Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change of muscle mass of quadriceps assessed with ultrasonography
研究概览
简要总结
Muscles atrophy and weakness are common in intensive care units, their origin is multifactorial. Passive then active mobilization with cyclo-ergometer have shown to improve functional abilities and limit muscle weakness among intensive care unit patients. Electrical muscle stimulation should limit the atrophy and muscle weakness in intensive care unit associated with early mobilization.
This study aims to compare the association early cyclo-ergometer mobilization with electrical muscle stimulation versus cyclo-ergometer mobilization only to prevent muscle atrophy and weakness in intensive care unit.
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)
盲法说明
Only one leg receives the electrical muscle stimulation, the leg which receives the electrical stimulation is randomized. An outcome assessor assess the outcome blindly.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated to a social security scheme
- •Patient hospitalized in intensive care unit for medical or surgical reasons, under assisted ventilation (invasive, non-invasive ventilation or oxygen-therapy at high speed via the Optiflow(r) system delivering a flow between 30 and 60 L.min and a FiO2 between 30 and 100%)
- •State of the patient deemed stable buy the doctor responsible for the care and allowing the action of the physiotherapist (acts on medical prescription)
- •Age more than 18 years old (major patient) and less than 75 years old
- •Duration of mechanical ventilation (invasive or not) less than or equal to 72 hours at the beginning of the inclusion
- •Predicable duration of stay greater than or equal to 3 days
排除标准
- •Impossibility to know the consent of the patient, his legal representative or the person of trust
- •Patient under safeguard of justice, tutorship or curatorship
- •Legionnaire not rectified
- •Cardiac stimulator or defibrillator
- •Cardiorespiratory state clinically not compatible withe early mobilization
- •Neurological problems: intracranial pressure > 20 mmHg, presence of ICU acquired neuropathy, pre-existing diagnosis of neuromuscular disease (MS, ALS...), acute stroke, epilepsy
- •Orthopedic problems: even partial amputation of a lower limb, unstable fracture, suspicion of fracture, non-fixed spinal cord injury, use of a technique that does not allow to comply with postoperative surgical instructions (range of motion, discharge...), untreated deep vein thrombosis, traumatic sequelae to the origin of disabling manifest muscle weakness of a lower limb at admission
- •Dermatological problems: severe lesions or complex dressing in the lower limbs
- •Morphological criteria : size < 1.5m, BMI > 35
- •Confirmed psychiatric illness or severe agitation
- •Abdominal surgery without protection by compression belt (medical prescription), or too fragile (medical opinion)
- •Pregnant or lactating women (postpartum is not an exclusion criterion)
- •Patients over 75 years old
- •Hemiplegia / sequential hemiparesis
- •Impossibility to practice electrostimulation on at least one lower limb (manifest muscle weakness of a lower limb at admission (e. g. related to a traumatic sequelae)
结局指标
主要结局
Change of muscle mass of quadriceps assessed with ultrasonography
时间窗: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Muscle mass of quadriceps assessed by ultrasonography. The member who receives the cyclo-ergometer mobilization alone serves as a control for the member who receives the mobilization by cyclo-ergometer and electrical muscle stimulation
次要结局
- Change of work variation of lower limb(Every cyclo-ergometer session, 5 days on 7 (at least 6 months))
- Change of power variation of lower limb(at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months))
- Change of pedalling symmetry right/left(at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months))
- Change of muscle strength of lower limb assessed by dynamometry(at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months))