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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention at 3 months

Awards & highlights

CongeNIRS Trial 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.Check my eligibility

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.See study design

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.

CongeNIRS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am 18 years old or older.

CongeNIRS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in brain hemodynamics

Secondary outcome measures

Changes in episodic memory

Changes in executive functions

Changes in general cognitive functioning

+1 more

Other outcome measures

Changes in cardiac hemodynamic

Changes in cardiorespiratory fitness

CongeNIRS 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

~860

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,719 Total Patients Enrolled

Louis Bherer, PhDPrincipal InvestigatorEPIC Center of the Montreal Heart Institute

8 Previous Clinical Trials

691 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities available for participants to join this research project?

"This medical trial, registered on clinicaltrials.gov is actively seeking individuals for its research study. Initially posted on February 7th 2022, the details of this project have been updated as recently as May 4th 2022."

Answered by AI

To what extent is this research endeavor being carried out?

"That is correct. According to clinicaltrials.gov, the trial was initiated on February 7th 2022 and has been actively recruiting ever since. 100 participants are needed across 1 site for this medical research study."

Answered by AI

Who is the ideal participant for this research endeavor?

"This trial is recruiting 100 volunteers, aged 18 to 60, with a history of cardiac-related illness. To qualify for enrollment, potential participants must possess the capacity to read and comprehend consent forms; have a verified diagnosis of moderate or intense risk congenital heart disease; be referred to an EPIC cardiovascular rehabilitation center; be physically adept enough to perform cardiopulmonary stress tests and exercise regimens in accordance with modern standards of care; as well as having access to the internet."

Answered by AI