| Trial registration number
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ISRCTN96796566 |
Full text link
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN96796566
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First author
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr. Laura Piejko
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Contact
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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l.piejko@awf.katowice.pl
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Registration date
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-21
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Recruitment status
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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1. COVID-19 (positive RT-PCR test and interstitial pneumonia observed in CT scan), 2. Clinically severe interstitial pneumonia with respiratory failure / pre ARDS (MEWS classification of 3-4 points), 3. <90-92% SpO2 at rest 4. Consent to participate in the study.
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Exclusion criteria
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Unstable ischemic heart disease, 2. Significant haemodynamic aortic stenosis, 3. Valve defects requiring surgical correction, 4. Complex ventricular arrhythmias, 5. Implantation of a cardiac pacemaker, cardioverter-defibrillator (ICD) and cardiac re-synchronizing pacemaker (CRT), 6. Acute myocarditis or pericarditis, 7. Uncontrolled hypertension, 8. End-stage renal disease and liver failure disease, 9. Lack of consent to participate in the study.
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Number of arms
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
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Inclusion age min
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Poland
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Type of patients
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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40
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primary outcome
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Quality of life in COVID-19 patients assessed with the Polish version of the CAT questionnaire at baseline and after treatment.
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Notes
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 28, 2021, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 879, "treatment_name": "Neuromuscular electrical stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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