Pulmonary Rehabilitation in African Countries

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Respiratory Conditions
• Intervention / Treatment: Other: Centre-based Pulmonary Rehabilitation; Other: Community-based Pulmonary Rehabilitation

Detailed Description

Overview of the Study This study is part of the EQUI-RESP-AFRICA programme, a global health research initiative led by the University of Edinburgh and partners across Africa. It focuses on improving care for people living with chronic respiratory diseases (CRDs)-long-term lung conditions that make breathing difficult and can severely limit daily life.

These conditions include illnesses such as chronic obstructive pulmonary disease (COPD), asthma, and lung damage following tuberculosis (TB). While these diseases are well-recognised in high-income countries, they are especially widespread-and often more complex-in low- and middle-income countries (LMICs), including Nigeria, South Africa, and Cameroon.

Despite this high burden, access to effective treatment is often limited. This study aims to address that gap by evaluating pulmonary rehabilitation (PR)-a structured, non-drug treatment that helps people breathe better, move more, and improve their quality of life.

What is Pulmonary Rehabilitation?

Pulmonary rehabilitation is a comprehensive programme that combines:

• Supervised exercise training (e.g., walking, strength exercises)
• Education about managing lung disease
• Psychological and emotional support
• Nutritional advice
• Training in self-management skills It is widely recommended in clinical guidelines and has been shown to reduce breathlessness, improve physical fitness, and enhance overall well-being. However, most of the evidence comes from high-income settings, and little is known about how best to deliver these programmes in lower-resource environments.

Why This Study is Needed?

Although earlier research suggests that pulmonary rehabilitation can work in LMICs, most studies have been small and of limited quality. There are still important unanswered questions:

• Can PR be delivered effectively in low-resource settings?
• What is the best way to organise and deliver these programmes?
• Will patients attend and complete the programme?
• Are community-based programmes as effective as hospital-based ones? This study is designed to answer these questions through a feasibility study and a pilot randomised controlled trial (RCT).

Study Design

The study has two main components:

1. Feasibility Study

   This first phase explores whether pulmonary rehabilitation can be delivered in the three countries. It examines:

   • Available infrastructure and resources
   • Training needs for healthcare staff
   • Acceptability of PR among patients and healthcare providers
   • Barriers and facilitators to implementation This phase also includes interviews with patients, healthcare professionals, and stakeholders (such as policymakers and community leaders).
2. Pilot Randomised Controlled Trial (RCT) The second phase tests the effectiveness of pulmonary rehabilitation in real-world settings.

Participants

• Around 90 adults (30 per country) with chronic respiratory diseases
• Conditions include COPD and post-TB lung disease
• All participants must be medically stable and able to exercise Randomisation

Participants are randomly assigned to one of two groups:

1. Centre-based PR (hospital or clinic setting)
2. Community-based PR, supported by local health workers and remote (telehealth) supervision Randomisation ensures that the groups are comparable and allows a fair comparison of the two delivery models.

The Intervention: What Participants Do

Participants in both groups take part in an 8-week rehabilitation programme, with:

• 3 sessions per week
• Each session lasts about 2 hours
• A total of 24 sessions

The programme includes:

Exercise Training

• Walking (indoors or outdoors)
• Cycling or step exercises
• Strength training using weights or improvised equipment
• Flexibility and balance exercises Education and Self-Management
• Understanding their lung condition
• Learning breathing techniques
• Proper use of inhalers
• Managing flare-ups Additional Support
• Psychological counselling (if needed)
• Nutritional advice
• Smoking cessation support

Community-based participants receive similar support, but sessions are delivered in local settings using simpler equipment and supported by community health workers, often with remote guidance from specialists.

Outcomes: What the Study Measures The study evaluates whether pulmonary rehabilitation improves patients' health and daily functioning.

Primary Outcome

• Exercise capacity, measured using the 6-minute walk test (how far a person can walk in six minutes) Secondary Outcomes
• Breathlessness
• Quality of life
• Anxiety and depression
• Muscle strength
• Lung function (spirometry)

Measurements are taken at:

• Baseline (before the programme)
• 8 weeks (end of programme)
• 6 months (to assess long-term effects) Qualitative Research

To complement the clinical data, the study includes interviews with:

• Patients
• Healthcare providers (e.g., doctors, physiotherapists)
• Stakeholders (e.g., policymakers, community leaders)

These interviews explore:

• Experiences with the programme
• Barriers to participation
• Suggestions for improvement
• Perceptions of feasibility and sustainability This helps ensure that future programmes are practical, acceptable, and scalable.

What Makes This Study Important

This research goes beyond simply testing whether pulmonary rehabilitation works. It aims to understand:

• How to deliver PR in low-resource settings
• Whether community-based care can expand access
• What factors influence success and sustainability The findings will inform future large-scale trials and guide policy decisions across Africa and other LMICs.

Expected Impact

If successful, this study could:

• Improve access to effective, non-drug treatments for millions of people with chronic lung disease
• Reduce disability, hospital admissions, and healthcare costs
• Support the integration of pulmonary rehabilitation into routine healthcare systems
• Provide a scalable model for other low-resource settings globally

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Obianuju Ozoh, Professor; Phone Number: +234 805 657 0994; Email: oozoh@unilag.edu.ng
• Study Contact Backup: Name: Ziyaad Dangor, Professor; Phone Number: +27 11 274 9200; Email: ziyaad.dangor@wits-vida.org

Study Locations

• Cameroon
  • Yaoundé, Cameroon
    • Regional Hospital Limbe
    • Contact: Yauba Saidu, Doctor; Phone Number: +237 000 2221 1284; Email: ysaidu@clintonhealthaccess.org
• Nigeria
  • Lagos
    • Lagos, Lagos, Nigeria, 00234
      • Lagos State University Hospital
      • Contact: Obianuju Ozoh, Professor; Phone Number: oozoh@unilag.edu.ng; Email: oozoh@unilag.edu.ng
      • Sub-Investigator: Jibril Mohammed, Professor
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2041
      • Chris Hani Baragwanath Academic Hospital
      • Contact: Ziyaad Dangor, Professor; Phone Number: +27 11 274 9200; Email: ziyaad.dangor@wits-vida.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Centre-based Pulmonary Rehabilitation; 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; Pulmonary Rehabilitation for this centre-based arm will take place in a designated hospital/clinic/medical facility and will be supervised by healthcare professionals.
Active Comparator: Community-based Pulmonary Rehabilitation; 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; Pulmonary Rehabilitation for patients in this arm will take place in the participant's community with regular telehealth/telemedicine supervision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life	Measure: St. George's Respiratory Questionnaire (SGRQ) Total Score; Unit of Measure: Total score (0-100); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate worse respiratory health-related quality of life.	8 weeks
Anxiety Symptoms	Measure: Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A); Unit of Measure: Score (0-21); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate greater anxiety symptoms.	8 weeks
Depressive Symptoms	Measure: Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D); Unit of Measure: Score (0-21); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate greater depressive symptoms.	8 weeks
Dyspnea Severity	Measure: Modified Medical Research Council (mMRC) Dyspnea Scale; Unit of Measure: Ordinal score (0-4); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate greater perceived breathlessness.	8 weeks
Disease Impact	Measure: COPD Assessment Test (CAT); Unit of Measure: Score (0-40); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate greater disease impact on health status.	8 weeks
Occupational Performance	Measure: Canadian Occupational Performance Measure (COPM) Performance Score; Unit of Measure: Score (1-10); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate better self-perceived occupational performance.	8 weeks
Occupational Satisfaction	Measure: Canadian Occupational Performance Measure (COPM) Satisfaction Score; Unit of Measure: Score (1-10); Time Frame: Change from baseline to 8 weeks; Description: Higher scores indicate greater satisfaction with occupational performance.	8 weeks
Pulmonary Function	Measure: Forced Expiratory Volume in 1 Second (FEV₁); Unit of Measure: Litres (L); Time Frame: Change from baseline to 8 weeks; Description: Pulmonary function will be assessed using spirometry according to standardised procedures. Higher values indicate better pulmonary function.	8 weeks
Peripheral Muscle Strength	Measure: Quadriceps Muscle Strength assessed using one-repetition maximum (1RM); Unit of Measure: Kilograms (kg); Time Frame: Change from baseline to 8 weeks; Description: Higher values indicate greater quadriceps muscle strength.	8 weeks
Body Mass Index	Measure: Body Mass Index (BMI); Unit of Measure: kg/m²; Time Frame: Change from baseline to 8 weeks; Description: BMI will be calculated as weight in kilograms divided by height in meters squared (kg/m²) using standardised measurements of height and weight. Higher values indicate greater body mass relative to height.	8 weeks

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Igor Rudan, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; COPD; Tuberculosis; South Africa; Africa; Pulmonary Rehabilitation; Cameroon; Nigeria; Chronic Respiratory Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma; Tuberculosis
• Other Study ID Numbers: AC26040; NIHR156234 (Other Grant/Funding Number: NIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share pseudonymised data from this trial with other researchers.
• IPD Sharing Time Frame: Available at the start date till end of the study
• IPD Sharing Access Criteria: Request made to the principal investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No