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

COVID-19 Clinical Trial

— WHO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396353
• Other study ID #: COVID-19
• Status: Completed
• Start date: June 4, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1574
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• SARS-CoV 2
• Sedentary Behavior
• Severe Acute Respiratory Syndrome

Intervention

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).

Locations

Country	Name	City	State
Brazil	Marcelo Rodrigues dos Santos	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of symptoms of the disease	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)
Secondary	Length of hospital stay	Length of hospital stay required due to COVID-19	Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Secondary	Percentage of mechanical ventilation	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)