Acute Post-COVID-19 syndrome
Conditions
Interventions
This is a randomized clinical trial. Patients will be summoned to the school clinic with a scheduled day and time, at which time the randomization envelope will be opened, carried out by the randomiza
Sponsors
Unifacisa
Universidade Federal de São Carlos- UFSCar
Universidade Estadual da Paraíba
Universidade Federal do Rio grande do Norte
Eligibility
Inclusion criteria
Inclusion criteria: Patients who prove RT-PCR negative for COVID-19 performed at the place of hospitalization following criteria for hospital discharge; who developed a moderate to severe form of the disease; who were hospitalized and admitted to an intensive care unit (ICU) will be included in the study, intermediate care unit or ward; undergoing invasive (via orotracheal tube or tracheostomy) or non-invasive mechanical ventilation and oxygen therapy (high-flow nasal atheter or mask with reservoir bag); who were discharged at least 30 days before the start of rehabilitation.
Exclusion criteria
Exclusion criteria: Participants who certify reinfection, rehospitalization and hospital admission will be excluded from the study; hemodynamically unstable patients (uncontrolled blood pressure and heart rate); unstable medical conditions (e.g., cardiovascular and pulmonary disorders - arrhythmias, decompensated atrial fibrillation, pulmonary thromboembolism, acute heart failure, pulmonary congestion, acute myocardial infarction and stroke); with severe pulmonary, cardiac or functional sequelae that require a more complete rehabilitation program, or cognitive conditions; dementia that makes it impossible to answer the questionnaires; finally those with confirmed mental disorders and who require sychological intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate functional capacity by performing the 6-minute Walk Test (6MWT), with the aim of measuring the greatest distance that the individual is able to walk on a flat path, with the speed being of their choice, in a period of time than 6 minutes. The cardiorespiratory variables HR, RR, dyspnea using the Borg scale and SatO2 will be measured and verified during the test. The patient will be instructed to walk at their own pace, in a corridor, with a flat surface and cover the greatest tolerable distance for six minutes, at a speed chosen by themselves, being authorized to interrupt walking in case of extreme fatigue or any other symptom. ; Assessing functional status will be assessed using a recently published scale to identify relevant aspects of daily life during follow-up after infection, the Post-COVID-19 Functional Status Scale. The scale is ordinal, containing six levels ranging from zero (“no symptoms”) to five (“death”), and comprises the entire range of functional outcomes, focusing on limitations in tasks and activities of daily living, both at home and work/study, as well as lifestyle changes. The scale assesses the domains of “constant care”, “basic activities of daily living (ADL)”; “instrumental activities of daily living (IADL)”; “participation in usual social roles” and “symptom checklist”. A reduction in the functionality and functional capacity of these individuals is expected due to the sedentary lifestyle associated with complications caused by the pathology under study; To subjectively assess the sensation of dyspnea in daily life using the Medical Research Council (MRC) scale, validated in Portuguese. The scale consists of 5 items, with a score from 0 to 4, from which the patient chooses the item that corresponds to how much dyspnea limits their daily life. The patient will report their subjective degree of dyspnea choosing a value between 1 and 5: 1 (only suffers from shortness of breath during intense exercise), 2 (suffers from shortness o | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess quality of life using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire, previously validated in its Brazilian version. The questionnaire consists of 36 items and assesses quality of life in eight domains: functional capacity (10 items), physical aspects (four items), pain (two items), general health status (five items), vitality (four items ), social aspects (two items), emotional aspects (three items) and mental health (five items) and a comparative question about the current perception of health and one year ago. The score for each domain varies from 0 (zero) to 100 (one hundred) points, with zero being the worst score and 100 being the best; Assess respiratory muscle strength using an analogue vacuum gauge connected to a pressure line, mouthpiece with filter and connector with a 2 mm diameter leak hole. Volunteers will be positioned seated, feet flat on the floor, spine erect, without support for the upper limbs, using a nose clip and will be instructed to perform the MIP maneuver from Residual Volume (RV) to total lung capacity (TLC), performing a maximum and sustained inspiration, and the MEP maneuver from the TLC performing a maximum and sustained expiration. A minimum of 3 maneuvers will be performed, with a one-minute interval between them, with 10% reproducibility between maneuvers. To record the data, the best of the three maneuvers will be adopted. The calculation of predicted MIP and MEP will be carried out for each individual using an equation specific to the Brazilian population. We expect to find a reduction in strength in these individuals and a subsequent increase in the biofeedback group; Assess dynamic balance using the “Timed Up and Go” (TUG) test. This test assesses the individual's level of balance and mobility, measuring, in seconds, the time taken by the volunteer to get up from a chair, without the help of their arms, walk three meters, turn around and come back. At the beginning of the test, the volun | — |
Countries
Brazil
Contacts
Public ContactAna Tereza Sales
Universidade Estadual da Paraíba
Outcome results
None listed