Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.
详细描述
Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ESRD on dialysis
- •Age greater than 20 years
- •Have means of transportation to and from the exercise session
- •Speak English (as the neuropsychological tests will be performed in English)
排除标准
- •Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (> NYHA grade II)
- •History of stroke in the last 2 months
- •Active respiratory disease
- •Uncontrolled hypertension
- •Severe uncontrolled diabetes
- •Persistent predialysis hyperkalemia
- •Active decompensated liver disease
- •Symptomatic peripheral vascular disease
- •Musculoskeletal abnormalities that will be prohibit their participation in the exercise program
- •Health conditions needing frequent hospitalizations
- •Other health conditions causing inability to follow exercise program correctly
- •Unwillingness to participate in structured exercise program
- •Current use of antipsychotics or anti-epileptics
- •Inability to hear, read or write which will limit their ability to perform the cognitive tests
研究组 & 干预措施
Exercise Group
Subjects randomized to this group will start 12 weeks of supervised aerobic exercise after baseline testing.
干预措施: Aerobic Exercise (Other)
Control Group
Subjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention.
干预措施: Aerobic Exercise (Other)
Control Group
Subjects randomized to this group will continue with 12 weeks of Standard Care. After 12 weeks, the subjects will cross over to the exercise arm and undergo baseline testing again and then start 12 weeks of exercise intervention.
干预措施: Standard Care Dialysis (Procedure)
结局指标
主要结局
Feasibility
时间窗: Up to 26 Weeks
Subject compliance with exercise training
次要结局
- Markers of inflammation(Baseline, within 1 week before and within 1 week after exercise intervention)
- Cognitive function(Baseline, within1 week before and within 1 week after exercise intervention)
研究者
Aditi Gupta, MD
Assistant Professor
University of Kansas Medical Center