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

Congenital Heart Disease Clinical Trial

— CongeNIRS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05195788
• Other study ID #: MHI 2022-3019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defects
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	EPIC Center of the Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cardiorespiratory fitness	Maximal incremental cardiopulmonary exercise test (VO2 max).	Baseline, post-intervention at 3 months
Other	Changes in cardiac hemodynamic	Cardiac output will be measured continuously at rest and during exercise (L/min).	Baseline, post-intervention at 3 months
Primary	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	Changes in general cognitive functioning	Cognitive performance. This component will be investigated using the Montreal Cognitive Assessment test.	Baseline, post-intervention at 3 months
Secondary	Changes in episodic memory	Memory performance. This component will be investigated using the Rey Auditory Verbal Learning test.	Baseline, post-intervention at 3 months
Secondary	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
Secondary	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