Physical Activity and the Course of COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200767
• Other study ID #: 1081/2021
• Status: Completed
• Start date: January 3, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Bytom	Upper Silesia
Poland	Wroclaw Medical University	Wroclaw	Lower Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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

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. — View 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. — View Citation

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. — View Citation

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. — View 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. Erratum In: JAMA. 2021 Mar 16;325(11):1113. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	hospitalization length	days spent in hospital before: death, transfer to ICU or recovery	From the date of admission to hospital until the date of death, transfer to ICU or discharge home;assessed up to 5 months