Effects of Individualized Cognitive Training on Cognition in Heart Failure

NCT ID: NCT05223426

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2024-11-30

Brief Summary

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

Detailed Description

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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

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Cognitive training followed by usual care

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

Group Type EXPERIMENTAL

Cognitive training

Intervention Type 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.

Usual Care

Intervention Type 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.

Usual care followed by cognitive training

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

Group Type EXPERIMENTAL

Cognitive training

Intervention Type 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.

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Montreal Health Innovations Coordinating Center (MHICC)

OTHER

Sponsor Role collaborator

Louis Bherer

OTHER

Sponsor Role lead

Responsible Party

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Louis Bherer

Associate scientific director, Direction of prevention, Montreal heart Institute

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Louis Bherer, PhD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

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

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Louis Bherer, PhD

Role: CONTACT

514-376-3330 ext. 2059

Caroll-Ann Blanchette, MSc

Role: CONTACT

514-374-1480 ext. 4340

Facility Contacts

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Louis Bherer, PhD

Role: primary

514-376-3330 ext. 2059

Caroll-Ann Blanchette, MSc

Role: backup

514-374-1480 ext. 4340

Loyda Jean-Charles, MSc

Role: primary

514-890-8000 ext. 17166

References

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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.

Reference Type BACKGROUND
PMID: 24145743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29909641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29538528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25593581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25510559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31885510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23997843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17719284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22068879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28433667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29313875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30585868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25773610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25405755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22629239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23138443 (View on PubMed)

Other Identifiers

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MP-33-2022-2981

Identifier Type: -

Identifier Source: org_study_id

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