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Pulmonary Rehabilitation in African Countries

2026年5月18日 更新者:University of Edinburgh

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

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.

研究概览

详细说明

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

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Obianuju Ozoh, Professor
  • 电话号码:+234 805 657 0994
  • 邮箱:oozoh@unilag.edu.ng

研究联系人备份

学习地点

    • Gauteng
      • Johannesburg、Gauteng、南非、2041
        • Chris Hani Baragwanath Academic Hospital
        • 接触:
      • Yaoundé、喀麦隆
    • Lagos
      • Lagos、Lagos、尼日利亚、00234
        • Lagos State University Hospital
        • 接触:
        • 副研究员:
          • Jibril Mohammed, Professor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Centre-based Pulmonary Rehabilitation
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.
Pulmonary Rehabilitation for this centre-based arm will take place in a designated hospital/clinic/medical facility and will be supervised by healthcare professionals.
有源比较器:Community-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.
Pulmonary Rehabilitation for patients in this arm will take place in the participant's community with regular telehealth/telemedicine supervision.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional Exercise Capacity: 6-minute walk test and clinical status.
大体时间: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).
8 weeks

次要结果测量

结果测量
措施说明
大体时间
Health-Related Quality of Life
大体时间: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.
8 weeks
Anxiety Symptoms
大体时间: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.
8 weeks
Depressive Symptoms
大体时间: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.
8 weeks
Dyspnea Severity
大体时间: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.
8 weeks
Disease Impact
大体时间: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.
8 weeks
Occupational Performance
大体时间: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.
8 weeks
Occupational Satisfaction
大体时间: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 weeks
Pulmonary Function
大体时间: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.
8 weeks
Peripheral Muscle Strength
大体时间: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.
8 weeks
Body Mass Index
大体时间: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.
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Igor Rudan、University of Edinburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We plan to share pseudonymised data from this trial with other researchers.

IPD 共享时间框架

Available at the start date till end of the study

IPD 共享访问标准

Request made to the principal investigators.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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