Trial registration number
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IRCT20201012049010N1 |
Full text link
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51591
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First author
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Mohammadali emamjomeh
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Contact
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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research.dpt@qums.ac.ir
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Registration date
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-12
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Recruitment status
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Factorial
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Masking
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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≥ 18 years old
Patients with definitive diagnosis of Covid-19
Hospitalization in non-intensive care unit
dyspnea according to the patient
O2-saturation <93% recorded by a pulse oximeter.
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Exclusion criteria
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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History of lung diseases (under treatment)
History of kidney diseases (under treatment)
History of heart diseases
history of allergy to latex or balloon material
Any case of prohibition from Intense aerobic activity by a physician
the need for hospitalization in intensive care units(ICU or CCU).
Pregnancy
History of neurological diseases
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Number of arms
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Qazvin University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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90
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primary outcome
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Intensity of dyspnea at rest
Intensity of dyspnea after 50 meters of walking with pulse oximeter
Oxygen saturation of arterial blood without oxygen therapy
Arterial blood oxygen saturation with oxygen therapy
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Notes
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Not reported
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Arms
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 177, "treatment_name": "Balloon-blowing", "treatment_type": "Respiratory support", "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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