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临床试验/NCT02068391
NCT02068391已完成不适用

Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Bradley MacIntosh

Imaging Scientist

Sunnybrook Health Sciences Centre

研究点 (2)

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