Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

21 ottobre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1574

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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).
Altro: 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.
Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of hospitalizations
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of symptoms of the disease
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo General Hospital

Investigatori

  • Investigatore principale: Marcelo R Santos, PhD, University of Sao Paulo Medical School

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 giugno 2020

Completamento primario (Effettivo)

1 ottobre 2020

Completamento dello studio (Effettivo)

1 ottobre 2020

Date di iscrizione allo studio

Primo inviato

18 maggio 2020

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2020

Primo Inserito (Effettivo)

20 maggio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 ottobre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 ottobre 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COVID-19

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su COVID-19

Prove cliniche su Electronic questionnaire

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Suriname

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi