Clinical trial NCT03987997: Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
Official title: Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weakness, Muscle
Keywords: Intensive Care Units
Critical Illness
Rehabilitation
Muscle atrophy
Muscle weakness
Cyclo-ergometer
Electrical muscle stimulation
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Leg with electrical muscle stimulation and cycling versus leg with cycling only
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change of muscle mass of quadriceps assessed with ultrasonography
timeFrame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Secondary outcomes:
measure: Change of muscle strength of lower limb assessed by dynamometry
timeFrame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
measure: Change of pedalling symmetry right/left
timeFrame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
measure: Change of power variation of lower limb
timeFrame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
measure: Change of work variation of lower limb
timeFrame: Every cyclo-ergometer session, 5 days on 7 (at least 6 months)
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital d'intruction des armées Clermont-Tonnerre
Study officials:
References: