The Cog-Train Feasibility Study: a Single-arm Trial Investigating the Feasibility of a Preoperative Cognitive Training Intervention (Cog-Train) in Cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Training performance gain
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of administering a 20-day preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients.
详细描述
Cognitive outcomes remain poor after cardiac surgery. Data from the field of cognitive neuroscience suggests that cognitive training, which harnesses the brain's adaptive plasticity to improve, maintain, or restore function in a target area, can be used to strengthen brain resilience and improve cognitive outcomes following challenge. While its effectiveness has been demonstrated in older adults as well as in other (nonsurgical) patient populations, no training intervention like this has ever before been used in any surgical patient in the preoperative period. The purpose of this study is to evaluate the feasibility of administering a 20-day cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients before their surgery. Data obtained will be used to design a full-scale randomised controlled trial (RCT) on Cog-Train's effectiveness in improving postoperative cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
- •Aged 60+ years
排除标准
- •Surgery scheduled for sooner than 21 days
- •'Off-pump' surgery being considered
- •Inability to obtain informed consent
- •Sensory or motor impairments impeding use of task
- •Communication barriers impeding administration of study procedures
- •Inability to demonstrate understanding of task and/or study procedures
- •Inability to make time commitment
研究组 & 干预措施
Cog-Train Intervention
干预措施: Cog-Train Intervention (Behavioral)
结局指标
主要结局
Training performance gain
时间窗: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Average increase in training task level achieved from first to last training day
Adherence to training regimen
时间窗: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Mean number of training days completed according to instructions
次要结局
- Side-effects(From 21 days prior to scheduled surgery to up to 14 days after surgery)
- Recruitment and retention(10 weeks)
- Satisfaction and acceptability(At 1 day prior to scheduled surgery)