Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive Functions (CongeNIRS)

Investigating the Impact of Cardiac Rehabilitation on Brain Activity and Cognition in Adults With Congenital Heart Disease

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Congenital Heart Disease; Congenital Heart Defects
• Intervention / Treatment: Behavioral: Cardiac rehabilitation

Detailed Description

Thanks to advances in medical research, individuals born with heart defects (Congenital Heart Disease: CHD), are now 95% more likely to reach adulthood, with around 250,000 adults with CHD currently living in Canada. CHD-related diseases and conditions are extremely common in the adult CHD population, and undermine the successes achieved by medical research. For example, compared to healthy peers, adults with CHD are between 3 to 6 times more likely to experience heart accidents or develop other heart conditions during lifetime. Adults with CHD also have more health problems, and have between 1.5 and 2 increased risk of precocious cognitive decline and dementia. Better lifestyle choices and management of medical risk factors play a crucial role in preventing such problems and in increasing the quality of life of those living with CHD. In this regard, physical activity has been suggested as one of the most cost-effective methods for decreasing mortality and incidence of cardiovascular diseases related to CHD. An increasing body of studies have shown that both physical activity and exercise training improve physical and mental health in adults with CHD, who typically tend to be less active than healthy adults. Although physical activity and exercise training have been shown to enhance cognition and brain activity in individuals with other cardiovascular diseases, such effects in CHD are yet to be investigated.

In the present project, the impact of a cardiac rehabilitation program on brain activity and on cognitive functions will be explored in adults with moderate and severe forms of CHD. The 3-month intervention will include an individualised program consisting of combined aerobic and muscle strengthening exercises provided by certified kinesiologists, to be completed at the research center and at home (hybrid program). Brain imaging technology (fNIRS) will be used to measure changes in brain activity related to the intervention. The benefits on cognitive functions, such as attention, executive functions and memory, will be measured with standardized neuropsychological tests before and after the intervention. The results of this project will contribute to a better understanding of the many benefits of exercise training in individuals with CHD, and will lay the foundations for optimal interventions, targeted to prevent CHD-related conditions and impairments.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 1N6
      • EPIC Center of the Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• being able to read, understand and sign the information and consent form;
• being aged 18 or more at the time of consent;
• having a diagnosis of congenital heart disease with moderate or severe risk;
• being referred to the EPIC center in cardiovascular rehabilitation;
• being able to perform a maximal cardiopulmonary stress test and an exercise training program in accordance with current recommendations for cardiovascular rehabilitation;
• having Internet access.

Exclusion Criteria:

• recent major cardiovascular events or interventions <3 months;
• uncontrolled mental or psychiatric disorder in the last 6 months;
• genetic syndromes affecting cognition;
• excessive alcohol consumption (> 15 drinks / week);
• current participation in other clinical trials;
• contraindication to stress testing and / or physical training;
• severe intolerance to physical exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Cardiac rehabilitation; The cardiac rehabilitation program is based on 3/week exercise training's sessions including aerobic and muscle building exercises. All exercises are individualized, supervised by a certified kinesiologist at the research center, and in line with the latest recommendations for physical activity in individuals with congenital heart disease. Participants are encouraged to do a minimum of 1 supervised session per week at the research center and may, with the agreement of the cardiologist and the kinesiologist, do the other training sessions at home (hybrid program). The characteristics of the activities are recorded with a heart rate sensor. Each session lasts a maximum of 60 minutes in total and includes approximately 30 minutes of aerobic exercise, and approximately 20 minutes of muscle strengthening exercises, with 5 to 10 minutes of warm-up and cool-down.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain hemodynamics	Neurovascular coupling (Stroop task). This component will be investigated at the cortical level using functional near infrared spectroscopy (fNIRS), and measured in changes in hemodynamics (oxygenated hemoglobin concentration).	Baseline, post-intervention at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in general cognitive functioning	Cognitive performance. This component will be investigated using the Montreal Cognitive Assessment test.	Baseline, post-intervention at 3 months
Changes in episodic memory	Memory performance. This component will be investigated using the Rey Auditory Verbal Learning test.	Baseline, post-intervention at 3 months
Changes in executive functions	Cognitive performance. This component will be investigated using tests of executive functions (n-back, Trail Making Test, dual task, Stroop), measured in accuracy (composite Z-score).	Baseline, post-intervention at 3 months
Changes in processing speed	Cognitive performance. This component will be investigated using tests of executive functions (Trail Making Test, dual task, Stroop), measured in reaction time (composite Z-score).	Baseline, post-intervention at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cardiorespiratory fitness	Maximal incremental cardiopulmonary exercise test (VO2 max).	Baseline, post-intervention at 3 months
Changes in cardiac hemodynamic	Cardiac output will be measured continuously at rest and during exercise (L/min).	Baseline, post-intervention at 3 months

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Principal Investigator: Louis Bherer, PhD, EPIC Center of the Montreal Heart Institute

Publications and helpful links

General Publications

• Tran D, Maiorana A, Ayer J, Lubans DR, Davis GM, Celermajer DS, d'Udekem Y, Cordina R. Recommendations for exercise in adolescents and adults with congenital heart disease. Prog Cardiovasc Dis. 2020 May-Jun;63(3):350-366. doi: 10.1016/j.pcad.2020.03.002. Epub 2020 Mar 19.
• Li X, Chen N, Zhou X, Yang Y, Chen S, Song Y, Sun K, Du Q. Exercise Training in Adults With Congenital Heart Disease: A SYSTEMATIC REVIEW AND META-ANALYSIS. J Cardiopulm Rehabil Prev. 2019 Sep;39(5):299-307. doi: 10.1097/HCR.0000000000000420.
• Tran DL, Maiorana A, Davis GM, Celermajer DS, d'Udekem Y, Cordina R. Exercise Testing and Training in Adults With Congenital Heart Disease: A Surgical Perspective. Ann Thorac Surg. 2021 Oct;112(4):1045-1054. doi: 10.1016/j.athoracsur.2020.08.118. Epub 2020 Dec 4.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Congenital Heart Disease; Cardiac rehabilitation; Cognition; Brain; fNIRS; Congenital Heart Defects
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: MHI 2022-3019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No