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

NCT06287502 | Completed

• 1 other identifier: KHRehab_LeungHC_2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Grip strength

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

  12 weeks

Secondary Outcomes (6)

• Body weight

  12 weeks

• Body mass index

  12 weeks

• Appendicular skeletal muscle mass index

  12 weeks

• 6-metre walk test

  12 weeks

• 5-time chair stand test

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Wait-list control

NO INTERVENTION

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

Interventions

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.

Intervention

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowloon Hospital, Hong Kong: lead

Study Sites (1)

Kowloon Hospital

Kowloon, Hong Kong

Location

Related Publications (2)

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.

  PMID: 30462162 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Interventions

Pliability

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Hin Cheung Leung, MBChB

  Kowloon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 1, 2024
• Study Start: September 9, 2022
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)