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 | Recruiting DMC

• 1 other identifier: MP-33-2018-2406
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in general cognitive functioning

  Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).

  Baseline and post-intervention at 6 months

• Change in processing speed

  Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

  Baseline and post-intervention at 6 months

• Change in executive functions

  Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

  Baseline and post-intervention at 6 months

• Change in episodic memory

  Validated remote version of neuropsychological tests (Composite Z-score).

  Baseline and post-intervention at 6 months

Secondary Outcomes (5)

• Change in cerebral autoregulation - frontal cortical region

  Baseline and post-intervention at 6 months

• Change in cerebral autoregulation - middle cerebral arteries

  Baseline and post-intervention at 6 months

• Change in cerebral pulsatility - cortical frontal region

  Baseline and post-intervention at 6 months

• Change in cerebral pulsatility - middle cerebral arteries

  Baseline and post-intervention at 6 months

• Change in cerebral activity

  Baseline and post-intervention at 6 months

Other Outcomes (12)

• Change in cardiorespiratory fitness

  Baseline and post-intervention at 6 months

• Change in 6-min walking test performance

  Baseline and post-intervention at 6 months

• Change in upper limb muscle strength

  Baseline and post-intervention at 6 months

Study Arms (3)

Combined

EXPERIMENTAL

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.

Other: Cognitive training; Other: Exercise training; Other: Usual care

Exercise

EXPERIMENTAL

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.

Other: Exercise training; Other: Usual care

Usual care

ACTIVE COMPARATOR

Usual medical care with no interventions

Other: Usual care

Interventions

Cognitive training OTHER

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.

Combined

Exercise training OTHER

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.

Combined; Exercise

Usual care OTHER

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.

Combined; Exercise; Usual care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (1)

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

Montreal, Quebec, H1T1N6, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity; Heart Failure

Interventions

Cognitive Training; Exercise

Condition Hierarchy (Ancestors)

Behavior; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Louis Bherer, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Bherer, PhD

CONTACT

+1 514-374-1480; louis.bherer@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate scientific director, Direction of prevention, Montreal Heart Institute

Model Details: parallel assignment (1:1:1)

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)