A randomized controlled feasibility trial (RCT) of a pulmonary rehabilitation (PR) programme for symptomatic COPD Patients in Georgia: A Breathe Well study

Aim: To assess the feasibility of delivering an RCT of a culturally tailored PR intervention in Tbilisi, Georgia. Methods: An RCT with qualitative interviews. Eligible participants with symptomatic COPD of MRC grade 2+ and ability to exercise with some degree of independence within a group setting Were recruited from primary and secondary care. The adapted PR programme included one pre-rehabilitation group meeting and 16 group sessions of exercise and education over 8 weeks; the control group offered a 2 – 3 hour group educational session after the 6-month follow-up. Data was collected at 8 weeks and six-months. Nine intervention participants and two rehabilitation specialists participated in in-depth interviews, data was analyzed using the framework approach. Results: 312 patients were contacted; 60 patients were randomized to the intervention and control arms (30/30); 6 were women (4 in intervention arm and 2 in control arm). 23 patients from intervention arm participated in the programme (77%); of these 13 patients attended 12 and more sessions (out of total 16 sessions)- 75% of the total sessions. Mean attendance to the PR programme was 7.8 sessions; 40% of intervention arm attended more than 75% of the sessions. 7 patients attended no PR sessions. Follow-up at six-months was 88%. Sessions were delivered with high fidelity. The exercise and educational booklets were well received, suggestions to include more breathing exercises were made. Education sessions and guidance by rehab specialists were highly valued; Attendance due to extreme cold or hot climate as well as deterioration in health seemed to be a problem for some. The cost of the programme came up as an important determinant for attendance in the future. Conclusion: A culturally adapted PR programme was acceptable for patients and PR specialists, the rolling out of such programmes, free of charge, was strongly supported. Implementation Science/Service Development Research Ideas on Respiratory Conditions and Tobacco Dependency Abstract Declaration of Interest The authors declare no conflicts of interest. This research was funded by the National Institute for Health Research (NIHR) NIHR global group on global COPD in primary care (project reference: 16/137/95) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care. References and Clinical Trial Registry Information