Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04302558
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2020-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-03-08', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle diameter (hypertrophy)', 'timeFrame': '2 weeks pre-operative, 8-10 days post-operative', 'description': 'Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris'}], 'secondaryOutcomes': [{'measure': 'Change in muscle strength', 'timeFrame': '2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative', 'description': 'Muscle strength will be measured in subjects as the percent strength of the injured leg compared to the non-injured leg based on handheld dynamometer and the number of leg presses performed at the 1-rep maximum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'referencesModule': {'references': [{'pmid': '40101801', 'type': 'DERIVED', 'citation': 'McGurren DP, Glattke KE, Chhabra A, Boddu SP, Poon SK, Flug JA, Brinkman JC, Goetzinger S, Lee JE, Nocella A, Rogge J, De Luigi AJ. Assessment of Interrater Reliability for Interpretation of Musculoskeletal Ultrasound Imaging of the Quadriceps Femoris. Am J Phys Med Rehabil. 2025 Oct 1;104(10):906-910. doi: 10.1097/PHM.0000000000002731. Epub 2025 Mar 6.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be between 13 and 40 years old\n* Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction\n* Subjects must be able to understand study procedures and comply with them for the entire duration of the study\n* Subjects must have normal contralateral limb strength\n\nExclusion Criteria:\n\n* Subjects with any personal history of deep vein thrombosis or with such history in their immediate family\n* Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading\n* Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg\n* Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent'}, 'identificationModule': {'nctId': 'NCT04302558', 'briefTitle': 'Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction', 'orgStudyIdInfo': {'id': '19-008473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Flow Restriction (BFR) group', 'description': 'Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while the blood flow to the leg is reduced by a blood flow restriction cuff.', 'interventionNames': ['Behavioral: Exercise Blood Flow Restriction training']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM Blood Flow Restriction (BFR) group', 'description': 'Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while a blood flow restriction cuff is applied but inflation pressure will be limited', 'interventionNames': ['Behavioral: SHAM Exercise Blood Flow Restriction training']}], 'interventions': [{'name': 'Exercise Blood Flow Restriction training', 'type': 'BEHAVIORAL', 'description': 'While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow', 'armGroupLabels': ['Blood Flow Restriction (BFR) group']}, {'name': 'SHAM Exercise Blood Flow Restriction training', 'type': 'BEHAVIORAL', 'description': 'While exercising Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow', 'armGroupLabels': ['SHAM Blood Flow Restriction (BFR) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Anikar Chhabra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anikar Chhabra', 'investigatorAffiliation': 'Mayo Clinic'}}}}