Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
研究概览
简要总结
Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively.
Even with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. Alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. Another conservative approach to increase cerebral perfusion is aerobic exercising. Physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. However, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. Herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients of 18 years of age or above
- •Subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion
- •Subjects do not qualify for flow augmentation through ECIC bypass or endovascular treatment
- •Persistent deficit in BOLD-CVR
- •Functional Ambulatory Categories >2
- •Discharged from hospitalization / inpatient rehabilitation
- •Living independent before stroke (mRS ≤3)
- •Written Informed Consent
排除标准
- •Severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (New York Health Association > II°), or hemodynamically significant valvular dysfunction
- •Complete arterial stenosis
- •Peripheral artery disease with mild to moderate claudication at < 200m or 200-1000m of walking
- •Contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication
- •Inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia)
- •Known or suspected non-compliance, documented drug, or alcohol abuse
- •Pregnancy
结局指标
主要结局
Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
时间窗: post-intervention (12 weeks)
Functional brain tissue perfusion and tissue at risk based on cerebrovascular reactivity by blood oxygenation-level dependent functional magnetic resonance imaging (BOLD-fMRI), measured as the percentage BOLD signal change /mmHg CO2.
次要结局
- Brain imaging - NOVA-qMRI(post-intervention (12 weeks))
- Brain imaging - Lesion volume(post-intervention (12 weeks))
- Six-Minute Walk Test (6MWT)(post-intervention (12 weeks) + follow-up (+3 months))
- Motricity Index of the Lower Extremity (MI-LE)(post-intervention (12 weeks) + follow-up (+3 months))
- 5-Chair-Rise-Test(post-intervention (12 weeks) + follow-up (+3 months))
- Brain imaging - intravoxel incoherent motion (IVIM)(post-intervention (12 weeks))
- Ten-Meter Walk Test (10MWT)(post-intervention (12 weeks) + follow-up (+3 months))
- Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)(post-intervention (12 weeks) + follow-up (+3 months))
- Montreal Cognitive Assessment (MoCA)(post-intervention (12 weeks) + follow-up (+3 months))
- Stroop test(post-intervention (12 weeks) + follow-up (+3 months))
- International Physical Activity Questionnaire (IPAQ)(post-intervention (12 weeks) + follow-up (+3 months))
- Word list learning(post-intervention (12 weeks) + follow-up (+3 months))
- Exercise stress testing(post-intervention (12 weeks))
- Brain imaging - Collateral status(post-intervention (12 weeks))
- Digit Span Test / Corsi block(post-intervention (12 weeks) + follow-up (+3 months))
- European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)(post-intervention (12 weeks) + follow-up (+3 months))