Cardiac Rehabilitation for Heart Disease
(CongeNIRS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLouis Bherer, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Montreal Heart Institute

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?The proposed trial is designed to evaluate the effect of an individualised cardiac rehabilitation program, consisting of aerobic and muscle strengthening exercises, on brain activity and cognitive functions in adults with congenital heart disease

Eligibility Criteria

Adults over 18 with moderate to severe congenital heart disease who can do a maximal stress test and exercise program, have internet access, and can consent. Not for those with recent major heart events, uncontrolled mental disorders, cognitive-affecting genetic syndromes, heavy alcohol use, or severe exercise intolerance.

Inclusion Criteria

I have been diagnosed with a serious form of congenital heart disease.

You have been referred to the EPIC center for cardiovascular rehabilitation.

Having Internet access

+3 more

Exclusion Criteria

I cannot undergo stress tests or physical training due to health reasons.

I have not had any major heart events or surgeries in the last 3 months.

You have difficulty doing physical exercise.

+4 more

Participant Groups

The trial is testing an individualized cardiac rehabilitation program that includes aerobic and muscle-strengthening exercises to see how it affects brain activity and cognitive functions in adults with congenital heart disease.

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants assigned to the Intervention group will undergo a cardiac rehabilitation program. The program will combine individualized aerobic and muscle strengthening exercises, comprising three sessions per week to be conducted in person at the EPIC center and at home, for a duration of three months. All sessions will be prepared by a certified kinesiologist.

Group II: ControlActive Control1 Intervention

Participants assigned to the control group will be encouraged to remain at the usual level of physical activity for the duration of the study. At the end of the study, they will gain free access to the same cardiac rehabilitation program provided to the intervention group.

Cardiac rehabilitation is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Cardiac rehabilitation for: