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EXercise TRAining and Sedentary Lifestyle on Clinical Outcomes in Patients With COVID-19 (WHO)

21. oktober 2020 opdateret af: University of Sao Paulo General Hospital

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

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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1574

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Sao Paulo
      • São Paulo, Sao Paulo, Brasilien, 05403-900
        • Marcelo Rodrigues dos Santos

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Surviving patients infected with SARS-CoV-2, as confirmed by a reverse transcription-polymerase chain reaction (RT-PCR) test, blood test (serology), and a rapid antibody test in Brazil and worldwide, will be considered eligible for the study. Only those patients fully recovered from the disease and asymptomatic will be included.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).
Andet: Electronic questionnaire
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).
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.
Andet: Electronic questionnaire
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of hospitalizations
Tidsramme: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Number of hospitalizations required due to COVID-19
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of symptoms of the disease
Tidsramme: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Symptoms such as fever, cough, shortness of breathe, and muscle pain due to COVID-19
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Length of hospital stay
Tidsramme: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Length of hospital stay required due to COVID-19
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Percentage of mechanical ventilation
Tidsramme: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Need for mechanical ventilation during hospitalization due to COVID-19
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo General Hospital

Efterforskere

  • Ledende efterforsker: Marcelo R Santos, PhD, University of Sao Paulo Medical School

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. juni 2020

Primær færdiggørelse (Faktiske)

1. oktober 2020

Studieafslutning (Faktiske)

1. oktober 2020

Datoer for studieregistrering

Først indsendt

18. maj 2020

Først indsendt, der opfyldte QC-kriterier

19. maj 2020

Først opslået (Faktiske)

20. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COVID-19

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All data will be shared publicly through the tool Open Science Framework.

IPD-delingstidsramme

Starting in June 2020. All the data will be available permanently.

IPD-delingsadgangskriterier

Data will be available to other researchers after the end of the study. Data will be available for statistical analyses. The personal data of volunteers will not be identified. The principal investigator will be responsible for requests and criteria for information that will be shared.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med COVID-19

Kliniske forsøg med Electronic questionnaire

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Oman

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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