Coronavirus Infections
Conditions
Interventions
After PHASE 2, participants will be randomized into two groups, control (CG, n = 50, without exercise) and training by telerehabilitation (GT, n = 50). The exercise program will last for 12 weeks, wil
Behavioural
Sponsors
Universidade Estadual Paulista - UNESP
Universidade Federal de São Carlos - UFSCar
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: At least 100 adult patients (aged over 18 years), of both sexes, diagnosed with COVID19 in molecular biology exam, admitted (intensive care unit or infirmary) to referral hospitals in the state of São Paulo will be evaluated. According to the phases of the study, and for inclusion, volunteers must: PHASE 1 (to assess endothelial function and functional capacity): present hemodynamic and respiratory stability; not having the need for emergency medical care; not to be at imminent risk of death. The inability to express consent to participate in the study will not be considered an exclusion criterion, however, in this case, the informed consent form must be signed by the legal guardian. PHASES 2 and 3: not being pregnant; not be lactating. Patients with decompensated cardiovascular and/or pulmonary disease, and/or pacemaker users, and/or who have absolute contraindications for physical exercise (acute myocardial infarction; unstabilized unstabilized angina; uncontrolled cardiac arrhythmias with repercussion will not be included) hemodynamic; symptomatic severe aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolism or pulmonary infarction; acute myocarditis or pericarditis; acute aortic dissection).
Exclusion criteria
Exclusion criteria: Exclusion criteria will include: important hemodynamic and/or electrocardiographic changes during the cardiopulmonary stress test; need for hospital readmission; failure to meet 60% of scheduled interventions. Even if exclusion occurs during the phases, these patients will still be followed up by telephone, up to 12 months, to assess out-of-hospital outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional capacity: in Phase 1 (Hospital), patients are expected to have a significant decrease in functional capacity, assessed by the Duke Activity Status Index, Baecke questionnaire and handgrip strength (dynamometry); Phase 2 (30 days after hospital discharge): patients are expected to show a natural improvement in functional capacity, but still below what is considered ideal; Phase 3 (telerehabilitation): it is expected that patients in the physical training group show improvement in functional capacity when compared to those in the control group.;Pulmonary function: 30 days after hospital discharge (Phase 2), as a respiratory sequela, patients are expected to have a decreased pulmonary function (mainly decreased vital capacity), as assessed by spirometry. In Phase 3 (telerehabilitation), patients in the physical training group are expected to show improvement in lung function when compared to the control group.;Respiratory muscle strength: 30 days after hospital discharge (Phase 2), patients are expected to have respiratory muscle weakness, assessed by manovacuometry to obtain maximum inspiratory (PI) and expiratory (PE) pressures. In Phase 3 (telerehabilitation), patients in the physical training group are expected to show improvement in respiratory muscle strength (PI and PE) when compared to those in the control group.;Arterial stiffness: 30 days after hospital discharge (Phase 2), patients are expected to have some degree of arterial stiffness, reflecting the increased carotid-femoral pulse wave velocity (PWV). In Phase 3 (telerehabilitation), it is expected that patients in the physical training group have decreased arterial stiffness (reduced PWV) when compared to the control group.;Cardiac autonomic modulation: 30 days after hospital discharge (Phase 2), it is expected that patients worsen in cardiac autonomic modulation, with reduced heart rate variability (HRV), increased sympathetic indices (low frequency) and reduced indices parasympathetic (high f | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactAlessandro;Ariane Heubel;Viana
Universidade Federal de São Carlos - UFSCar;Universidade Estadual Paulista - UNESP
Outcome results
None listed