Covid19NCT04659486
Adolescents With COVID-19/MIS-C at HCFMUSP
A study testing Home-based exercise training in people with Covid19 and Corona Virus Infection, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- school-age children and adolescents diagnosed with COVID-19
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas Faculdade de Medicina USP
São Paulo, São Paulo
About this study
Official title: Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP
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.
Read the detailed 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.
- Conditions
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
- Being tested
- Home-based exercise training
- Keywords
- Covid19, Children, Adolescents
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
The instrument was translated and validated for the Brazilian population
Measured: 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
Measured: Change from Baseline at 6 months
Secondary outcomes (58)
Flow-volume loop assessed by spirometry
Aims to investigate the mechanisms that lead to dyspnea and, consequently, intolerance to physical effort
Measured: Baseline, 3 months, 6 months
Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument
It will also be assessed for school-age children (7-10 years old) and adolescents (11-18 years old) and by their primary caregiver
Measured: Baseline, 3 months, 6 months, 12 months
Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)
Measured: Baseline, 3 months, 6 months, 12 months
Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);
Measured: Baseline, 3 months, 6 months,12 months
Lactate dehydrogenase
Measured: Baseline, 3 months, 6 months, 12 months
Aspartate and alanine aminotransferase
Measured: Baseline, 3 months, 6 months, 12 months
Serum urea and creatinine
Measured: Baseline, 3 months, 6 months, 12 months
Triglycerides
Measured: Baseline, 3 months, 6 months, 12 months
Creatinine phosphokinase (CK)
Measured: Baseline, 3 months, 6 months, 12 months
Amilase
Measured: Baseline, 3 months, 6 months, 12 months
Lipase
Measured: Baseline, 3 months, 6 months, 12 months
Troponin T
Measured: Baseline, 3 months, 6 months, 12 months
Pro-BNP
Measured: Baseline, 3 months, 6 months, 12 months
Lung abnormalities will be assessed by pulmonary computed tomography
Patchy ground-glass opacities, crazy-paving pattern, and localization and pattern of large, confluent or small nodular lesions will be assessed
Measured: Baseline, 3 months, 6 months, 12 months
Systolic and diastolic function will be assessed by echocardiogram
Conventional transthoracic echocardiogram with color Doppler to assess systolic and diastolic function
Measured: Baseline, 3 months, 6 months, 12 months
Valve dysfunction will be assessed by echocardiogram
Conventional transthoracic echocardiogram with color Doppler to search for valve dysfunction
Measured: Baseline, 3 months, 6 months, 12 months
Pericardial effusion will be assessed by echocardiogram
Conventional transthoracic echocardiogram with color Doppler to search for pericardial effusion
Measured: Baseline, 3 months, 6 months, 12 months
Coronary arteries will be assessed by echocardiogram
Conventional transthoracic echocardiogram with color Doppler to search for aspects of the coronary arteries
Measured: Baseline, 3 months, 6 months, 12 months
Ischemia will be assessed by echocardiogram
Echocardiogram with two-dimensional speckle-tracking technique to identify subclinical changes suggestive of ischemia or myocarditis
Measured: Baseline, 3 months, 6 months, 12 months
Immunocompetence, including thymic function
Baseline levels of cytokines IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-y, and IL-17A in serum samples will be tested by flow cytometry using the CBA technique (Cytometric bead array, BD Biosciences)
Measured: Baseline, 3 months, 6 months, 12 months
Leukogram will be assessed by leukocyte and lymphocyte counts
Measured: Baseline, 3 months, 6 months,, 12 months
Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry
T cell lineages: CD3CD4, CD3CD8, naive cells (CD45RA+), memory cells (CD45RA-), effector cells (CD38+HLADR+)
Measured: Baseline, 3 months, 6 months, 12 months
Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry
B cell lineages: CD19, naive cells (CD27-), memory cells (CD27+), plasmablasts (CD27+CD38+CD138-), (plasmocytes CD27+CD38+CD138+)
Measured: Baseline, 3 months, 6 months, 12 months
Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry
NK cells: (CD3-CD16+CD56+), degranulated: CD107a+
Measured: Baseline, 3 months, 6 months, 12 months
Serum levels of anti-Streptococcus pneumoniae IgG antibodies
Measured: Baseline, 3 months, 6 months, 12 months
Anti-pneumococcal vaccine response will be assessed by ELISA
The antipneumococcal antibody titer against 6 polysaccharides (serotypes 1, 5, 6B, 9V, 14, and 18C) will be analyzed by ELISA. The seroconversion criteria is IgG values > 1.3 mg/mL for each polysaccharide assessed
Measured: Baseline, 3 months, 6 months, 12 months
Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)
TRECs evaluate the peripheral function of the thymus from cells that have recently been released, using the RT-PCR technique
Measured: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the autoantibodies of the thyroid gland
(anti-thyroperoxidase antibodies, anti-thyroglobulin)
Measured: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation
Measured: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence
Measured: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay
Measured: Baseline, 3 months, 6 months, 12 months
Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)
Measured: Baseline, 3 months, 6 months, 12 months
Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)
Measured: Baseline, 3 months, 6 months,, 12 months
Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed
Measured: Baseline, 3 months, 6 months, 12 months
Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group
Measured: Baseline, 3 months, 6 months, 12 months
Bone age will be assessed using non-dominant hand and wrist radiography
Measured: Baseline, 12 months
Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Measured: Baseline, 3 months, 6 months, 12 months
Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Measured: Baseline, 3 months, 6 months, 12 months
Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur
Measured: Baseline, 3 months, 6 months, 12 months
Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur
Measured: Baseline, 3 months, 6 months, 12 months
Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body
Measured: Baseline, 3 months, 6 months, 12 months
Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body
Measured: Baseline, 3 months, 6 months, 12 months
Body composition (visceral adipose tissue) will be assessed by Bone densitometry
Measured: Baseline, 3 months, 6 months, 12 months
Body composition (lean mass) will be assessed by Bone densitometry
Measured: Baseline, 3 months, 6 months, 12 months
Body composition (fat mass) will be assessed by Bone densitometry
Measured: Baseline, 3 months, 6 months, 12 months
Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)
Measured: Baseline, 3 months, 6 months, 12 months
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test
Measured: Baseline, 3 months, 6 months, 12 months
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test
Measured: Baseline, 3 months, 6 months, 12 months
Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test
Measured: Baseline, 3 months, 6 months, 12 months
Pediatric gait assessment will be assessed by musculoskeletal ultrasound
Measured: Baseline, 3 months, 6 months, 12 months
Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment
According to the gene sequence studied, the analysis will be performed using the Sanger sequencing technique with capillary electrophoresis in a 3130 automatic sequencer (Applied Biosystems).
The genetic polymorphisms of the ABO system gene (rs505922), two polymorphisms of the OPRM1 gene (rs1799971 and rs1799972) and a polymorphism of the BDNF gene (rs6265) will be investigated, with possible contributions to the risk of impaired gait.
Measured: Baseline, 3 months, 6 months, 12 months
Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"
This is an 18-item parent questionnaire for children and adolescents (18 years and younger). This rating scale includes positive "weaknesses" and negative "strengths" scoring, assessing symptoms of Attention-Deficit/Hyperactivity Disorder. Parents are asked to compare their child's behavior in a variety of settings over the past month to other children on a 7-point: 3-Far below, 2-Below, 1-Slightly below, 0-Average, -1-Slightly average, -2-Above, -3-Far above. Higher scores indicate greater symptomology
Measured: Baseline, 3 months, 6 months, 12 months
Mental health will be assessed by the "Strengths and Difficulties Questionnaire"
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, and includes 25 items on psychological attribute: emotional symptoms (5 items), conduct problems (5 items) hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items). Higher scores indicate greater difficulties
Measured: Baseline, 3 months, 6 months, 12 months
Mental health will be assessed by the "Depression, Anxiety and Stress Scale"
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress (7 items each subscale). Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores for the total DASS-total scale range between 0 and 120. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".
Measured: Baseline, 3 months, 6 months, 12 months
Physical activity levels assessed by ActivPAL
ActivPAL will be used for 7 days for at least 10 hours/day
Measured: Baseline, 3 months, 6 months, 12 months
Food consumption levels assessed by food records
24-hour recalls will be assessed on three non-consecutive days (two weekdays, and one weekend). Online Dietbox will be used.
Measured: Baseline, 3 months, 6 months, 12 months
Blood flow will be assessed using a Doppler Ultrasound
Baseline blood flow measurements will be assessed in the brachial artery
Measured: Baseline, 3 months, 6 months, 12 months
Endothelial function will be assessed using a Doppler Ultrasound
Flow-mediated vasodilation (VMF) will be assessed in the brachial artery
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start24 Sep 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Clovis Silva, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659486
- Sponsor's protocol ID
- 37460620.8.0000.0068
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39501479
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP
- ClinicalTrials.gov ID
- NCT04659486
- Acronym / sponsor ID
- 37460620.8.0000.0068
- Conditions
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
- Keywords
- Covid19, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Home-based exercise trainingA 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 |
| 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- school-age children and adolescents diagnosed with COVID-19
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise trainingOnline 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). | Behavioural | Exercise training |
Primary outcome
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
Time frame: Change from Baseline at 3 months
The instrument was translated and validated for the Brazilian population
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)
Time frame: Change from Baseline at 6 months
The instrument was translated and validated for the Brazilian population
58 secondary outcomes
Flow-volume loop assessed by spirometry
Time frame: Baseline, 3 months, 6 months
Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument
Time frame: Baseline, 3 months, 6 months, 12 months
Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)
Time frame: Baseline, 3 months, 6 months, 12 months
Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);
Time frame: Baseline, 3 months, 6 months,12 months
Lactate dehydrogenase
Time frame: Baseline, 3 months, 6 months, 12 months
Aspartate and alanine aminotransferase
Time frame: Baseline, 3 months, 6 months, 12 months
Serum urea and creatinine
Time frame: Baseline, 3 months, 6 months, 12 months
Triglycerides
Time frame: Baseline, 3 months, 6 months, 12 months
Creatinine phosphokinase (CK)
Time frame: Baseline, 3 months, 6 months, 12 months
Amilase
Time frame: Baseline, 3 months, 6 months, 12 months
Lipase
Time frame: Baseline, 3 months, 6 months, 12 months
Troponin T
Time frame: Baseline, 3 months, 6 months, 12 months
Pro-BNP
Time frame: Baseline, 3 months, 6 months, 12 months
Lung abnormalities will be assessed by pulmonary computed tomography
Time frame: Baseline, 3 months, 6 months, 12 months
Systolic and diastolic function will be assessed by echocardiogram
Time frame: Baseline, 3 months, 6 months, 12 months
Valve dysfunction will be assessed by echocardiogram
Time frame: Baseline, 3 months, 6 months, 12 months
Pericardial effusion will be assessed by echocardiogram
Time frame: Baseline, 3 months, 6 months, 12 months
Coronary arteries will be assessed by echocardiogram
Time frame: Baseline, 3 months, 6 months, 12 months
Ischemia will be assessed by echocardiogram
Time frame: Baseline, 3 months, 6 months, 12 months
Immunocompetence, including thymic function
Time frame: Baseline, 3 months, 6 months, 12 months
Leukogram will be assessed by leukocyte and lymphocyte counts
Time frame: Baseline, 3 months, 6 months,, 12 months
Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry
Time frame: Baseline, 3 months, 6 months, 12 months
Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry
Time frame: Baseline, 3 months, 6 months, 12 months
Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry
Time frame: Baseline, 3 months, 6 months, 12 months
Serum levels of anti-Streptococcus pneumoniae IgG antibodies
Time frame: Baseline, 3 months, 6 months, 12 months
Anti-pneumococcal vaccine response will be assessed by ELISA
Time frame: Baseline, 3 months, 6 months, 12 months
Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)
Time frame: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the autoantibodies of the thyroid gland
Time frame: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation
Time frame: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence
Time frame: Baseline, 3 months, 6 months, 12 months
Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay
Time frame: Baseline, 3 months, 6 months, 12 months
Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)
Time frame: Baseline, 3 months, 6 months, 12 months
Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)
Time frame: Baseline, 3 months, 6 months,, 12 months
Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed
Time frame: Baseline, 3 months, 6 months, 12 months
Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group
Time frame: Baseline, 3 months, 6 months, 12 months
Bone age will be assessed using non-dominant hand and wrist radiography
Time frame: Baseline, 12 months
Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Time frame: Baseline, 3 months, 6 months, 12 months
Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine
Time frame: Baseline, 3 months, 6 months, 12 months
Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur
Time frame: Baseline, 3 months, 6 months, 12 months
Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 39501479Astley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clovis Silva, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise training in people with Covid19 and Corona Virus Infection, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL) (time frame: Change from Baseline at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.