Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03055260
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Intensity Blood Flow Restriction Training Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'russell.giveans@gmail.com', 'phone': '5042314007', 'title': 'Russel Giveans', 'organization': 'University of Minenesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'No participants completed the placebo arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Blood Flow Restriction Cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.\n\nBlood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Blood Flow Restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.\n\nBlood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'One Repetition Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blood Flow Restriction Cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.\n\nBlood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}, {'id': 'OG001', 'title': 'Blood Flow Restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.\n\nBlood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}], 'classes': [{'categories': [{'measurements': [{'value': '302.9', 'spread': '67.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'One repetition maximum on the single leg press. Isometric quadriceps extension strength.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed the placebo arm.'}, {'type': 'SECONDARY', 'title': 'Quadriceps Muscle Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Blood Flow Restriction Cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.\n\nBlood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}, {'id': 'OG001', 'title': 'Blood Flow Restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.\n\nBlood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants completed the placebo arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Blood Flow Restriction Cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.\n\nBlood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}, {'id': 'FG001', 'title': 'Blood Flow Restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.\n\nBlood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Blood Flow Restriction Cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.\n\nBlood flow restriction cuff: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}, {'id': 'BG001', 'title': 'Blood Flow Restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.\n\nBlood Flow restriction Cuff-Placebo: The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'One Repetition Maximum', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '267.1', 'spread': '63.2', 'groupId': 'BG000'}, {'value': '267.1', 'spread': '63.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.'}, {'title': 'Quadriceps Muscle Thickness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.4', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure.'}], 'populationDescription': 'No participants completed the placebo arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-01', 'size': 199726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-30T13:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2017-02-08', 'resultsFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One Repetition Maximum', 'timeFrame': '6 weeks', 'description': 'One repetition maximum on the single leg press. Isometric quadriceps extension strength.'}], 'secondaryOutcomes': [{'measure': 'Quadriceps Muscle Thickness', 'timeFrame': '6 weeks', 'description': 'Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Muscle Mass']}, 'referencesModule': {'references': [{'pmid': '21922259', 'type': 'BACKGROUND', 'citation': 'Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.'}, {'pmid': '26463594', 'type': 'BACKGROUND', 'citation': 'Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.'}]}, 'descriptionModule': {'briefSummary': "The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. After baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested and compared to the initial measurements.", 'detailedDescription': 'Session 1 - baseline testing\n\n* 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements of both right and left quadriceps muscle using ultrasound technology.\n* After day 1 testing; randomly allocate subjects to either control group or experimental group\n\nSessions 2-13 - 6 weeks of exercise protocol, 2x/per week\n\nBoth the experimental and control groups will complete the same protocol for the entirety of the study:\n\n* 5- minute warm up\n* Using a single-leg press exercise machine: Subjects complete the testing protocol with either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb.\n\n * Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by \\~30-90 seconds.\n * Right and left legs will be alternating, but only one leg will have the occlusion cuff\n\nSession 14 - Re-test\n\n\\- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-49\n\nExclusion Criteria:\n\n* Pregnant\n* Hypertensive\n* Recent back or lower extremity injury\n* History of blood clotting\n* Varicose veins\n* Adults lacking the capacity to consent for themselves'}, 'identificationModule': {'nctId': 'NCT03055260', 'briefTitle': 'Low Intensity Blood Flow Restriction Training Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy', 'orgStudyIdInfo': {'id': '1612M02121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood flow restriction cuff', 'description': 'This group will receive an active cuff that partially restricts blood flow to the experimental limb.', 'interventionNames': ['Device: Blood flow restriction cuff']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Blood Flow restriction Cuff-Placebo', 'description': 'This group will wear a placebo cuff, of which will not restrict blood flow at all.', 'interventionNames': ['Device: Blood Flow restriction Cuff-Placebo']}], 'interventions': [{'name': 'Blood flow restriction cuff', 'type': 'DEVICE', 'description': 'The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.', 'armGroupLabels': ['Blood flow restriction cuff']}, {'name': 'Blood Flow restriction Cuff-Placebo', 'type': 'DEVICE', 'description': 'The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.', 'armGroupLabels': ['Blood Flow restriction Cuff-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Health Services', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jon Schoenecker, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fairview Health Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fairview Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}