The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol

Abstract Background Sarcopenia is a progressive and generalised loss of muscle mass and function with advancing age and is a major contributor to frailty. These conditions lead to functional disability, loss of independence, and lower quality of life. Sedentary behaviour is adversely associated with...

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Main Authors: Daniel P. Bailey, Cherry Kilbride, Jamie H. Harper, Christina Victor, Marsha L. Brierley, David J. Hewson, Angel M. Chater
Format: Article
Language:English
Published: BMC 2023-01-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:https://doi.org/10.1186/s40814-022-01225-7
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author Daniel P. Bailey
Cherry Kilbride
Jamie H. Harper
Christina Victor
Marsha L. Brierley
David J. Hewson
Angel M. Chater
author_facet Daniel P. Bailey
Cherry Kilbride
Jamie H. Harper
Christina Victor
Marsha L. Brierley
David J. Hewson
Angel M. Chater
author_sort Daniel P. Bailey
collection DOAJ
description Abstract Background Sarcopenia is a progressive and generalised loss of muscle mass and function with advancing age and is a major contributor to frailty. These conditions lead to functional disability, loss of independence, and lower quality of life. Sedentary behaviour is adversely associated with sarcopenia and frailty. Reducing and breaking up sitting should thus be explored as an intervention target for their management. The primary aim of this study, therefore, is to examine the feasibility, safety, and acceptability of conducting a randomised controlled trial (RCT) that evaluates a remotely delivered intervention to improve sarcopenia and independent living via reducing and breaking up sitting in frail older adults. Methods This mixed-methods randomised controlled feasibility trial will recruit 60 community-dwelling older adults aged ≥ 65 years with very mild or mild frailty. After baseline measures, participants will be randomised to receive the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or serve as controls (usual care) for 6 months. Frail-LESS is a remotely delivered intervention comprising of tailored feedback on sitting, information on the health risks of excess sitting, supported goal setting and action planning, a wearable device that tracks inactive time and provides alerts to move, health coaching, and peer support. Feasibility will be assessed in terms of recruitment, retention and data completion rates. A process evaluation will assess intervention acceptability, safety, and fidelity of the trial. The following measures will be taken at baseline, 3 months, and 6 months: sitting, standing, and stepping using a thigh-worn activPAL4 device, sarcopenia (via hand grip strength, muscle mass, and physical function), mood, wellbeing, and quality of life. Discussion This study will determine the feasibility, safety, and acceptability of evaluating a remote intervention to reduce and break up sitting to support improvements in sarcopenia and independent living in frail older adults. A future definitive RCT to determine intervention effectiveness will be informed by the study findings. Trial registration ISRCTN, ISRCTN17158017; Registered 6 August 2021, https://www.isrctn.com/ISRCTN17158017
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spelling doaj.art-fbd7428cc49c46f18592fb38bc683c6a2023-01-08T12:05:01ZengBMCPilot and Feasibility Studies2055-57842023-01-019111210.1186/s40814-022-01225-7The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocolDaniel P. Bailey0Cherry Kilbride1Jamie H. Harper2Christina Victor3Marsha L. Brierley4David J. Hewson5Angel M. Chater6Centre for Physical Activity in Health and Disease, Brunel University LondonCentre for Physical Activity in Health and Disease, Brunel University LondonCentre for Physical Activity in Health and Disease, Brunel University LondonDivision of Global Public Health, Brunel University LondonCentre for Physical Activity in Health and Disease, Brunel University LondonInstitute for Health Research, University of BedfordshireInstitute for Sport and Physical Activity Research, University of BedfordshireAbstract Background Sarcopenia is a progressive and generalised loss of muscle mass and function with advancing age and is a major contributor to frailty. These conditions lead to functional disability, loss of independence, and lower quality of life. Sedentary behaviour is adversely associated with sarcopenia and frailty. Reducing and breaking up sitting should thus be explored as an intervention target for their management. The primary aim of this study, therefore, is to examine the feasibility, safety, and acceptability of conducting a randomised controlled trial (RCT) that evaluates a remotely delivered intervention to improve sarcopenia and independent living via reducing and breaking up sitting in frail older adults. Methods This mixed-methods randomised controlled feasibility trial will recruit 60 community-dwelling older adults aged ≥ 65 years with very mild or mild frailty. After baseline measures, participants will be randomised to receive the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or serve as controls (usual care) for 6 months. Frail-LESS is a remotely delivered intervention comprising of tailored feedback on sitting, information on the health risks of excess sitting, supported goal setting and action planning, a wearable device that tracks inactive time and provides alerts to move, health coaching, and peer support. Feasibility will be assessed in terms of recruitment, retention and data completion rates. A process evaluation will assess intervention acceptability, safety, and fidelity of the trial. The following measures will be taken at baseline, 3 months, and 6 months: sitting, standing, and stepping using a thigh-worn activPAL4 device, sarcopenia (via hand grip strength, muscle mass, and physical function), mood, wellbeing, and quality of life. Discussion This study will determine the feasibility, safety, and acceptability of evaluating a remote intervention to reduce and break up sitting to support improvements in sarcopenia and independent living in frail older adults. A future definitive RCT to determine intervention effectiveness will be informed by the study findings. Trial registration ISRCTN, ISRCTN17158017; Registered 6 August 2021, https://www.isrctn.com/ISRCTN17158017https://doi.org/10.1186/s40814-022-01225-7SarcopeniaFrailtySedentary behaviourProlonged sittingBehaviour changeactivPAL
spellingShingle Daniel P. Bailey
Cherry Kilbride
Jamie H. Harper
Christina Victor
Marsha L. Brierley
David J. Hewson
Angel M. Chater
The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
Pilot and Feasibility Studies
Sarcopenia
Frailty
Sedentary behaviour
Prolonged sitting
Behaviour change
activPAL
title The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
title_full The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
title_fullStr The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
title_full_unstemmed The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
title_short The Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting: a randomised controlled feasibility trial protocol
title_sort frail less less sitting and sarcopenia in frail older adults intervention to improve sarcopenia and maintain independent living via reductions in prolonged sitting a randomised controlled feasibility trial protocol
topic Sarcopenia
Frailty
Sedentary behaviour
Prolonged sitting
Behaviour change
activPAL
url https://doi.org/10.1186/s40814-022-01225-7
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