Heart Failure Clinical Trial
— SYNAPSEOfficial 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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Louis Bherer | The Montreal Health Innovations Coordinating Center (MHICC) |
Canada,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|