NCT04659486

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

December 1, 2020

Last Update Submit

December 8, 2020

Conditions

Covid19Corona Virus InfectionSARS (Severe Acute Respiratory Syndrome)SARS-CoV Infection

Keywords

Covid19ChildrenAdolescents

Outcome Measures

Primary Outcomes (2)

  • Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

    The instrument was translated and validated for the Brazilian population

    Change from Baseline at 3 months

  • Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

    The instrument was translated and validated for the Brazilian population

    Change from Baseline at 6 months

Secondary Outcomes (58)

  • Flow-volume loop assessed by spirometry

    Baseline, 3 months, 6 months

  • Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument

    Baseline, 3 months, 6 months, 12 months

  • Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)

    Baseline, 3 months, 6 months, 12 months

  • Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);

    Baseline, 3 months, 6 months,12 months

  • Lactate dehydrogenase

    Baseline, 3 months, 6 months, 12 months

  • +53 more secondary outcomes

Study Arms (2)

Exercise training

EXPERIMENTAL

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

Behavioral: Home-based exercise training

Control

NO INTERVENTION

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

Interventions

Home-based exercise trainingBEHAVIORAL

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).

Exercise training

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas Faculdade de Medicina USP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 39501479DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Clovis Silva, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 9, 2020

Study Start

September 24, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)