Yoga outcomes get assessed in cystic fibrosis (YOGA-CF): protocol of a multi-centre interventional randomised controlled clinical trial – investigating effects of a 12-week yoga intervention for adults with cystic fibrosis
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Journal Article
Abstract
Introduction
Yoga is an emerging exercise choice for people with cystic fibrosis (CF), but evidence of its effect in this population is scarce, with a recent systematic review advocating for further research. Yoga Outcomes Get Assessed in CF (YOGA-CF) is a real-world multi-centre randomised controlled trial (RCT) investigating a bespoke CF-specific online 12-week yoga intervention, versus usual care, to determine effectiveness for adults with CF.
Methods & Analysis
A multi-centre RCT of adults with CF across the United Kingdom (UK). Participants are randomised to usual care or a 12-week online bespoke yoga programme with an expectation of two classes completed weekly. Assessments of lung function, one-minute sit-to-stand, the Cystic Fibrosis Questionnaire-Revised (CFQ-R) and other trial questionnaires are completed pre- and post-intervention (0 and 12 weeks), and after 12-weeks of follow-up (week 24). The primary outcome is difference in respiratory-related quality of life measured using the CFQ-R before and after yoga/control. Sample size was calculated based upon detecting a minimally clinically important difference (MCID) of 4 for the CFQ-R respiratory domain, with power of 80% and 5% significance level (total target, n=314).
Ethics & Dissemination
Ethics approval gained from the South-Yorkshire and Humber Research Ethics Committee (REC) (reference: 23/YH/0270, project ID 303898). Dissemination to involve direct participant feedback and lay webinar, scientific conference presentation and publication in a peer-reviewed journal.
Trial registration details
www.clinicaltrials.gov.uk reference: NCT06120465
Yoga is an emerging exercise choice for people with cystic fibrosis (CF), but evidence of its effect in this population is scarce, with a recent systematic review advocating for further research. Yoga Outcomes Get Assessed in CF (YOGA-CF) is a real-world multi-centre randomised controlled trial (RCT) investigating a bespoke CF-specific online 12-week yoga intervention, versus usual care, to determine effectiveness for adults with CF.
Methods & Analysis
A multi-centre RCT of adults with CF across the United Kingdom (UK). Participants are randomised to usual care or a 12-week online bespoke yoga programme with an expectation of two classes completed weekly. Assessments of lung function, one-minute sit-to-stand, the Cystic Fibrosis Questionnaire-Revised (CFQ-R) and other trial questionnaires are completed pre- and post-intervention (0 and 12 weeks), and after 12-weeks of follow-up (week 24). The primary outcome is difference in respiratory-related quality of life measured using the CFQ-R before and after yoga/control. Sample size was calculated based upon detecting a minimally clinically important difference (MCID) of 4 for the CFQ-R respiratory domain, with power of 80% and 5% significance level (total target, n=314).
Ethics & Dissemination
Ethics approval gained from the South-Yorkshire and Humber Research Ethics Committee (REC) (reference: 23/YH/0270, project ID 303898). Dissemination to involve direct participant feedback and lay webinar, scientific conference presentation and publication in a peer-reviewed journal.
Trial registration details
www.clinicaltrials.gov.uk reference: NCT06120465
Date Acceptance
2025-12-07
Citation
BMJ Open Respiratory Research
ISSN
2052-4439
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Open Respiratory Research
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
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Publication Status
Accepted