Protocol for the cultural adaptation of pulmonary rehabilitation and subsequent testing in a randomised controlled feasibility trial for adults with chronic obstructive pulmonary disease in Sri Lanka
Sally J Singh,
Michael C Steiner,
Robert C Free,
Andy Barton,
Amy V Jones,
Akila R Jayamaha,
Chamilya H Perera,
Mark W Orme,
Upendra K D C Wijayasiri,
Thamara D Amarasekara,
Ravini S Karunatillake,
Amitha Fernando,
Anthony L P Seneviratne,
Rupert Jones,
Zainab K Yusuf,
Ruhme B Miah,
Dominic Malcolm,
Jesse A Matheson,
Savithri W Wimalasekera
Affiliations
Sally J Singh
Department of Respiratory Sciences, University of Leicester, Leicester, UK
Michael C Steiner
NIHR Leicester Biomedical Research Centre –Respiratory, Department of Respiratory Sciences, College of Life Sciences, University of Leicester, Leicester, UK
Robert C Free
1 Department of Respiratory Sciences, University of Leicester, Leicester, UK
Andy Barton
consultant
Amy V Jones
Centre of Exercise and Reshabilitaiton Sciences, NIHR Leicester Biomedical Research Centre, Leicester, UK
Akila R Jayamaha
1 Health Sciences, KIU, Colombo, Sri Lanka
Chamilya H Perera
1 Health Sciences, KIU, Colombo, Sri Lanka
Mark W Orme
Assessment of Movement Behaviours (AMBer) Group, Diabetes Research Centre, University of Leicester, Leicester, UK
Upendra K D C Wijayasiri
4 Sports Medicine Unit, Colombo South Teaching Hospital, Kalubowila-Dehiwela, Sri Lanka
Thamara D Amarasekara
5 Faculty of Allied Health Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
Ravini S Karunatillake
6 Central Chest Clinic, National Hospital of Sri Lanka, Colombo, Sri Lanka
Amitha Fernando
Covid High Dependency Unit, National Hospital of Sri Lanka, Colombo, Sri Lanka
Anthony L P Seneviratne
7 Primary Care Respiratory Group, Colombo, Sri Lanka
Rupert Jones
Plymouth Marjon University, Plymouth, UK
Zainab K Yusuf
Department of Respiratory Sciences, University of Leicester Department of Respiratory Sciences, Leicester, UK
Ruhme B Miah
Department of Respiratory Sciences, University of Leicester Department of Respiratory Sciences, Leicester, UK
Dominic Malcolm
School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK
Jesse A Matheson
10 Department of Economics, University of Sheffield, Sheffield, UK
Savithri W Wimalasekera
11 Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
Introduction International guidelines recommend pulmonary rehabilitation (PR) should be offered to adults living with chronic obstructive pulmonary disease (COPD), but PR availability is limited in Sri Lanka. Culturally appropriate PR needs to be designed and implemented in Sri Lanka. The study aims to adapt PR to the Sri Lankan context and determine the feasibility of conducting a future trial of the adapted PR in Sri Lanka.Methods and analysis Eligible participants will be identified and will be invited to take part in the randomised controlled feasibility trial, which will be conducted in Central Chest Clinic, Colombo, Sri Lanka. A total of 50 participants will be recruited (anticipated from April 2021) to the trial and randomised (1:1) into one of two groups; control group receiving usual care or the intervention group receiving adapted PR. The trial intervention is a Sri Lankan-specific PR programme, which will consist of 12 sessions of exercise and health education, delivered over 6 weeks. Focus groups with adults living with COPD, caregivers and nurses and in-depth interviews with doctors and physiotherapist will be conducted to inform the Sri Lankan specific PR adaptations. After completion of PR, routine measures in both groups will be assessed by a blinded assessor. The primary outcome measure is feasibility, including assessing eligibility, uptake and completion. Qualitative evaluation of the trial using focus groups with participants and in-depth interviews with PR deliverers will be conducted to further determine feasibility and acceptability of PR, as well as the ability to run a larger future trial.Ethics and dissemination Ethical approval was obtained from the ethics review committee of Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka and University of Leicester, UK. The results of the trial will be disseminated through patient and public involvement events, local and international conference proceedings, and peer-reviewed journals.Trial registration number ISRCTN13367735
