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

NCT03987997 | Unknown

• 2 other identifiers: 2016RC022018-A01330-55
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Weakness, Muscle

Keywords

Intensive Care Units; Critical Illness; Rehabilitation; Muscle atrophy; Muscle weakness; Cyclo-ergometer; Electrical muscle stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Change of pedalling symmetry right/left

  at day 0, then every 7 days (+/- 2 days) until ICU discharge (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 work variation of lower limb

  Every cyclo-ergometer session, 5 days on 7 (at least 6 months)

Study Arms (2)

Association electrical muscle stimulation with cyclo-ergometer

ACTIVE COMPARATOR

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

Cyclo-ergometer only

OTHER

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

Interventions

Early association of electrical muscle stimulation with cyclo-ergometer DEVICE

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

Association electrical muscle stimulation with cyclo-ergometer; Cyclo-ergometer only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Predicable duration of stay greater than or equal to 3 days

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'intruction des armées Clermont-Tonnerre

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Muscle Weakness; Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only one leg receives the electrical muscle stimulation, the leg which receives the electrical stimulation is randomized. An outcome assessor assess the outcome blindly.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Leg with electrical muscle stimulation and cycling versus leg with cycling only

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 17, 2019
• Study Start: August 9, 2018
• Primary Completion: November 26, 2021
• Study Completion: December 26, 2021
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)