Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-25 @ 7:03 AM
Study NCT ID:
NCT03699566
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-05', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal voluntary inspiratory (PImax)', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'inspiratory pressure measurement in cm H2O'}, {'measure': 'Prone Bridge Test', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Trunk endurance test aganist the time'}], 'secondaryOutcomes': [{'measure': 'Maximal voluntary expiratory (PEmax)', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Expiratory pressure measurement in cm H2O'}, {'measure': 'Side Bride Test', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Trunk endurance test aganist the time'}, {'measure': 'Forced Vital Capacity ( FVC)', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Dinamic volume measure for lungs'}, {'measure': 'Forced Expiratuar Volume 1. Second ( Fev1)', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Dinamic volume measure for lungs'}, {'measure': 'Abdominal Flexor Endurance Test', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Trunk endurance test aganist the time'}, {'measure': 'Sorensen Test', 'timeFrame': 'Baseline assessment no follow- up', 'description': 'Back Muscles endurance test aganist the time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trunk muscle endurance', 'respiratory muscle strength', 'respiratory functions'], 'conditions': ['Respiratory Muscles and Core Stabilization']}, 'descriptionModule': {'briefSummary': 'The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.', 'detailedDescription': 'The study was conducted on 60 healthy volunteers ranging in age from 20 to 36 years. 27 woman and 33 men participated in the study. Respiratory muscle strength, trunk muscle endurance, pulmonary function test values and physical activity levels were evaluated for the subjects participating in the study.Respiratory muscle strength and respiratory function tests were performed with a Cosmed Pony Fx portable spirometer. Trunk muscle endurance of the individuals were evaluated by prone bridge, side bridge, flexor endurance and sorensen test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not having any chronic disease\n* Not being pregnant\n\nExclusion Criteria:\n\n* History of cardiopulmonary disease.\n* Morbid obesity\n* Major surgical history'}, 'identificationModule': {'nctId': 'NCT03699566', 'briefTitle': 'Assessment of Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Relationship Between Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals', 'orgStudyIdInfo': {'id': 'Fuat1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Individuals aged 18-65 without chronic disease.\n\nInterventions: Assessment of Respiratory Muscle Strength, Spirometer, Trunk Muscles Endurance Tests', 'interventionNames': ['Other: Assessment of Respiratory Muscle Strength', 'Other: Spirometer', 'Other: Trunk Muscles Endurance Tests']}], 'interventions': [{'name': 'Assessment of Respiratory Muscle Strength', 'type': 'OTHER', 'description': 'The maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressure measurements of the subjects were performed using Cosmed Pony FX model (Italy 2001) while the subjects were in the sitting position with a nose clip.', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Spirometer', 'type': 'OTHER', 'description': 'Spirometric measurements were conducted with Cosmed, Pony FX (descopt spirometer- Italy 2001) spirometer using a nose clips while the subjects were in 90 degree relaxed sitting position.', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Trunk Muscles Endurance Tests', 'type': 'OTHER', 'description': 'Trunk muscle endurance of the subjects was measured using four different tests (Side Bridge Test- SBT, Prone Bridge Test- PBT, Flexor Endurance Test- FET, Sorenson Test- ST).', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Nevin Güzel, prof. dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'T.C. Dumlupınar Üniversitesi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Fuat YÜKSEL', 'investigatorAffiliation': 'Gazi University'}}}}