Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT05200767
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity and the Course of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-01', 'size': 356472, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-12-15T03:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': 'From the date of admission to hospital until the date of death; assessed up to 5 months', 'description': 'death due to COVID-19 ( coronavirus disease 2019) complication of the disease'}, {'measure': 'recovery', 'timeFrame': 'From the date of admission to hospital until the date of a dismission from the hospital; assessed up to 5 months', 'description': 'patient discharged home from hospital'}, {'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', 'description': 'patient moved to intensive care unit'}], 'secondaryOutcomes': [{'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', 'description': 'days spent in hospital before: death, transfer to ICU or recovery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'IPAQ', 'physical activity level', 'disease severity'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '33442016', 'type': 'BACKGROUND', '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.'}, {'pmid': '32788073', 'type': 'BACKGROUND', '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.'}, {'pmid': '31849894', 'type': 'BACKGROUND', '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.'}, {'pmid': '32167524', 'type': 'BACKGROUND', '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.'}, {'pmid': '32031570', 'type': 'BACKGROUND', '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.'}, {'pmid': '12900694', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Biernat E, Stupnicki R, Gajewski AK. International Physical Activity Questionnaire (IPAQ) - Polish version. Wych Fiz Sport. 2007;51(1):47-54. (In Polish).'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethodology:\n\nTo 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).\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized due to COVID-19 (confirmed COVID-19 infection by PCR method or equivalent diagnostic technique) at the COVID-19 treatment unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>=18\n* confirmed COVID-19 ( coronavirus disease 2019) infection\n* hospitalization in the COVID-19 treatment unit\n\nExclusion Criteria:\n\n* pregnancy;\n* inability to complete the questionnaire during hospitalization or up to a week after discharge;\n* 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;\n* symptomatic chronic respiratory disease not responding to therapy before hospitalization for COVID-19 (or no therapy);\n* any dyspnea at rest in the last month before COVID-19;\n* injury to the locomotor system in the last month before contracting COVID-19;\n* hospitalization in the last month before contracting COVID-19.'}, 'identificationModule': {'nctId': 'NCT05200767', 'briefTitle': 'Physical Activity and the Course of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'The Level of Usual Physical Activity and Its Impact on the Course of COVID-19 in Hospitalized Patients.', 'orgStudyIdInfo': {'id': '1081/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19', 'description': 'Adults aged 18 at the least of any sex and race hospitalized for SARS-CoV-2 infection', 'interventionNames': ['Other: completing surveys']}], 'interventions': [{'name': 'completing surveys', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Bytom', 'state': 'Upper Silesia', 'country': 'Poland', 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}], 'overallOfficials': [{'name': 'Edyta Sutkowska, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'url': 'http://ppm.umed.wroc.pl/info/researchdata/UMW9cf7247169fc4d2b8dad0921ad2207fb/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1. after publication with no time limit for IPD\n2. supplementary materials - depends on the publisher', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication: results of IPAQ, data about the primary and secondary outcomes, laboratory tests, also statistical analysis will be available at the link connected with URN: urn:umed-wroc-prod:UMW9cf7247169fc4d2b8dad0921ad2207fb after publishing; other supporting documents will be available as supplementary materials accompanying the article after publishing', 'accessCriteria': '1. under processing of determined- for IPD\n2. according to the publisher law- for the supplementary materials'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Silesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Edyta Sutkowska', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}