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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-09

Study Completion Date

2021-12-26

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.

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Detailed Description

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Conditions

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Weakness, Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Leg with electrical muscle stimulation and cycling versus leg with cycling only

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Only one leg receives the electrical muscle stimulation, the leg which receives the electrical stimulation is randomized. An outcome assessor assess the outcome blindly.

Study Groups

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Association electrical muscle stimulation with cyclo-ergometer

Randomized leg with receive electrical muscle stimulation of the quadriceps in addition to early mobilization of lower limbs with cyclo-ergometer.

Group Type ACTIVE_COMPARATOR

Early association of electrical muscle stimulation with cyclo-ergometer

Intervention Type DEVICE

Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.

Cyclo-ergometer only

This control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported)

Group Type OTHER

Early association of electrical muscle stimulation with cyclo-ergometer

Intervention Type DEVICE

Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.

Interventions

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Early association of electrical muscle stimulation with cyclo-ergometer

Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No