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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04396353
Collaborator
(none)
1,574
1
3.9
402.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electronic questionnaire

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
1574 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
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
Actual Study Start Date :
Jun 4, 2020
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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).

Other: 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.

Other: 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).

Outcome Measures

Primary Outcome Measures

  1. Number of hospitalizations [Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)]

    Number of hospitalizations required due to COVID-19

Secondary Outcome Measures

  1. Percentage of symptoms of the disease [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

  2. Length of hospital stay [Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)]

    Length of hospital stay required due to COVID-19

  3. Percentage of mechanical ventilation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marcelo Rodrigues dos Santos São Paulo Sao Paulo Brazil 05403-900

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Marcelo R Santos, PhD, University of Sao Paulo Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT04396353
Other Study ID Numbers:
  • COVID-19
First Posted:
May 20, 2020
Last Update Posted:
Oct 22, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020