- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200767
Physical Activity and the Course of COVID-19
The Level of Usual Physical Activity and Its Impact on the Course of COVID-19 in Hospitalized Patients.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lower Silesia
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Wroclaw, Lower Silesia, Poland
- Wroclaw Medical University
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Upper Silesia
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Bytom, Upper Silesia, Poland
- Medical University of Silesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19
Adults aged 18 at the least of any sex and race hospitalized for SARS-CoV-2 infection
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: From the date of admission to hospital until the date of death; assessed up to 5 months
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death due to COVID-19 ( coronavirus disease 2019) complication of the disease
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From the date of admission to hospital until the date of death; assessed up to 5 months
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recovery
Time Frame: From the date of admission to hospital until the date of a dismission from the hospital; assessed up to 5 months
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patient discharged home from hospital
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From the date of admission to hospital until the date of a dismission from the hospital; assessed up to 5 months
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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
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patient moved to intensive care unit
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From the date of admission to hospital until the date of transfer to ICU; assessed up to 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospitalization length
Time Frame: From the date of admission to hospital until the date of death, transfer to ICU or discharge home;assessed up to 5 months
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days spent in hospital before: death, transfer to ICU or recovery
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From the date of admission to hospital until the date of death, transfer to ICU or discharge home;assessed up to 5 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Edyta Sutkowska, PhD, Wroclaw Medical University
Publications and helpful links
General Publications
- 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. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- 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. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.
- 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.
- 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. Erratum In: Front Microbiol. 2020 Jun 09;11:1304.
- 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.
- 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.
- Biernat E, Stupnicki R, Gajewski AK. International Physical Activity Questionnaire (IPAQ) - Polish version. Wych Fiz Sport. 2007;51(1):47-54. (In Polish).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1081/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
- after publication with no time limit for IPD
- supplementary materials - depends on the publisher
IPD Sharing Access Criteria
- under processing of determined- for IPD
- according to the publisher law- for the supplementary materials
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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