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- Klinische proef NCT04396353
EXercise TRAining and Sedentary Lifestyle on Clinical Outcomes in Patients With COVID-19 (WHO)
The Impact of EXercise TRAining, Physical Activity and Sedentary Lifestyle on Clinical Outcomes in Surviving Patients Infected With the Severe Acute Respiratory Syndrome Coronavirus 2: Cross-sectional Study
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the 2019 novel coronavirus (COVID-19) disease, initially discovered in the city of Wuhan, China, at the end of December 2019. In March 2020, the World Health Organization (WHO) declared SARS-CoV-2 as a worldwide pandemic. The disease quickly spread to several continents, also reaching Brazil strongly. This pandemic claimed (and still does) several victims, affecting more than 3 million confirmed cases worldwide with more than 200,000 deaths (official data: coronavirus.jhu.edu/map.html). In Brazil alone, by the time of writing this research project, 60,311 cases have been confirmed with 4,117 deaths. Epidemiological studies show that these numbers can be even higher, reaching up to eight times the number of cases.
As a new virus with such lethality and without the knowledge of its pathophysiology, WHO and the governments of each country have adopted isolation and social distance as a preventive measure to contain the spread of the virus, especially among the most vulnerable people such as the elderly, obese, diabetics and patients with cardiovascular diseases. So far, there is no effective and scientifically proven treatment for the disease, nor a vaccine for its effective control. In this sense, preventive measures such as personal hygiene, good nutrition and physical exercise seem to be the best forms of prevention. However, it is not known whether these measures can prevent contagion or whether they help the recovery of patients infected with SARS-CoV-2. It is well known that exercise training improves the response of the immune system providing protection against infections caused by intracellular microorganisms, thus being an important prevention strategy against SARS-CoV-2.
The present study aims to assess the impact of exercise training, physical activity, and sedentary lifestyle on clinical outcomes in surviving patients infected with the SARS-CoV-2 virus. Therefore, this study will evaluate cross-sectionally and through a questionnaire in Portuguese and English on the internet, whether physically active patients have better outcomes for the disease such as shorter hospital stay, lesser symptoms, lesser need for mechanical ventilation and medications.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Sao Paulo
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São Paulo, Sao Paulo, Brazilië, 05403-900
- Marcelo Rodrigues dos Santos
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Men and women recovered and survivors of the disease
- With or without symptoms
- Patients with disease confirmation by reverse transcription-polymerase chain reaction (RT-PCR) test, blood test (serology), and a rapid antibody test
- With or without the need for hospitalization (nursery, semi-intensive and intensive unit)
- With or without the need for drug treatment
- Presence of any chronic disease such as diabetes, hypertension, coronary artery disease, obesity, metabolic syndrome, cancer, among others
- Literate patients in Portuguese and/or English.
Exclusion Criteria:
- Illiterate patients with difficulties in filling out the electronic form
- Patients still hospitalized and/or with symptoms of COVID-19
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Physically active
Those who receive regular amounts of physical activity.
Those who participate in a minimum of 150 minutes of moderate exercise, or 75 minutes of a more vigorous regimen as recommended by the health organizations.
Additionally, a person who spend less time sitting (i.e.
watching television, surfing the web, playing video games).
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Clinical, anthropometric, and sociodemographic variables to characterize the sample will be collected using the Google Form.
The same tool will be used to collect clinical variables (outcomes), as well as to obtain data on the level of physical activity and sedentary behavior time (predictor variables) prior to SARS-CoV-2 contamination.
For this, we will use the International Physical Activity Questionnaire (IPAQ).
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Sedentary
Those who do not receive regular amounts of physical activity.
Where physical inactivity is considered the failure to meet the recommendations of the health organizations, stating that an individual should participate in a minimum of 150 minutes of moderate exercise, or 75 minutes of a more vigorous regimen.
Sitting about 70-85% of the time (i.e.
watching television, surfing the web, playing video games) is also considered a person living a sedentary lifestyle.
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Clinical, anthropometric, and sociodemographic variables to characterize the sample will be collected using the Google Form.
The same tool will be used to collect clinical variables (outcomes), as well as to obtain data on the level of physical activity and sedentary behavior time (predictor variables) prior to SARS-CoV-2 contamination.
For this, we will use the International Physical Activity Questionnaire (IPAQ).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of hospitalizations
Tijdsspanne: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Number of hospitalizations required due to COVID-19
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Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of symptoms of the disease
Tijdsspanne: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Symptoms such as fever, cough, shortness of breathe, and muscle pain due to COVID-19
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Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Length of hospital stay
Tijdsspanne: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Length of hospital stay required due to COVID-19
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Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Percentage of mechanical ventilation
Tijdsspanne: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Need for mechanical ventilation during hospitalization due to COVID-19
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Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Marcelo R Santos, PhD, University of Sao Paulo Medical School
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- COVID-19
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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