Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases - Effects of Therapeutic Exercise and Nutrition Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Change of grip force
研究概览
简要总结
The objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.
详细描述
The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. These patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. Past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin D) in order to achieve the best prevention and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55-85 years old
- •3-6 months after onset
- •walk independently for at least 10m
排除标准
- •lower limb Brunnstrom stage >5
- •combine other neuropathy diseases
- •significant deformity of lower limb include: Modified Ashworth scale(MAS) >3; contracture, fracture, chronic joint pain.
- •joint arthroplasty
- •unstable vital sign
- •can not cooperate study
结局指标
主要结局
Change of grip force
时间窗: before intervention; follow-up: 3 months after intervention
Use a grip force meter (kg) to test both hands for test 3 times
Change of postural sway velocity
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway velocity (mm/s)
Change of swing time
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support time
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: single support time (ms)
Change of double support time
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: double support time (ms)
Change of postural sway displacement
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway displacement (mm)
Change of postural sway area
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway area (mm\^2)
Change of muscle thickness
时间窗: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of international Quality of Life Assessment Short Form -36 (SF-36)
时间窗: before intervention; follow-up: 3 months after intervention
including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions. Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change of step time
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: step time (ms)
Change of amplitude of Muscle activity
时间窗: before intervention; follow-up: 3 months after intervention
use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters.
Change of muscle fiber length
时间窗: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber orientation angle
时间窗: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle cross section area
时间窗: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm\^2). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of physiological cost index (PCI)
时间窗: before intervention; follow-up: 3 months after intervention
Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR - Resting HR (beats/min) / Walking speed (m/s)
Change of walking speed
时间窗: baseline: before intervention; follow-up: 3 months after intervention
distance: 6m, patients can walk with foor orthosis and assistive devices
Change of step length
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance length
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of stance time
时间窗: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: stance time (ms)
次要结局
- Change of concentration of CRP (C-Reactive Protein)(before intervention; follow-up: 3 months after intervention)
- Change of concentration of ALB (Serum albumin)(before intervention; follow-up: 3 months after intervention)
- Change of Fugl-Meyer Assessment (FMA)(before intervention; follow-up: 3 months after intervention)
- Change of concentration of Glomerular Filtration Rate (GFR)(before intervention; follow-up: 3 months after intervention)
- Change of concentration of Hemoglobin (Hb)(Time Frame: before intervention; follow-up: 3 months after intervention)
- Change of concentration of Glucose SPOT(Time Frame: before intervention; follow-up: 3 months after intervention)
- Change of concentration of Cholesterol(before intervention; follow-up: 3 months after intervention)
- Change of concentration of Transferrin(before intervention; follow-up: 3 months after intervention)
- Change of concentration of Triglyceride(before intervention; follow-up: 3 months after intervention)
- Change of Body Mass Index (BMI)(before intervention; follow-up: 3 months after intervention)
- Change of Mini-mental state examination (MMSE)(before intervention; follow-up: 3 months after intervention)
- Change of Berg balance test (BBS)(before intervention; follow-up: 3 months after intervention)
- Change of Modified Ashworth scale (MAS)(before intervention; follow-up: 3 months after intervention)
- Change of Muscle tone(before intervention; follow-up: 3 months after intervention)
研究者
Ta-Sen Wei,MD
Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor
Changhua Christian Hospital