Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization (AFMPR)
Primary Purpose
Weakness, Muscle
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early association of electrical muscle stimulation with cyclo-ergometer
Sponsored by
About this trial
This is an interventional prevention trial for Weakness, Muscle focused on measuring Intensive Care Units, Critical Illness, Rehabilitation, Muscle atrophy, Muscle weakness, Cyclo-ergometer, Electrical muscle stimulation
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)
Sites / Locations
- Hôpital d'intruction des armées Clermont-TonnerreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Association electrical muscle stimulation with cyclo-ergometer
Cyclo-ergometer only
Arm Description
Randomized leg with receive electrical muscle stimulation of the quadriceps in addition to early mobilization of lower limbs with cyclo-ergometer.
This control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change of pedalling symmetry right/left
Assessed with the cyclo-ergometer associated pic torque
Change of power variation of lower limb
Power variation of lower limb assessed with cyclo-ergometer
Change of work variation of lower limb
Work variation of lower limb assessed with cyclo-ergometer
Full Information
NCT ID
NCT03987997
First Posted
May 13, 2019
Last Updated
June 14, 2019
Sponsor
Direction Centrale du Service de Santé des Armées
1. Study Identification
Unique Protocol Identification Number
NCT03987997
Brief Title
Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
Acronym
AFMPR
Official Title
Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
November 26, 2021 (Anticipated)
Study Completion Date
December 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weakness, Muscle
Keywords
Intensive Care Units, Critical Illness, Rehabilitation, Muscle atrophy, Muscle weakness, Cyclo-ergometer, Electrical muscle stimulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Leg with electrical muscle stimulation and cycling versus leg with cycling only
Masking
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.
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Association electrical muscle stimulation with cyclo-ergometer
Arm Type
Active Comparator
Arm Description
Randomized leg with receive electrical muscle stimulation of the quadriceps in addition to early mobilization of lower limbs with cyclo-ergometer.
Arm Title
Cyclo-ergometer only
Arm Type
Other
Arm Description
This control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported)
Intervention Type
Device
Intervention Name(s)
Early association of electrical muscle stimulation with cyclo-ergometer
Intervention Description
Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.
Primary Outcome Measure Information:
Title
Change of muscle mass of quadriceps assessed with ultrasonography
Description
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
Time Frame
at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Secondary Outcome Measure Information:
Title
Change of muscle strength of lower limb assessed by dynamometry
Description
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
Time Frame
at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Title
Change of pedalling symmetry right/left
Description
Assessed with the cyclo-ergometer associated pic torque
Time Frame
at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Title
Change of power variation of lower limb
Description
Power variation of lower limb assessed with cyclo-ergometer
Time Frame
at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
Title
Change of work variation of lower limb
Description
Work variation of lower limb assessed with cyclo-ergometer
Time Frame
Every cyclo-ergometer session, 5 days on 7 (at least 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Hôpital d'intruction des armées Clermont-Tonnerre
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe GIACARDI, MD
Phone
+33 2 98 43 74 92
Email
christophe.giacardi@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Thibault BAUDIC, Intern
Phone
+33 683922914
Email
thibaut.baudic@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Christophe GIACARDI, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
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