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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The Montreal Health Innovations Coordinating Center (MHICC) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Usual care | Active Comparator | Usual medical care with no interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness | Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min) | Baseline and post-intervention at 6 months |
| Change in 6-min walking test performance | maximum distance performed in 6 minutes (distance, m) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis Bherer, PhD | Contact | +1 514-374-1480 | 4355 | louis.bherer@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Louis Bherer, PhD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T1N6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42327429 | Derived | 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. |
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parallel assignment (1:1:1)
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This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.
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| 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. |
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| 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. |
|
| 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. | 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. | 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 | 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. | Baseline and post-intervention at 6 months |
| Baseline and post-intervention at 6 months |
| Change in upper limb muscle strength | Grip strength test score (kg). | Baseline and post-intervention at 6 months |
| Change in quality of life | score on the 23 items of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline and post-intervention at 6 months |
| Change in perceived self care behaviour | European Heart Failure Self-care Behaviour Scale (EHFScB-9) will be completed. This self-reported questionnaire assesses the adherence to different self-care behaviours (e.g., eating low-salt diet, etc.). | Baseline and post-intervention at 6 months |
| Change in anxiety | State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety). | Baseline and post-intervention at 6 months |
| Change in depressive symptoms | Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology). | Baseline and post-intervention at 6 months |
| Change in sleep quality | Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology). | Baseline and post-intervention at 6 months |
| Cognitive reserve | Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve). | Baseline |
| Genotyping data | genotyping data that include the APOE gene | baseline |
| Change in NT-pro-BNP | NT-pro-BNP (ng/L) | Baseline and post-intervention at 6 months |
| Change in high-sensitive Troponin T | hsTnT (ng/mL) | Baseline and post-intervention at 6 months |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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