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Congenital Heart DiseaseCongeNIRSNCT05195788

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

A study testing Cardiac rehabilitation in people with Congenital Heart Disease and Congenital Heart Defects, run by Montreal Heart Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
7 Feb 2022to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • EPIC Center of the Montreal Heart Institute

    Montreal, Quebec, H1T 1N6

Other trials in Canada

About this study

Official title: 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

Read the 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.

Being tested
Cardiac rehabilitation
Keywords
Congenital Heart Disease, Congenital Heart Defects, Brain, fNIRS, Cognition, Cardiac rehabilitation, Exercise
Medical subject headings
Heart Defects, Congenital, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac rehabilitationBehavioural

    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.

Study groups in NCT05195788
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Cardiac rehabilitation
ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, post-intervention at 3 months

Secondary outcomes (4)

  1. Changes in general cognitive functioning

    Cognitive performance. This component will be investigated using the Montreal Cognitive Assessment test.

    Measured: Baseline, post-intervention at 3 months

  2. Changes in episodic memory

    Memory performance. This component will be investigated using the Rey Auditory Verbal Learning test.

    Measured: Baseline, post-intervention at 3 months

  3. 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).

    Measured: Baseline, post-intervention at 3 months

  4. 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).

    Measured: Baseline, post-intervention at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start7 Feb 2022
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195788
Sponsor's protocol ID
MHI 2022-3019
Acronym
CongeNIRS
Status last verified
Nov 2023
First submitted
13 Dec 2021
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32201288

  • 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.

    PubMed 31343584

  • 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.

    PubMed 33285131

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac rehabilitation in people with Congenital Heart Disease and Congenital Heart Defects, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain hemodynamics (time frame: Baseline, post-intervention at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195788, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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