Clinical trial NCT04396353: EXercise TRAining and Sedentary Lifestyle on Clinical Outcomes in Patients With COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV 2
Corona Virus Infection
Sedentary Behavior
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 1574
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of hospitalizations
timeFrame: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Secondary outcomes:
measure: Percentage of symptoms of the disease
timeFrame: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
measure: Length of hospital stay
timeFrame: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
measure: Percentage of mechanical ventilation
timeFrame: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Marcelo Rodrigues dos Santos
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo Medical School
name: Marcelo R Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: