Clinical trial NCT05200767: Physical Activity and the Course of COVID-19
Official title: The Level of Usual Physical Activity and Its Impact on the Course of COVID-19 in Hospitalized Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
IPAQ
physical activity level
disease severity
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Medical University of Silesia
First posted: 2022-01-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized due to COVID-19 (confirmed COVID-19 infection by PCR method or equivalent diagnostic technique) at the COVID-19 treatment unit

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.

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.

Primary outcomes:
measure: death
timeFrame: From the date of admission to hospital until the date of death; assessed up to 5 months
measure: recovery
timeFrame: From the date of admission to hospital until the date of a dismission from the hospital; assessed up to 5 months
measure: transfer to intensive care unit (ICU)
timeFrame: From the date of admission to hospital until the date of transfer to ICU; assessed up to 5 months
Secondary outcomes:
measure: hospitalization length
timeFrame: From the date of admission to hospital until the date of death, transfer to ICU or discharge home;assessed up to 5 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
state: Lower Silesia
city: Bytom
country: Poland
facility: Medical University of Silesia
state: Upper Silesia
Study officials:
affiliation: Wroclaw Medical University
name: Edyta Sutkowska, PhD
role: STUDY_CHAIR
References:
citation: Brodin P. Immune determinants of COVID-19 disease presentation and severity. Nat Med. 2021 Jan;27(1):28-33. doi: 10.1038/s41591-020-01202-8. Epub 2021 Jan 13.
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citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: Biernat E, Stupnicki R, Gajewski AK. International Physical Activity Questionnaire (IPAQ) - Polish version. Wych Fiz Sport. 2007;51(1):47-54. (In Polish).