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Trial - NCT04595097


Column Value
Trial registration number NCT04595097
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04595097

First author
Last imported at : April 5, 2023, 8 p.m.
Source : ClinicalTrials.gov

Vinicius Zacarias Maldaner da silva

Contact
Last imported at : April 5, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-20

Recruitment status
Last imported at : April 5, 2023, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: to be eligible, participants must be: - over 18 years of age - confirmed covid-19 diagnosis - individuals that required hospitalization and either i) non-invasive respiratory support (cpap, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment.

Exclusion criteria
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- pregnancy - dependence on others to perform activities of daily living during the month prior to the current icu admission (gait aids are acceptable) - documented cognitive impairment - proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including icu acquired weakness) - severe neurological disease - death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Escola Superior de Ciencias da Saude

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 16, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

138

primary outcome
Last imported at : May 12, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Cardiopulmonary Exercise Testing Measurements

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 657, "treatment_name": "Inspiratory muscle training", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 657, "treatment_name": "Inspiratory muscle training", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]