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Cognitive & Physical Exercise for Heart Failure (ReCARDIO Trial)
N/A
Recruiting
Led By Louis Bherer, PhD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 60 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-intervention at 6 months
Awards & highlights
ReCARDIO Trial Summary
This trial will test whether physical and cognitive exercise can improve cognitive and brain health in people with heart failure, and whether sex affects these results.
Who is the study for?
This trial is for men and women aged 60 or older with stable chronic heart failure who can perform cognitive and physical training. They must not have severe limitations in daily activities, recent malignancies, planned heart surgeries, uncontrolled diabetes, severe respiratory diseases, or any condition that severely limits exercise.Check my eligibility
What is being tested?
The study aims to compare the effects of combined physical exercise and cognitive training versus usual care on brain health in heart failure patients. It will also explore if these effects differ between sexes.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, general risks may include muscle soreness from exercise and mental fatigue from cognitive tasks. Any discomfort should be mild and temporary.
ReCARDIO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
ReCARDIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post-intervention at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-intervention at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in episodic memory
Change in executive functions
Change in general cognitive functioning
+1 moreSecondary outcome measures
Change in cerebral activity
Change in cerebral autoregulation - frontal cortical region
Change in cerebral autoregulation - middle cerebral arteries
+4 moreOther outcome measures
Change in 6-min walking test performance
Change in NT-pro-BNP
Change in anxiety
+9 moreReCARDIO Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ExerciseExperimental Treatment2 Interventions
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.
Group II: CombinedExperimental Treatment3 Interventions
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.
Group III: Usual careActive Control1 Intervention
Usual medical care with no interventions
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,551 Total Patients Enrolled
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,670 Total Patients Enrolled
Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
68,603 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can participate in mental and physical exercises.I have stable heart failure and have been on the same heart medication for at least 2 months.I cannot tolerate heavy physical activity.I am 60 years old or older.I haven't had a heart attack, stroke, or severe heart failure in the last month.I am scheduled for a heart-related surgery or procedure within the next 6 months.You have serious heart or lung problems that make it unsafe for you to do exercise testing.I have a severe lung or breathing problem.I do not have uncontrolled diabetes or untreated thyroid issues.My doctor expects I have less than a year to live due to my cancer.I do not have conditions like arthritis or Parkinson's that limit my exercise.I am on long-term dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Combined
- Group 2: Exercise
- Group 3: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity for this clinical trial?
"Affirmative, clinicaltrials.gov data suggests that this trial is still in search of patients. It was initially posted on September 1st 2021 and last amended on the 29th of the same month. Approximately 216 people are needed to be recruited from one medical centre."
Answered by AI
What are the major goals of this clinical trial?
"The primary goal of this trial, which will be evaluated over a Baseline and post-intervention 6 months period, is to assess the modification in episodic memory. Secondary outcomes include an analysis of pulsatility between systole and diastole via transcranial Doppler (TCD) imaging of middle cerebral arteries, as well as a study of vasoreactivity changes in prefrontal cortex measured by near-infrared spectroscopy (NIRS), and also a comparative assessment using TCD imaging on middle cerebral arteries."
Answered by AI
Are individuals still being accepted for this experimental procedure?
"This clinical trial is actively recruiting patients, with its inception on September 1st 2021 and last edit occurring on the 29th of that same month."
Answered by AI
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