Effects of Individualized Cognitive Training on Cognition in Heart Failure

Heart Failure Clinical Trial

— SYNAPSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223426
• Other study ID #: MP-33-2022-2981
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Montreal Heart Institute
• Contact: Louis Bherer, PhD
• Phone: 514-376-3330
• Email: louis.bherer[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Centre de recherche du centre Hospitalier de l'Université de Montréal (CRCHUM)	Montréal	Quebec
Canada	Preventive medicine and physical activity center (centre EPIC), Montreal heart Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Louis Bherer	The Montreal Health Innovations Coordinating Center (MHICC)

Country where clinical trial is conducted

Canada, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in depressive symptomatology	Patient Health Questionnaire (PHQ-9) (Score ranges from 0 to 27, with a higher score indicating a more severe depression state.)	Before and after the 6 weeks of interventions
Other	Change in anxiety	General Anxiety Disorder questionnaire (GAD-7) (Total score ranges from 0 to 21, with an increasing score on the scale is indicating a worse anxiety state.)	Before and after the 6 weeks of interventions
Other	Change in perceived stress	Perceived Stress Scale questionnaire (PSS-10) (Score ranges from 0-40, with a higher score indicating a worse sleep quality)	Before and after the 6 weeks of interventions
Other	Change in quality of sleep	Pittsburgh Sleep Quality Index questionnaire (PSQI) (19 self-assessment questions are grouped into seven components. The scores for the seven components are summed to give an overall score that ranges from 0 to 21 points, with "0" indicating no difficulty and "21" indicating severe difficulty in all components. A score higher than 5 indicates problematic sleep in one or more components)	Before and after the 6 weeks of interventions
Other	Change in Risk of sleep apnea	Berlin Questionnaire (Participants are classified into a high or a low risk of sleep apnea based their responses to the individual items and their overall scores in the symptom categories. A High Risk represent 2 or more categories where the score is positive. A low risk represents 1 or no category where the score is positive.)	Before and after the 6 weeks of interventions
Other	Change in self-reported physical activity	Physical Activity Scale for the Elderly Questionnaire (PASE) (The overall score ranges from 0 to 400, with a higher score indicating a better level of physical activity)	Before and after the 6 weeks of interventions
Other	Change in Walking test speed	4-meter walking test (m/s)	Before and after the 6 weeks of interventions
Other	Change in functional mobility	Timed up and Go test (s)	Before and after the 6 weeks of interventions
Other	Change in balance performance	Timed one-leg standing test (s)	Before and after the 6 weeks of interventions
Other	Change in lower limb muscles strength	Timed Sit-to-Stand test (s)	Before and after the 6 weeks of interventions
Other	Cognitive Reserve	Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve)	Baseline
Other	Self-reported masculinity and femininity traits	Short Form BEM Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits and 10 items neutral, not scored. Two scores, rage from 10-70, are calculated for femininity and masculinity, respectively. A higher score is indicating a higher trait.)	Baseline
Other	Dietary patterns	Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorized as unhealthy, 30-37 as somewhat unhealthy and 38 or more as a healthy diet.)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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	Change in general cognitive functioning	Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.)	Before and after the 6 weeks of interventions
Secondary	Changes in performance on neuropsychological tests	Remote version of validated neuropsychological test; Memory capacity; -Rey Auditory Verbal Learning Test; (z-score change)	Before and after the 6 weeks of interventions
Secondary	Changes in performance on neuropsychological tests	Remote version of validated neuropsychological test; Processing speed; -Trail making test Part A; (z-score change)	Before and after the 6 weeks of interventions
Secondary	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)	Before and after the 6 weeks of interventions
Secondary	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.)	Before and after the 6 weeks of interventions
Secondary	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.)	Before and after the 6 weeks of interventions