Effects of Individualized Cognitive Training on Cognition in Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Cognitive training; Other: Usual Care

• Registration Number: NCT05223426
• Lead Sponsor: Louis Bherer

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.

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-04
• Study Start: 2023-01-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cognitive training followed by usual care	Cognitive training	Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
Cognitive training followed by usual care	Usual Care	Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
Usual care followed by cognitive training	Usual Care	Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
Usual care followed by cognitive training	Cognitive training	Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in performance on trained computerized cognitive tasks	Before and after the 6 weeks of interventions	Trained version of computerized dual-task, modified stroop and n-back tasks; Accuracy (%)
Changes in performance on transfer computerized cognitive tasks	Before and after the 6 weeks of interventions	Transfer version of computerized dual-task, modified stroop and n-back tasks; Accuracy (%)

Secondary Outcome Measures

Name	Time	Method
Changes in performance on neuropsychological tests	Before and after the 6 weeks of interventions	Remote version of validated neuropsychological test; Executive functions; * Trail making test Part B; * Verbal fluency test; * Digit span test; (z-score change)
Change in quality of life	Before and after the 6 weeks of interventions	36-Items Short form health Survey (SF-36) (Score ranges from 0-100, with a higher score indicating more favorable health status.)
Change in self-care behavior	Before and after the 6 weeks of interventions	European Heart-Failure Self-care Behavior Scale-9 (EHFsB-9) (The minimal score is 9 while the maximal score is 45. The higher the score, the less the patient performs self-care behaviors.)
Change in general cognitive functioning	Before and after the 6 weeks of interventions	Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.)

Trial Locations

Locations (2)

Preventive medicine and physical activity center (centre EPIC), Montreal heart Institute; 🇨🇦 Montréal, Quebec, Canada

Centre de recherche du centre Hospitalier de l'Université de Montréal (CRCHUM); 🇨🇦 Montréal, Quebec, Canada