An interventional study of Centre-based Pulmonary Rehabilitation and Community-based Pulmonary Rehabilitation in Chronic Respiratory Conditions, sponsored by University of Edinburgh. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Prevention
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:
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:
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 150 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 this centre-based arm will take place in a designated hospital/clinic/medical facility and will be supervised by healthcare professionals.
Pulmonary Rehabilitation for patients in this arm will take place in the participant's community with regular telehealth/telemedicine supervision.
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).
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We plan to share pseudonymised data from this trial with other researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Available at the start date till end of the study
Access criteria: Request made to the principal investigators.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →