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
Recruiting · NCT04970888 · Interventional (participants receive a specific treatment) · Lead sponsor: Montreal Heart Institute
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive trainingExercise trainingUsual care
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute - Montreal, Quebec, Canada