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

Not Applicable

Active, not recruiting

• Conditions: Sarcopenia; Osteoporosis
• Interventions: Dietary Supplement: β-hydroxy β-methylbutyrate (HMB); Behavioral: Resistance, aerobic, flexibility and balance exercise training

• Registration Number: NCT06287502
• Lead Sponsor: Kowloon Hospital, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-23
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Grip strength	12 weeks	Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States).

Secondary Outcome Measures

Name	Time	Method
Body weight	12 weeks
Body mass index	12 weeks
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.
Appendicular skeletal muscle mass index	12 weeks	ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea).
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.
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 .

Trial Locations

Locations (1)

Kowloon Hospital; 🇭🇰 Kowloon, Hong Kong