Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis

Kowloon Hospital, Hong Kong

Status: Completed

Conditions: Osteoporosis; Sarcopenia

Treatments: Dietary Supplement: β-hydroxy β-methylbutyrate (HMB); Behavioral: Resistance, aerobic, flexibility and balance exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT06287502

KHRehab_LeungHC_2

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

13 participants in 2 patient groups

Intervention

Experimental group

Description:

Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB) during the 12-week study period.

Treatment:

Behavioral: Resistance, aerobic, flexibility and balance exercise training

Dietary Supplement: β-hydroxy β-methylbutyrate (HMB)

Wait-list control

No Intervention group

Description:

The waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.