Osteoporosis, Sarcopenia
Conditions
Brief summary
This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.
Interventions
DIETARY_SUPPLEMENTβ-hydroxy β-methylbutyrate (HMB)
Ensure NutriVigor, a nutritional supplement, was provided to subjects according to the manufacturer's recommendation of two servings per day. Each serving consists of 54.1g of powder which provides \ 231kcal, 8.61g protein, 1.21 g β-hydroxy β-methylbutyrate, 130 IU vitamin D and 0.29 g omega-3 fatty acid.
BEHAVIORALResistance, aerobic, flexibility and balance exercise training
The exercise intervention consists of 75-minutes sessions delivered by physiotherapists at the Integrated Rehabilitation Day Centre (IRDC) in Kowloon Hospital, twice per week for 12 weeks with a total of 24 supervised sessions. Each exercise session consists of 5 minutes of warm up, 30 minutes of resistance training, 20 minutes of aerobic training, 15 minutes of balance or neuromuscular exercises and 5 minutes of cool down.
Sponsors
Kowloon Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of sarcopenia: * Low hand grip strength (Male: \<28 kg, Female: \<18 kg) AND * Low appendicular skeletal mass by bioimpedance analysis (Male: \<7.0 kg/m2 Female: \<5.7 kg/m2) 2. Diagnosed with osteoporosis by: * Fragility fracture or * T-score ≤-2.5 SDs at any site based upon BMD measurement by Dual Energy X-ray Absorptiometry (DXA) scan
Exclusion criteria
1. Incompetent in giving consent or following commands 2. Non-ambulatory subject 3. Unstable medical conditions contributing to sarcopenia, for example but not limited to: 1. End stage organ failure 2. Unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions 3. Active malignancy 4. Chronic kidney disease stage IV or above or with hyperkalaemia 5. Diabetes mellitus on medications or with unstable control 6. Terminal illness 7. Obese subjects (BMI ≥ 25.0) 8. Self-reported allergy to the ingredients of the nutrition supplement 9. Patients with metallic implants 10. Any orthopaedic pathologies affecting the strength of bilateral upper limbs 11. Any hereditary or acquired muscular diseases 12. Participation in other regular exercise programme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 12 weeks | Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-time chair stand test | 12 weeks | Starting from sitting on a standard chair with folded arm across chest, subject is asked to rise from the chair and return to the seated position as quickly as possible for five repetitions. |
| Body weight | 12 weeks | — |
| 6-metre walk test | 12 weeks | In 6-metre walk test, a 10-metre walkway is marked at the 0-, 2-, 8-, and 10-metre points. The time for the patient to finish the central 6 metres will be recorded by a digital stopwatch by the same tester. |
| Appendicular skeletal muscle mass index | 12 weeks | ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea). |
| Short Physical Performance Battery (SPPB) | 12 weeks | The SPPB, a reliable and valid tool to evaluate functional capability, consisted of three components: standing balance, walking speed and chair stand . |
| Body mass index | 12 weeks | — |
Countries
Hong Kong
Outcome results
None listed