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临床试验/NCT00363961
NCT00363961已完成不适用

Resistance Training During Maintenance Dialysis

Tufts University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
- Physical function (short physical performance battery)

研究概览

简要总结

There is a rising incidence of kidney failure in the US, with poor outcomes and high cost. End-stage renal disease (ESRD) affects almost 375,000 individuals in the US at a cost of more than $14 billion per year. Despite advances in dialysis and transplantation therapies, kidney failure leads to poor outcomes, poor prognosis and high health care costs. Malnutrition and the underlying systemic inflammatory response developed during the course of chronic kidney disease, worsen during ESRD, and lead to adverse outcomes, increased morbidity and mortality. Muscle wasting, impaired functional capacity and poor quality of life are the most important factors associated with malnutrition and inflammation in renal failure. We have shown in pre dialysis patients with moderate chronic renal insufficiency that the anabolic effects of resistance exercise training result in significant improvements in protein utilization, nutritional status and functional capacity even in the context of anorexia and prescribed low protein diets. Therefore, we propose to develop, test and implement a progressive resistance exercise routine for ESRD patients during the hemodialysis session. By implementing such intervention, we hope to offer a therapeutic strategy that can be incorporated to the standard of care of ESRD patients by working in conjunction with the dialysis unit staff.

详细描述

The hypotheses to be investigated are that, compared to ESRD patients on maintenance dialysis receiving stretches only, the addition of 30-45 min of progressive resistance training during the hemodialysis session will counteract the burden of renal disease and will result in:

  1. A feasible and safe exercise modality for ESRD patients.
  2. Will contribute to improved nutritional status and reduced systemic inflammation
  3. Will result in improved quality of life

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female ESRD patients over 30 years of age
  • ESRD patients undergoing maintenance hemodialysis 3x/wk for at least 3 months
  • Willing to be randomized to either study group
  • Compliance with at least 80% of the dialysis sessions

排除标准

  • Unstable cardiovascular disease
  • Any uncontrolled chronic condition
  • Cardiac surgery, myocardial infarction, joint replacement, or low extremity fracture within the previous 6 months
  • Severe cognitive impairment resulting in inability to understand and provide written informed consent form and or follow instructions
  • Current resistance training
  • Low extremity amputees

结局指标

主要结局

- Physical function (short physical performance battery)

时间窗: 6 months

次要结局

  • Muscle mass, inflammation biomarkers, quality of life(SF36), and Activities of Daily Living(6 months)

研究者

申办方类型
Other

研究点 (2)

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