Physical Activity and the Course of COVID-19

NCT05200767 | Completed

• 1 other identifier: 1081/2021
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

COVID-19; IPAQ; physical activity level; disease severity

Outcome Measures

Primary Outcomes (3)

• death

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

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

• recovery

  patient discharged home from hospital

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

• transfer to intensive care unit (ICU)

  patient moved to intensive care unit

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

Secondary Outcomes (1)

• 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 Arms (1)

COVID-19

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

Other: completing surveys

Interventions

completing surveys 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.

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Medical University of Silesia: collaborator

Study Sites (2)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Location

Medical University of Silesia

Bytom, Upper Silesia, Poland

Location

Related Publications (7)

• 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.

  PMID: 33442016 BACKGROUND

• 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.

  PMID: 32788073 BACKGROUND

• 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.

  PMID: 31849894 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

• 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.

  PMID: 32031570 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Edyta Sutkowska, PhD

  Wroclaw Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 21, 2022
• Study Start: January 3, 2022
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1. after publication with no time limit for IPD 2. supplementary materials - depends on the publisher
• Access Criteria: 1. under processing of determined- for IPD 2. according to the publisher law- for the supplementary materials

Locations

PL (2)