跳至主要内容
临床试验/NCT00695383
NCT00695383已完成不适用

Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery

KU Leuven1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2005年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
90
试验地点
1
主要终点
six-minute walking distance

研究概览

简要总结

This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

详细描述

Inactivity during prolonged bed rest leads to muscle dysfunction. Muscle function decreases even faster in ICU patients due to inflammation, pharmacological agents (corticosteroids, muscle relaxants, neuromuscular blockers, antibiotics), and the presence of neuromuscular syndromes, associated with critical illness. A recent recommendation document advices to start early with active and passive exercise in critically ill patients. However, no evidence is available concerning the feasibility of an early muscle training intervention in the acute ICU phase when patients are still under sedation. A rather new method to train bed-bound patients is the use of a bedside cycle ergometer. This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

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

性别
All
接受健康志愿者
否

入选标准

  • •ICU stay > 5 days
  • •Expected prolonged stay of at least 7 more days
  • •Cardiorespiratory status that allows at least passive exercise therapy

排除标准

  • •Persistent or progressive neurological or (neuro)muscular disease
  • •Coagulation disorders (INR > 1.5, [BP] < 50000/mm³)
  • •Intracranial pressure > 20 mmHg
  • •Psychiatric disorders or severe confusion

研究组 & 干预措施

1

Experimental

干预措施: Bedside cycle exercise therapy (Behavioral)

2

Active Comparator

干预措施: Standard physiotherapy program (Behavioral)

结局指标

主要结局

six-minute walking distance

时间窗: hospital discharge

次要结局

  • quadriceps force(ICU discharge and hospital discharge)
  • functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)(ICU discharge and hospital discharge)

研究者

发起方
KU Leuven
申办方类型
Other

研究点 (1)

Loading locations...

相似试验