Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in cerebral blood flow from baseline to 6 months
研究概览
简要总结
Silent ischemic, also known as "covert stroke vascular disease" (CSVD), contributes to neurological deficits that are caused by damage to small blood vessels in the brain. CSVD occurs six to ten times more often that an acute stroke. It is misleading to think, however, that CSVD is an inevitable part of "getting old" because people with CSVD are at high risk of developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more likely to develop day to day problems in planning, decision-making and speed of thinking. Unfortunately, there are no proven therapies designed to address CSVD. We propose to test whether aerobic exercise is an intervention that can combat CSVD because the disease is fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to study the brain in terms of structure, perfusion and function. Participants will be randomly assigned to either our established aerobic exercise program or a control stretching program. Both groups will take part in lab exercise sessions, which are designed to monitor progress and assess adherence to the program. The duration and intensity of their exercise will increase as participants progress. We will use activity log books, phone calls and extra "booster" exercise sessions, as needed, to maximize retention and adherence. We aim to show that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter, supports regional tissue growth, and improves cognitive function in CSVD adults with substantial risk of acute stroke and dementia. A positive outcome of this research will provide strong support for additional clinical trials aimed at sustaining cognition and maintaining independent living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Covert stroke: white matter hyperintensities of presumed vascular origin
- •Ability to walk for 10 minutes without assistance from another person
- •Fluent in English
- •Ability to consent
排除标准
- •Highly fit individuals exercising ≥ 150 minutes per week
- •Multiple Sclerosis
- •Disabling stroke (ischemic or hemorrhagic)
- •Major concurrent illness (e.g. chronic obstructive lung disorder, current or metastatic cancer, chronic kidney disease)
- •Major psychiatric illness (e.g. bipolar, schizophrenia, major depression)
- •Contraindications to MRI scanning (e.g. claustrophobia, implants, prostheses, metallic fragments)
- •Contraindications to exercise (participants must have medical clearance to exercise from their attending physician)
- •Recent change in health status (e.g. hospitalization within past month)
研究组 & 干预措施
Exercise
This group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12.
干预措施: Exercise Program (Behavioral)
Stretching
This group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12.
干预措施: Stretching Program (Behavioral)
Stretching
This group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12.
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Change in cerebral blood flow from baseline to 6 months
时间窗: 6 months
Pseudo-continuous arterial spin labeling MRI
Change in brain structure from baseline to 6 months
时间窗: 6 months
Cortical and subcortical grey matter density using structural MRI
次要结局
- Change in brain activity related to attention and executive control tasks from baseline to 6 months(6 months)
研究者
Dr. Bradley MacIntosh
Imaging Scientist
Sunnybrook Health Sciences Centre
