Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03149133
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator and outcome assessor are blinded to groups.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness', 'timeFrame': '6 weeks', 'description': 'The thickness of the biceps brachii muscle determined by B-mode ultrasound'}, {'measure': 'Stiffness', 'timeFrame': '6 weeks', 'description': 'The stiffness of the biceps brachii muscle determined by ultrasound elastography'}], 'secondaryOutcomes': [{'measure': 'Strength change', 'timeFrame': '6 weeks', 'description': 'Arm flexion strength determined by isokinetic dynammometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biomechanics', 'Strength training', 'Elastography', 'Ultrasound'], 'conditions': ['Muscle Tightness', 'Hypertrophy', 'Occlusion Vein']}, 'descriptionModule': {'briefSummary': 'Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. However, the effects on hypertrophy and the stiffness of the muscle tissue are not studied. We aimed to measure these changes by ultrasound technology in a randomized controlled design.', 'detailedDescription': 'Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The participants are free from any systemic disease, infection or recent injury. Both groups perform hypertrophy training with different intensities. The outcome measures are; thickness determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both groups will be made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy recreational athletes\n\nExclusion Criteria:\n\n* Any kind of systemic disorder\n* Active or chronic infection\n* Recent (last 6 months) musculoskeletal injury\n* Performed strength training at last 72 hours'}, 'identificationModule': {'nctId': 'NCT03149133', 'briefTitle': 'Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle, An Ultrasound-Based Study', 'orgStudyIdInfo': {'id': '2016/248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classical Hypertrophy', 'description': 'The classical hypertrophy group performs strength training with 75-80% of 1-Repetition Maximum.', 'interventionNames': ['Other: Heavy hypertrophy training']}, {'type': 'EXPERIMENTAL', 'label': 'Occlusive Training', 'description': 'The occlusive hypertrophy group performs strength training with %35-50 of 1-Repetition Maximum.', 'interventionNames': ['Other: Light hypertrophy training']}], 'interventions': [{'name': 'Heavy hypertrophy training', 'type': 'OTHER', 'description': 'Training with 75-80 % of 1-RM', 'armGroupLabels': ['Classical Hypertrophy']}, {'name': 'Light hypertrophy training', 'type': 'OTHER', 'description': 'Training with 35-50 % of 1-RM', 'armGroupLabels': ['Occlusive Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'ÖMER BATIN GÖZÜBÜYÜK', 'investigatorAffiliation': 'Istanbul University'}}}}