Effects of Individualized Cognitive Training on Cognition in Heart Failure (SYNAPSE)

November 10, 2023 updated by: Louis Bherer

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T1N6
      • Montréal, Quebec, Canada
        • Recruiting
        • Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
        • Contact:
        • Principal Investigator:
          • François Tournoux, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive training followed by usual care
Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
Other: Cognitive training
A cognitive training program will be individually developed for each participant based on baseline neuropsychological tests. It will include: Computerized cognitive training: this training include: the Dual-Task, the Stroop and the N-Back task. The tasks are accompanied by feedback based on the participant's responses (e.g., progress graph, feedback, etc.). In order to promote participants' learning, the level of difficulty of the tasks increased as training sessions progressed. Two sets of stimuli will be used to maximize the generalization of learning. Memory training: This training is adapted from the MEMO+ training program (Belleville et al., 2018). These sessions, also home-based, will be done through online video and are covering a variety of topics: memory (normal aging, mnemonic strategies), attention, aging, etc. Each week, participants will be asked to complete the equivalent of 6 training sessions of 15 minutes each, for a total of 1h30 per week.
Other: Usual Care
Participants will be asked to continue the care and follow-up as usually planned with the attending cardiologist. Apart from weekly follow-ups with the research team member, no changes will be made to the participant's medical care.
Experimental: Usual care followed by cognitive training
Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
Other: Cognitive training
A cognitive training program will be individually developed for each participant based on baseline neuropsychological tests. It will include: Computerized cognitive training: this training include: the Dual-Task, the Stroop and the N-Back task. The tasks are accompanied by feedback based on the participant's responses (e.g., progress graph, feedback, etc.). In order to promote participants' learning, the level of difficulty of the tasks increased as training sessions progressed. Two sets of stimuli will be used to maximize the generalization of learning. Memory training: This training is adapted from the MEMO+ training program (Belleville et al., 2018). These sessions, also home-based, will be done through online video and are covering a variety of topics: memory (normal aging, mnemonic strategies), attention, aging, etc. Each week, participants will be asked to complete the equivalent of 6 training sessions of 15 minutes each, for a total of 1h30 per week.
Other: Usual Care
Participants will be asked to continue the care and follow-up as usually planned with the attending cardiologist. Apart from weekly follow-ups with the research team member, no changes will be made to the participant's medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in performance on trained computerized cognitive tasks
Time Frame: Before and after the 6 weeks of interventions

Trained version of computerized dual-task, modified stroop and n-back tasks

Reaction time (ms)
Before and after the 6 weeks of interventions
Changes in performance on trained computerized cognitive tasks
Time Frame: Before and after the 6 weeks of interventions

Trained version of computerized dual-task, modified stroop and n-back tasks

Accuracy (%)
Before and after the 6 weeks of interventions
Changes in performance on transfer computerized cognitive tasks
Time Frame: Before and after the 6 weeks of interventions

Transfer version of computerized dual-task, modified stroop and n-back tasks

Reaction time (ms)
Before and after the 6 weeks of interventions
Changes in performance on transfer computerized cognitive tasks
Time Frame: Before and after the 6 weeks of interventions

Transfer version of computerized dual-task, modified stroop and n-back tasks

Accuracy (%)
Before and after the 6 weeks of interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in general cognitive functioning
Time Frame: 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.)
Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
Time Frame: Before and after the 6 weeks of interventions

Remote version of validated neuropsychological test

Memory capacity

-Rey Auditory Verbal Learning Test

(z-score change)
Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
Time Frame: Before and after the 6 weeks of interventions

Remote version of validated neuropsychological test

Processing speed

-Trail making test Part A

(z-score change)
Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
Time Frame: 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)
Before and after the 6 weeks of interventions
Change in quality of life
Time Frame: 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.)
Before and after the 6 weeks of interventions
Change in self-care behavior
Time Frame: 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.)
Before and after the 6 weeks of interventions

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptomatology
Time Frame: Before and after the 6 weeks of interventions
Patient Health Questionnaire (PHQ-9) (Score ranges from 0 to 27, with a higher score indicating a more severe depression state.)
Before and after the 6 weeks of interventions
Change in anxiety
Time Frame: Before and after the 6 weeks of interventions
General Anxiety Disorder questionnaire (GAD-7) (Total score ranges from 0 to 21, with an increasing score on the scale is indicating a worse anxiety state.)
Before and after the 6 weeks of interventions
Change in perceived stress
Time Frame: Before and after the 6 weeks of interventions
Perceived Stress Scale questionnaire (PSS-10) (Score ranges from 0-40, with a higher score indicating a worse sleep quality)
Before and after the 6 weeks of interventions
Change in quality of sleep
Time Frame: Before and after the 6 weeks of interventions
Pittsburgh Sleep Quality Index questionnaire (PSQI) (19 self-assessment questions are grouped into seven components. The scores for the seven components are summed to give an overall score that ranges from 0 to 21 points, with "0" indicating no difficulty and "21" indicating severe difficulty in all components. A score higher than 5 indicates problematic sleep in one or more components)
Before and after the 6 weeks of interventions
Change in Risk of sleep apnea
Time Frame: Before and after the 6 weeks of interventions
Berlin Questionnaire (Participants are classified into a high or a low risk of sleep apnea based their responses to the individual items and their overall scores in the symptom categories. A High Risk represent 2 or more categories where the score is positive. A low risk represents 1 or no category where the score is positive.)
Before and after the 6 weeks of interventions
Change in self-reported physical activity
Time Frame: Before and after the 6 weeks of interventions
Physical Activity Scale for the Elderly Questionnaire (PASE) (The overall score ranges from 0 to 400, with a higher score indicating a better level of physical activity)
Before and after the 6 weeks of interventions
Change in Walking test speed
Time Frame: Before and after the 6 weeks of interventions
4-meter walking test (m/s)
Before and after the 6 weeks of interventions
Change in functional mobility
Time Frame: Before and after the 6 weeks of interventions
Timed up and Go test (s)
Before and after the 6 weeks of interventions
Change in balance performance
Time Frame: Before and after the 6 weeks of interventions
Timed one-leg standing test (s)
Before and after the 6 weeks of interventions
Change in lower limb muscles strength
Time Frame: Before and after the 6 weeks of interventions
Timed Sit-to-Stand test (s)
Before and after the 6 weeks of interventions
Cognitive Reserve
Time Frame: Baseline
Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve)
Baseline
Self-reported masculinity and femininity traits
Time Frame: Baseline
Short Form BEM Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits and 10 items neutral, not scored. Two scores, rage from 10-70, are calculated for femininity and masculinity, respectively. A higher score is indicating a higher trait.)
Baseline
Dietary patterns
Time Frame: Baseline
Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorized as unhealthy, 30-37 as somewhat unhealthy and 38 or more as a healthy diet.)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Bherer

Collaborators

The Montreal Health Innovations Coordinating Center (MHICC)

Investigators

  • Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-33-2022-2981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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