Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial): study protocol for a randomised controlled trial

Garry Tew; Laura Bissell; Belen Corbacho; Caroline Fairhurst; Jenny Howsam; Jess Hugill-Jones; Camila Maturana; Shirley-Anne Paul; Tim Rapley; Jenny Roche; Fi Rose; David Torgerson; Lesley Ward; Laura Wiley; David Yates; Catherine Hewitt

doi:10.1186/s13063-021-05217-5

Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial): study protocol for a randomised controlled trial

Garry Tew^*, Laura Bissell, Belen Corbacho, Caroline Fairhurst, Jenny Howsam, Jess Hugill-Jones, Camila Maturana, Shirley-Anne Paul, Tim Rapley, Jenny Roche, Fi Rose, David Torgerson, Lesley Ward, Laura Wiley, David Yates, Catherine Hewitt

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Background
Multimorbidity 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.

Methods
This 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.

Discussion
This 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 registration
ISRCTN ISRCTN13567538. Registered on 18 March 2019

Original language	English
Article number	269
Number of pages	17
Journal	Trials
Volume	22
Issue number	1
Early online date	12 Apr 2021
DOIs	https://doi.org/10.1186/s13063-021-05217-5
Publication status	Published - 1 Dec 2021

Keywords

Multimorbidity
Mind-body therapies
Health-related quality of life
Randomised controlled trial

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Trials_structured_Study_Protocol_template_R1_CLEANAccepted author manuscript, 1.47 MBLicence: CC BY
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Cite this

Tew, G., Bissell, L., Corbacho, B., Fairhurst, C., Howsam, J., Hugill-Jones, J., Maturana, C., Paul, S.-A., Rapley, T., Roche, J., Rose, F., Torgerson, D., Ward, L., Wiley, L., Yates, D., & Hewitt, C. (2021). Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial): study protocol for a randomised controlled trial. Trials, 22(1), Article 269. https://doi.org/10.1186/s13063-021-05217-5

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abstract = "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{\textquoteright}s Gentle Years Yoga{\textcopyright} (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",

keywords = "Multimorbidity, Mind-body therapies, Health-related quality of life, Randomised controlled trial",

author = "Garry Tew and Laura Bissell and Belen Corbacho and Caroline Fairhurst and Jenny Howsam and Jess Hugill-Jones and Camila Maturana and Shirley-Anne Paul and Tim Rapley and Jenny Roche and Fi Rose and David Torgerson and Lesley Ward and Laura Wiley and David Yates and Catherine Hewitt",

note = "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.",

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doi = "10.1186/s13063-021-05217-5",

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Tew, G, Bissell, L, Corbacho, B, Fairhurst, C, Howsam, J, Hugill-Jones, J, Maturana, C, Paul, S-A, Rapley, T, Roche, J, Rose, F, Torgerson, D, Ward, L, Wiley, L, Yates, D & Hewitt, C 2021, 'Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial): study protocol for a randomised controlled trial', Trials, vol. 22, no. 1, 269. https://doi.org/10.1186/s13063-021-05217-5

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

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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

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M1 - 269

ER -

Yoga for older adults with multimorbidity (The Gentle Years Yoga Trial): study protocol for a randomised controlled trial

Abstract

Keywords

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