Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT04146506
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender Differences in the Tolerance to Stretch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': 'Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises', 'description': 'Passive knee extension Range of motion'}, {'measure': 'Range of Motion', 'timeFrame': 'Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises', 'description': 'Passive knee extension Range of motion'}, {'measure': 'Pain Thresholds', 'timeFrame': 'Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises', 'description': 'Pressure Pain Thresholds'}, {'measure': 'Pain Thresholds', 'timeFrame': 'Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises', 'description': 'Pressure Pain Thresholds'}, {'measure': 'Torque', 'timeFrame': 'Passive resistive torque was measured at baseline just prior to muscle stretching exercises', 'description': 'Passive Resistive Torque'}, {'measure': 'Torque', 'timeFrame': 'Passive resistive torque was measured 30 seconds after muscle stretching exercises', 'description': 'Passive Resistive Torque'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Range of Motion, Articular', 'Muscle Stretching Exercises']}, 'descriptionModule': {'briefSummary': 'The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.', 'detailedDescription': 'Given that there may be differences in the way men and women perceive a painful stimulus, this suggests that there may be potential gender differences in the tolerance to stretch following stretching.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy male and female volunteers between the ages of 18 to 45 are eligible for participation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of any pain or other conditions which might affect the somatosensory system and pain perception\n\nExclusion Criteria:\n\n* Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness'}, 'identificationModule': {'nctId': 'NCT04146506', 'briefTitle': 'Gender Differences in the Tolerance to Stretch', 'organization': {'class': 'OTHER', 'fullName': 'University College of Northern Denmark'}, 'officialTitle': 'The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?', 'orgStudyIdInfo': {'id': 'UniversityCND2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male', 'description': 'Static Muscle stretching exercises of the knee flexors', 'interventionNames': ['Other: Muscle stretching exercises']}, {'label': 'Female', 'description': 'Static Muscle stretching exercises of the knee flexors', 'interventionNames': ['Other: Muscle stretching exercises']}], 'interventions': [{'name': 'Muscle stretching exercises', 'type': 'OTHER', 'description': 'Muscle stretching exercises consisting of static stretching exercises of the knee flexors', 'armGroupLabels': ['Female', 'Male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9220', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'University College of Northern Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Dorte Drachman, Msc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College of Northern Denmark, Department of Physiotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD (range of motion, PPT and Torque data) will be shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College of Northern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}