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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06287502
• Other study ID #: KHRehab_LeungHC_2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Kowloon Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Dietary Supplement:
• ß-hydroxy ß-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 ß-hydroxy ß-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.

Locations

Country	Name	City	State
Hong Kong	Kowloon Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Kowloon Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength	Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States).	12 weeks
Secondary	Body weight		12 weeks
Secondary	Body mass index		12 weeks
Secondary	Appendicular skeletal muscle mass index	ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea).	12 weeks
Secondary	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
Secondary	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
Secondary	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