Pulmonary rehabilitation service set up in Georgia

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Participants are individually randomly allocated to one of two study arms: culturally‐adapted pulmonary rehabilitation programme and a shorter programme (control group). Trial arm 1: Culturally‐adapted pulmonary rehabilitation programme A pre‐rehabilitation session, which will include a 1:1 session for a tailored exercise prescription. This will be followed by an 8‐week (2 supervised sessions per week) adapted pulmonary rehabilitation (PR) programme, consisting of two main components: exercise and education on the management of COPD. Trial arm 2: Short education programme Participants randomised to the control group will be offered to attend a 2–3 hour educational session. This will be carried out by the rehabilitations specialists 6 months after study enrolment, once follow‐up is complete. CONDITION: Chronic obstructive pulmonary disease ; Respiratory ; Chronic obstructive pulmonary disease, unspecified PRIMARY OUTCOME: As the primary outcome measures are feasibility outcome measures, most will be assessed at the end of the delivery of the PR intervention, i.e. 8‐12 weeks depending on time to attend the 16 PR session (referred to as programme end). Feasibility study outcomes will include:; 1. Delivery with fidelity (assessment of exercise prescription at programme end); 2. Acceptability to participants (qualitative interviews at programme end); 3. Recruitment rate; 4. Follow‐up rate at 6 months; 5. Adherence to intervention (attendance rates and completion of exercise prescription at programme end); 6. Ability to carry out trial procedures (6 months); 7. Feasibility of methods to measure costs of PR (assessments of 8‐week follow up questionnaire); 8. Other COPD‐related health care utilisation (8‐week and 6‐month follow up questionnaires); 9. Patient‐incurred costs (8‐week follow‐up questionnaire) SECONDARY OUTCOME: Outcome measures to inform a future trial to evaluate clinical and cost effectiveness (end of PR programme and at 6 months): ; 1. Health‐related quality of life (HRQoL), measured with SGRQ and EQ‐5D‐5L; 2. Exercise capacity measured by the incremental shuttle walk test (ISWT) ; 3. Smoking status validated by cotinine (saliva test); 4. The impact of COPD on their life, measured with the COPD Assessment Test (CAT); 5. Self‐reported physical activity, measured using IPAQ; 6. Self‐efficacy, measured using the Stanford self‐efficacy for managing chronic disease 6‐item questionnaire ; 7. Anxiety and depression, measured using PHQ‐9 and GAD‐7; 8. Self‐reported exacerbations; 9. Self‐reported health care utilisation including hospital admissions; 10. Self‐reported costs/resource use incurred by patients INCLUSION CRITERIA: 1. MRC score 2+ 2. Confirmed COPD diagnosis based on spirometry (predicted ratio of FEV1/FVC of 0.7) 3. Patient must be able to walk 10 meters independently 4. Patient able to exercise with some degree of independence, and within a group setting
Epistemonikos ID: a45483b0a29ae9824f4ea121d155626dc92c6ea0
First added on: Aug 24, 2024