Effects of exercise and cognitive training on brain health in heart failure patients
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
This study is testing if combining exercise with brain training can help improve thinking skills and brain health in older adults with chronic heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Montreal Heart Institute Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04970888 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate how combined physical exercise and cognitive training can improve cognitive function and brain health in patients with chronic heart failure. The study will involve 216 participants aged 60 and older, who will be randomly assigned to one of three groups: combined intervention, exercise alone, or usual care. The research will also explore how sex influences the effectiveness of these interventions. By assessing changes in cerebral autoregulation and vasoreactivity, the study seeks to provide insights into non-pharmacological strategies for enhancing cognition in heart failure patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older with stable chronic heart failure who can participate in physical and cognitive training.
Not a fit: Patients with recent acute cardiovascular events or severe exercise intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients with heart failure.
How similar studies have performed: While similar interventions have shown promise in patients with cardiovascular risk factors and mild cognitive impairment, this specific approach in heart failure has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Montreal, Quebec
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Louis Bherer, PhD — Montreal Heart Institute
- Study coordinator: Louis Bherer, PhD
- Email: louis.bherer@umontreal.ca
- Phone: +1 514-374-1480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.