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Completed

NCT Number: NCT06287502

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

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.

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Key information

Conditions

Sarcopenia Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kowloon Hospital

Kowloon, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Self-reported allergy to the ingredients of the nutrition supplement
  • Patients with metallic implants
  • Any orthopaedic pathologies affecting the strength of bilateral upper limbs
  • Any hereditary or acquired muscular diseases
  • Participation in other regular exercise programme

Treatment and study plan

β-hydroxy β-methylbutyrate (HMB)

Dietary Supplement

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.

Resistance, aerobic, flexibility and balance exercise training

Behavioral

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.

Primary outcomes

  1. Grip strength

    Time frame: 12 weeks

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

Secondary outcomes

  1. Body weight

    Time frame: 12 weeks

  2. Body mass index

    Time frame: 12 weeks

  3. Appendicular skeletal muscle mass index

    Time frame: 12 weeks

    ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea).

  4. 6-metre walk test

    Time frame: 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.

  5. 5-time chair stand test

    Time frame: 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.

  6. Short Physical Performance Battery (SPPB)

    Time frame: 12 weeks

    The SPPB, a reliable and valid tool to evaluate functional capability, consisted of three components: standing balance, walking speed and chair stand .

Sponsors and collaborators

Lead sponsor

Kowloon Hospital, Hong Kong

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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