Chronic Heart FailureReCARDIONCT04970888
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
A study testing Cognitive training and Exercise training in people with Chronic Heart Failure and Aging, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Heart Failure, Aging
- What is being tested?
- Cognitive training and Exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
Louis Bherer, PhD, 514-374-1480 ext. 4355, louis.bherer@umontreal.ca
Louis Bherer, PhD
About this study
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.
Read the detailed description
Cognitive impairment (CI) affects up to 50% of patients with heart failure (HF), and is associated with high mortality rates, poor quality of life, reduced functional capacities, and an overwhelming economic burden in Western countries. Non-pharmacological strategies could help enhance cognition in HF patients with CI. Combined physical exercise and cognitive training interventions have recently shown promising enhancement effects on cognition in patients with cardiovascular risk factors and mild cognitive impairment. The effects of combined interventions have never been tested in HF.
The main objective is to assess the effects of combined physical exercise and cognitive training interventions on cognition in patients with HF. Secondary objectives include: to characterize baseline and intervention-related changes in cerebral autoregulation, pulsatility and neurovascular coupling and to assess the role of sex on intervention effects.
Two-hundred and sixteen participants (36 men and 36 women/group) with stable HF regardless of aetiology and LVEF will take part in this study. All participants will have signed a written consent form before taking part in the study.
Patients will be stratified according to sex and LVEF (FEVG < 40% et FEVG > 40%), and will be randomly assigned to one of the 3 following study arms: 1) Combined physical exercise and cognitive training; 2) Physical exercise alone; and 3) Usual medical care.
- Conditions
- Chronic Heart Failure, Aging
- Being tested
- Cognitive training, Exercise training, Usual care
- Keywords
- cognition, physical exercise, cognitive training, brain functions, combined intervention, heart failure, biomarkers, cerebral vasoreactivity, fitness
- Medical subject headings
- Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
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 trainingOther
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 careOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise training; Other: Usual care |
| Usual care | Active comparator | Usual medical care with no interventions Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognitive functioning
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Measured: Baseline and post-intervention at 6 months
Change in processing speed
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months
Change in executive functions
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months
Change in episodic memory
Validated remote version of neuropsychological tests (Composite Z-score).
Measured: Baseline and post-intervention at 6 months
Secondary outcomes (5)
Change in cerebral autoregulation - frontal cortical region
Variations of prefrontal cortical oxygen saturation (rSO2, [HbO]/([HbO]+[HbR])) will be measured by Near Infrared Spectroscopy (NIRS), as a surrogate of cortical blood flow. Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of oxygen saturation measures and variations of peripheral blood pressure.
Measured: Baseline and post-intervention at 6 months
Change in cerebral autoregulation - middle cerebral arteries
Variations of cerebral blood flow velocity (cm/s) at the level of the middle cerebral artery will be measured by Transcranial Doppler (TCD). Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of cerebral blood flow measures and variations of peripheral blood pressure.
Measured: Baseline and post-intervention at 6 months
Change in cerebral pulsatility - cortical frontal region
Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.
Measured: Baseline and post-intervention at 6 months
Change in cerebral pulsatility - middle cerebral arteries
Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries
Measured: Baseline and post-intervention at 6 months
Change in cerebral activity
Significant changes in brain activity evoked by a Stroop task relative to baseline will be assessed by t-statistics maps, computed from variations of [HbO] and [HbR] measured by NIRS at the prefrontal cortex.
Measured: Baseline and post-intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment (1:1:1)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Montreal Health Innovations Coordinating Center (MHICC)
- Responsible party
- Principal investigator, Louis Bherer, Montreal Heart Institute
- Investigators
- Louis Bherer, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970888
- Sponsor's protocol ID
- MP-33-2018-2406
- Acronym
- ReCARDIO
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bherer L, Besnier F, Gagnon C, Vrinceanu T, Vincent T, Mohammadi H, Gauthier C, Duquesne C, Blanchette CA, Berube B, Said SN, Iglesies-Grau J, L'Allier P, Boulet J, Nigam A, Dionne V, Benhalima H, Dube MP, Duchesne S, Belleville S, Brassard P, Gagnon D, Lesage F, Gayda M, Soucy JP, Bouabdallaoui N, Liu-Ambrose T, Barha C, Poirier J, Eric Thorin, Vu M, Tournoux F, Vitali P, O'Meara E, Racine N, Rouleau JL. Investigating Physical Exercise and Cognitive Training Effects on Cognition and Brain Health in Men and Women with Heart Failure: The ReCARDIO Trial. CJC Open. 2026 Feb 26;8(6):637-645. doi: 10.1016/j.cjco.2026.02.014. eCollection 2026 Jun.
PubMed 42327429
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04970888
- Acronym / sponsor ID
- ReCARDIO / MP-33-2018-2406
- Conditions
- Chronic Heart Failure, Aging
- Keywords
- cognition, physical exercise, cognitive training, brain functions, combined intervention, heart failure, biomarkers, cerebral vasoreactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Montreal Health Innovations Coordinating Center (MHICC)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive impairment (CI) affects up to 50% of patients with heart failure (HF), and is associated with high mortality rates, poor quality of life, reduced functional capacities, and an overwhelming economic burden in Western countries. Non-pharmacological strategies could help enhance cognition in HF patients with CI. Combined physical exercise and cognitive training interventions have recently shown promising enhancement effects on cognition in patients with cardiovascular risk factors and mild cognitive impairment. The effects of combined interventions have never been tested in HF.
The main objective is to assess the effects of combined physical exercise and cognitive training interventions on cognition in patients with HF. Secondary objectives include: to characterize baseline and intervention-related changes in cerebral autoregulation, pulsatility and neurovascular coupling and to assess the role of sex on intervention effects.
Two-hundred and sixteen participants (36 men and 36 women/group) with stable HF regardless of aetiology and LVEF will take part in this study. All participants will have signed a written consent form before taking part in the study.
Patients will be stratified according to sex and LVEF (FEVG < 40% et FEVG > 40%), and will be randomly assigned to one of the 3 following study arms: 1) Combined physical exercise and cognitive training; 2) Physical exercise alone; and 3) Usual medical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- parallel assignment (1:1:1)
| Arm | Type | Receives |
|---|---|---|
| Combined | Experimental | Other: Cognitive training, Other: Exercise training, Other: Usual careCombined 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. |
| Exercise | Experimental | Other: Exercise training, Other: Usual careThe 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. |
| Usual care | Active comparator | Other: Usual careUsual medical care with no interventions |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThe 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. | Other | Combined |
| Exercise trainingParticipants 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. | Other | Combined, Exercise |
| Usual careAll 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. | Other | Combined, Exercise, Usual care |
Primary outcome
Change in general cognitive functioning
Time frame: 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
Time frame: Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in executive functions
Time frame: Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory
Time frame: Baseline and post-intervention at 6 months
Validated remote version of neuropsychological tests (Composite Z-score).
5 secondary outcomes
Change in cerebral autoregulation - frontal cortical region
Time frame: Baseline and post-intervention at 6 months
Change in cerebral autoregulation - middle cerebral arteries
Time frame: Baseline and post-intervention at 6 months
Change in cerebral pulsatility - cortical frontal region
Time frame: Baseline and post-intervention at 6 months
Change in cerebral pulsatility - middle cerebral arteries
Time frame: Baseline and post-intervention at 6 months
Change in cerebral activity
Time frame: Baseline and post-intervention at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 42327429Bherer L, Besnier F, Gagnon C, Vrinceanu T, Vincent T, Mohammadi H, Gauthier C, Duquesne C, Blanchette CA, Berube B, Said SN, Iglesies-Grau J, L'Allier P, Boulet J, Nigam A, Dionne V, Benhalima H, Dube MP, Duchesne S, Belleville S, Brassard P, Gagnon D, Lesage F, Gayda M, Soucy JP, Bouabdallaoui N, Liu-Ambrose T, Barha C, Poirier J, Eric Thorin, Vu M, Tournoux F, Vitali P, O'Meara E, Racine N, Rouleau JL. Investigating Physical Exercise and Cognitive Training Effects on Cognition and Brain Health in Men and Women with Heart Failure: The ReCARDIO Trial. CJC Open. 2026 Feb 26;8(6):637-645. doi: 10.1016/j.cjco.2026.02.014. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis Bherer, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Exercise training in people with Chronic Heart Failure and Aging, 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis Bherer, PhD (+1 514-374-1480 ext. 4355, louis.bherer@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general cognitive functioning (time frame: Baseline and post-intervention at 6 months). The study lists 4 primary outcomes in all. 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 NCT04970888, which also lists 1 linked publication.
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 2 Dec 2025.