Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT04789512
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Strength in Volleyball Players Suffered From 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2021-03-06', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '10 minute', 'description': 'Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.'}], 'secondaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '5 minute', 'description': 'Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEV1 will be evaluated. The percentage of predicted value \\<70% will be expressed as abnormal.'}, {'measure': 'FVC', 'timeFrame': '5 minute', 'description': 'Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FVC will be evaluated. The percentage of predicted value \\<70% will be expressed as abnormal'}, {'measure': 'FEV1/FVC', 'timeFrame': '5 minute', 'description': 'Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEV1/FVC will be evaluated.'}, {'measure': 'PEF', 'timeFrame': '5 minute', 'description': 'Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. PEF will be evaluated. The percentage of predicted value \\<70% will be expressed as abnormal.'}, {'measure': 'FEF2575', 'timeFrame': '5 minute', 'description': 'Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. FEF2575 will be evaluated. The percentage of predicted value \\<50% will be expressed as abnormal.'}, {'measure': 'Fat mass', 'timeFrame': '2 minute', 'description': 'Fat mass will be evaluated using TANITA bioelectrical impedance analysis.'}, {'measure': 'Fat mass percent', 'timeFrame': '2 minute', 'description': 'Fat mass percent will be evaluated using TANITA bioelectrical impedance analysis.'}, {'measure': 'Fat-free mass', 'timeFrame': '2 minute', 'description': 'Fat-free mass will be evaluated using TANITA bioelectrical impedance analysis.'}, {'measure': 'Body mass index', 'timeFrame': '2 minute', 'description': 'Body mass index will be evaluated using TANITA bioelectrical impedance analysis.'}, {'measure': 'Predicted muscle mass', 'timeFrame': '2 minute', 'description': 'Predicted muscle mass will be evaluated using TANITA bioelectrical impedance analysis.'}, {'measure': 'Symptom severity perceptions', 'timeFrame': '1 minute', 'description': 'Symptom severity perceptions will be evaluated Numeric Rating Scale.The severity of symptoms perceptions related to Covid are scored 0-10 point. Higher scores indicate higher severity of symptoms.'}, {'measure': 'Performance situations perceptions', 'timeFrame': '1 minute', 'description': 'Performance situations perceptions will be evaluated Numeric Rating Scale. Performance situations perceptions of all players are also scored 0-10 point. Higher scores indicate greater performance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory muscles', 'pulmonary functions'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34748144', 'type': 'DERIVED', 'citation': 'Celik Z, Guzel NA, Kafa N, Kokturk N. Respiratory muscle strength in volleyball players suffered from COVID-19. Ir J Med Sci. 2022 Oct;191(5):1959-1965. doi: 10.1007/s11845-021-02849-z. Epub 2021 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and non-Covid-19.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female volleyball players', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative\n* willing to participate in the study\n\nExclusion Criteria:\n\n* having a history of chronic lung disease\n* unwilling to participate in the study'}, 'identificationModule': {'nctId': 'NCT04789512', 'briefTitle': 'Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Evaluation of Respiratory Muscle Strength and Pulmonary Functions in Volleyball Players Suffering From Covid-19', 'orgStudyIdInfo': {'id': '2021-189'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Covid-19 players', 'description': 'Female volleyball players with Covid-19', 'interventionNames': ['Other: Respiratory functions']}, {'label': 'non-Covid-19 players', 'description': 'Female volleyball players with non Covid-19', 'interventionNames': ['Other: Respiratory functions']}], 'interventions': [{'name': 'Respiratory functions', 'type': 'OTHER', 'description': 'Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players', 'armGroupLabels': ['Covid-19 players', 'non-Covid-19 players']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Zeliha ÇELİK', 'investigatorAffiliation': 'Gazi University'}}}}