Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Association between PASE and HOMA
研究概览
简要总结
Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. It is known that physical exercise increases insulin sensitivity in healthy subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is not known.
Chronic low-grade inflammation is associated with an increased risk of stroke. Physical exercise has shown to increase IL-6 directly after exercise in untrained subjects. When fitness is increased in each subject then the peak IL-6 concentration after exercise decreases and so does the basal level of IL-6. It is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased.
This study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation.
Stroke patients have been randomized to intervention with physical exercise or control in the ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA). Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participated in the ExStroke Pilot trail
排除标准
- •Diabetes Mellitus
- •Not able to give informed consent
结局指标
主要结局
Association between PASE and HOMA
Association between PASE and IL-6
次要结局
- IL-6 concentration is lower in the intervention group than control group.
- TNF-alfa and IL-6 is positively associated.
- IL-18 is associated to HOMA
- Correlation between PASE and HOMA in the intervention group vs. controls
- HOMA mean value in the 2 groups
