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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

Must not have

Severe exercise intolerance

Severe respiratory disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-intervention at 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot tolerate heavy physical activity.

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I have a severe lung or breathing problem.

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I do not have uncontrolled diabetes or untreated thyroid issues.

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My doctor expects I have less than a year to live due to my cancer.

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I am on long-term dialysis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in episodic memory

Change in executive functions

Change in general cognitive functioning

+1 more

Secondary study objectives

Change in cerebral activity

Change in cerebral autoregulation - frontal cortical region

Change in cerebral autoregulation - middle cerebral arteries

+4 more

Other study objectives

Change in 6-min walking test performance

Change in NT-pro-BNP

Change in anxiety

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met