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

NCT04396353 | Completed DMC

• 1 other identifier: COVID-19
• Study Type: observational
• Target: 1,574
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV 2; Corona Virus Infection; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• Number of hospitalizations

  Number of hospitalizations required due to COVID-19

  Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Secondary Outcomes (3)

• Percentage of symptoms of the disease

  Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

• Length of hospital stay

  Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

• Percentage of mechanical ventilation

  Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Study Arms (2)

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

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

Interventions

Electronic questionnaire OTHER

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).

Physically active; Sedentary

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Illiterate patients with difficulties in filling out the electronic form
• Patients still hospitalized and/or with symptoms of COVID-19

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Marcelo Rodrigues dos Santos

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Marcelo R Santos, PhD

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 20, 2020
• Study Start: June 4, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting in June 2020. All the data will be available permanently.
• Access Criteria: 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.

Locations

BR (1)