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Column | Value |
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Trial registration number | RBR-8d82mtz |
Full text link
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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First author
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
anacochar@hotmail.com |
Registration date
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2022-04-27 |
Recruitment status
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Recruiting |
Study design
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
unclear |
Study aim
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Will be selected for this study, individuals between 18 and 60 years, both sexes, who had a positive diagnosis for COVID-19, confirmed by the RT-PCR test or who were diagnosed using clinical criteria associated with radiological image, computed tomography, D-dimer , presenting a picture compatible with COVID-19, hemodynamic stability and who presented a decrease in oxygen saturation. In addition, patients who did not progress to mechanical ventilatory support and who, after the active viral period, evolved with sequelae caused by the disease will be considered. |
Exclusion criteria
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Participants will be excluded from the study if they present lowered level of consciousness or who are unable to obey simple commands, acute decline in neurological status, hypotension (MAP less 60 mmHg) or hypertension (MAP up to 120 mmHg), tetany, continuous renal replacement therapy, Body Mass Index - BMI up to 30 kg/m2, previous thoracic surgery, chest instability, presence of chest tube, with complications from other serious underlying diseases, such as decompensated diabetes, obstructive and restrictive pulmonary disease, coronary heart disease, stroke with sequelae, fractures with sequelae, cancer, osteoporosis, immunodeficiency, fever, use of illicit drugs, congenital malformations, deformities, rejection of the treatment and any clinical alteration that makes the handling and execution of the technique unfeasible. |
Number of arms
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Ana Paula Cochar |
Inclusion age min
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
60 |
Countries
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Brazil |
Type of patients
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
0 |
primary outcome
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
The hypothesis of the present study is that patients with sequelae after COVID-19 allocated in the experimental group (physio + BMT) show an acute improvement in lung function (eg; increase in maximal expiratory and inspiratory pressures and maximal expiratory flow) and in function cardiovascular (eg; decreased heart rate and 2% to 3% increase in oxygen saturation) after the treatment period when compared to the control group (physio+sham). |
Notes
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Phase
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not reported |
Arms
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "osteopatic manipulative treatment", "treatment_id": 2463, "treatment_name": "Bmt", "treatment_type": "Rehabilitation", "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"}] |