Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Walking test distance at six minutes
研究概览
简要总结
Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.
详细描述
Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.
For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.
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
- Single (Outcomes Assessor)
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
- •Criteria of functional independence before hospital admission (Barthel scale > 70 points).
- •Invasive mechanical ventilation < 72 hours.
- •Signed informed consent.
排除标准
- •Neuromuscular disease (peripheric or central neurologic disorder).
- •Presumed fatal evolution in 48 hours.
- •Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
- •Admission due to cardiac arrest.
- •Pregnancy.
- •Thrombopenia less than 50.
- •Severe agitation.
- •Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
- •Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.
研究组 & 干预措施
Cycle ergometer physiotherapy
15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
干预措施: Cycle ergometer physiotherapy (Procedure)
Conventional physiotherapy
30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit
干预措施: Conventional physiotherapy (Procedure)
结局指标
主要结局
Walking test distance at six minutes
时间窗: At hospital discharge, with an expected average of 4 weeks after hospital admission
Basic activities of daily living score (BADL)
时间窗: At 28 days after hospital discharge, that is an expected average of 8 weeks
Short Form-36 Health Survey (SF-36), physical functioning section
时间窗: At 28 days after hospital discharge, that is an expected average of 8 weeks
次要结局
- ICU mobilization scale(During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge)
- Presence of intensive care acquired paresis (Medical Research Council score < 48 points)(During ICU admission and ICU discharge, with an expected average of 2 weeks)
- Lung Functional Testing(At the end of hospital stay, with an expected average of 5 weeks)
- Basic activities of daily living score (BADL)(At 7 days and at 6 months after hospital discharge, that is up to 1 year)
- Isometric quadriceps force (N/kg)(During ICU admission, with an expected average of 2 weeks)
- Walking test distance at six minutes(At 28 days and at 6 months after hospital discharge, that is up to 1 year)
- Short Form-36 Health Survey (SF-36), physical functioning section(At 7 days and at 6 months after hospital discharge, that is up to 1 year)
研究者
Gemma Rialp
M.D.
Hospital Son Llatzer