The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Handgrip strength
研究概览
简要总结
The goal of this clinical randomized trial is to test whether an integrated care involving peripheral functional magnetic stimulation and nutritional supplement is beneficial in population with age-related sarcopenia, as compared to usual care.
详细描述
We will recruit participants with sarcopenia or possible sarcopenia. The participants will be divided into 2 groups. One group, the "integrated care" group, will receive both the peripheral functional magnetic stimulation to both the upper and lower limbs and nutritional supplement for consecutive 8 weeks. The other group, the "usual care" group, will receive an educational digital versatile disc (DVD) and a handbook for exercise suggestions on sarcopenia. We will compare before and after the intervention about the body composition, handgrip strength, 5-time chair stand test, 6-meter walk, and blood test for C-reactive protein and other cytokines related to sarcopenia. The participant's nutritional condition, activity level, life quality will also be analyzed via questionnaires before and after the 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
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 65 to 90
- •Can walk independently for over 15 minutes
- •Diagnosed with possible sarcopenia or sarcopenia (by Asian Working Group for Sarcopenia: 2019 Consensus Update onSarcopenia Diagnosis and Treatment)
排除标准
- •Cognitive impairment
- •History of cerebrovascular disease
- •Deep vein thrombosis
- •Malignancy under treatment
- •Coagulopathy
- •Serious orthopedic condition over limbs
- •Inability to walk independently without assistive device
- •Any other conditions not suggested to performance exercise
- •Medical implants (e.g. pacemaker, defibrillator, deep brain nerve stimulation, infusion pump, etc.)
结局指标
主要结局
Handgrip strength
时间窗: Before the intervention, and 1-2 weeks after the 8-week intervention
We use a dynamometer to measure the handgrip strength (kg)
5-time chair stand test
时间窗: Before the intervention, and 1-2 weeks after the 8-week intervention
We measure the time of a subject to transfer from a seated to a standing position and back to sitting five times.
Body composition
时间窗: Before the intervention, and 1-2 weeks after the 8-week intervention
We use dual energy x-ray absorptiometry to evaluate the muscle mass (kg/m2) in the subjects.
6-meter walk
时间窗: Before the intervention, and 1-2 weeks after the 8-week intervention
We measure the time of a subject to walk with the usual speed straightly for 6 meters.
次要结局
- Leg circumference(Before the intervention, and 1-2 weeks after the 8-week intervention)
- Nutritional status(Before the intervention, and 1-2 weeks after the 8-week intervention)
- Cytokines related to sarcopenia(Before the intervention, and 1-2 weeks after the 8-week intervention)
- Life quality(Before the intervention, and 1-2 weeks after the 8-week intervention)
- Activity level(Before the intervention, and 1-2 weeks after the 8-week intervention)
