Adolescents With COVID-19/MIS-C at HCFMUSP

University of Sao Paulo

Status: Unknown

Conditions: SARS (Severe Acute Respiratory Syndrome); Corona Virus Infection; SARS-CoV Infection; Covid19

Treatments: Behavioral: Home-based exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04659486

37460620.8.0000.0068

Details and patient eligibility

About

This is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.

Full description

School-age children and adolescents COVID-19 survivors may have persistent inflammation, a chronic course of COVID-19, with isolated or concomitant aggressions of various organs and systems, making this disease a potential chronic condition, impacting aspects of quality of life related to health (HRQoL), physical and mental health. In addition, pediatric COVID-19 can induce autoimmunity (with the possibility of primary hypothyroidism and type I diabetes mellitus), delayed linear growth and delayed pubertal development, secondary immunodeficiency and present genetic polymorphisms in brain plasticity impacting rehabilitation. School-aged children and adolescents with COVID-19 could present muscle weakness, dysautonomy, asthenia and physical inactivity, so it is essential that safe and effective interventions are developed to maintain adequate levels of physical activity and that they can be implemented on a large scale. However, to date, there are no systematic longitudinal studies that have evaluated all these aspects in a pediatric population that survived COVID-19, particularly with chronic conditions and who were hospitalized in a tertiary service.

Enrollment: 100 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• school-age children and adolescents diagnosed with COVID-19

Exclusion criteria

• school-age children and adolescents with MIS-C, who present: myocardial dysfunction, refractory cardiac arrhythmias, coronary artery aneurysms with or without thrombi, electrocardiographic alterations suggestive of myocardial infarction or ischemia and clinical signs of heart failure;
• presence of any limitation or physical disability that prevents the practice of exercise;
• pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Exercise training

Experimental group

Description:

A 12 weeks parallel-group randomized controlled trial will be performed, in which covid-19 survivors adolescents will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength and aerobic exercises

Treatment:

Behavioral: Home-based exercise training

Control

No Intervention group

Description:

The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.