Recruiting

Exercise & Cognitive Training

Sponsor:

Montreal Heart Institute

Code:

NCT04970888

Conditions

Chronic Heart Failure

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cognitive training

Exercise training

Usual care

Study Details

Brief 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.

Conditions

Chronic Heart Failure

Aging

Study ID

NCT04970888

Start date

Sep 1, 2021

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Combined

Combined physical exercise and cognitive training. The combined intervention will include a cognitive training with aerobic and resistance exercises training, three sessions per week for 6 months. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based.

experimental: Exercise

The physical exercises intervention will include aerobic and resistance exercises training, three sessions per week for 6 months. Participants will be allowed to perform exercise training sessions either home-based or centre-based.

active comparator: Usual care

Usual medical care with no interventions

Interventions

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.

Primary outcome measure

  • Change in general cognitive functioning [ Time Frame: Baseline and post-intervention at 6 months ]
  • Change in processing speed [ Time Frame: Baseline and post-intervention at 6 months ]
  • Change in executive functions [ Time Frame: Baseline and post-intervention at 6 months ]
  • Change in episodic memory [ Time Frame: Baseline and post-intervention at 6 months ]

Central Contacts and Locations

Central contacts

Locations

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T1N6

Contacts

Principal Investigator:

Louis Bherer, PhD

More Information

Sponsor

Montreal Heart Institute

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • cognition
  • physical exercise
  • cognitive training
  • brain functions
  • combined intervention
  • heart failure
  • biomarkers
  • cerebral vasoreactivity
  • fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2025-12-02.