Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT04484961
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2020-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
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This was a single episode treated with ibuprofen per the PI.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine if BFR Changes Loss of LE Lean Muscle Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'Pre-Surgery Whole Limb Lean Mass', 'categories': [{'measurements': [{'value': '8.97', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': '6 week post surgery Whole Limb Lean Mass', 'categories': [{'measurements': [{'value': '8.37', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '8.93', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': '12 Week Post Surgery Whole Limb Lean Mass', 'categories': [{'measurements': [{'value': '8.58', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '9.04', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Surgery Thigh Lean Mass', 'categories': [{'measurements': [{'value': '3.18', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': '6 week post surgery Thigh Lean Mass', 'categories': [{'measurements': [{'value': '2.91', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': '12 week post surgery Thigh Lean Mass', 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Determine if BFR Changes Loss of Bone Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'Whole Limb Bone Mass at Pre-surgery', 'categories': [{'measurements': [{'value': '567.9', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '568.2', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Whole Limb Bone Mass at 6 weeks post-operation', 'categories': [{'measurements': [{'value': '555', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '567.2', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Whole Limb Bone Mass at 12 weeks post-operation', 'categories': [{'measurements': [{'value': '550.9', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '565.4', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Femur Bone Mass at Pre-surgery', 'categories': [{'measurements': [{'value': '156.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '156.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Femur Bone Mass at 6 weeks post surgery', 'categories': [{'measurements': [{'value': '151.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '154.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Femur Bone Mass at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '148.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '153', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'Bone mass was measured in grams using DEXA (iDXA, GE®)', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Determine if BFR Changes Loss of Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'Distal Femur Bone Mineral density at pre-surgery', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Distal Femur Bone Mineral density at 6 weeks post-operation', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Distal Femur Bone Mineral density at 12 weeks post-operation', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Tibia Bone Mineral density at pre-surgery', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Tibia Bone Mineral density at 6 weeks post surgery', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Tibia Bone Mineral density at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Fibia Bone Mineral Density at pre-surgery', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Fibia Bone Mineral Density at 6 weeks post-surgery', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Proximal Fibia Bone Mineral Density at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'SL Squat Week 8', 'categories': [{'measurements': [{'value': '34.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'SL Squat Week 12', 'categories': [{'measurements': [{'value': '40.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '43.0', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8 and Week 12 post-surgery', 'description': 'Single leg (SL) squat (best of 3 attempts)', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'SL eccentric step down at 8 weeks post surgery', 'categories': [{'measurements': [{'value': '44.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'SL eccentric step down at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '61.0', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'SL eccentric step down (reps to fatigue or inadequate technique)', 'unitOfMeasure': 'reps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'Y-balance anterior (best of 3 attempts) at 8 weeks post surgery', 'categories': [{'measurements': [{'value': '48.7', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Y-balance anterior (best of 3 attempts) at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '55.9', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'Y-balance anterior (best of 3 attempts)', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'Y-balance posteromedial (best of 3 attempts) at 8 weeks post surgery', 'categories': [{'measurements': [{'value': '93.3', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Y-balance posteromedial (best of 3 attempts) at 12 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'spread': '10.3', 'groupId': 'OG000'}, {'value': '91.9', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Y-balance posterolateral (best of 3 attempts) at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '104.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '99.7', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'Y-balance posterolateral (best of 3 attempts)', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard PT, No BFR Injured Limb'}, {'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR 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{'id': 'OG001', 'title': 'Experimental - BFR', 'description': 'Standard PT, BFR Injured Limb'}], 'classes': [{'title': 'SL hamstring curl (1RM) at 8 weeks post surgery', 'categories': [{'measurements': [{'value': '29.9', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'SL hamstring curl (1RM) at 12 weeks post surgery', 'categories': [{'measurements': [{'value': '38.5', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'SL hamstring curl (1RM)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control - Routine Rehab', 'description': 'Participants in this group received standard ACL rehab with no blood flow restriction therapy.'}, {'id': 'FG001', 'title': 'Experimental - BFR', 'description': 'Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.\n\nBlood flow restriction (BFR): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Houston hospital and clinic locations', 'preAssignmentDetails': 'Examples of why a patient might be enrolled and then not assigned to a study arm would be:\n\n* new injury\n* deciding on a different PT location\n* time constraints'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control - Routine Rehab', 'description': 'Participants in this group received standard ACL rehab with no blood flow restriction therapy.'}, {'id': 'BG001', 'title': 'Experimental - BFR', 'description': 'Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.\n\nBlood flow restriction (BFR): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': 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'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2015-12-28', 'size': 317274, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-22T17:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2020-07-13', 'resultsFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if BFR Changes Loss of LE Lean Muscle Mass', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)'}, {'measure': 'Determine if BFR Changes Loss of Bone Mass', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'Bone mass was measured in grams using DEXA (iDXA, GE®)'}, {'measure': 'Determine if BFR Changes Loss of Bone Mineral Density', 'timeFrame': 'Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery', 'description': 'Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)'}], 'secondaryOutcomes': [{'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': 'Week 8 and Week 12 post-surgery', 'description': 'Single leg (SL) squat (best of 3 attempts)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'SL eccentric step down (reps to fatigue or inadequate technique)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'Y-balance anterior (best of 3 attempts)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'Y-balance posteromedial (best of 3 attempts)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'Y-balance posterolateral (best of 3 attempts)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'SL leg press (1RM)'}, {'measure': 'Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing', 'timeFrame': '8 weeks post surgery, 12 weeks post surgery', 'description': 'SL hamstring curl (1RM)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Tear']}, 'referencesModule': {'references': [{'pmid': '16339340', 'type': 'BACKGROUND', 'citation': 'Abe T, Kearns CF, Sato Y. 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Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.'}, {'type': 'BACKGROUND', 'citation': 'Bowman EN, El-shaar R, Milligan H, et al. The Proximal and Distal Effects of Blood Flow Restriction Therapy on Upper and Lower Extremity Strengthening: A Randomized Controlled Trial. Orthop J Sports Med. 2019;7(7_suppl5):2325967119S2325900337.'}, {'pmid': '17909396', 'type': 'BACKGROUND', 'citation': 'Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.'}, {'pmid': '26446893', 'type': 'BACKGROUND', 'citation': 'Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. 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Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.'}, {'pmid': '21088601', 'type': 'BACKGROUND', 'citation': 'Hamrick MW. A role for myokines in muscle-bone interactions. Exerc Sport Sci Rev. 2011 Jan;39(1):43-7. doi: 10.1097/JES.0b013e318201f601.'}, {'pmid': '29879638', 'type': 'BACKGROUND', 'citation': 'Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.'}, {'type': 'BACKGROUND', 'citation': 'Lambert B, Hedt C, Epner E, et al. BFR For Proximal Benefit: Blood Flow Restriction Therapy For The Shoulder? 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Epub 2017 Feb 1.'}, {'type': 'BACKGROUND', 'citation': 'Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.'}, {'pmid': '25430600', 'type': 'BACKGROUND', 'citation': 'Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.'}, {'pmid': '19653816', 'type': 'BACKGROUND', 'citation': 'Swift JM, Nilsson MI, Hogan HA, Sumner LR, Bloomfield SA. Simulated resistance training during hindlimb unloading abolishes disuse bone loss and maintains muscle strength. J Bone Miner Res. 2010 Mar;25(3):564-74. doi: 10.1359/jbmr.090811.'}, {'pmid': '19065114', 'type': 'BACKGROUND', 'citation': 'Thangamani VB, Flanigan DC, Merk BR. Intra-articular distal femur fracture extending from an expanded femoral tunnel in an anterior cruciate ligament (ACL) reconstructed knee: a case report. J Trauma. 2009 Dec;67(6):E209-12. doi: 10.1097/TA.0b013e3181469f42.'}, {'pmid': '25264670', 'type': 'BACKGROUND', 'citation': 'Vechin FC, Libardi CA, Conceicao MS, Damas FR, Lixandrao ME, Berton RP, Tricoli VA, Roschel HA, Cavaglieri CR, Chacon-Mikahil MP, Ugrinowitsch C. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015 Apr;29(4):1071-6. doi: 10.1519/JSC.0000000000000703.'}, {'pmid': '22303759', 'type': 'BACKGROUND', 'citation': 'Wright R, Spindler K, Huston L, Amendola A, Andrish J, Brophy R, Carey J, Cox C, Flanigan D, Jones M, Kaeding C, Marx R, Matava M, McCarty E, Parker R, Vidal A, Wolcott M, Wolf B, Dunn W. Revision ACL reconstruction outcomes: MOON cohort. J Knee Surg. 2011 Dec;24(4):289-94. doi: 10.1055/s-0031-1292650.'}, {'pmid': '22105051', 'type': 'BACKGROUND', 'citation': 'Yamanaka T, Farley RS, Caputo JL. Occlusion training increases muscular strength in division IA football players. J Strength Cond Res. 2012 Sep;26(9):2523-9. doi: 10.1519/JSC.0b013e31823f2b0e.'}, {'pmid': '30197599', 'type': 'BACKGROUND', 'citation': 'Zargi T, Drobnic M, Strazar K, Kacin A. Short-Term Preconditioning With Blood Flow Restricted Exercise Preserves Quadriceps Muscle Endurance in Patients After Anterior Cruciate Ligament Reconstruction. Front Physiol. 2018 Aug 24;9:1150. doi: 10.3389/fphys.2018.01150. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.', 'detailedDescription': "On the day of the procedure, the surgeon will measure the subject's thigh circumference 1/3 distance from the superior pole of the patella to the inguinal crease. The subject will then undergo the normal BTB autograft ACL reconstruction procedure. A subject will be excluded from the study if a meniscal repair is performed. At the subject's two week post-operative clinic visit, the physician will measure thigh circumference at 1/3 distance from the superior pole of the patella to the inguinal crease. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal ACL rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.\n\nThe BFR exercises will consist of: bilateral leg press week 3-10, eccentric leg press weeks 4-10, hamstring curl week 4-6, eccentric hamstring curl weeks 7-10, straight leg press weeks 6-10. The pressure used will be elevated to occluded blood flow by 80% (80% occlusion pressure) which will be determined for each individual subject. Subjects will do exercises at 20% of 1RM in 4 sets of 30-15-15-15 repetitions separated by 30 seconds of rest. Repetition maximum (1RM) will be determined by the contralateral leg, using the greatest amount of weight with full range of motion and proper form. This will be done over three separate tries, separated by one minute breaks. Resistance loads will be adjusted every 2 weeks as strength improves. During the exercise protocol, if patients are unable to complete the prescribed amount of repetitions, rest periods between sets will be increased as needed. The control group will do these exercises without BFR. Both study and control groups will also do the surgeons' standard post-ACL reconstruction physical therapy protocol.\n\nCuff pressures will be determined using the Loenneke et al outline, based off of thigh circumference and estimated cuff pressure for 50% artery occlusion \\[19\\].\n\nBody composition (DEXA), bone density (DEXA), IKDC and Tegner Lysholm scores will be recorded at first rehabilitation visit, two weeks, eight weeks and 12 weeks following the initiation of rehab (1 wk following surgery). Y- balance, single leg squat distance, and single leg step down will be measured at 8 weeks and 12 weeks of rehab. Return to play will be recorded as the number of months after the day of operation until subject returns to sport."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-35\n* Received ACL surgery with a patellar tendon autograft\n\nExclusion Criteria:\n\n* Concomitant meniscal tear or additional ligamentous injury to the knee\n* Obesity (BMI\\>30)\n* Diabetes\n* Cardiovascular, renal, liver or pulmonary disease\n* Active infections\n* Cancer (current or treated within the past 2 years) or coagulation disorder\n* Rapid weight change within the past year\n* Physically unable to participate in the intervention\n* Are not currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA. The NCAA banned substances list can be viewed from: http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs\n* Unable to complete a minimum of 85% of the assigned rehabilitation sessions.'}, 'identificationModule': {'nctId': 'NCT04484961', 'briefTitle': 'Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'Pro000138201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control - Routine Rehab', 'description': 'Participants in this group received standard ACL rehab with no blood flow restriction therapy.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental - BFR', 'description': 'Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.', 'interventionNames': ['Device: Blood flow restriction (BFR)']}], 'interventions': [{'name': 'Blood flow restriction (BFR)', 'type': 'DEVICE', 'description': 'The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.', 'armGroupLabels': ['Experimental - BFR']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patrick McCulloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Patrick McCulloch,MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}