Resistance Exercise or Vibration With HMB for Sarcopenia
Elastic-band Resistance Exercise or Vibration Treatment With Hydroxymethylbutyrate (HMB) Supplement for Sarcopenic Older People
1 other identifier
interventional
144
1 country
1
Brief Summary
Sarcopenia is a geriatric syndrome characterised by the progressive loss of skeletal muscle mass and function with a risk of adverse outcomes. In Hong Kong, the prevalence of sarcopenia in community-dwelling older people was 9%. According to a meta-analysis on the effect of sarcopenia on health outcomes in older people, sarcopenia significantly increased hazard ratios of falling by 3.23×, functional decline by 3.03× and fracture risk by up to 3.75×, thus making sarcopenia a major risk factor for fragility fractures. Elastic-band exercise alone was shown to enhance skeletal muscle mass, performance and gait speed. Low-magnitude high-frequency vibration (LMHFV) was shown to be effective in enhancing muscle strength, balancing ability and reducing fall risk. HMB supplementation is advantageous due to its simplicity in administration and found to be effective in maintaining total lean mass, appendicular lean mass, leg and arm lean masses. The objective of this study is to evaluate the effectiveness of elastic-band exercise or vibration treatment in combination with HMB supplementation on the control of sarcopenia by a single-blinded randomized controlled study. Community-dwelling older people failing the sarcopenia screening according to the Asian Working Group on Sarcopenia (AWGS) will be recruited and randomized to (1) control, (2) Exercise + HMB or (3) LMHFV + HMB group by envelope drawing of computer-generated random numbers. Control group will be given promotional materials of sarcopenia and will not receive any intervention. The Exercise + HMB group will be instructed to take a thirty-minute home-based elastic band exercise practiced for 30 mins per day, 3 times per week for 3 months. The LMHFV + HMB group will be assigned to participating community centres and receive vibration treatment at 35Hz, 0.3g (peak to peak magnitude), displacement of \<0.1mm, for 20 min/day, at least 3 days/week for 3 months. Both HMB treatment groups will given 3.0 g/day for 3 months. Outcome assessments will be performed at baseline and end-point of 3 months. Outcome assessor and statistician will be blinded to group allocation. Muscle strength in the lower extremity will be the primary outcome. Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test, quality of life by short-form 36 will be taken as secondary outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedStudy Start
First participant enrolled
September 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2023
CompletedMarch 10, 2022
March 1, 2022
3.9 years
July 18, 2019
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle strength in the lower extremity
Quadriceps muscle strength will be measured at the maximum of the quadriceps muscle contraction by a dynamometer. Participants will be instructed to seat on a chair with the knee and hip flexed at 90 degrees and pelvis fixed. The peak isometric forces will be measured 3 times on each leg and the maximum will be taken.
3 months, change is being assessed.
Secondary Outcomes (6)
Balancing ability
3 months, change is being assessed
Timed-up-go test (TUG)
3 months, change is being assessed
Dual energy x-ray absortiometry (DXA)
3 months, change is being assessed.
Gait speed
3 months, change is being assessed.
Muscle strength in the upper extremity
3 months, change is being assessed.
- +1 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONNo intervention on sarcopenic subjects screened (based on the AWGS definition).
Exercise + HMB Group
ACTIVE COMPARATORSarcopenic subjects on combined treatment of elastic-band exercise and HMB supplementation
Vibration Treatment + HMB Group
ACTIVE COMPARATORSarcopenic subjects on combined treatment of vibration treatment and HMB supplementation
Interventions
Hydroxymethylbutyrate supplementation at 3.0 g/day with dietary advice.
Low-magnitude High Frequency Vibration is a non-invasive biophysical intervention which provides mechanical stimulation with no reported adverse effects. Our previous studies on bone showed that LMHFV can help boost the patients' bone mineral density (BMD) and muscle health.
Subjects enrolled in the elastic-band exercise group will be instructed with 1 session of group training (at baseline) and 1 follow-up home visit (at 4 weeks) including instructions on 5-10 min warm-up and cool-down routines, 30 min chair-based resistance exercises using Thera-Bands as previously reported with training to both upper and lower body muscle groups including both hand and knee extensor muscles. The subjects will be instructed to perform the instructed exercises 3 times per week, one hour after HMB intake, for 12 weeks. The elastic band strengths will be progressively increased from 1.3 kg to 2.1 kg (yellow to green) of tensional force as instructed by a qualified coach in our project team based on each subject's "multiple repetition maximum", where multiple repetition maximum is defined by reaching fatigue by 8 repetitions of stretching.
Eligibility Criteria
You may qualify if:
- years old or above
- failing the sarcopenia screening based on the AWGS definition:
- hand-grip strength (male at \<26 kg, female at \<18kg),
- gait speed test (\<0.8m/s), and/or height-adjusted skeletal muscle mass by bio-impedance analysis (BIA, male at \<7kg/m\^2 and female at \<5.4kg/m\^2) defined by appendicular skeletal muscle mass/height\^2.
You may not qualify if:
- pathological bone diseases
- chronic inflammatory conditions known to affect muscle metabolism; including diabetes, rheumatoid arthritis
- neurological conditions affecting normal gait
- dependent ambulatory capability
- subjects taking regular guided exercise programmes of more than three times per week
- subjects with cardiovascular concern such as with pace-maker in-situ or malignancy
- chair-bound or bed-bound subjects
- recovering from fractures/surgeries or with implants (affecting DXA scan)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelical Luthera Church Social Service - Hong Kong
Hong Kong, Hong Kong
Related Publications (10)
Stout JR, Smith-Ryan AE, Fukuda DH, Kendall KL, Moon JR, Hoffman JR, Wilson JM, Oliver JS, Mustad VA. Effect of calcium beta-hydroxy-beta-methylbutyrate (CaHMB) with and without resistance training in men and women 65+yrs: a randomized, double-blind pilot trial. Exp Gerontol. 2013 Nov;48(11):1303-10. doi: 10.1016/j.exger.2013.08.007. Epub 2013 Aug 24.
PMID: 23981904BACKGROUNDLeung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
PMID: 24676848BACKGROUNDYu R, Wong M, Leung J, Lee J, Auyeung TW, Woo J. Incidence, reversibility, risk factors and the protective effect of high body mass index against sarcopenia in community-dwelling older Chinese adults. Geriatr Gerontol Int. 2014 Feb;14 Suppl 1:15-28. doi: 10.1111/ggi.12220.
PMID: 24450557BACKGROUNDSayer AA. Sarcopenia. BMJ. 2010 Aug 10;341:c4097. doi: 10.1136/bmj.c4097. No abstract available.
PMID: 20699307BACKGROUNDBeaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.
PMID: 28095426BACKGROUNDChen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PMID: 24461239BACKGROUNDCruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PMID: 20392703BACKGROUNDZhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.
PMID: 30462162BACKGROUNDDeutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
PMID: 23514626BACKGROUNDChow SK, Chim YN, Cheng KY, Ho CY, Ho WT, Cheng KC, Wong RM, Cheung WH. Elastic-band resistance exercise or vibration treatment in combination with hydroxymethylbutyrate (HMB) supplement for management of sarcopenia in older people: a study protocol for a single-blinded randomised controlled trial in Hong Kong. BMJ Open. 2020 Jun 30;10(6):e034921. doi: 10.1136/bmjopen-2019-034921.
PMID: 32606057DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor of Orthopaedics and Traumatology
Study Record Dates
First Submitted
July 18, 2019
First Posted
July 22, 2019
Study Start
September 4, 2019
Primary Completion
July 29, 2023
Study Completion
July 29, 2023
Last Updated
March 10, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Individual participant data will be made available beginning 3 months and ending 3 years following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal may access data to achieve aims in the approved proposal. Data requestors should direct their proposals to no-fall@ort.cuhk.edu.hk and data will be available after signing a data access agreement.
Data may be obtained from a third party and are not publicly available. Individual participant data that underlie the results reported in this article will be made available after deidentification .