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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Cognitive & Physical Exercise for Heart Failure?

Research shows that computerized cognitive training (CCT) can improve memory and cognitive function in heart failure patients, which may help with daily activities and quality of life. Additionally, CCT has been linked to increased levels of brain-derived neurotrophic factor (BDNF), a protein that supports brain health. ^{1 2 3 4 5}

Is cognitive and physical exercise safe for heart failure patients?

The research does not specifically address safety concerns, but computerized cognitive training and cardiac rehabilitation have been studied in heart failure patients without reported safety issues, suggesting they are generally safe. ^{1 2 3 5 6}

How is the Cognitive & Physical Exercise treatment for heart failure different from other treatments?

This treatment is unique because it combines cognitive training (mental exercises) and physical exercise to improve both brain function and physical health in heart failure patients. Unlike standard treatments that may focus solely on physical rehabilitation, this approach aims to enhance memory, self-care, and quality of life by improving blood flow to the brain and increasing brain-derived neurotropic factor (BDNF) levels, which support brain health. ^{1 3 6 7 8}

Research Team

Louis Bherer, PhD

Principal Investigator

Montreal Heart Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceived Facilitators and Barriers to Treatment Fidelity in Computerized Cognitive Training Interventions. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Nurse-Enhanced Computerized Cognitive Training Increases Serum Brain-Derived Neurotropic Factor Levels and Improves Working Memory in Heart Failure. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Can Computerized Cognitive Training Improve Cognition in Patients With Heart Failure?: A Review. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training and 24-Month Mortality in Heart Failure. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation is associated with lasting improvements in cognitive function in older adults with heart failure. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Possible neurocognitive benefits of exercise in persons with heart failure. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise and Cognitive Training Intervention Improves Self-Care, Quality of Life and Functional Capacity in Persons With Heart Failure. [2022]