Is it possible to deliver Pulmonary Rehabilitation in a hospital setting to people in Sri Lanka living with chronic obstructive lung disease?
- Conditions
- Chronic obstructive pulmonary diseaseRespiratory
- Registration Number
- ISRCTN13367735
- Lead Sponsor
- niversity of Leicester
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33243812/ protocol (added 30/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Stage 1 (patient):
1. Aged =18 years
2. Physician diagnosis of COPD
Stage 1 (staff):
1. Healthcare staff that would typically refer patients to a clinical PR programme, such as physicians & clinicians.
Added 02/03/2020:
Stage 1 (family caregivers):
1. Family member/person who looks after a patient with COPD
2. Aged =18 years
Stage 2:
1. Aged =18 years
2. Physician diagnosis of COPD
3. Spirometry confirmed COPD, based on GOLD criteria, with FEV1/FVC <0.7, and FEV1<80% predicted
4. Medical Research Council (MRC) dyspnoea score grade 2 or higher
Stage 1 (patients):
1. Unable or unwilling to provide informed consent
Stage 2 (staff):
1. Unable or unwilling to provide informed consent
Stage 2:
1. Comorbidities such as severe or unstable cardiovascular, other internal diseases and locomotor difficulties that preclude exercise
2. Malignant disease or other serious illness which will interfere with participation in the Pulmonary Rehabilitation programme
3. Unable or unwilling to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility measures including:<br>1. Suitability of the inclusion criteria <br>2. Refusal rate<br>3. Uptake and completion of the study<br>4. Willingness of patients to be recruited and the willingness of healthcare professionals to refer to this study and future trials <br>5. Service provider and multi-disciplinary teams’ willingness and ability to deliver the new PR programme<br>6. The practicality of delivering the intervention in the proposed setting <br>7. The time needed to collect and analyse the data<br>8. Test methods for the collection of data as well as data completeness and accuracy<br>9. The acceptability of the PR programme, assessed through focus groups<br>10. Compliance to the PR sessions<br>11. Adherence to home exercise assessed via a self-report exercise diary<br>12. The training and resource needed to deliver the intervention (ensuring readiness for a future multi-centre trial)
- Secondary Outcome Measures
Name Time Method Measured at baseline and at 6 weeks post baseline:<br>1. Anxiety and depression level, measured using Hospital Anxiety and Depression Scale (HADS)<br>2. Breathlessness, measured using Medical Research Council (MRC) Dyspnea scale<br>3. Health status, measured using COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ)<br>4. Economic impact, measured using Work Productivity and Activity impairment (WPAI) Questionnaire<br>5. Nutritional status, measured by body weight using scales, body composition using bioelectrical impedance and skinfold thickness, and 7-day diet diary<br>6. Lung health, assessed by spirometry, impulse oscillometry and diffusing capacity for carbon monoxide<br>7. Exercise capacity, measured by incremental shuttle walking test (ISWT) and the endurance shuttle walking test (ESWT)<br>8. Physical activity, measured by ActiGraph wGT3x-BT accelerometer<br>9. Physical function, measured by 5x sit-to-stand test