Cerebral Blood Flow Regulation and Cognitive Function in Adults With Cardiovascular Disease - Influence of Exercise Training and Intensity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Cerebral blood flow regulation (as cerebrovascular reactivity)
研究概览
简要总结
This study is being done to better understand the influence of cardiovascular disease on brain blood flow regulation and cognitive function, determine whether exercise-based cardiac rehabilitation can lead to better regulation of brain blood flow that may help to improve or maintain cognitive function, and determine whether exercise intensity influences changes in brain blood flow regulation and cognitive function.
详细描述
This study will investigate the influence of exercise training and intensity (as part of cardiac rehabilitation) on improving cerebral blood flow regulation and cognitive function following a cardiac event. This will be a randomized control trial, recruiting adults in mid-life (years 40-65) with coronary artery disease, enrolling in cardiac rehabilitation following a cardiac-related hospital admission. Patients that enroll in the Mayo Clinic cardiac rehabilitation will be randomized 1:1 to high intensity interval training (HIIT) or moderate intensity continuous training (MICT), with stratification for sex and coronary artery bypass graft surgery. Patients that decline enrollment in cardiac rehabilitation will be recruited as an observational control group, which will be matched to the intervention groups by age decade, sex, BMI category, and surgical status. Patients that enroll in cardiac rehabilitation but decline randomization will be recruited as an observational cardiac rehabilitation group. A healthy control group without cardiovascular disease will also be recruited for baseline comparison of outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cardiac rehabilitation - High intensity interval training (HIIT)
Patients attending cardiac rehabilitation randomized to HIIT.
干预措施: Cardiac rehabilitation - high intensity interval training (HIIT) (Behavioral)
Cardiac rehabilitation - Moderate intensity continuous training (MICT)
Patients attending cardiac rehabilitation randomized to MICT.
干预措施: Cardiac rehabilitation - moderate intensity continuous training (MICT) (Behavioral)
Cardiac rehabilitation - control
The control group (12 week period) will include participants who have declined cardiac rehabilitation.
干预措施: Cardiac rehabilitation - control (Behavioral)
Healthy control group
Healthy age-matched adults without cardiovascular disease, who will complete baseline assessments only. No intervention period.
Cardiac rehabilitation - observational
This observational group will include patients who are completing an exercise-based cardiac rehabilitation program in line with standard care but are not part of the randomized exercise protocol groups (HIIT or MICT). Participants in this group will be combined with HIIT and MICT (as exercise-based cardiac rehabilitation group) for Aims 1b and 2b.
干预措施: Cardiac rehabilitation - observational (Behavioral)
结局指标
主要结局
Cerebral blood flow regulation (as cerebrovascular reactivity)
时间窗: Baseline and follow-up at 3-months
Measured as the change in cerebral blood flow during a stepped protocol of increases in inhaled carbon dioxide concentrations. Reactivity will be measured as the regression slope of cerebral blood flow velocity (cm per second) per mmHg increase in end-tidal carbon dioxide.
次要结局
- Cognitive function(Baseline and follow-up at 3-months)
研究者
Bruce Johnson
Principal Investigator
Mayo Clinic