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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB : 2014-A00566-41 | Other Identifier | ANSM; Ministry of Health ; French government |
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Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.
We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical muscle stimulation and bicycling | Active Comparator | Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization) |
|
| Standard early passive/active rehabilitation | No Intervention | In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early electrical stimulation and early leg bicycling added to early standard rehabilitation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global muscle strength assessed by the MRC (Medical research Council, 1978) score | Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group | on the day of ICU discharge (+/- 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in thickness of the rectus femoris muscle of each thigh | Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day). | from inclusion to ICU discharge (+ / - 1 day) |
| Frequency of delirium in the ICU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Boulain, MD | Centre Hospitalier Régional d'Orléans, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional d'Orléans | Orléans | 45000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30043066 | Derived | Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592. |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001). |
| During ICU stay |
| Quality of life | Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire | 6 months after ICU discharge |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |