Effects of Individualized Cognitive Training on Cognition in Heart Failure

NCT05223426 | Unknown DMC

• 1 other identifier: MP-33-2022-2981
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Changes in performance on trained computerized cognitive tasks

  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

  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

  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

  Transfer version of computerized dual-task, modified stroop and n-back tasks Accuracy (%)

  Before and after the 6 weeks of interventions

Secondary Outcomes (6)

• Change in general cognitive functioning

  Before and after the 6 weeks of interventions

• Changes in performance on neuropsychological tests

  Before and after the 6 weeks of interventions

• Changes in performance on neuropsychological tests

  Before and after the 6 weeks of interventions

• Changes in performance on neuropsychological tests

  Before and after the 6 weeks of interventions

• Change in quality of life

  Before and after the 6 weeks of interventions

Other Outcomes (13)

• Change in depressive symptomatology

  Before and after the 6 weeks of interventions

• Change in anxiety

  Before and after the 6 weeks of interventions

• Change in perceived stress

  Before and after the 6 weeks of interventions

Study Arms (2)

Cognitive training followed by usual care

EXPERIMENTAL

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

Other: Cognitive training; Other: Usual Care

Usual care followed by cognitive training

EXPERIMENTAL

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

Other: Cognitive training; Other: Usual Care

Interventions

Cognitive training OTHER

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.

Cognitive training followed by usual care; Usual care followed by cognitive training

Usual Care OTHER

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.

Cognitive training followed by usual care; Usual care followed by cognitive training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louis Bherer: lead
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (2)

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

Montreal, Quebec, H1T1N6, Canada

NOT YET RECRUITING

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

Montreal, Quebec, Canada

RECRUITING

Related Publications (17)

• 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.

  PMID: 24145743 BACKGROUND

• 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.

  PMID: 29909641 BACKGROUND

• 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.

  PMID: 29538528 BACKGROUND

• 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.

  PMID: 25593581 BACKGROUND

• 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.

  PMID: 25510559 BACKGROUND

• 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.

  PMID: 31885510 BACKGROUND

• 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.

  PMID: 23997843 BACKGROUND

• 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.

  PMID: 17719284 BACKGROUND

• 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.

  PMID: 22068879 BACKGROUND

• 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.

  PMID: 28433667 BACKGROUND

• 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.

  PMID: 29313875 BACKGROUND

• 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.

  PMID: 30585868 BACKGROUND

• 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.

  PMID: 25773610 BACKGROUND

• 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.

  PMID: 25405755 BACKGROUND

• 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.

  PMID: 22629239 BACKGROUND

• Pendlebury ST, Welch SJ, Cuthbertson FC, Mariz J, Mehta Z, Rothwell PM. Telephone assessment of cognition after transient ischemic attack and stroke: modified telephone interview of cognitive status and telephone Montreal Cognitive Assessment versus face-to-face Montreal Cognitive Assessment and neuropsychological battery. Stroke. 2013 Jan;44(1):227-9. doi: 10.1161/STROKEAHA.112.673384. Epub 2012 Nov 8.

  PMID: 23138443 BACKGROUND

• Blanchette CA, Besnier F, Dupuy EG, Gagnon C, Vincent T, Rouleau JL, Bouabdallaoui N, Grau JI, Racine N, Tournoux F, Apullan FJ, Vitali P, Belleville S, Bherer L. A multicenter randomized single-blinded clinical trial to investigate the effects of an individualized home-based cognitive training program in patients with chronic heart failure: the SYNAPSE protocol. Trials. 2025 Nov 17;26(1):511. doi: 10.1186/s13063-025-09193-y.

  PMID: 41250150 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louis Bherer, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Bherer, PhD

CONTACT

514-376-3330; louis.bherer@umontreal.ca

Caroll-Ann Blanchette, MSc

CONTACT

514-374-1480; caroll-ann.blanchette-bisson@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind masking: the research personnel performing the outcome assessments at baseline, between the intervention (two months) and after the intervention (four months) will be blinded to groups' intervention order. Participants will be aware of the order in which they receive the intervention.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate scientific director, Direction of prevention, Montreal heart Institute

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: February 4, 2022
• Study Start: January 19, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)