Resistance Exercise or Vibration With HMB for Sarcopenia

Sarcopenia Clinical Trial

Official title:

Elastic-band Resistance Exercise or Vibration Treatment With Hydroxymethylbutyrate (HMB) Supplement for Sarcopenic Older People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028206
• Other study ID #: CREC 2018.602
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: July 29, 2023

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: Simon K.H. CHOW, PhD
• Phone: (852)3505-1559
• Email: skhchow[@]ort.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 fracture.

A recent study reported a randomized controlled trial (RCT) of 3-month intervention of elastic-band exercise alone has shown significant enhancement in skeletal muscle mass by a 0.7 kg gain and a better performance demonstrated by 0.14 m/s faster gait speed. This project targets to investigate the application of elastic-band exercise for older people to carry out at home for sarcopenia intervention.

Low-magnitude high-frequency vibration (LMHFV) has previously shown to be effective in enhancing muscle strength, balancing ability and reducing fall risk in a RCT involving 710 subjects. Community-dwelling older people treated at 35 Hz, 0.3 g and 20 minutes per day for 18-months showed reduced hazard ratio for fall or fracture (HR=0.56, 95% CI at 0.40-0.78, p=0.001), 2.46 kg increase in quadriceps strength (95% CI at 1.70-3.22, p<0.001) and overall statistically significant improvements in balancing ability.

HMB supplementation is advantageous due to its simplicity in administration compared to various other schemes. In a RCT on the efficacy of HMB supplementation on 10-day bed-rested older adults aged 60-76, 3.0-g/day was found to be effective in maintaining total lean mass, appendicular lean mass, leg and arm lean masses with significant differences.

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 the 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 29, 2023
• Est. primary completion date: July 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years old or above

• failing the sarcopenia screening based on the AWGS definition:

1. hand-grip strength (male at <26 kg, female at <18kg),

2. 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Hydroxymethylbutyrate
Hydroxymethylbutyrate supplementation at 3.0 g/day with dietary advice.

Device:
• Low-magnitude High Frequency Vibration (LMHFV)
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.

Behavioral:
• Elastic-band Exercise
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.

Locations

Country	Name	City	State
Hong Kong	Evangelical Luthera Church Social Service - Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (9)

Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyère 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. Review. — View Citation

Chen 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. — View Citation

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková 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. — View Citation

Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of ß-hydroxy-ß-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. — View Citation

Leung 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. — View Citation

Sayer AA. Sarcopenia. BMJ. 2010 Aug 10;341:c4097. doi: 10.1136/bmj.c4097. — View Citation

Stout JR, Smith-Ryan AE, Fukuda DH, Kendall KL, Moon JR, Hoffman JR, Wilson JM, Oliver JS, Mustad VA. Effect of calcium ß-hydroxy-ß-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. — View Citation

Yu 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. Erratum in: Geriatr Gerontol Int. 2014 Jul;14(3):730. — View Citation

Zhu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Balancing ability	Biodex Balance System SD (BioSway, Biodex Medical Systems, USA) will be used to measure the balancing ability of the subjects. This is a verified assessment tool to measure the angular excursion of subject's center of gravity during movement. Parameters of balancing ability include reaction time, movement velocity, maximum/end-point excursion and directional control in limit of stability test.	3 months, change is being assessed
Secondary	Timed-up-go test (TUG)	Time will be recorded for participants to rise from a chair, walk 3 meters, turn around, and walk back to the chair then sitting down.	3 months, change is being assessed
Secondary	Dual energy x-ray absortiometry (DXA)	Whole body muscle mass measurement	3 months, change is being assessed.
Secondary	Gait speed	A 6-meter-walk test will be used to calculate the gait speed of the participant.	3 months, change is being assessed.
Secondary	Muscle strength in the upper extremity	Handgrip strength will be measured by a dynamometer (5030JI, JAMAR, USA) on each hand of the subject. Participants will be instructed to hold the device with the arm at right angle and elbow to the side of the body.	3 months, change is being assessed.
Secondary	Quality of life by short-form-36	Health-related quality of life will be assessed by the validated Chinese version of the 36-item Short-Form Health Survey (SF-36).	3 months, change is being assessed.

External Links

•   2016 Population By-census. Thematic Report: Older Persons. Hong Kong.: Census and Statistics Department; 2018.