Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change of Surface electromyography
研究概览
简要总结
Despite numerous kinds of evidence on functional health and CNS protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. The aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.
详细描述
In order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to intermittent fasting group or control group. In both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. The intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. The efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who was diagnosed first ischemic stroke within preceeding 1 year through brain MRI/CT
排除标准
- •Musculo-skeletal disease with limbs malformation or joint contracture
- •Weigh more than 135 kg or taller than 195 cm
- •Diabetes mellitus
- •unstable patient in neurology
- •Refusal of participation
结局指标
主要结局
Change of Surface electromyography
时间窗: 1 day before the initiation of intervention, and 6 months after the stroke onset
root mean square and root peak square of compound motor action potential
次要结局
- Change of Korean-modified Barthel index(1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset)
研究者
Chang Ho Hwang
Associate Professor
Ulsan University Hospital