TY - JOUR
T1 - Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial)
T2 - study protocol for a randomised controlled trial
AU - Tew, Garry
AU - Bissell, Laura
AU - Corbacho, Belen
AU - Fairhurst, Caroline
AU - Howsam, Jenny
AU - Hugill-Jones, Jess
AU - Maturana, Camila
AU - Paul, Shirley-Anne
AU - Rapley, Tim
AU - Roche, Jenny
AU - Rose, Fi
AU - Torgerson, David
AU - Ward, Lesley
AU - Wiley, Laura
AU - Yates, David
AU - Hewitt, Catherine
N1 - Funding information: The trial was funded by the United Kingdom National Health Service (NHS) through the National Institute for Health Research Health Technology Assessment programme, open call project number 17/94/36.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS, or the Department of Health.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - BackgroundMultimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga’s Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain.MethodsThis is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles.DiscussionThis pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity.Trial registrationISRCTN ISRCTN13567538. Registered on 18 March 2019
AB - BackgroundMultimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga’s Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain.MethodsThis is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles.DiscussionThis pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity.Trial registrationISRCTN ISRCTN13567538. Registered on 18 March 2019
KW - Multimorbidity
KW - Mind-body therapies
KW - Health-related quality of life
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85104262626&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05217-5
DO - 10.1186/s13063-021-05217-5
M3 - Article
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 269
ER -