Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- change of cerebrovascular reserve capacity
研究概览
简要总结
The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).
详细描述
The primary objective: Intense aerobic exercise (24/8 weeks) improves CVR > 20% measured by Transcranial Doppler (TCD) in patients with hemodynamic relevant intra- or extracranial stenoses by enhanced cerebral arterio- and angiogenesis.
Secondary objectives:
Intense aerobic exercise (24/8 weeks) leads to:
- an increase of Endothelial progenitor cell counts (EPCs)
- qualitative and quantitative changes of endothelial markers and cytokines representing the inflammatory activity of atherosclerosis and neovascularisation
- an improvement in cognitive performance and quality of life (QoL)
- changes of the mean vessel size and of cerebral perfusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD
排除标准
- •continuous physical activity ≥ 60 min/week within the last 3 months
- •cerebral bleeding or ischaemic stroke < 3 months
- •contraindications for spiro-ergometry, IAEx, or MRI
结局指标
主要结局
change of cerebrovascular reserve capacity
时间窗: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
次要结局
- Endothelial Progenitor Cells, cyto- and chemokines(after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up)
- Neuropsychological Testing/ Quality of life(immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up)
研究者
Gerhard Jan Jungehuelsing
MD
Charite University, Berlin, Germany