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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

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posted on 18.12.2020, 09:44 by Akila R Jayamaha, Chamilya H Perera, Mark W Orme, Amy V Jones, Upendra K D C Wijayasiri, Thamara D Amarasekara, Ravini S Karunatillake, Amitha Fernando, Anthony L P Seneviratne, Andy Barton, Rupert Jones, Zainab K Yusuf, Ruhme B Miah, Dominic Malcolm, Jesse A Matheson, Robert C. Free, Adrian Manise, Michael C. Steiner, Savithri W Wimalasekera, Sally J. Singh
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

Funding

National Institute for Health Research (NIHR) (17/63/20)

History

School

  • Sport, Exercise and Health Sciences

Published in

BMJ Open

Volume

10

Publisher

BMJ Journals

Version

VoR (Version of Record)

Rights holder

© The authors

Publisher statement

This is an Open Access Article. It is published by BMJ under the Creative Commons Attribution 4.0 Unported Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/

Acceptance date

11/11/2020

Publication date

2020-11-26

Copyright date

2020

ISSN

2044-6055

Language

en

Depositor

Dr Dominic Malcolm. Deposit date: 17 December 2020

Article number

e041677

Licence

Exports