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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis
• Intervention / Treatment: Dietary supplement: β-hydroxy β-methylbutyrate (HMB); Behavioral: Resistance, aerobic, flexibility and balance exercise training

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Kowloon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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); 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.; Behavioral: Resistance, aerobic, flexibility and balance exercise training; 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.
No Intervention: Wait-list control; The waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight		12 weeks
Body mass index		12 weeks
Appendicular skeletal muscle mass index	ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea).	12 weeks
6-metre walk test	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.	12 weeks
5-time chair stand test	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.	12 weeks
Short Physical Performance Battery (SPPB)	The SPPB, a reliable and valid tool to evaluate functional capability, consisted of three components: standing balance, walking speed and chair stand .	12 weeks

Collaborators and Investigators

• Sponsor: Kowloon Hospital, Hong Kong
• Investigators: Principal Investigator: Hin Cheung Leung, MBChB, Kowloon Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Bone Diseases, Metabolic; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Osteoporosis; Sarcopenia; Mechanical Phenomena; Physical Phenomena; Pliability
• Other Study ID Numbers: KHRehab_LeungHC_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No