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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.

調査の概要

詳細な説明

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

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Obianuju Ozoh, Professor
  • 電話番号:+234 805 657 0994
  • メールoozoh@unilag.edu.ng

研究連絡先のバックアップ

研究場所

      • Yaoundé、カメルーン
    • Lagos
      • Lagos、Lagos、ナイジェリア、00234
        • Lagos State University Hospital
        • コンタクト:
        • 副調査官:
          • Jibril Mohammed, Professor
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ、2041
        • Chris Hani Baragwanath Academic Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Functional Exercise Capacity: 6-minute walk test and clinical status.
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-Related Quality of Life
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Igor Rudan、University of Edinburgh

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年11月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年5月18日

最初の投稿 (実際)

2026年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月18日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

Available at the start date till end of the study

IPD 共有アクセス基準

Request made to the principal investigators.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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いいえ

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