Pulmonary rehabilitation service set up in Georgia

Conditions

Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease, unspecified

Mariam Maglakelidze, Ia Kurua, N. Maglakelidze, Tamaz Maglakelidze, Ivane Chkhaidze et al. (29 authors)

BMJ Open2022-09-014 citations

10.1136/bmjopen-2021-056902

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Musculoskeletal or neurological conditions that prevent exercise 2. Unstable CVD (e.g. unstable angina, aortic valve disease, unstable pulmonary hypertension) 3. Severe cognitive impairment 4. Severe psychotic disturbance 5. Contagious infectious disease 6. Very poor balance

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Georgia

Outcome results

None listed