Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women with Heart Failure
- Conditions
- AgingChronic Heart Failure
- Interventions
- Other: Usual careOther: Cognitive trainingOther: Exercise training
- Registration Number
- NCT04970888
- Lead Sponsor
- Montreal Heart Institute
- 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.
- 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 and vasoreactivity and to assess the role of sex on the effects of the interventions.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- Age ≥ 60 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Usual medical care with no interventions Combined Cognitive training 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. Combined Usual care 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. Exercise Exercise training 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. Combined Exercise training 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. Exercise Usual care 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.
- Primary Outcome Measures
Name Time Method Change in executive functions Baseline and post-intervention at 6 months Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in general cognitive functioning 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 Baseline and post-intervention at 6 months Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in episodic memory Baseline and post-intervention at 6 months Validated remote version of neuropsychological tests (Composite Z-score).
- Secondary Outcome Measures
Name Time Method Change in cerebral vasoreactivity - middle cerebral arteries Baseline and post-intervention at 6 months Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries.
Change in cerebral pulsatility - cortical frontal region Baseline and post-intervention at 6 months 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 Baseline and post-intervention at 6 months Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries
Change in cerebral activity Baseline and post-intervention at 6 months Significant changes in brain activity evoked by a N-back 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.
Change in cerebral autoregulation - middle cerebral arteries Baseline and post-intervention at 6 months 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 autoregulation - frontal cortical region Baseline and post-intervention at 6 months 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 vasoreactivity - prefrontal cortex Baseline and post-intervention at 6 months Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region.
Trial Locations
- Locations (1)
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada