COVID-19
Conditions
Interventions
This is a three-arm, double-blind, randomized controlled clinical study. The initial assessment will be divided into two days, on the first day sociodemographic and clinical information, level of phys
E02.760.169.063.500.387
Sponsors
Faculdade de Ciências Socias Aplicadas
Fundação Pedro Américo
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both genders; who prove two negative rt-PCR tests for COVID-19 carried out at the place of hospitalization following criteria for hospital discharge of severely ill patients (CDC, 2021); who developed the severe form of the disease measured by the clinical progression scale proposed by the World Health Organization (WHO) (MARSHALL et al., 2020); who were hospitalized and admitted to the intensive care unit (ICU), intermediate care unit or ward, undergoing invasive (via orotracheal tube or tracheostomy) or non-invasive mechanical ventilation and oxygen therapy (high-flow nasal catheter or mask with reservoir bag ); and who were discharged from hospital at least 30 days before the start of rehabilitation
Exclusion criteria
Exclusion criteria: Participants who confirm reinfection will be excluded from the study; rehospitalization and hospitalization (MARSHALL et al., 2020); hemodynamically unstable patients (uncontrolled blood pressure and heart rate); unstable medical conditions, for example cardiovascular and pulmonary disorders (arrhythmias, decompensated atrial fibrillation, pulmonary thromboembolism, acute heart failure, pulmonary congestion, acute myocardial infarction and stroke); musculoskeletal and neurological conditions that affect mobility (paraplegia, tetraplegia, amputations and severe joint deformities); or cognitive and dementia conditions that make it impossible to answer the questionnaires and perform the exercise protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of a rehabilitation program that is based on physical exercises for individuals who have survived COVID-19 and developed the severe stage of the disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify the sociodemographic characteristics of the participants, including gender, age, marital status, education, number of people they live with, and the number of rooms in their house. ;Verify the clinical characteristics of COVID-19 survivors, such as the severity of the disease, length of hospital stay, interventions during the course of the disease (e.g., drug treatment, oxygen supply - catheter or mechanical ventilation), presence of symptoms after hospital discharge, and pre-existing comorbidities.;Identify and quantify cardiac, pulmonary, neuromuscular, functional and quality-of-life sequelae of COVID-19 survivors;Evaluate the effectiveness of the rehabilitation program in the following outcomes: cardiorespiratory fitness and exercise tolerance; capacity and functional status; Peripheral and respiratory muscle strength; Mobility and diaphragmatic thickness; Quadriceps thickness; Neuromuscular fitness and dynamic balance; Quality of life and body composition.;Determine which group (with and without the addition of inspiratory muscle training) showed greater gains in all investigated outcomes.;Identify the effectiveness of the long-term rehabilitation program and maintenance of the benefits achieved through a six-month follow-up and 12 months from the end of the rehabilitation protocols.;Compare and identify potential associations between variables. | — |
Countries
Brazil
Contacts
Public ContactNailton ;Ester Laura Albuquerque Filho;Cordeiro Oliveira Costa
Universidade do Estado do Rio Grande do Norte;Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
Outcome results
None listed