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

Primary Purpose

Congenital Heart Disease, Congenital Heart Defects

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Congenital Heart Disease, Congenital Heart Defects, Brain, fNIRS, Cognition, Cardiac rehabilitation, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • EPIC Center of the Montreal Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Changes in general cognitive functioning
Cognitive performance. This component will be investigated using the Montreal Cognitive Assessment test.
Changes in episodic memory
Memory performance. This component will be investigated using the Rey Auditory Verbal Learning test.
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).
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).

Full Information

First Posted
December 13, 2021
Last Updated
May 4, 2022
Sponsor
Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05195788
Brief Title
Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive Functions
Acronym
CongeNIRS
Official Title
Investigating the Impact of Cardiac Rehabilitation on Brain Activity and Cognition in Adults With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Congenital Heart Defects
Keywords
Congenital Heart Disease, Congenital Heart Defects, Brain, fNIRS, Cognition, Cardiac rehabilitation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in brain hemodynamics
Description
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).
Time Frame
Baseline, post-intervention at 3 months
Secondary Outcome Measure Information:
Title
Changes in general cognitive functioning
Description
Cognitive performance. This component will be investigated using the Montreal Cognitive Assessment test.
Time Frame
Baseline, post-intervention at 3 months
Title
Changes in episodic memory
Description
Memory performance. This component will be investigated using the Rey Auditory Verbal Learning test.
Time Frame
Baseline, post-intervention at 3 months
Title
Changes in executive functions
Description
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).
Time Frame
Baseline, post-intervention at 3 months
Title
Changes in processing speed
Description
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).
Time Frame
Baseline, post-intervention at 3 months
Other Pre-specified Outcome Measures:
Title
Changes in cardiorespiratory fitness
Description
Maximal incremental cardiopulmonary exercise test (VO2 max).
Time Frame
Baseline, post-intervention at 3 months
Title
Changes in cardiac hemodynamic
Description
Cardiac output will be measured continuously at rest and during exercise (L/min).
Time Frame
Baseline, post-intervention at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Talamonti, PhD
Phone
(1) 514-374-1480
Ext
4321
Email
deborah.talamonti@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Bherer, PhD
Phone
(1) 514-374-1480
Ext
4355
Email
louis.bherer@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Bherer, PhD
Organizational Affiliation
EPIC Center of the Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPIC Center of the Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Talamonti, PhD
Phone
(1) 514-374-1480
Ext
4321
Email
Deborah.Talamonti@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Louis Bherer, PhD
Phone
(1) 514-374-1480
Ext
4355
Email
louis.bherer@umontreal.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32201288
Citation
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.
Results Reference
background
PubMed Identifier
31343584
Citation
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.
Results Reference
background
PubMed Identifier
33285131
Citation
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.
Results Reference
background

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

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