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Cardiac Rehabilitation for Heart Disease (CongeNIRS Trial)

N/A
Waitlist Available
Led By Louis Bherer, PhD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having a diagnosis of congenital heart disease with moderate or severe risk
Being aged 18 or more at the time of consent
Must not have
Genetic syndromes affecting cognition
Contraindication to stress testing and / or physical training
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention at 3 months
Awards & highlights

Summary

This trial will look at whether an exercise program can help improve brain function in adults with congenital heart disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial focuses on benefits rather than side effects, typical risks of cardiac rehab may include muscle soreness or strain. More serious but rare complications could involve cardiovascular stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a serious form of congenital heart disease.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a genetic condition that affects my thinking.
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I cannot undergo stress tests or physical training due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention at 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in brain hemodynamics
Secondary study objectives
Changes in episodic memory
Changes in executive functions
Changes in general cognitive functioning
+1 more
Other study objectives
Changes in cardiac hemodynamic
Changes in cardiorespiratory fitness

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac rehabilitation
2006
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
122 Previous Clinical Trials
78,660 Total Patients Enrolled
Louis Bherer, PhDPrincipal InvestigatorEPIC Center of the Montreal Heart Institute
8 Previous Clinical Trials
691 Total Patients Enrolled
~28 spots leftby Sep 2025
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