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临床试验/NCT00376207
NCT00376207已完成不适用

Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年1月1日最近更新:
适应症

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

研究者

申办方类型
Other

研究点 (1)

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