Weakness, MuscleAFMPRNCT03987997
Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
A study testing Early association of electrical muscle stimulation with cyclo-ergometer in people with Weakness, Muscle, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Weakness, Muscle
- What is being tested?
- Early association of electrical muscle stimulation with cyclo-ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2018to 26 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital d'intruction des armées Clermont-Tonnerre
Brest, 29200
Christophe GIACARDI, MD, +33 2 98 43 74 92, christophe.giacardi@intradef.gouv.fr
Thibault BAUDIC, Intern, +33 683922914, thibaut.baudic@yahoo.fr
About this study
Official title: 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.
- Conditions
- Weakness, Muscle
- Being tested
- Early association of electrical muscle stimulation with cyclo-ergometer
- Keywords
- Intensive Care Units, Critical Illness, Rehabilitation, Muscle atrophy, Muscle weakness, Cyclo-ergometer, Electrical muscle stimulation
- Medical subject headings
- Muscle Weakness, Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early association of electrical muscle stimulation with cyclo-ergometerDevice
Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Device: Early association of electrical muscle stimulation with cyclo-ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: Every cyclo-ergometer session, 5 days on 7 (at least 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start9 Aug 2018
- Primary completion26 Nov 2021 (estimated)
- Study completion26 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weakness, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Leg with electrical muscle stimulation and cycling versus leg with cycling only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987997
- Sponsor's protocol ID
- 2016RC02
- Other IDs
- 2018-A01330-55
- Acronym
- AFMPR
- Status last verified
- Jun 2019
- First submitted
- 13 May 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization
- ClinicalTrials.gov ID
- NCT03987997
- Acronym / sponsor ID
- AFMPR / 2016RC02
- Conditions
- Weakness, Muscle
- Keywords
- Intensive Care Units, Critical Illness, Rehabilitation, Muscle atrophy, Muscle weakness, Cyclo-ergometer, Electrical muscle stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 26 Nov 2021 (estimated)
- Study completion
- 26 Dec 2021 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Leg with electrical muscle stimulation and cycling versus leg with cycling only
| Arm | Type | Receives |
|---|---|---|
| Association electrical muscle stimulation with cyclo-ergometer | Active comparator | Device: Early association of electrical muscle stimulation with cyclo-ergometerRandomized leg with receive electrical muscle stimulation of the quadriceps in addition to early mobilization of lower limbs with cyclo-ergometer. |
| Cyclo-ergometer only | Other | Device: Early association of electrical muscle stimulation with cyclo-ergometerThis control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early association of electrical muscle stimulation with cyclo-ergometerEarly electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU. | Device | Association electrical muscle stimulation with cyclo-ergometer, Cyclo-ergometer only |
Primary outcome
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
4 secondary outcomes
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)
Change of pedalling symmetry right/left
Time frame: at day 0, then every 7 days (+/- 2 days) until ICU discharge (at least 6 months)
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)
Change of work variation of lower limb
Time frame: Every cyclo-ergometer session, 5 days on 7 (at least 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hôpital d'intruction des armées Clermont-Tonnerre
Brest, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early association of electrical muscle stimulation with cyclo-ergometer in people with Weakness, Muscle, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.