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Heart FailureSYNAPSENCT05223426

Effects of Individualized Cognitive Training on Cognition in Heart Failure

A study testing Cognitive training in people with Heart Failure, run by Louis Bherer at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Heart Failure
What is being tested?
Cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesCanada
Study dates
19 Jan 2023to Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Louis Bherer, PhD contact

514-376-3330 ext. 2059

louis.bherer@umontreal.ca

Caroll-Ann Blanchette, MSc contact

514-374-1480 ext. 4340

caroll-ann.blanchette-bisson@umontreal.ca

Canada2 sites, 2 recruiting

  • Preventive medicine and physical activity center (centre EPIC), Montreal heart Institute

    Montreal, Quebec, H1T1N6

    Louis Bherer, PhD, 514-376-3330 ext. 2059, louis.bherer@umontreal.ca

    Caroll-Ann Blanchette, MSc, 514-374-1480 ext. 4340, caroll-ann.blanchette-bisson@umontreal.ca

    Not yet recruiting

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

    Montreal, Quebec

    Loyda Jean-Charles, MSc, 514-890-8000 ext. 17166, loyda.jean-charles.chum@ssss.gouv.qc.ca

    François Tournoux, MD

    Recruiting

Other trials in Canada

About this study

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

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

Read the 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.

Conditions
Heart Failure
Being tested
Cognitive training, Usual Care
Keywords
Heart failure, Cognition, Individualized cognitive training, Home-based intervention, Remote monitoring
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive trainingOther

    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 CareOther

    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.

Study groups in NCT05223426
Study groupRoleWhat they receive
Cognitive training followed by usual careExperimentalUsual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
Receives: Other: Cognitive training; Other: Usual Care
Usual care followed by cognitive trainingExperimentalUsual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
Receives: Other: Cognitive training; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in performance on trained computerized cognitive tasks

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

    Reaction time (ms)

    Measured: Before and after the 6 weeks of interventions

  2. Changes in performance on trained computerized cognitive tasks

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

    Accuracy (%)

    Measured: Before and after the 6 weeks of interventions

  3. Changes in performance on transfer computerized cognitive tasks

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

    Reaction time (ms)

    Measured: Before and after the 6 weeks of interventions

  4. Changes in performance on transfer computerized cognitive tasks

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

    Accuracy (%)

    Measured: Before and after the 6 weeks of interventions

Secondary outcomes (6)

  1. Change in general cognitive functioning

    Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.)

    Measured: Before and after the 6 weeks of interventions

  2. Changes in performance on neuropsychological tests

    Remote version of validated neuropsychological test

    Memory capacity

    -Rey Auditory Verbal Learning Test

    (z-score change)

    Measured: Before and after the 6 weeks of interventions

  3. Changes in performance on neuropsychological tests

    Remote version of validated neuropsychological test

    Processing speed

    -Trail making test Part A

    (z-score change)

    Measured: Before and after the 6 weeks of interventions

  4. 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)

    Measured: Before and after the 6 weeks of interventions

  5. 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.)

    Measured: Before and after the 6 weeks of interventions

  6. 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.)

    Measured: Before and after the 6 weeks of interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start19 Jan 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223426
Sponsor's protocol ID
MP-33-2022-2981
Acronym
SYNAPSE
Status last verified
Nov 2023
First submitted
29 Sep 2021
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Turk-Adawi KI, Oldridge NB, Tarima SS, Stason WB, Shepard DS. Cardiac rehabilitation patient and organizational factors: what keeps patients in programs? J Am Heart Assoc. 2013 Oct 21;2(5):e000418. doi: 10.1161/JAHA.113.000418.

    PubMed 24145743

  • Resurreccion DM, Moreno-Peral P, Gomez-Herranz M, Rubio-Valera M, Pastor L, Caldas de Almeida JM, Motrico E. Factors associated with non-participation in and dropout from cardiac rehabilitation programmes: a systematic review of prospective cohort studies. Eur J Cardiovasc Nurs. 2019 Jan;18(1):38-47. doi: 10.1177/1474515118783157. Epub 2018 Jun 18.

    PubMed 29909641

  • Rego MLM, Cabral DAR, Fontes EB. Cognitive Deficit in Heart Failure and the Benefits of Aerobic Physical Activity. Arq Bras Cardiol. 2018 Jan;110(1):91-94. doi: 10.5935/abc.20180002.

    PubMed 29538528

  • Leto L, Feola M. Cognitive impairment in heart failure patients. J Geriatr Cardiol. 2014 Dec;11(4):316-28. doi: 10.11909/j.issn.1671-5411.2014.04.007.

    PubMed 25593581

  • Hawkins MA, Schaefer JT, Gunstad J, Dolansky MA, Redle JD, Josephson R, Moore SM, Hughes JW. What is your patient's cognitive profile? Three distinct subgroups of cognitive function in persons with heart failure. Appl Nurs Res. 2015 May;28(2):186-91. doi: 10.1016/j.apnr.2014.10.005. Epub 2014 Oct 31.

    PubMed 25510559

  • Doehner W. Dementia and the heart failure patient. Eur Heart J Suppl. 2019 Dec;21(Suppl L):L28-L31. doi: 10.1093/eurheartj/suz242. Epub 2019 Dec 23.

    PubMed 31885510

  • Dodson JA, Chaudhry SI. Geriatric conditions in heart failure. Curr Cardiovasc Risk Rep. 2012 Oct;6(5):404-410. doi: 10.1007/s12170-012-0259-8.

    PubMed 23997843

  • Dickson VV, Tkacs N, Riegel B. Cognitive influences on self-care decision making in persons with heart failure. Am Heart J. 2007 Sep;154(3):424-31. doi: 10.1016/j.ahj.2007.04.058.

    PubMed 17719284

  • de Tournay-Jette E, Dupuis G, Denault A, Cartier R, Bherer L. The benefits of cognitive training after a coronary artery bypass graft surgery. J Behav Med. 2012 Oct;35(5):557-68. doi: 10.1007/s10865-011-9384-y. Epub 2011 Nov 9.

    PubMed 22068879

  • Cannon JA, Moffitt P, Perez-Moreno AC, Walters MR, Broomfield NM, McMurray JJV, Quinn TJ. Cognitive Impairment and Heart Failure: Systematic Review and Meta-Analysis. J Card Fail. 2017 Jun;23(6):464-475. doi: 10.1016/j.cardfail.2017.04.007. Epub 2017 Apr 19.

    PubMed 28433667

  • Belleville S, Hudon C, Bier N, Brodeur C, Gilbert B, Grenier S, Ouellet MC, Viscogliosi C, Gauthier S. MEMO+: Efficacy, Durability and Effect of Cognitive Training and Psychosocial Intervention in Individuals with Mild Cognitive Impairment. J Am Geriatr Soc. 2018 Apr;66(4):655-663. doi: 10.1111/jgs.15192. Epub 2018 Jan 4.

    PubMed 29313875

  • Kua ZJ, Valenzuela M, Dong Y. Can Computerized Cognitive Training Improve Cognition in Patients With Heart Failure?: A Review. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):E19-E27. doi: 10.1097/JCN.0000000000000558.

    PubMed 30585868

  • Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.

    PubMed 25773610

  • Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

    PubMed 25405755

  • Lussier M, Gagnon C, Bherer L. An investigation of response and stimulus modality transfer effects after dual-task training in younger and older. Front Hum Neurosci. 2012 May 18;6:129. doi: 10.3389/fnhum.2012.00129. eCollection 2012.

    PubMed 22629239

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive training in people with Heart Failure, run by Louis Bherer at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Louis Bherer, PhD (514-376-3330 ext. 2059, louis.bherer@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in performance on trained computerized cognitive tasks (time frame: Before and after the 6 weeks of interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223426, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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