Resistance Exercise or Vibration With HMB for Sarcopenia
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Hydroxymethylbutyrate
Low-magnitude High Frequency Vibration (LMHFV)
Elastic-band Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring vibration treatment, sarcopenia, elastic-band resistance, hydroxymethylbutyrate, elderly, randomized control trial
Eligibility Criteria
Inclusion Criteria:
- 65 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.
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)
Sites / Locations
- Evangelical Luthera Church Social Service - Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control Group
Exercise + HMB Group
Vibration Treatment + HMB Group
Arm Description
No intervention on sarcopenic subjects screened (based on the AWGS definition).
Sarcopenic subjects on combined treatment of elastic-band exercise and HMB supplementation
Sarcopenic subjects on combined treatment of vibration treatment and HMB supplementation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Dual energy x-ray absortiometry (DXA)
Whole body muscle mass measurement
Gait speed
A 6-meter-walk test will be used to calculate the gait speed of the participant.
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.
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).
Full Information
NCT ID
NCT04028206
First Posted
July 18, 2019
Last Updated
March 8, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04028206
Brief Title
Resistance Exercise or Vibration With HMB for Sarcopenia
Official Title
Elastic-band Resistance Exercise or Vibration Treatment With Hydroxymethylbutyrate (HMB) Supplement for Sarcopenic Older People
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
July 29, 2023 (Anticipated)
Study Completion Date
July 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
vibration treatment, sarcopenia, elastic-band resistance, hydroxymethylbutyrate, elderly, randomized control trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention on sarcopenic subjects screened (based on the AWGS definition).
Arm Title
Exercise + HMB Group
Arm Type
Active Comparator
Arm Description
Sarcopenic subjects on combined treatment of elastic-band exercise and HMB supplementation
Arm Title
Vibration Treatment + HMB Group
Arm Type
Active Comparator
Arm Description
Sarcopenic subjects on combined treatment of vibration treatment and HMB supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydroxymethylbutyrate
Intervention Description
Hydroxymethylbutyrate supplementation at 3.0 g/day with dietary advice.
Intervention Type
Device
Intervention Name(s)
Low-magnitude High Frequency Vibration (LMHFV)
Other Intervention Name(s)
Vibration treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Elastic-band Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength in the lower extremity
Description
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.
Time Frame
3 months, change is being assessed.
Secondary Outcome Measure Information:
Title
Balancing ability
Description
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.
Time Frame
3 months, change is being assessed
Title
Timed-up-go test (TUG)
Description
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.
Time Frame
3 months, change is being assessed
Title
Dual energy x-ray absortiometry (DXA)
Description
Whole body muscle mass measurement
Time Frame
3 months, change is being assessed.
Title
Gait speed
Description
A 6-meter-walk test will be used to calculate the gait speed of the participant.
Time Frame
3 months, change is being assessed.
Title
Muscle strength in the upper extremity
Description
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.
Time Frame
3 months, change is being assessed.
Title
Quality of life by short-form-36
Description
Health-related quality of life will be assessed by the validated Chinese version of the 36-item Short-Form Health Survey (SF-36).
Time Frame
3 months, change is being assessed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 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.
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon K.H. CHOW, PhD
Phone
(852)3505-1559
Email
skhchow@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Y.K. CHENG
Phone
(852)3505-2756
Email
keithykcheng@cuhk.edu.hk
Facility Information:
Facility Name
Evangelical Luthera Church Social Service - Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kam Lee Lam
Phone
31247633
Ext
852
Email
kamleelam@elchk.org.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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 .
IPD Sharing Time Frame
Individual participant data will be made available beginning 3 months and ending 3 years following article publication.
IPD Sharing 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.
IPD Sharing URL
https://clinicalstudydatarequest.com
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23981904
Citation
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Links:
URL
https://www.censtatd.gov.hk/hkstat/sub/sp459.jsp?productCode=B1120105
Description
2016 Population By-census. Thematic Report: Older Persons. Hong Kong.: Census and Statistics Department; 2018.
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Resistance Exercise or Vibration With HMB for Sarcopenia
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