Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Global muscle strength assessed by the MRC (Medical research Council, 1978) score
研究概览
简要总结
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.
We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.
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
- 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
- •age over 18 yrs
- •expected length of stay in the ICU higher than 72 hours
- •motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview
排除标准
- •Opposition expressed by the patient, his/her legal representative or a member of his/her family
- •Pregnant woman
- •Resuscitated cardiac arrest before inclusion
- •Patient carrying a pacemaker or an implantable defibrillator
- •Patient under extracorporeal membrane oxygenation
- •Severe acute cerebral disease requiring deep sedation
- •Brain death
- •Guillain-Barré syndrome
- •Myasthenia gravis
- •Known Dementia than can affect the main endpoint assessment
- •Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
- •Unstable traumatic injuries of the spine
- •Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
- •Amputation of a lower limb at the trans-metatarsal level or higher
- •Inclusion in another interventional study with muscle strength assessment as the primary endpoint
- •Moribund patient
结局指标
主要结局
Global muscle strength assessed by the MRC (Medical research Council, 1978) score
时间窗: on the day of ICU discharge (+/- 1 day)
Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group
次要结局
- Frequency of delirium in the ICU.(During ICU stay)
- Changes in thickness of the rectus femoris muscle of each thigh(from inclusion to ICU discharge (+ / - 1 day))
- Quality of life(6 months after ICU discharge)