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Clinical Trials/NCT05200767
NCT05200767
Completed
Not Applicable

The Level of Usual Physical Activity and Its Impact on the Course of COVID-19 in Hospitalized Patients.

Wroclaw Medical University2 sites in 1 country140 target enrollmentJanuary 3, 2022
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Wroclaw Medical University
Enrollment
140
Locations
2
Primary Endpoint
death
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Being active has a beneficial effect on human immunology. Patients hospitalized for COVID-19 (coronavirus disease 2019) will be surveyed for their prior physical activity. In order to show the relationship between the level of usual physical activity and the course of the disease, the following variables will be monitored to express the disease severity: death or transfer to ICU (intensive care unit), or recovery, also the length of hospitalization will be analyzed as a secondary outcome. Depending on the availability of data, the following will also be analyzed: complications other than respiratory failure, C-reactive protein (CRP) and procalcitonin (PCT) levels on admission, and other laboratory parameters, need for oxygen therapy.

Detailed Description

The aim of the study is to assess the relationship between the level of physical activity before falling ill with COVID-19 (coronavirus disease 2019) and the severity of the disease. The course of the disease is often surprising and independent of factors that have been selected as poor prognostic factors ( e.g. diabetes, obesity), therefore it is advisable to look for a relationship for those variables that have not yet been analyzed. Methodology: To show if the usual physical activity impacts the course of COVID-19 the relationship between the results from the modified, short form of IPAQ (International Physical Activity Questionnaire) and the disease termination (death or transfer to intensive care unit or recovery) as well as the hospitalization length will be analyzed. The modification of the questionnaire is necessary due to the specific course of COVID-19, thus the patients will be asked about the "usual" physical activity before the disease (not about the last 7 days). After written consent patients (age \>= 18) from the temporal hospital, dedicated to COVID-19, will be surveyed with IPAQ. If the patient's condition is too poor, the patient will be able to: provide answers on a different day up to 7 days from discharge from the hospital, or indicate a relative who can answer for him/her. The basic laboratory parameters e.g.: morphology, C-reactive protein, procalcitonin, kidney and liver function, D-dimer, gasometry, and X-rays picture of the lungs will be collected from the patient's medical record if available. Also, information about the type and duration of the used ventilation will be collected if available.

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wroclaw Medical University
Responsible Party
Principal Investigator
Principal Investigator

Edyta Sutkowska

assistant professor

Wroclaw Medical University

Eligibility Criteria

Inclusion Criteria

  • age \>=18
  • confirmed COVID-19 ( coronavirus disease 2019) infection
  • hospitalization in the COVID-19 treatment unit

Exclusion Criteria

  • pregnancy;
  • inability to complete the questionnaire during hospitalization or up to a week after discharge;
  • history of a significant cardiovascular event in the last 6 months (acute coronary syndrome, stroke, amputation, revascularization of peripheral vessels, pulmonary or peripheral embolism of any etiology) if the patient did not complete the rehabilitation process;
  • symptomatic chronic respiratory disease not responding to therapy before hospitalization for COVID-19 (or no therapy);
  • any dyspnea at rest in the last month before COVID-19;
  • injury to the locomotor system in the last month before contracting COVID-19;
  • hospitalization in the last month before contracting COVID-19.

Outcomes

Primary Outcomes

death

Time Frame: From the date of admission to hospital until the date of death; assessed up to 5 months

death due to COVID-19 ( coronavirus disease 2019) complication of the disease

recovery

Time Frame: From the date of admission to hospital until the date of a dismission from the hospital; assessed up to 5 months

patient discharged home from hospital

transfer to intensive care unit (ICU)

Time Frame: From the date of admission to hospital until the date of transfer to ICU; assessed up to 5 months

patient moved to intensive care unit

Secondary Outcomes

  • hospitalization length(From the date of admission to hospital until the date of death, transfer to ICU or discharge home;assessed up to 5 months)

Study Sites (2)

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