Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization

Study Overview
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Brief Summary
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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.

Official Title
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Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization

Conditions
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Weakness, Muscle

Intervention / Treatment
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* Device: Early association of electrical muscle stimulation with cyclo-ergometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Leg with electrical muscle stimulation and cycling versus leg with cycling only
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Association electrical muscle stimulation with cyclo-ergometer<br>Randomized leg with receive electrical muscle stimulation of the quadriceps in addition to early mobilization of lower limbs with cyclo-ergometer. | Device: Early association of electrical muscle stimulation with cyclo-ergometer<br>* Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.<br>|
| Other: Cyclo-ergometer only<br>This control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported) | Device: Early association of electrical muscle stimulation with cyclo-ergometer<br>* Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle mass of quadriceps assessed with ultrasonography | 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 | at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle strength of lower limb assessed by dynamometry | Muscle strength of lower limb assessed by dynamometry. 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 | at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) | 
| Change of pedalling symmetry right/left | Assessed with the cyclo-ergometer associated pic torque | at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) | 
| Change of power variation of lower limb | Power variation of lower limb assessed with cyclo-ergometer | at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) | 
| Change of work variation of lower limb | Work variation of lower limb assessed with cyclo-ergometer | Every cyclo-ergometer session, 5 days on 7 (at least 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Units, Critical Illness, Rehabilitation, Muscle atrophy, Muscle weakness, Cyclo-ergometer, Electrical muscle stimulation