Effects of Individualized Cognitive Training on Cognition in Heart Failure (SYNAPSE)

Louis Bherer

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Usual Care; Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT05223426

MP-33-2022-2981

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Cognitive training followed by usual care

Experimental group

Description:

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

Treatment:

Other: Usual Care

Other: Cognitive training

Usual care followed by cognitive training

Experimental group

Description:

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

Treatment:

Other: Usual Care

Other: Cognitive training