The SYNAPSE trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
54
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.
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.
Preventive medicine and physical activity center (centre EPIC), Montreal heart Institute
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCentre de recherche du centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada
RECRUITINGChanges in performance on trained computerized cognitive tasks
Trained version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on trained computerized cognitive tasks
Trained version of computerized dual-task, modified stroop and n-back tasks Accuracy (%)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on transfer computerized cognitive tasks
Transfer version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on transfer computerized cognitive tasks
Transfer version of computerized dual-task, modified stroop and n-back tasks Accuracy (%)
Time frame: Before and after the 6 weeks of interventions
Change in general cognitive functioning
Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
Remote version of validated neuropsychological test Memory capacity -Rey Auditory Verbal Learning Test (z-score change)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Remote version of validated neuropsychological test Processing speed -Trail making test Part A (z-score change)
Time frame: Before and after the 6 weeks of interventions
Changes in performance on neuropsychological tests
Remote version of validated neuropsychological test Executive functions * Trail making test Part B * Verbal fluency test * Digit span test (z-score change)
Time frame: Before and after the 6 weeks of interventions
Change in quality of life
36-Items Short form health Survey (SF-36) (Score ranges from 0-100, with a higher score indicating more favorable health status.)
Time frame: Before and after the 6 weeks of interventions
Change in self-care behavior
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.)
Time frame: Before and after the 6 weeks of interventions