跳至主要内容
临床试验/NCT00792454
NCT00792454已完成不适用

Reduction of Mortality Prior to and During the First 90 Days of Dialysis Through a Renal Rehabilitation Program

MaineHealth2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
MaineHealth
入组人数
116
试验地点
2
主要终点
Mortality prior to and During the First 90 Days of Dialysis

研究概览

简要总结

The mortality rate of treated patients with end stage renal disease(ESRD)is 22 deaths patient-years at risk in 2006. Incident patients with ESRD are most vulnerable within the first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years. The vast majority of these deaths are due to cardiovascular causes. As cardiac rehabilitation programs have shown a 20% reduction in one year overall mortality rate post myocardial infarction the investigator proposes that a similar type of rehabilitation program will also have a benificial effect on morbidity and mortality in patients with chronic kidney disease(CKD)and ESRD.The overall goal of this project is to study whether a renal rehabilitation program based on guided exercise implemented in patients with stage III and stage IV CKD can influence the mortality rate of these patients prior to and during the first 90 days of dialysis

Hypothesis:The application of a guided exercise program (renal rehabilitation) instituted in patients with stage III or Stage IV CKD will decrease the mortality rate prior to the initiation of renal replacement therapy.

Hypothesis:The application of renal rehabilitation during the late stages of CKD will decrease the mortality risk during the first 90 days of renal rehabilitation therapy.

Hypothesis:A guided exercise program will have an immediate and prolonged effect on activity levels, mental health and adaption to chronic illness in patients with advanced CKD.

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

入选标准

  • greater than 18 yo
  • stage III CKD (GFR<60ml/min)
  • stage IV CKD (GFR<30ml/min)

排除标准

  • active angina pectoris
  • lower extremity amputation with no prosthesis
  • orthopedic disorder severly exacerbated by activity
  • chronic lung disease resulting in significant shortness of breath or oxygen de-saturation at rest
  • cerebro cascular disease manifested by ongoing TIAs
  • malignant carcinoma

结局指标

主要结局

Mortality prior to and During the First 90 Days of Dialysis

时间窗: 5 years

次要结局

  • Measurement of physical fitness and quality of life(5 years)

研究者

发起方
MaineHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

James C Wasserman

principal investigator

MaineHealth

研究点 (2)

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