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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Changes in performance on trained computerized cognitive tasks
研究概览
简要总结
The SYNAPSE trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Cognitive training followed by usual care
Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
干预措施: Cognitive training (Other)
Cognitive training followed by usual care
Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
干预措施: Usual Care (Other)
Usual care followed by cognitive training
Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
干预措施: Cognitive training (Other)
Usual care followed by cognitive training
Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
干预措施: Usual Care (Other)
结局指标
主要结局
Changes in performance on trained computerized cognitive tasks
时间窗: Before and after the 6 weeks of interventions
Trained version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms)
Changes in performance on transfer computerized cognitive tasks
时间窗: Before and after the 6 weeks of interventions
Transfer version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms)
次要结局
- 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)
- Change in self-care behavior(Before and after the 6 weeks of interventions)
- Change in general cognitive functioning(Before and after the 6 weeks of interventions)
研究者
Louis Bherer
Associate scientific director, Direction of prevention, Montreal heart Institute
Montreal Heart Institute