Clinical trial NCT05195788: Cardiac Rehabilitation in Congenital Heart Disease: Effects on Brain and Cognitive Functions
Official title: Investigating the Impact of Cardiac Rehabilitation on Brain Activity and Cognition in Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Congenital Heart Disease
Congenital Heart Defects
Keywords: Congenital Heart Disease
Congenital Heart Defects
Brain
fNIRS
Cognition
Cardiac rehabilitation
Exercise
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in brain hemodynamics
timeFrame: Baseline, post-intervention at 3 months
Secondary outcomes:
measure: Changes in general cognitive functioning
timeFrame: Baseline, post-intervention at 3 months
measure: Changes in episodic memory
timeFrame: Baseline, post-intervention at 3 months
measure: Changes in executive functions
timeFrame: Baseline, post-intervention at 3 months
measure: Changes in processing speed
timeFrame: Baseline, post-intervention at 3 months
Other outcomes:
measure: Changes in cardiorespiratory fitness
timeFrame: Baseline, post-intervention at 3 months
measure: Changes in cardiac hemodynamic
timeFrame: Baseline, post-intervention at 3 months
Locations:
city: Montréal
country: Canada
facility: EPIC Center of the Montreal Heart Institute
state: Quebec
Study officials:
affiliation: EPIC Center of the Montreal Heart Institute
name: Louis Bherer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.