Centre-based Pulmonary Rehabilitation
OtherPulmonary Rehabilitation for this centre-based arm will take place in a designated hospital/clinic/medical facility and will be supervised by healthcare professionals.
NCT Number: NCT07602673
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Regional Hospital Limbe, Yaoundé, Cameroon
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8 weeks
Primary Outcome: Functional Exercise Capacity (6-Minute Walk Distance)
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Contact information is provided by the study sponsor or research team.
Obianuju Ozoh, Professor
CONTACT
Ziyaad Dangor, Professor
CONTACT
University of Edinburgh
Other
Respiratory Medicine and Pulmonary Rehabilitation Feasibility Study and Randomised Controlled Trial in Nigeria, South Africa and Cameroon
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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