Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT05490966
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2022-08-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in lumbar range of motion', 'timeFrame': '1 hour', 'description': 'Lumbar range of motion will be evaluated using Modified modified Schober test.'}], 'primaryOutcomes': [{'measure': 'Change of trunk extensors muscle stiffness', 'timeFrame': '1 hour', 'description': 'Muscle stiffness will be measured at rest and during standardised sub-maximal exertions in prone lying position. Muscle stiffness will be expressed as the shear modulus value in kilopascals.'}], 'secondaryOutcomes': [{'measure': 'Change of muscle electromyography mean amplitude', 'timeFrame': '1 hour', 'description': 'Muscle activation of trunk extensors will be measured using superficial electromyography at rest and during two standardised sub-maximal exertions in prone lying position (single arm raise and upper body raise). Mean amplitude in six to eight second time frames will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multifidus', 'erector spinae', 'muscle stiffness'], 'conditions': ['Muscle Tightness']}, 'descriptionModule': {'briefSummary': 'Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.', 'detailedDescription': 'Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave elastography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically active at least 3 hours a week\n\nExclusion Criteria:\n\n* Low back pain in the past 6 months\n* History of chronic low back pain\n* History of spinal or pelvic operation\n* Hypermobility, more than 4 points on Beighton scale\n* Cardiovascular or systemic diseases\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05490966', 'briefTitle': 'Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness', 'orgStudyIdInfo': {'id': 'SWE_Isometric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isometric fatigue', 'description': 'Fatiguing intermittent isometric exertions of trunk extensor muscles will be performed.', 'interventionNames': ['Other: isometric trunk extensor muscles fatigue']}], 'interventions': [{'name': 'isometric trunk extensor muscles fatigue', 'type': 'OTHER', 'description': 'Participants will perform three sets of intermittent isometric efforts between 50 and 60 percents of their maximal isometric strength. A padded force sensor will be placed approximately at the level of the 7th thoracic vertebrae. The first two sets will last six minutes each, while the third set will last three minutes. Between each set participants will rest for two minutes.', 'armGroupLabels': ['Isometric fatigue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'country': 'Slovenia', 'facility': 'University of Primorska, Faculty of Health Sciences', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}], 'overallOfficials': [{'name': 'Matej Voglar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Primorska, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Coded individual dat will be uploaded on public scientific data repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Primorska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, PhD', 'investigatorFullName': 'MatejVoglar', 'investigatorAffiliation': 'University of Primorska'}}}}