Prevalence and the Effect of Lifestyle Modification Project (LMP) on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia in Chinese Adults and Elderly: a Multicenter Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- relative skeletal muscle index
研究概览
简要总结
The purposes of this study were to investigate the prevalence and risk factors for sarcopenia in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent
排除标准
- •age<18 year Concurrent severe cardiac disease, unstable diabetes mellitus,uncontrolled chronic disease,liver and renal failer, which may significantly interfere with study compliance.
- •Participants received any drugs or supplements known to influence effcet size,such as protein powder, calcium, or vitamin D before the 3 months preceding the study. Participants with electronic or mental device
研究组 & 干预措施
nutritional intervention
This group received multi-dimensional intensive nutritional intervention for 3 month, which included whey (30g/d,plus three times every week ),vitamin D (1000IU) and omega-3 fatty acid (DHA 1200mg and EPA 800mg).
干预措施: nutritional intervention (Behavioral)
resistance training program
This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing.
干预措施: resistance training program (Behavioral)
lifestyle modification project
This group receive multi-dimensional intensive nutritional intervention and resistance training program.
干预措施: lifestyle modification project (Behavioral)
control
This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.
干预措施: control (Behavioral)
结局指标
主要结局
relative skeletal muscle index
时间窗: 3 months
RSMI(Unit: kg/m2)is defined as muscle mass
次要结局
- gait speed(3 months)
- quality of life on EQ-5D scale(3 months)
- the change of physical function on frail index(3 months)
- Hand grip(3 months)
- the rate of infection complication(3 months)
- medical cost on cost-effectiveness ratio(3 months)
- The rate of fracture(3 months)
- mortality rate(3 months)