Connective Tissue Diseases in Old Age, Musculoskeletal Abnormalities, Sarcopenia
Conditions
Keywords
Sarcopenia, Vibration, Hydroxymethylbutyrate
Brief summary
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.
Detailed description
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.
Interventions
0.3g, 35Hz, 20mins/day, at least 3 times/week
DIETARY_SUPPLEMENTβ-hydroxy β-methylbutyrate (HMB) supplement
Oral nutritional HMB supplement at 3g/day
DIETARY_SUPPLEMENTProtein supplement
Daily protein supplement intake
Sponsors
Abbott
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged 60 years or above * Subjects failed in AWGS algorithm 1. skeletal muscle mass by BIA (male at \<7.0 kg/m\^2, female at \<5.7 kg/m\^2), and 2. handgrip strength (male at \<28 kg, female at \<18kg), and/or 3. gait speed test (\>1m/s)
Exclusion criteria
* Subjects with pathological bone diseases * Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis) * Subjects with neurological problems * Subjects receiving regular exercise * Subjecs who are chair-/bed- bound * Subjects with malignancy * Subjects with cardiovascular concern such as with pace-maker in-situ * Subjects with acute fractures or severe osteoarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle performance-gait speed | 6 months | Gait speed will be assessed by a 6-meter-walk test. |
| Muscle strength-handgrip | 6 months | Handgrip strength will be measured by a dynamometer on each hand of the subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodex Balance System-OSI | 6 months | Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity. |
| Dual energy x-ray absortiometry (DXA) | 6 months | Whole body muscle mass measurement |
| 36-item Short-Form Health Survey (SF-36) | 6 months | 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-up-and-go test (TUG) | 6 months | 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 |
| Biodex Balance System-LOS | 6 months | Limits of stability will be recorded to evaluate the dynamic posture stability. Maximum scores will be 100 where the higher scores indicate better performance. |
Countries
Hong Kong
Contacts
Primary ContactWing Hoi Cheung, PhD
Backup ContactMeng Chen Michelle Li, PhD
Outcome results
None listed