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

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ClinicalTrials.gov Identifier: NCT03987997
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

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.


Condition or disease Intervention/treatment Phase
Weakness, Muscle Device: Early association of electrical muscle stimulation with cyclo-ergometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Leg with electrical muscle stimulation and cycling versus leg with cycling only
Masking: Single (Outcomes Assessor)
Masking Description: Only one leg receives the electrical muscle stimulation, the leg which receives the electrical stimulation is randomized. An outcome assessor assess the outcome blindly.
Primary Purpose: Prevention
Official Title: Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : November 26, 2021
Estimated Study Completion Date : December 26, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Emodepside

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.

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.




Primary Outcome Measures :
  1. Change of muscle mass of quadriceps assessed with ultrasonography [ Time Frame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) ]
    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


Secondary Outcome Measures :
  1. Change of muscle strength of lower limb assessed by dynamometry [ Time Frame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) ]
    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

  2. Change of pedalling symmetry right/left [ Time Frame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) ]
    Assessed with the cyclo-ergometer associated pic torque

  3. Change of power variation of lower limb [ Time Frame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months) ]
    Power variation of lower limb assessed with cyclo-ergometer

  4. Change of work variation of lower limb [ Time Frame: Every cyclo-ergometer session, 5 days on 7 (at least 6 months) ]
    Work variation of lower limb assessed with cyclo-ergometer



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987997


Locations
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France
Hôpital d'intruction des armées Clermont-Tonnerre Recruiting
Brest, France, 29200
Contact: Christophe GIACARDI, MD    +33 2 98 43 74 92    christophe.giacardi@intradef.gouv.fr   
Contact: Thibault BAUDIC, Intern    +33 683922914    thibaut.baudic@yahoo.fr   
Principal Investigator: Christophe GIACARDI, MD         
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées

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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT03987997     History of Changes
Other Study ID Numbers: 2016RC02
2018-A01330-55 ( Registry Identifier: IDRCB )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Direction Centrale du Service de Santé des Armées:
Intensive Care Units
Critical Illness
Rehabilitation
Muscle atrophy
Muscle weakness
Cyclo-ergometer
Electrical muscle stimulation

Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Emodepside
Antiparasitic Agents
Anti-Infective Agents