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

NCT05195788 | Unknown

• 1 other identifier: MHI 2022-3019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease; Congenital Heart Defects

Keywords

Congenital Heart Disease; Congenital Heart Defects; Brain; fNIRS; Cognition; Cardiac rehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in general cognitive functioning

  Baseline, post-intervention at 3 months

• Changes in episodic memory

  Baseline, post-intervention at 3 months

• Changes in executive functions

  Baseline, post-intervention at 3 months

• Changes in processing speed

  Baseline, post-intervention at 3 months

Other Outcomes (2)

• Changes in cardiorespiratory fitness

  Baseline, post-intervention at 3 months

• Changes in cardiac hemodynamic

  Baseline, post-intervention at 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO 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.

Interventions

Cardiac rehabilitation BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

EPIC Center of the Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

Location

Related Publications (3)

• 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.

  PMID: 32201288 BACKGROUND

• 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.

  PMID: 31343584 BACKGROUND

• 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.

  PMID: 33285131 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louis Bherer, PhD

  EPIC Center of the Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientific Director, Direction of Prevention

Model Details: The CongeNIRS study uses the prospective, randomised, open-label, blinded end-point (PROBE) design. The participation in this study is expected to be three months and two weeks, comprising three months of physical training and 2 weeks of testing (baseline and three months, one week each).

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 19, 2022
• Study Start: February 7, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)