Effects of exercise training on health-related quality of life in children and adolescents after COVID-19 and pediatric multisystem inflammatory syndrome

• Grant number: 22/16239-1
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate
• Effective date (Start): April 01, 2024
• Effective date (End): June 30, 2024
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Bruno Gualano
• Grantee: Camilla Astley Amaral Pedroso
• Supervisor: Naomi Gauthier Md
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Research place: Harvard University, Boston, United States
• Associated to the scholarship: 21/02742-0 - 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, BP.DR

Abstract

Coronavirus disease 2019 (COVID-19), a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has shown low infection rates in the pediatric population. However, children and adolescents with COVID-19 may have persistent inflammation, with isolated or concomitant lesions on various organs. The multisystemic inflammatory syndrome in children (MIS-C) temporarily associated with COVID-19 is even more severe and presents important cardiac manifestations. Although the prolonged effect of this condition is unknown, it is assumed that COVID-19 and MIS-C prospectively affect physical and mental health, and possibly reduce the quality of life in this population. 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, it is necessary to provide interventions aimed to improve physical and mental health, as well as investigating the possible beneficial effects of an exercise training program in pediatric patients recovering from COVID-19 and MIS-C. Our main objective is to evaluate whether a home-based exercise program will improve the quality of life in children and adolescents who had COVID-19 and MIS-C. Second, we will also assess the effects of exercise on cardiac and endothelial function, aerobic capacity, metabolic health, and inflammation. Importantly, the safety of exercising after COVID-19 treatment will be examined. Methods: This is a randomized clinical trial (Study 1) and a quasi-experimental trial (Study 2) which include a convenience sample with 40 children and adolescents who recovered from COVID-19, and 10 with MIS-C. A control group (n=40) balanced in terms of age, sex, and pediatric pre-existing chronic conditions will be also recruited. 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. We will assess the quality of life through questionnaires, conventional and speckle tracking echocardiogram, brachial flow-mediated dilation, cardiopulmonary exercise, and inflammatory markers. In addition, patients diagnosed with MIS-C will perform a cardiac magnetic resonance using the N-13 ammonia PET-CT technique (13NPET-CT) to assess coronary flow reserve (CFR). Statistical analysis: Continuous variables will be described as median and interquartile range (IQR) or mean and standard deviation (SD). Count variables will be presented as numbers and percentages. Comparisons between groups at baseline (COVID-19 vs. controls) will be performed by a Two-tailed unpaired T-test or Fisher exact test. As appropriate, the intervention effects will be assessed by mixed model, Mann-Whitney, or Student's t-test. We will carry out an intention-to-treat analysis as a first option and the secondary, by complete case. P-values less than 0.05 will be considered statistically significant. (AU)