Clinical trial NCT06287502: Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
Official title: Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sarcopenia
Osteoporosis
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Grip strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
measure: Appendicular skeletal muscle mass index
timeFrame: 12 weeks
measure: 6-metre walk test
timeFrame: 12 weeks
measure: 5-time chair stand test
timeFrame: 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Kowloon Hospital
Study officials:
affiliation: Kowloon Hospital
name: Hin Cheung Leung, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.