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临床试验/NCT03135210
NCT03135210已完成不适用

The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation

University of Minnesota2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年11月13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
4
试验地点
2
主要终点
Time to Ambulation

研究概览

简要总结

Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.

详细描述

The investigators are conducting this study to explore the impact of closed-chain leg exercise in individuals undergoing ECMO.

Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation. The investgators hypothesize that adding leg exercise will decrease time to ambulation.

Aim 2: To determine the impact of closed chain leg exercise on functional ability. The investigators hypothesize that adding leg exercise will improve functional outcomes when added to an existing early mobilization program.

Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The investigators hypothesize that hospital related outcomes will improve when leg exercise is added to an existing early mobilization program.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with refractory respiratory failure undergoing ECMO at the University of Minnesota Medical Center, Fairview.
  • Able to follow 3 out of 3 one-step commands via protocol.
  • Active Inpatient Physical Therapy Referral.
  • ECMO delivery is veno-venous with internal jugular catheter.

排除标准

  • Femoral catheter of any kind present
  • Veno-arterial ECMO set-up
  • Sedation such that self-consent is not attainable
  • Medical instability, as determined by primary critical care physician

结局指标

主要结局

Time to Ambulation

时间窗: Baseline, to day 45 if applicable

Time to ambulation is measured as the number of days required for the participant to regain the ability to walk without the need for any kind of assistance. The unit of measure is days.

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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