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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR156234 | Other Grant/Funding Number | NIHR |
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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.
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:
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:
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:
Pilot Randomised Controlled Trial (RCT) The second phase tests the effectiveness of pulmonary rehabilitation in real-world settings.
Participants
Participants are randomly assigned to one of two groups:
The Intervention: What Participants Do
Participants in both groups take part in an 8-week rehabilitation programme, with:
The programme includes:
Exercise Training
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
Measurements are taken at:
To complement the clinical data, the study includes interviews with:
These interviews explore:
What Makes This Study Important
This research goes beyond simply testing whether pulmonary rehabilitation works. It aims to understand:
Expected Impact
If successful, this study could:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Exercise Capacity: 6-minute walk test and clinical status. | Primary Outcome: Functional Exercise Capacity (6-Minute Walk Distance)
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life |
| 8 weeks |
| Anxiety Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Igor Rudan | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Limbe | Yaoundé | Cameroon |
We plan to share pseudonymised data from this trial with other researchers.
Available at the start date till end of the study
Request made to the principal investigators.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2026 | May 18, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - Patient Interviews | Apr 15, 2026 | Apr 28, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - PR RCT | Apr 15, 2026 | Apr 28, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent - HCPs, Managers & Stakeholders Interviews | Apr 15, 2026 | Apr 28, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
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| 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. |
|
|
| 8 weeks |
| Depressive Symptoms |
| 8 weeks |
| Dyspnea Severity |
| 8 weeks |
| Disease Impact |
| 8 weeks |
| Occupational Performance |
| 8 weeks |
| Occupational Satisfaction |
| 8 weeks |
| Pulmonary Function |
| 8 weeks |
| Peripheral Muscle Strength |
| 8 weeks |
| Body Mass Index |
| 8 weeks |
| Lagos State University Hospital | Lagos | Lagos | 00234 | Nigeria |
|
| Chris Hani Baragwanath Academic Hospital | Johannesburg | Gauteng | 2041 | South Africa |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |