Physical Activity and the Course of COVID-19

NCT ID: NCT05200767

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-09-30

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19

Adults aged 18 at the least of any sex and race hospitalized for SARS-CoV-2 infection

completing surveys

Intervention Type: OTHER

The level of "usual" physical activity before the disease ( COVID-19- coronavirus disease 2019) will be analysed based on the IPAQ ( International Physical Activity Questionnaire) results.

Interventions

completing surveys

The level of "usual" physical activity before the disease ( COVID-19- coronavirus disease 2019) will be analysed based on the IPAQ ( International Physical Activity Questionnaire) results.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: collaborator

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Edyta Sutkowska

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edyta Sutkowska, PhD

Role: STUDY_CHAIR

Wroclaw Medical University

Locations

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Medical University of Silesia

Bytom, Upper Silesia, Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 33442016 (View on PubMed)

Ejaz H, Alsrhani A, Zafar A, Javed H, Junaid K, Abdalla AE, Abosalif KOA, Ahmed Z, Younas S. COVID-19 and comorbidities: Deleterious impact on infected patients. J Infect Public Health. 2020 Dec;13(12):1833-1839. doi: 10.1016/j.jiph.2020.07.014. Epub 2020 Aug 4.

Reference Type: BACKGROUND

PMID: 32788073 (View on PubMed)

Guo L, Wei D, Zhang X, Wu Y, Li Q, Zhou M, Qu J. Clinical Features Predicting Mortality Risk in Patients With Viral Pneumonia: The MuLBSTA Score. Front Microbiol. 2019 Dec 3;10:2752. doi: 10.3389/fmicb.2019.02752. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31849894 (View on PubMed)

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

Reference Type: BACKGROUND

PMID: 32167524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32031570 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12900694 (View on PubMed)

Biernat E, Stupnicki R, Gajewski AK. International Physical Activity Questionnaire (IPAQ) - Polish version. Wych Fiz Sport. 2007;51(1):47-54. (In Polish).

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1081/2021

Identifier Type: -

Identifier Source: org_study_id