- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Sao Paulo
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São Paulo, Sao Paulo, Brésil, 05403-900
- Marcelo Rodrigues dos Santos
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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).
|
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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of hospitalizations
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of symptoms of the disease
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marcelo R Santos, PhD, University of Sao Paulo Medical School
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- COVID-19
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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