About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Cognitive training
Other interventionThe 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
Other interventionParticipants 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
Other interventionAll 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in general cognitive functioning
Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Change in processing speed
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in executive functions
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory
Validated remote version of neuropsychological tests (Composite Z-score).
Secondary outcomes
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.
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.
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.
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
Other outcomes
Change in cardiorespiratory fitness
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)
Change in 6-min walking test performance
maximum distance performed in 6 minutes (distance, m)
Change in upper limb muscle strength
Grip strength test score (kg).
Change in quality of life
score on the 23 items of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Sponsors and contacts
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Montreal Heart Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
The Montreal Health Innovations Coordinating Center (MHICC)
Collaborator