Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-13 @ 4:02 AM
Study NCT ID:
NCT06566950
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2024-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BFR Training on Muscle Morphology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2024-08-18', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle cross-sectional area', 'timeFrame': '8 weeks', 'description': 'Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and peroneus longus muscle.'}, {'measure': 'Vastus medial obliques fiber angle', 'timeFrame': '8 weeks', 'description': 'Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle.'}, {'measure': 'Patella position', 'timeFrame': '8 weeks', 'description': 'Using a musculoskeletal ultrasonography, researchers will determine the patella position.'}], 'secondaryOutcomes': [{'measure': 'Incidence of patellofemoral pain syndrome', 'timeFrame': '1 year', 'description': 'Researchers will determine the incidence of patellofemoral pain syndrome with the physical examination of grind test.'}, {'measure': 'Incidence of anterior cruciate ligament injury', 'timeFrame': '1 year', 'description': "Researchers will determine the incidence of anterior cruciate ligament injury with the physical examination of Lachman's test."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Flow Restriction Training', 'Eccentric Training', 'Muscle Morphology', 'Patellofemoral Pain Syndrome', 'Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:\n\nIs LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?\n\nThe three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:\n\nParticipants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.\n\nParticipants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).\n\nIn order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 15 and 35\n* Play level 1 sports (fight martial arts, basketball, futsal, and soccer) at least twice a week\n* Never experienced an Patellofemoral Pain Syndrome or ACL injury before\n* Never experienced a grade III sprain or strain\n* Consent to participate in the study until its conclusion and provide informed consent.\n\nExclusion Criteria:\n\n* Having a tumor, cancer, vena thromboembolic disease, obesity, diabetes, hypertension, anemia, and renal failure\n* Disabilities or those who are disabled.'}, 'identificationModule': {'nctId': 'NCT06566950', 'briefTitle': 'BFR Training on Muscle Morphology', 'organization': {'class': 'OTHER', 'fullName': 'Udayana University'}, 'officialTitle': 'Effectiveness of Blood Flow Restriction Training on Muscle Morphology and Prevention of Patellofemoral Pain Syndrome and Anterior Cruciate Ligament Injury', 'orgStudyIdInfo': {'id': '1791/UN14.2.2.VII.14/LT.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low load-BFRt', 'description': '70% of the arterial occlusion pressure and 30% of the maximum repetition rate', 'interventionNames': ['Procedure: Low load-BFRt']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Low load-BFRt', 'description': '10% of the arterial occlusion pressure and 30% of the maximum repetition rate', 'interventionNames': ['Procedure: Sham Low load-BFRt']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High load-Eccentric training', 'description': '70% of the maximum repetition rate', 'interventionNames': ['Procedure: High load-Eccentric training']}], 'interventions': [{'name': 'Low load-BFRt', 'type': 'PROCEDURE', 'description': "The participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as stairs, single leg squat, and single leg deadlift.", 'armGroupLabels': ['Low load-BFRt']}, {'name': 'Sham Low load-BFRt', 'type': 'PROCEDURE', 'description': "The participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as stairs, single leg squat, and single leg deadlift.", 'armGroupLabels': ['Sham Low load-BFRt']}, {'name': 'High load-Eccentric training', 'type': 'PROCEDURE', 'description': 'The physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as stairs, single leg squat, and single leg deadlift.', 'armGroupLabels': ['High load-Eccentric training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80232', 'city': 'Denpasar', 'state': 'Bali', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'I Putu Gde Surya Adhitya, PhD', 'role': 'CONTACT', 'email': 'surya_adhitya@unud.ac.id', 'phone': '+6288975003567'}], 'facility': 'Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}], 'centralContacts': [{'name': 'I Putu Gde Surya Adhitya, PhD', 'role': 'CONTACT', 'email': 'surya_adhitya@unud.ac.id', 'phone': '+6288975003567'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Udayana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'I Putu Gde Surya Adhitya', 'investigatorAffiliation': 'Udayana University'}}}}