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The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.
Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electrical muscle stimulation | Experimental | conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction |
|
| conventional physical therapy | Active Comparator | conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrical muscle stimulation | Device | electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction |
| Measure | Description | Time Frame |
|---|---|---|
| intensive care unit acquired weakness | Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness | at awakening of the subject, an average of 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| muscle strength | Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). | at awakening of the subject, an average of 8 days |
| muscle mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2016 | Dec 3, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2016 | Dec 3, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D012772 | Shock, Septic |
| D018908 | Muscle Weakness |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D007239 | Infections |
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|
| conventional physical therapy | Procedure | conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al |
|
ultrasonography |
| at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days |
| maximum inspiratory pressure | maximum inspiratory pressure | at awakening of the subject, an average of 8 days |
| days of mechanical ventilation | number of days wirh mechanical ventilation | an average of 11 days |
| Number of Participants with weaning failure | Number of Participants who presented reintubation | 48 hours post extubation day |
| days of ICU stay | number of days in ICU | at ICU discharge, an average of 18 days |
| mortality at 28 days | mortality | at 28 days post ICU admission |
| gait ability at hospital discharge | presence or not of gait ability | at hospital discharge, an averange of 3 months |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |