Hemodialysis-based Interventions to Preserve Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cognitive function measured using the Modified Mini Mental Status
研究概览
简要总结
This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test two interventions (cognitive training and exercise training) against the standard of care.
详细描述
This will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to demonstrate feasibility for the interventions (cognitive training and exercise training) in Aim 1. The investigators will formally test whether whether cognitive training (tablet-based brain games) and exercise training (stationary foot pedal) administered during HD slow cognitive decline as well as improve secondary outcomes (physical function, frailty, and health-related quality of life (HRQOL) as part of Aim 2. The investigators will compare these two interventions against the standard of care. Pre- and post-intervention assessments will be conducted at the dialysis unit by a study coordinator and by research assistants. Participants will be followed for 6 months to assess cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with end stage renal disease and receiving hemodialysis at the DaVita Dialysis Centers located at 409 N. Caroline St., Baltimore, MD will be approached by our study coordinator to determine eligibility.
- •Must be at least 18 years or older at enrollment
- •Must be English speaking
- •Must be willing to participate in research and able to give informed consent
排除标准
- •Chronic lung disease requiring oxygen
- •Cerebrovascular disease
- •Musculoskeletal conditions that limit mobility
- •Lower or upper extremity amputation
- •Orthopedic disorders exacerbated by physical activity
- •Decreased mental capacity
- •Dementia (diagnosed)
研究组 & 干预措施
Standard of care
Participants randomized to the standard of care arm will not receive any intervention.
Cognitive training (CT)
Participants randomized to the CT arm will be given a tablet with connection to Lumosity®, which is a web-based "brain game". Participants will use the tablets to play brain games at each dialysis session.
干预措施: cognitive training (Other)
Exercise training (ET)
Participants randomized to ET arm will be given a stationary foot peddler. This foot peddler will be situated at a comfortable distance from the dialysis chair so that the patient can comfortably reach the peddler. Participants will use the foot peddlers at each dialysis session.
干预措施: exercise training (Other)
结局指标
主要结局
Cognitive function measured using the Modified Mini Mental Status
时间窗: 6 months post-intervention
Cognitive decline assessed as both the change in Modified Mini Mental Status and Trail making Test A and B scores as well as 10% decline in these measures of cognitive function
次要结局
- health-related quality of life (HRQOL)(6 months post-intervention)
- Cognitive function(6 months post-intervention)
- physical function measured using the Short Physical Performance Battery (SPBB)(6 months post-intervention)
- Fried frailty phenotype(6 months post-intervention)