Cognitive & Physical Exercise for Heart Failure

(ReCARDIO Trial)

Overseen By Louis Bherer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montreal Heart Institute

Must be taking: ACE-I, ARBs, MRA

Disqualifiers: Acute cardiovascular event, Severe exercise intolerance, Severe respiratory disease, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how combining physical exercise with brain training (cognitive training) can improve brain health in people with heart failure (HF). Participants will either engage in a mix of exercise and mental activities, perform only physical exercises, or continue their usual care routine. Individuals who have experienced heart failure for at least two months and have moderate symptoms, such as shortness of breath during regular activities, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance brain health alongside heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that participants have stable heart failure treatment for at least 2 months, so you may need to continue your current heart failure medications.

What prior data suggests that these interventions are safe for heart failure patients?

Research shows that both brain training and exercise are generally safe for people with heart failure. Studies on brain training indicate it can boost thinking skills without serious side effects, helping individuals manage their condition better.

Exercise is also well-tolerated. In one study, among more than 300 exercise sessions, only one minor incident occurred (a brief fainting spell). Another review found exercise to be safe and beneficial for heart failure patients, improving their overall health and ability to exercise.

Overall, past studies have shown positive results for both treatments without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they combine cognitive and physical exercise to tackle heart failure in a unique way. Unlike typical treatments that focus mainly on medication, this approach integrates mental exercises with aerobic and resistance training, offering a holistic method to improve heart health. Participants can choose between home-based or center-based sessions, providing flexibility and accessibility. This innovative strategy aims to enhance both cognitive function and physical endurance, potentially offering a comprehensive improvement in quality of life for those with heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that cognitive training, which participants in this trial may receive, can greatly improve thinking and memory for people with heart failure. This training might also help them adhere to their treatment plans and reduce symptoms. Exercise training, another treatment option in this trial, has proven to improve heart function and enhance the quality of life for heart failure patients. It can increase exercise capacity, making daily activities easier and less tiring. Both cognitive and exercise training have shown promising results, suggesting they could effectively improve brain health in heart failure patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Louis Bherer, PhD

Principal Investigator

Montreal Heart Institute

Are You a Good Fit for This Trial?

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.

Inclusion 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 am 60 years old or older.

Exclusion Criteria

I cannot tolerate heavy physical activity.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo combined physical exercise and cognitive training interventions, or physical exercise alone, or receive usual medical care

6 months

3 sessions per week

Follow-up

Participants are monitored for changes in cognitive and brain health, as well as other health parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training
• Exercise Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 2 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: Combined Experimental Treatment 3 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 care Active Control 1 Intervention

Usual medical care with no interventions

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborator

Trials

14

Recruited

10,900+

Published Research Related to This Trial

In a study involving 256 heart failure patients, 8 weeks of computerized cognitive training (CCT) did not show significant improvements in delayed-recall memory or serum BDNF levels compared to an active control or usual care.

All groups demonstrated improvements in memory, daily living activities, and quality of life over time, suggesting that the nurse-enhancement interventions may have contributed to these positive outcomes rather than the CCT itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure. Pressler, SJ., Jung, M., Gradus-Pizlo, I., et al.[2023]

The study identified four key facilitators that help ensure treatment fidelity in computerized cognitive training (CCT) for heart failure patients, including proper training for facilitators, a supportive work environment, a clear implementation guide, and the confidence of the intervenors.

Conversely, three main barriers were noted that could hinder treatment fidelity: technical issues, logistical challenges, and the characteristics of the patient sample, highlighting areas for improvement in future CCT interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Facilitators and Barriers to Treatment Fidelity in Computerized Cognitive Training Interventions. Algashgari, EY., Jung, M., Von Ah, D., et al.[2023]

Heart failure (HF) affects over 6 million Americans and is linked to cognitive impairments and increased risk of neurological disorders like Alzheimer's disease.

Exercise may enhance cerebral blood flow in patients with HF, potentially leading to cognitive improvements, suggesting that physical activity could be a modifiable factor for better brain health in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible neurocognitive benefits of exercise in persons with heart failure. Galioto, R., Fedor, AF., Gunstad, J.[2020]

A 12-week cardiac rehabilitation program for 52 heart failure patients led to significant improvements in attention and executive function, with these benefits lasting up to 12 months after the program ended.

While memory showed no immediate improvement during the program, it did improve between the 12-week and 12-month follow-ups, suggesting potential long-term cognitive benefits from cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation is associated with lasting improvements in cognitive function in older adults with heart failure. Alosco, ML., Spitznagel, MB., Cohen, R., et al.[2021]

A 12-week home-based program combining aerobic exercise and computerized cognitive training significantly improved heart failure self-care behaviors and quality of life in 69 older participants, primarily female and African American.

Participants in the combined exercise and cognitive training group showed enhanced functional capacity, walking an average of 388 meters compared to 336 meters in the exercise-only group, indicating the effectiveness of this integrated approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Cognitive Training Intervention Improves Self-Care, Quality of Life and Functional Capacity in Persons With Heart Failure. Gary, RA., Paul, S., Corwin, E., et al.[2022]

The Brain Fitness cognitive training intervention significantly increased serum brain-derived neurotrophic factor (BDNF) levels in heart failure patients after 12 weeks, suggesting a positive biological response to the training.

While no significant improvements in overall memory were observed, there was a notable enhancement in working memory among participants who engaged in the Brain Fitness program compared to those in the health education control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Enhanced Computerized Cognitive Training Increases Serum Brain-Derived Neurotropic Factor Levels and Improves Working Memory in Heart Failure. Pressler, SJ., Titler, M., Koelling, TM., et al.[2018]

In a study of 142 heart failure patients over 24 months, computerized cognitive training (CCT) did not significantly reduce mortality rates compared to control groups, with 8.3% of CCT participants and 12.8% of controls dying during the study.

Key predictors of 24-month mortality included older age, poorer global cognition, memory issues, and higher depressive symptoms, highlighting the need for interventions that address these factors to improve outcomes in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training and 24-Month Mortality in Heart Failure. Jung, M., Smith, AB., Giordani, B., et al.[2023]

Computerized cognitive training (CCT) shows potential in improving cognitive functions, such as processing speed and working memory, in patients with heart failure, based on a review of 4 randomized controlled trials involving 138 participants.

While CCT may also positively impact daily living functional outcomes, the overall quality of evidence is moderate to low, indicating a need for further research with larger sample sizes to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Computerized Cognitive Training Improve Cognition in Patients With Heart Failure?: A Review. Kua, ZJ., Valenzuela, M., Dong, Y.[2020]

Citations

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Computerized Cognitive Training and 24-Month Mortality in ... Cognitive dysfunction predicts mortality in heart failure (HF). Computerized cognitive training (CCT) has shown preliminary efficacy in improving cognitive ...

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3. link.springer.com link.springer.com/article/10.1007/s41465-025-00328-2

Improving Cognitive Function in Patients with Heart Failure Cognitive training led to broad and sustained cognitive gains in patients with stable heart failure that may support adherence and reduce morbidity and ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08745-6

The efficacy of computerized cognitive training in patients with ... The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916415001281

Nurse-Enhanced Computerized Cognitive Training ... Nurse-Enhanced Computerized Cognitive Training Increases Serum Brain-Derived Neurotropic Factor Levels and Improves Working Memory in Heart Failure. Author ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10808269/

Computerized Cognitive Training and 24-Month Mortality in ... Cognitive dysfunction predicts mortality in heart failure (HF). Computerized cognitive training (CCT) has shown preliminary efficacy in improving cognitive ...

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Digital computerised cognitive training for preventing cognitive ... The primary outcome is the change in global cognitive function measured at 12 weeks. Patients who have completed their 12-week training in the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05601817

Virtual Reality and Computerized Cognitive Intervention for ... Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal ...