoundé, Cameroon

Location

Lagos State University Hospital

Lagos, Lagos, 00234, Nigeria

Location

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, 2041, South Africa

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Tuberculosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Igor Rudan

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Obianuju Ozoh, Professor

CONTACT

+234 805 657 0994; oozoh@unilag.edu.ng

Ziyaad Dangor, Professor

CONTACT

+27 11 274 9200; ziyaad.dangor@wits-vida.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Centre-based PR Programme: Participants in the intervention group will receive 24 supervised centre-based pulmonary rehabilitation. The application of treatments to each patient will be based on his/her pre-PR assessment status. The interventions will include physical exercise training (treadmill walking, stationary cycling, strength training. The participants will also receive group general physical exercise for lower and upper extremities, supervised outdoor walks, balance/flexibility exercises, group educational sessions and group relaxation training (and neuromuscular electrical stimulation, if applicable), for those who have an indication (and if applicable), occupational therapy, dietary intervention, psychosocial counselling, and exacerbation management will be offered. Community-based PR: Participants in the community-based PR groups will also be prescribed patient-tailored pulmonary rehabilitation. These exercise interventions will be delivered by healthcare professionals.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available at the start date till end of the study
• Access Criteria: Request made to the principal investigators.

Locations

NG (1); CA (1); ZA (1)