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临床试验/NCT02895243
NCT02895243已完成不适用

Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Post kidney transplant mortality

研究概览

简要总结

This pilot study will be a clinical trial to test the feasibility and effectiveness of a kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease (ESRD) who are within 3-6 months of transplantation.

详细描述

Prehabilitation is the enhancement of functional capacity of a patient to improve their ability to withstand a future stressor. The investigators primary objective is to demonstrate feasibility for prehabilitation in Aim 1 and test whether the number of prehabilitation sessions is associated with increased physical activity. The investigators will formally test whether prehabilitation is associated with a reduction in short term and long term KT outcomes as part of Aim 2. The investigators will test whether there is an effect of prehabilitation on short-term (KT length of stay> 2 weeks, early hospital readmission and delayed graft function) and long-term (acute rejection (within the first year), 1 year patient and graft survival) outcomes compared to standard of care controls. Participants will be followed for 3-6 months or until they receive a kidney transplant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins
  • Must be at least 18 years or older at enrollment
  • Must be English speaking
  • Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation
  • Must be willing to participate in a prehabilitation program and able to give informed consent

排除标准

  • Patients who have any of the following medical conditions will be excluded from the study:
  • Active Angina pectoris
  • Chronic lung disease and daily use of oxygen
  • Cerebral vascular disease
  • Musculoskeletal conditions that would limit participation in prehabilitation
  • Lower- or upper-extremity amputation
  • Orthopedic disorders exacerbated by physical activity
  • Decreased mental capacity
  • Patients who live outside of Maryland will not be included in the study.

结局指标

主要结局

Post kidney transplant mortality

时间窗: 1 year

1 year patient survival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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