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| Column | Value |
|---|---|
| Trial registration number | NCT05450120 |
|
Full text link
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
2022-07-08 |
|
Recruitment status
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: subjects admitted in icu for >72hs, undergoing orotracheal intubation and on mechanical ventilation for >48hs, with a diagnosis of acute respiratory distress syndrome (ards) according to berlin definition secondary to covid-19, with shock or organ failure, according to the diagnosis and treatment protocol for novel coronavirus pneumonia (7th interim edition) guideline, and clinical stability: mean arterial pressure < 60 mmhg; heart rate >60 and <120 beats/minute; respiratory rate <30 breaths/minute; oxygen saturation ≥ 92%; fraction of inspired oxygen (fio2) ≤0.6; absence of vasopressor dose increase absence of dysrhythmia (except for chronic atrial fibrillation); controlled sepsis; hemoglobin (hb) > 8g m/d, plaquettes >20.000, glucemia >70 e <180; without nmbs |
|
Exclusion criteria
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
patients with movement resistance walking without assistance before the icu (except using a cane) cognitive impairment before acute illness signs of intracranial hypertension, neuromuscular disease (myasthenia gravis, amyotrophic lateral sclerosis, guillain-barré) and stroke; hip fracture, unstable cervical spine, or pathological fracture prior hospitalization (30 days before icu) readmission to the icu, within the current hospitalization presence of an implanted cardiac pacemaker or defibrillator, pregnancy, acute myocardial infarction and, for the experimental group (eg), against indications for nmes (deep vein thrombosis, skin lesions, rhabdomyolysis). |
|
Number of arms
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Universidade Federal de Sao Carlos |
|
Inclusion age min
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Brazil |
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Type of patients
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
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Severity scale
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
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Total sample size
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
88 |
|
primary outcome
Last imported at : Aug. 9, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Functional independence;Skeletal muscle strength |
|
Notes
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 454, "treatment_name": "Electrical stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2384, "treatment_name": "Rehabilitation clinical and functional", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}] |