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Cardiac Rehab and Cerebral Blood Flow Study

Not Applicable
Recruiting
Conditions
Cardiovascular Diseases
Interventions
Behavioral: Cardiac rehabilitation - high intensity interval training (HIIT)
Behavioral: Cardiac rehabilitation - control
Behavioral: 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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cardiac rehabilitation - High intensity interval training (HIIT)Cardiac rehabilitation - high intensity interval training (HIIT)Patients attending cardiac rehabilitation randomized to HIIT.
Cardiac rehabilitation - controlCardiac rehabilitation - controlThe 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 - observationalCardiac rehabilitation - observationalThis 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
NameTimeMethod
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
NameTimeMethod
Cognitive functionBaseline 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

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