Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Cardiopulmonary capacity
研究概览
简要总结
Stroke patients usually have difficulties with moving and are venerable to secondary problems such as sarcopenia and strength loss. These problems may accelerate the disability process during aging. It is well known that exercise helps to maintain or promote human fitness. This study is conducted to explore the beneficial effects of exercise and protein supplement on fitness and body composition among patients with chronic stroke.
详细描述
This is a multicenter randomized control trial. Participants will be recruited from 4 teaching hospitals in Taipei. Participants are randomly assigned to 2 groups:
- protein supplementation + exercise (PRO group);
- carbohydrate supplementation + exercise (CHO group);
The 1-hour exercise intervention includes aerobic cycling exercise followed by progressive resisted exercise with TheraBand. PRO group receives PS immediately before and after the exercise while the CHO group receive sham product (the same calories with no protein). The Interventions are arranged 3 sessions a week for 10 weeks. The outcome measurements are performed at 0-week, 10-week, and 20-week.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stroke>6months
- •Age : 20-75 y
- •Able to walk independently over 10 mins (with or without orthosis)
- •Able to use stationary bike
排除标准
- •Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
- •Not able to exercise due to severe cardiopulmonary dysfunction
- •Malnutrition (MNA<11)
- •Severe obesity (BMI>35)
- •Renal insufficiency
- •Unable to tolerate our cardiopulmonary exercise test (CPET) (eg, too short stature to fit the machine, leg spasticity is too strong to peddle the cycling, unable to maintain 50 rpm at the beginning of CPET, indications for early termination of CPET based on the American College of Sport Medicine suggestions)
结局指标
主要结局
Cardiopulmonary capacity
时间窗: 10 weeks
VO2-peak. Oxygen consumption (VO2- peak) were measured during our cardiopulmonary test (with a ramped stationary biking and a gas analyzer). The workload was increased at a ramp rate of 5-10 W/min. A cadence at 50\~70 rpm was to be maintained.
次要结局
- 6 minutes walk test(20 weeks)
- Total body lean and fat mass(20 weeks)
- Burg Balance Test(20 weeks)
- Physical performance (short physical performance battery)(20 weeks)
- CardioPulmonary Exercise Test(20 weeks)
- Timed up and go (TUG)(20 weeks)
- Physical performance (modified physical performance test)(20 weeks)
- Maximal isometric voluntary contraction(20 weeks)
研究者
Yen-Nung Lin
Director of Department of Rehabilitation, WanFang Hospital
Taipei Medical University WanFang Hospital