Effect of a Cycling Exercise on Restoration of Muscle Strength in Patients Undergoing Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of ventilator days
研究概览
简要总结
Prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. Muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. Emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. It has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. The aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.
详细描述
This prospective randomized study is being performed at the Department of Anesthesiology, Resuscitation and Intensive Care (CARIM) of the University Hospital Ostrava.
All mechanically ventilated patients are followed. At the time of weaning initiation, the randomization into two groups (the study (cycling) and control group) is performed. The physiotherapy will be carried out twice a day in both groups according to the mobility protocol. The cycling exercise is performed only in the study group, once a day. Before a patient is released from the ICU, a cycling test, dynamometry test will be performed on both groups.
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
盲法说明
This is an open-label study, no masking model is applied.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •ICU admission
- •Mechanically ventilated for more than 5 days
- •Indications for starting weaning
- •Informed consent for participation
排除标准
- •Inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness)
- •Encephalopathy (ischemic, traumatic)
- •Extreme obesity (body mass index ≥ 40)
- •Anticipated survival time ≤ 7 days
- •Patient height ≤ 1.5 m
- •More than 48 hours of mechanical ventilation outside of the department
研究组 & 干预措施
Cycling Exercise
Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.
干预措施: Cycling Exercise (Other)
Cycling Exercise
Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.
干预措施: Conventional Physiotherapy (Other)
Conventional Physiotherapy
Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Number of ventilator days
时间窗: 43 months
The influence of cycling exercises on the number of ventilator days will be assessed in the patients. The number of ventilator days will be compared in both groups of patients.
次要结局
- Muscle strength(43 months)