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

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

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.

Study Overview

• Status: Unknown
• Conditions: Weakness, Muscle
• Intervention / Treatment: Device: Early association of electrical muscle stimulation with cyclo-ergometer

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • Hôpital d'intruction des armées Clermont-Tonnerre
    • Contact: Christophe GIACARDI, MD; Phone Number: +33 2 98 43 74 92; Email: christophe.giacardi@intradef.gouv.fr
    • Contact: Thibault BAUDIC, Intern; Phone Number: +33 683922914; Email: thibaut.baudic@yahoo.fr
    • Principal Investigator: Christophe GIACARDI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Early association of electrical muscle stimulation with cyclo-ergometer; Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.
Other: Cyclo-ergometer only; 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; Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Anticipated): November 26, 2021
• Study Completion (Anticipated): December 26, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Critical Illness; Intensive Care Units; Muscle atrophy; Muscle weakness; Cyclo-ergometer; Electrical muscle stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 2016RC02; 2018-A01330-55 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No