Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Wait-list control
The waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.
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.
干预措施: β-hydroxy β-methylbutyrate (HMB) (Dietary Supplement)
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.
干预措施: Resistance, aerobic, flexibility and balance exercise training (Behavioral)
结局指标
主要结局
Grip strength
时间窗: 12 weeks
Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States).
次要结局
- Body weight(12 weeks)
- Body mass index(12 weeks)
- 5-time chair stand test(12 weeks)
- Appendicular skeletal muscle mass index(12 weeks)
- 6-metre walk test(12 weeks)
- Short Physical Performance Battery (SPPB)(12 weeks)
研究者
Leung Hin Cheung
Principal Investigator
Kowloon Hospital, Hong Kong