Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
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
干预措施: Bedside cycle exercise therapy (Behavioral)
2
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)
