Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT05012878
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.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients with Cardiovascular Disease:
Inclusion criteria
for Healthy controls:
Exclusion criteria
for participants in randomized cardiac rehabilitation groups (HIIT & MICT) :
Exclusion criteria
for participants in the observational control group and observational cardiac rehabilitation group:
During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 4x4-min high intensity aerobic intervals at a rating of perceived exertion 15-17 (hard to very hard), interspersed by a 3-min active recovery at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (4-min) and cool-down (3-min) at a light intensity.
Other names: CR-HIIT
During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 34-min of continuous aerobic exercise at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (3-min) and cool-down (3-min) at a light intensity.
Other names: CR-MICT
Participants will receive exercise advice in line with usual hospital discharge procedures. This involves exercise physiologists providing verbal and written information on achieving the national physical activity guidelines (150min/week of moderate intensity exercise) 60 and range of movement exercises for surgical patients with sternotomy. However, no structured or supervised exercise training program or other contact with participants will be provided after hospital discharge, to reflect the usual care process for patients that decline cardiac rehabilitation.
Other names: CR-Control
During cardiac rehabilitation (12-weeks), program frequency and exercise training protocol will align with clinical care decisions and/or patient choice rather than random assignment.
Other names: CR-Observational
Time frame: 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.
Time frame: 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.
Time frame: Baseline and follow-up at 3-months
Measured as the change in cerebral blood flow during a visual stimulus
Time frame: Baseline and follow-up at 3-months
Measured as the change in cerebral blood flow from seated position to standing position.
Time frame: Baseline and follow-up at 3-months
Measured as the regression slope of cerebral blood flow per increase in cardiac output (L) during a staged submaximal exercise test to 75% of maximal heart rate.
Time frame: Baseline and follow-up at 3-months
Measured using MRPAGE and FLAIR MRI. Expressed as percentage of total intracranial volume
Time frame: Baseline and follow-up at 3-months
Measured using arterial spin labelling MRI. Global cerebral blood flow will be expressed as the average of gray matter perfusion across all atlas regions.
Mayo Clinic
Other
Cerebral Blood Flow Regulation and Cognitive Function in Adults With Cardiovascular Disease - Influence of Exercise Training and Intensity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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