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NCT Number: NCT07602673

Pulmonary Rehabilitation in African Countries

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.

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Key information

About this study

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:

  • 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).
  • 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:

  • Centre-based PR (hospital or clinic setting)
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 8 weeks

    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).

Secondary outcomes

  1. Health-Related Quality of Life

    Time frame: 8 weeks

    • 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.
  2. Anxiety Symptoms

    Time frame: 8 weeks

    • 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.
  3. Depressive Symptoms

    Time frame: 8 weeks

    • 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.
  4. Dyspnea Severity

    Time frame: 8 weeks

    • 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.
  5. Disease Impact

    Time frame: 8 weeks

    • 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.
  6. Occupational Performance

    Time frame: 8 weeks

    • 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.
  7. Occupational Satisfaction

    Time frame: 8 weeks

    • 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. Pulmonary Function

    Time frame: 8 weeks

    • 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.
  9. Peripheral Muscle Strength

    Time frame: 8 weeks

    • 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.
  10. Body Mass Index

    Time frame: 8 weeks

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Obianuju Ozoh, Professor

CONTACT

[email protected]

+234 805 657 0994

Ziyaad Dangor, Professor

CONTACT

[email protected]

+27 11 274 9200

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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