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

NCT ID: NCT06287502

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

β-hydroxy β-methylbutyrate (HMB)

Intervention Type: 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

Intervention Type: 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.

Wait-list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowloon Hospital, Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Leung Hin Cheung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hin Cheung Leung, MBChB

Role: PRINCIPAL_INVESTIGATOR

Kowloon Hospital

Locations

Kowloon Hospital

Kowloon, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: BACKGROUND

PMID: 32033882 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30462162 (View on PubMed)

Other Identifiers

KHRehab_LeungHC_2

Identifier Type: -

Identifier Source: org_study_id