Recruiting

Cognitive Training

Sponsor:

Louis Bherer

Code:

NCT05223426

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cognitive training

Usual Care

Study Details

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.

Conditions

Heart Failure

Study ID

NCT05223426

Start date

Jan 19, 2023

Status verified date

Nov, 2023

Completion date

Nov, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cognitive training followed by usual care

Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.

experimental: Usual care followed by cognitive training

Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.

Interventions

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.

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.

Primary outcome measure

  • Changes in performance on trained computerized cognitive tasks [ Time Frame: 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 ]
  • Changes in performance on transfer computerized cognitive tasks [ Time Frame: 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 ]

Central Contacts and Locations

Locations

Centre de recherche du centre Hospitalier de l'Université de Montréal (CRCHUM)

Recruiting

Montréal, Quebec, Canada

Contacts

Principal Investigator:

François Tournoux, MD

More Information

Sponsor

Louis Bherer

Last update posted

Nov 14, 2023

Last verified

Nov, 2023

Keywords

  • Heart failure
  • Cognition
  • Individualized cognitive training
  • Home-based intervention
  • Remote monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Bherer on 2023-11-14.