Cardiac Rehab and Cerebral Blood Flow Study

Cardiovascular Diseases Clinical Trial

Official title:

Cerebral Blood Flow Regulation and Cognitive Function in Adults With Cardiovascular Disease - Influence of Exercise Training and Intensity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012878
• Other study ID #: 20-010808
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Jenna Taylor, PhD
• Phone: (507) 284-1329
• Email: Taylor.Jenna-Lee[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria for Patients with Cardiovascular Disease:

• Aged 40-years and older.

• Eligible for cardiac rehabilitation following a cardiac-related hospital admission, coronary artery disease (including angina, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft surgery).

Inclusion Criteria for Healthy controls:

• Aged 40-years and older.

• Never been diagnosed with cardiovascular disease or coronary artery disease.

• No history of cardiovascular disease risk factors including hypertension, hyperlipidemia, diabetes, obesity (body mass index > 30) or smoking.

• Current body mass index < 30kg/m2

Exclusion Criteria for participants in randomized cardiac rehabilitation groups (HIIT & MICT) :

• Known cerebrovascular or neurological disease

• Known moderate-severe respiratory disease, pregnancy,

• Orthopedic limitations affecting exercise capability

• Unable to read and speak English

• Unable to complete study-related activities

• Contraindications to hypercapnia

• Contraindications to maximal exercise testing

• MRI incompatible devices

• Unwillingness to undergo MRI scan (e.g. due to anxiety or claustrophobia).

Exclusion Criteria for participants in the observational control group and observational cardiac rehabilitation group:

• Known cerebrovascular or neurological disease

• Known moderate-severe respiratory disease, pregnancy,

• Unable to read and speak English

• Unable to complete study-related activities

• Contraindications to hypercapnia

• MRI incompatible devices

• Unwillingness to undergo MRI scan (e.g. due to anxiety or claustrophobia)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Cardiac rehabilitation - high intensity interval training (HIIT)
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.
• Cardiac rehabilitation - moderate intensity continuous training (MICT)
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.
• Cardiac rehabilitation - control
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.
• Cardiac rehabilitation - observational
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral blood flow regulation (as neurovascular coupling)	Measured as the change in cerebral blood flow during a visual stimulus	Baseline and follow-up at 3-months
Other	Cerebral blood flow regulation (as autoregulation)	Measured as the change in cerebral blood flow from seated position to standing position.	Baseline and follow-up at 3-months
Other	Cerebral blood flow regulation to exercise	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.	Baseline and follow-up at 3-months
Other	Cerebral ventricular and white matter hyperintensity volumes	Measured using MRPAGE and FLAIR MRI. Expressed as percentage of total intracranial volume	Baseline and follow-up at 3-months
Other	Resting cerebral blood flow with MRI	Measured using arterial spin labelling MRI. Global cerebral blood flow will be expressed as the average of gray matter perfusion across all atlas regions.	Baseline and follow-up at 3-months
Primary	Cerebral blood flow regulation (as cerebrovascular reactivity)	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.	Baseline and follow-up at 3-months
Secondary	Cognitive function	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.	Baseline and follow-up at 3-months