Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial

Introduction Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyra...

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Main Authors: Maoyi Tian, Ling Qin, Simon Kwoon Ho Chow, Wing Hoi Cheung, A A Welch, Can Cui, Parco M Siu, Meng Chen Michelle Li, Yu Kin Cheng, Ronald Man Yeung Wong, Timothy CY Kwok, Minghui Yang, Clinton Rubin, Sheung Wai Law
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Language:English
Published: BMJ Publishing Group 2024-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/1/e074858.full
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author Maoyi Tian
Ling Qin
Simon Kwoon Ho Chow
Wing Hoi Cheung
A A Welch
Can Cui
Parco M Siu
Meng Chen Michelle Li
Yu Kin Cheng
Ronald Man Yeung Wong
Timothy CY Kwok
Minghui Yang
Clinton Rubin
Sheung Wai Law
author_facet Maoyi Tian
Ling Qin
Simon Kwoon Ho Chow
Wing Hoi Cheung
A A Welch
Can Cui
Parco M Siu
Meng Chen Michelle Li
Yu Kin Cheng
Ronald Man Yeung Wong
Timothy CY Kwok
Minghui Yang
Clinton Rubin
Sheung Wai Law
author_sort Maoyi Tian
collection DOAJ
description Introduction Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.Methods and analysis In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.Ethics and dissemination This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.Trial registration number NCT05525039.
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spelling doaj-art-e2f2c51c52944f4d85534b0db3a2c5132025-08-20T03:12:46ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-074858Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trialMaoyi Tian0Ling Qin1Simon Kwoon Ho Chow2Wing Hoi Cheung3A A Welch4Can Cui5Parco M Siu6Meng Chen Michelle Li7Yu Kin Cheng8Ronald Man Yeung Wong9Timothy CY Kwok10Minghui Yang11Clinton Rubin12Sheung Wai Law131 The George Institute for Global Health, University of New South Wales, Newtown, New South Wales, AustraliaMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongLi Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, Hong KongDepartment of Public Health and Primary Care, University of East Anglia, Norwich, UKMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongDivision of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongDepartment of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong11Department of Orthopaedics and Traumatology, Beijing Jishuitan Hospital, Capital Medical University, Beijing, ChinaDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, New York, USAMusculoskeletal Research Laboratory, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong KongIntroduction Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.Methods and analysis In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.Ethics and dissemination This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.Trial registration number NCT05525039.https://bmjopen.bmj.com/content/14/1/e074858.full
spellingShingle Maoyi Tian
Ling Qin
Simon Kwoon Ho Chow
Wing Hoi Cheung
A A Welch
Can Cui
Parco M Siu
Meng Chen Michelle Li
Yu Kin Cheng
Ronald Man Yeung Wong
Timothy CY Kwok
Minghui Yang
Clinton Rubin
Sheung Wai Law
Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
BMJ Open
title Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
title_full Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
title_fullStr Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
title_full_unstemmed Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
title_short Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
title_sort biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia a study protocol for single blinded randomised controlled trial
url https://bmjopen.bmj.com/content/14/1/e074858.full
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