Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 10:18 AM
Study NCT ID:
NCT05868304
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Force plate measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4, 6, 8, 12, and 16 weeks.', 'description': 'Force (N)'}, {'measure': 'The change in Force plate measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Power (W)'}, {'measure': 'The change in Force plate measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Velocity M/Se'}, {'measure': 'the changes in Force plate measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Relative strength index (RSI)'}, {'measure': 'the change in Force plate measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Displacement'}, {'measure': 'the changes in Force Frame measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Force (N)'}, {'measure': 'the changes in Force Frame measures from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'power (W)'}, {'measure': 'the changes in Force Frame measure from baseline to 16 weeks', 'timeFrame': 'Measured at 4,6,8,12 and 16 weeks.', 'description': 'Velocity M/sec'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Flow Restriction (BFR)', 'Healthy Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.', 'detailedDescription': 'The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. The primary research procedures are:\n\nSubjects will be randomized into either BFR or conventional strengthening groups.\n\nBFR and conventional strengthening programs will be implemented. Force plate and force frame data will be collected at baseline, 4, 6, 8, 12, and 16 weeks.\n\nSubject Population. The study will enroll 18 healthy volunteers. The study includes 6 visits.\n\nThe total study duration for each subject is 16 weeks.\n\nThe device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers without history of knee pathology requiring physical therapy or surgery\n* Individuals between 18 and 40 years old\n\nExclusion Criteria:\n\n* History of venous thromboembolism or other hematologic disorder Pregnant\n* Coronary artery disease, peripheral arterial disease, or hypertension (\\> 140/90 mmHg)'}, 'identificationModule': {'nctId': 'NCT05868304', 'briefTitle': 'Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00002454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 - Standard strengthening group (no BFR)', 'description': 'Participants will warm up on a stationary bike for 5 minutes\n\nThe program will consist of the following exercises using a 30,15,15,15 rep scheme:\n\nBanded squats Step ups (8 inch) Romanian dead lifts (RDL)', 'interventionNames': ['Other: Stanard strengthening program.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - Low-load BFR group', 'description': 'Participants will warm up on a stationary bike for 5 minutes BFR will be applied to non-dominant limb (dominant limb is determined as the preferred leg for kicking a ball)\n\nThe program will consist of the following exercises using a 30,15,15,15 rep scheme:\n\nBanded squats Step ups (8 inch) Romanian dead lifts (RDL)', 'interventionNames': ['Device: BFR', 'Other: Stanard strengthening program.']}], 'interventions': [{'name': 'BFR', 'type': 'DEVICE', 'description': 'Exercises may involve warm up on a stationary bike for 5 minutes, application of a BFR cuff (a cuff that often uses air to inflate around a limb) on the selected extremity, and exercise sets (e.g. banded squats, step ups, Romanian dead lifts). We will record metrics on an iPad. Testing will be done with ForceDecks and ForceFrames (system for measuring muscle strength and imbalance).', 'armGroupLabels': ['Group 2 - Low-load BFR group']}, {'name': 'Stanard strengthening program.', 'type': 'OTHER', 'description': 'The exercise program will be completed 3 times per week Participants will warm up on a stationary bike for 5 minutes\n\nThe program will consist of the following exercises using a 30,15,15,15 rep scheme:\n\nBanded squats Step ups (8 inch) Romanian dead lifts (RDL)', 'armGroupLabels': ['Group 1 - Standard strengthening group (no BFR)', 'Group 2 - Low-load BFR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedar Sinai Kerlan jobe orthopedic institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Orr Limpisvasti', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}