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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01330-55 | Registry Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Cyclo-ergometer only | Other | This control group correspond to the leg which don't receive electrical muscle stimulation (as usually supported) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early association of electrical muscle stimulation with cyclo-ergometer | Device | Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'intruction des armées Clermont-Tonnerre | Recruiting | Brest | 29200 | France |
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Leg with electrical muscle stimulation and cycling versus leg with cycling only
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Only one leg receives the electrical muscle stimulation, the leg which receives the electrical stimulation is randomized. An outcome assessor assess the outcome blindly.
| 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) |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D016638 | Critical Illness |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
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