Pulmonary Rehabilitation in African Countries
A legfontosabb adatok
- Ki végzi
- University of Edinburgh
- Hol
- Johannesburg (Dél-afrikai Köztársaság)A helyszín megnézéseMég 2 másik országban, 2 helyszínen
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 150 fő, tervezett
- Kezdés
- 2027. jan.
- Várható befejezés
- 2028. dec. 1.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Centre-based Pulmonary Rehabilitation
- Community-based Pulmonary Rehabilitation
- A regiszteradat frissítve
- 2026. november 9.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek hosszú ideje fennálló tüdőbetegségük van (COPD, asztma vagy tuberkulózis utáni tüdőkárosodás), tüdőrehabilitációra van szükségük, és elég jó állapotban vannak a mozgáshoz. Egészségügyi szakemberek és más érintettek az interjúkban vehetnek részt.
- Életkor
- 18 év vagy idősebb
- Nem
- Minden nem
- A betegség stádiuma
- COPD, asztma vagy tuberkulózis utáni tüdőbetegség, közepesen súlyos vagy súlyos állapotban, csökkent terhelhetőséggel, rossz életminőséggel vagy erős tünetekkel, főleg légszomjjal.
- Korábbi kezelés
- Nem végezhetett tüdőrehabilitációt az elmúlt egy évben.
A részvétel fő kizáró okai
- Más jelentős, hosszan tartó betegség, például szívelégtelenség, ischaemiás szívbetegség, cukorbetegség vagy demencia
- Terhesség
- Aktív tüdő-tuberkulózis
- Jelenlegi vagy nemrégiben lezajlott állapotromlás
- Nem tud részt venni mozgásban, például súlyos ízületi gyulladás vagy bénulás miatt
A regiszter feltételei, szó szerint
Mind a 21 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Patients with other significant chronic co-morbidities such as heart failure, ischemic heart disease, DM, and confusion/dementia
- 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)
- Pregnant women
- 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
Helyszínek itt: Dél-afrikai Köztársaság
Még 2 másik országban, 2 helyszínen
- Chris Hani Baragwanath Academic HospitalJohannesburg, Dél-afrikai KöztársaságContact: Ziyaad Dangor, ProfessorNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Centre-based Pulmonary RehabilitationMár használt kezelés, összehasonlításként
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 RehabilitationMár használt kezelés, összehasonlításként
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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Respiratory Medicine and Pulmonary Rehabilitation Feasibility Study and Randomised Controlled Trial in Nigeria, South Africa and Cameroon
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
- A regiszteradat frissítve
- 2026. november 9.