Comparing the Effects of Combining Cognitive and Physical Exercise Training on Cognition, and Cerebral Blood Flow Regulation in Men and Women With Chronic Heart Failure

NCT04970888 · tracked via the Priya Life Science Canada tracker

Sponsor

Montreal Heart Institute

Phase

Not applicable

Started

2021-09-01

Last updated

2025-12-02

Condition(s) studied

Chronic Heart FailureAging

Investigational drug(s) / intervention(s)

Cognitive trainingExercise trainingUsual care

Cognitive training: The cognitive training will involve attention control training and memory training, with thrice-weekly 30-min sessions. Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed mnemotechnic, as well as be taught about memory in aging in general.

Exercise training: Participants will follow a 20-week physical training program, with 60-min thrice-weekly trainings. The training sessions will start with a 5-min warm-up, followed by an aerobic training (20 min) after which 20-min of resistance/muscular training will take place. The program will end with a 10-min cool-down. Training will be adapted to individuals' baseline capacity as measured by the baseline cardiorespiratory test. For home-training sessions, participants will have access to a complete exercise training program. A certified kinesiologist will supervise trainings. With the Heart rate sensor Polar H10, all the characteristics of the activities will be recorded (type of the activity, intensity, heart rate, duration). A kinesiologist will call participants every week to ensure the smooth running of the exercises training sessions and individualize the care according to the patient's level.

Usual care: All patients will receive usual care and be treated according to evidence-based treatments. This will include optimal medical therapy, systematic information regarding dietary and fluid management, and a recommendation for regular physical activity consistent with the latest update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Moreover, patients who benefit from a prescription for a cardiovascular rehabilitation program will be able to follow it, but they will not receive other forms of intervention for the duration of the study.

Study summary

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

Eligibility

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 50 years old * Stable chronic HF on maximally tolerated background treatment for at least 2 months (stable therapy with ACE-I, ARBs and MRA for at least 2 months), regardless of LVEF * with no limitation of physical activity in ordinary physical activity (i.e. NYHA class I), moderate symptoms (i.e. NYHA class II) or marked limitation in activity (i.e. NYHA class III) * Able to perform cognitive and physical training. Exclusion Criteria: * Acute cardiovascular event 1 month prior to randomization, including emergency visit or hospitalization for decompensated HF, acute myocardial infarction, stroke, and transient ischemic attack * Planned cardiovascular intervention within 6 months (implantation of any cardiac device, cardiac revascularization, heart transplantation) * Severe exercise intolerance * Contraindications for exercise testing (e.g., uncorrected severe aortic or carotid stenosis, severe pulmonary hypertension, severe non-revascularizable coronary disease including left main coronary stenosis, significant myocardial ischemia or arrhythmia during low-intensity exercise, acute HF) * Severe respiratory disease * Non-cardiopulmonary limitation to exercise (e.g., arthritis, claudication or any peripheral neurological disease including other neurodegenerative diseases such as disabling Parkinson) * Uncontrolled diabetes or untreated thyroid dysfunction * Current or recent malignancy with life expectancy \< 1 year * Chronic hemodialysis or peritoneal dialysis * Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor.

Primary outcome measure(s)

Change in general cognitive functioning — Baseline and post-intervention at 6 months
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Change in processing speed — Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in executive functions — Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory — Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests (Composite Z-score).

Trial sites (1)

Facility	City	Region	Status
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute	Montreal	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04970888 on ClinicalTrials.gov ↗ ← All trials in Canada