Cardiac Rehab and Cerebral Blood Flow Study

Mayo Clinic

Status: Completed

Conditions: Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05012878

20-010808

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 5 patient groups, including a placebo group

Cardiac rehabilitation - High intensity interval training (HIIT)

Experimental group

Description:

Patients attending cardiac rehabilitation randomized to HIIT.

Treatment:

Behavioral: Cardiac rehabilitation - high intensity interval training (HIIT)

Cardiac rehabilitation - Moderate intensity continuous training (MICT)

Active Comparator group

Description:

Patients attending cardiac rehabilitation randomized to MICT.

Treatment:

Behavioral: Cardiac rehabilitation - moderate intensity continuous training (MICT)

Cardiac rehabilitation - control

Placebo Comparator group

Description:

The control group (12 week period) will include participants who have declined cardiac rehabilitation.

Treatment:

Behavioral: Cardiac rehabilitation - control

Healthy control group

No Intervention group

Description:

Healthy age-matched adults without cardiovascular disease, who will complete baseline assessments only. No intervention period.

Cardiac rehabilitation - observational

Other group

Description:

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.

Treatment:

Behavioral: Cardiac rehabilitation - observational