Pulmonary Rehabilitation in African Countries

University of Edinburgh

Status: Begins enrollment in 1 month

Conditions: Chronic Respiratory Conditions

Treatments: Other: Community-based Pulmonary Rehabilitation; Other: Centre-based Pulmonary Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07602673

NIHR156234 (Other Grant/Funding Number)

AC26040

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Centre-based Pulmonary Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: Centre-based Pulmonary Rehabilitation

Community-based Pulmonary Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: Community-based Pulmonary Rehabilitation