Clinical trial NCT05223426: Effects of Individualized Cognitive Training on Cognition in Heart Failure
Official title: A Multicenter Randomized Single-blinded Clinical Trial to Investigate the Effects of a Home-based Cognitive Training for individualS Affected bY chroNic heArt Failure: an Individualized Program to increaSE Cognitive Functions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Cognition
Individualized cognitive training
Home-based intervention
Remote monitoring
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: The Montreal Health Innovations Coordinating Center (MHICC)
First posted: 2022-02-04
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The SYNAPSE trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.

Detailed description: The purpose of the SYNAPSE study is to evaluate the effects of an individualized home-based training program aimed to improve cognitive functions and well-being in heart failure patients. Heart failure is characterized by the inability of the heart to pump blood efficiently through the body. Nearly half of patients with heart failure present with cognitive deficits. Memory and executive functions that allow us to perform complex tasks are mainly affected. These cognitive deficits are linked to an increased risk of hospitalization and mortality, in addition to decreasing patients' well-being and ability to care for themselves. Although rehabilitation programs that include physical activity and counseling help reduce heart and brain health risks, these programs are unpopular. Among the few who enroll, between 24% and 50% drop out before the completion of the program. Offering alternative options such as cognitive training would help to reach this proportion of patients. The literature has shown that cognitive training is effective in preventing or reducing cognitive deficits in older adults with or without cognitive loss. Although still understudied in patients with heart failure, a better understanding of the association between heart failure and changes in cognition would allow better adaptation of patient care to their situations and needs.

Eligibility criteria: Inclusion Criteria:

* Adult aged 50 or older
* Have access to Internet
* Have access to a computer or a tablet;
* Have the ability to perform cognitive training;
* Have the ability to read, understand and consent to the informed consent form;
* Have chronic heart failure on tolerated therapy for at least two months;
* Without limitation of physical activity to severe limitation of physical activity (i.e. NYHA class I, class II, class III OR class IV).

Exclusion Criteria:

* Acute cardiovascular event 1 month before randomization;
* Cardiovascular procedure scheduled within 3 months;
* Uncontrolled diabetes or untreated thyroid dysfunction;
* Current or recent malignancy with a life expectancy of less than 1 year;
* Neurological disease;
* Chronic hemodialysis or peritoneal dialysis.

Primary outcomes:
measure: Changes in performance on trained computerized cognitive tasks
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on trained computerized cognitive tasks
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on transfer computerized cognitive tasks
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on transfer computerized cognitive tasks
timeFrame: Before and after the 6 weeks of interventions
Secondary outcomes:
measure: Change in general cognitive functioning
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on neuropsychological tests
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on neuropsychological tests
timeFrame: Before and after the 6 weeks of interventions
measure: Changes in performance on neuropsychological tests
timeFrame: Before and after the 6 weeks of interventions
measure: Change in quality of life
timeFrame: Before and after the 6 weeks of interventions
measure: Change in self-care behavior
timeFrame: Before and after the 6 weeks of interventions
Other outcomes:
measure: Change in depressive symptomatology
timeFrame: Before and after the 6 weeks of interventions
measure: Change in anxiety
timeFrame: Before and after the 6 weeks of interventions
measure: Change in perceived stress
timeFrame: Before and after the 6 weeks of interventions
measure: Change in quality of sleep
timeFrame: Before and after the 6 weeks of interventions
measure: Change in Risk of sleep apnea
timeFrame: Before and after the 6 weeks of interventions
measure: Change in self-reported physical activity
timeFrame: Before and after the 6 weeks of interventions
measure: Change in Walking test speed
timeFrame: Before and after the 6 weeks of interventions
measure: Change in functional mobility
timeFrame: Before and after the 6 weeks of interventions
measure: Change in balance performance
timeFrame: Before and after the 6 weeks of interventions
measure: Change in lower limb muscles strength
timeFrame: Before and after the 6 weeks of interventions
measure: Cognitive Reserve
timeFrame: Baseline
measure: Self-reported masculinity and femininity traits
timeFrame: Baseline
measure: Dietary patterns
timeFrame: Baseline
Locations:
city: Montréal
country: Canada
facility: Preventive medicine and physical activity center (centre EPIC), Montreal heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Centre de recherche du centre Hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Louis Bherer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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