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Effect of exercise training on the quality of life and overall health in children and adolescents after COVID-19 and Multisystem Inflammatory Syndrome in children

Grant number: 21/02742-0
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): March 01, 2022
Effective date (End): June 30, 2024
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal researcher:Bruno Gualano
Grantee:Camilla Astley Amaral Pedroso
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Coronavirus Disease 2019 (COVID-19), a disease caused by SARS-CoV-2, has shown low infection rates in the pediatric population. Children and adolescents with COVID-19 may have persistent inflammation, with isolated or concomitant lesions on various organs. Although we do not know the prolonged effects of this condition on the organism, it is assumed that COVID-19 prospectively affects the physical and mental health of this population. The Multisystemic Inflammatory Syndrome in Children (MIS-C) temporarily associated with COVID-19 is even more severe and presents important cardiac manifestations such as myocardial dysfunction, Myocarditis and affects coronary arteries with echocardiographic signs of Vasculitis, dilation and/or Aneurysms. Bearing in mind that children and adolescents with chronic diseases are generally hypoactive, and the measures to avoid the spread of COVID-19 have significantly increased sedentary behavior and physical inactivity in the general population, it is necessary to provide interventions aimed to improve physical and mental health, as well as investigating the possible effects of an exercise training program on pediatric patients surviving from COVID-19. Due to the scarcity of information in this subject, we will conduct two studies. Study 1 will be a randomized clinical trial composed of 40 patients diagnosed with COVID-19. Study 2 will have a quasi-experimental design composed of 10 patients diagnosed with MIS-C. Both will have the same outcomes and intervention. In addition, patients with MIS-C will perform a clinical investigation for cardiac parameters of inflammation using the [18 F] FDG PET technique and myocardial perfusion and Myocarditis using the [13N] PET technique. The primary objective of this study will be the effect of the exercise training program on health-related quality of life. Secondary objectives are the effects of exercise training on body composition and bone metabolism, physical activity levels, functional capacity, cardiorespiratory and pulmonary capacity, endothelial function and levels of inflammatory cytokines. Methods: This is a randomized clinical trial and a quasi-experimental trial that will include a convenience sample with 40 children and adolescents who recovered from COVID-19 and 10 with MIS-C, treated at Hospital das Clínicas, Universidade de São Paulo (HC-FMUSP). The inclusion criteria as the following: a) diagnosed with COVID-19 MIS-C in 2020 and 2021; b) confirmation of infection by SARS-CoV-2 (RT-PCR in real time or by antibody test); c) age at diagnosis up to 7 to 18 years old and d) previously healthy individual or with some pre-existing chronic condition. This study is part of an institutional project that is under development at HC-FMUSP, in which include projects that prospectively evaluate evolutionary aspects of COVID-19 in the cardiac, genetic, neural and inflammatory markers. Statistical analysis: In study 1, the effects of the intervention will be tested by the mixed model; in study 2, the effects of the intervention will be tested by the Mann-Whitney or Student's T test. Data will be expressed as median (interquartile range) or mean standard deviation, in addition to a 95% confidence interval, when appropriate. The results of categorical variables will be presented as frequency (percentage) and compared using Fisher's exact test or Pearson's chi-square test, as appropriate. The primary analysis will be by intention of treatment, and the secondary, by complete case. P-values less than 0.05 will be considered statistically significant. (AU)

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