An interventional study of Low-magnitude High-frequency Vibration and β-hydroxy β-methylbutyrate (HMB) supplement in Sarcopenia, Connective Tissue Diseases in Old Age and Musculoskeletal Abnormalities, sponsored by Chinese University of Hong Kong. Recruiting at 3 sites in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention
The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by \~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by \~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by \~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.
In this study, a single-blinded RCT is to investigate the effect of combination treatment of VT and HMB on hand grip, gait speed, muscle mass (DXA) in sarcopenic subjects.
Subjects over age of 65 will be screened by performing SARC-F, handgrip, gait speed and bioelectric impedance assessment (BIA) based on AWGS definition. The participants failed in AWGS algorithm will be invited to join the research. Exclusion criteria are those with (1)pathological bone diseases, (2) chronic inflammatory conditions (e.g. rheumatoid arthritis), (3) neurological problems affecting gait, (4) taking regular supervised exercise training for more than 3 times/week, (5) chair-bound or bed-bound, and (6) malignancy.
Recruited subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months. Subjects assigned to HMB+VT group will recieve both VT and HMB supplements for 6 months. The primary outcome is muscle strength showing subjects' functional ability. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline, 3 months and 6 months post-treatment.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Subjects failed in AWGS algorithm
Exclusion Criteria:
Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.
Dietary Supplement: Protein supplement
Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.
Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement · Dietary Supplement: Protein supplement
Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months
Device: Low-magnitude High-frequency Vibration · Dietary Supplement: Protein supplement
Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.
Device: Low-magnitude High-frequency Vibration · Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement · Dietary Supplement: Protein supplement
0.3g, 35Hz, 20mins/day, at least 3 times/week
Also known as: Vibration Treatment
Oral nutritional HMB supplement at 3g/day
Daily protein supplement intake
Muscle strength-handgrip
Handgrip strength will be measured by a dynamometer on each hand of the subject.
Time frame: 6 months
Muscle performance-gait speed
Gait speed will be assessed by a 6-meter-walk test.
Time frame: 6 months
Dual energy x-ray absortiometry (DXA)
Whole body muscle mass measurement
Time frame: 6 months
Biodex Balance System-LOS
Limits of stability will be recorded to evaluate the dynamic posture stability. Maximum scores will be 100 where the higher scores indicate better performance.
Time frame: 6 months
Biodex Balance System-OSI
Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity.
Time frame: 6 months
Time-up-and-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
Time frame: 6 months
36-item Short-Form Health Survey (SF-36)
Health-related quality of life will be assessed by the validated Chinese version of SF-36. Scores range from 0 to 100 where higher scores indicate better health status
Time frame: 6 months
Plan to share: No
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Musculoskeletal Abnormalities
Chinese University of Hong Kong