Resistance Exercise or Vibration With HMB for Sarcopenia

NCT04028206 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-03-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2023-07-29
Completion
2023-07-29

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028206 on ClinicalTrials.gov