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Adolescents With COVID-19/MIS-C at HCFMUSP

NCT ID: NCT04659486

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Covid19 Children Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise training

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

Group Type EXPERIMENTAL

Home-based exercise training

Intervention Type BEHAVIORAL

Online strength and aerobic home-based exercise training, 3 times per week, for 12 weeks. The exercise program is composed by 2 intensity-levels (starter and advanced).

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based exercise training

Online strength and aerobic home-based exercise training, 3 times per week, for 12 weeks. The exercise program is composed by 2 intensity-levels (starter and advanced).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital das Clínicas da Faculdade de Medicina da USP

UNKNOWN

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clovis Silva, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Hospital das Clinicas Faculdade de Medicina USP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Astley C, Drezner JA, Sieczkowska SM, Ihara A, Franco T, Gil S, DO Prado DML, Longobardi I, Suguita P, Fink T, Lindoso L, Matsuo O, Martins F, Bain V, Leal GN, Badue MF, Marques HH, Silva CA, Roschel H, Gualano B. Exercise in Pediatric COVID-19: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Mar 1;57(3):514-523. doi: 10.1249/MSS.0000000000003589. Epub 2024 Nov 6.

Reference Type DERIVED
PMID: 39501479 (View on PubMed)

Other Identifiers

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37460620.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id