Cardiac Rehab and Cerebral Blood Flow Study
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: Cardiac rehabilitation - high intensity interval training (HIIT)Behavioral: Cardiac rehabilitation - controlBehavioral: Cardiac rehabilitation - moderate intensity continuous training (MICT)Behavioral: Cardiac rehabilitation - observational
- Registration Number
- NCT05012878
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac rehabilitation - High intensity interval training (HIIT) Cardiac rehabilitation - high intensity interval training (HIIT) Patients attending cardiac rehabilitation randomized to HIIT. Cardiac rehabilitation - control Cardiac rehabilitation - control The control group (12 week period) will include participants who have declined cardiac rehabilitation. Cardiac rehabilitation - Moderate intensity continuous training (MICT) Cardiac rehabilitation - moderate intensity continuous training (MICT) Patients attending cardiac rehabilitation randomized to MICT. Cardiac rehabilitation - observational 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.
- Primary Outcome Measures
Name Time Method Cerebral blood flow regulation (as cerebrovascular reactivity) 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.
- Secondary Outcome Measures
Name Time Method Cognitive function Baseline and follow-up at 3-months The main domains of cognitive function assessed using a neuropsychometric testing battery will be executive function, processing speed, and memory. Scores from these domains will be combined as the NIH Toolbox Fluid composite score, and assessed for change from baseline to follow-up. Analyses will also be completed for each separate cognitive domain.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States