Skip to main content
Clinical Trials/NCT06287502
NCT06287502
Completed
Not Applicable

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

Kowloon Hospital, Hong Kong1 site in 1 country13 target enrollmentSeptember 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Kowloon Hospital, Hong Kong
Enrollment
13
Locations
1
Primary Endpoint
Grip strength
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2022
End Date
June 30, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kowloon Hospital, Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Leung Hin Cheung

Principal Investigator

Kowloon Hospital, Hong Kong

Eligibility Criteria

Inclusion Criteria

  • 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)
  • 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

  • Incompetent in giving consent or following commands
  • Non-ambulatory subject
  • Unstable medical conditions contributing to sarcopenia, for example but not limited to:
  • End stage organ failure
  • Unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions
  • Active malignancy
  • Chronic kidney disease stage IV or above or with hyperkalaemia
  • Diabetes mellitus on medications or with unstable control
  • Terminal illness
  • Obese subjects (BMI ≥ 25.0)

Outcomes

Primary Outcomes

Grip strength

Time Frame: 12 weeks

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

Secondary Outcomes

  • Body weight(12 weeks)
  • Body mass index(12 weeks)
  • 5-time chair stand test(12 weeks)
  • Appendicular skeletal muscle mass index(12 weeks)
  • 6-metre walk test(12 weeks)
  • Short Physical Performance Battery (SPPB)(12 weeks)

Study Sites (1)

Loading locations...

Similar Trials