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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention at 3 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met