Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-02 @ 5:07 AM
Study NCT ID:
NCT06496035
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'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': 'NONE', 'maskingDescription': "Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture healing', 'timeFrame': '6 weeks, 12 weeks, 6 months', 'description': 'Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months', 'description': 'Knee extension and ankle plantarflexion strength measured with a dynamometer'}, {'measure': 'Muscle girth', 'timeFrame': '2, 4, 6, 12 weeks and 6 months', 'description': 'Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line'}, {'measure': 'Physical function', 'timeFrame': '2, 6,12 weeks and 6 months', 'description': 'Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tibial Fractures', 'Lower Extremity Fracture']}, 'descriptionModule': {'briefSummary': 'This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.', 'detailedDescription': 'This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with closed tibial shaft fracture\n* Ability to begin physical therapy treatment within 2 weeks post-operatively\n\nExclusion Criteria:\n\n* History of osteoporosis or osteopenia\n* Impaired circulation in the limb\n* Active deep vein thrombosis\n* Clotting disorders or other elevated risk of embolism\n* Sickle cell anemia\n* Infection in extremity\n* Renal compromise\n* Severe uncontrolled hypertension (SBP\\>180)\n* Lymphedema\n* Under age 18\n* Pregnancy\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT06496035', 'briefTitle': 'Blood Flow Restriction Training in Patients With Lower Extremity Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function', 'orgStudyIdInfo': {'id': '24-0894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood flow restriction training', 'description': 'Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device', 'interventionNames': ['Device: Blood Flow Restriction with low load exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional physical therapy', 'description': 'Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.', 'interventionNames': ['Other: Therapeutic Exercise']}], 'interventions': [{'name': 'Blood Flow Restriction with low load exercise', 'type': 'DEVICE', 'description': 'Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.', 'armGroupLabels': ['Blood flow restriction training']}, {'name': 'Therapeutic Exercise', 'type': 'OTHER', 'description': 'Exercise performed at appropriate load as guided by physical therapist', 'armGroupLabels': ['Traditional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan E Smith, PT, DPT', 'role': 'CONTACT', 'email': 'megan.smith@dhha.org', 'phone': '651-319-1730'}, {'name': 'Mathew A Haager, PT, DPT', 'role': 'CONTACT', 'email': 'mat.haager@dhha.org', 'phone': '5639407061'}], 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Megan E Smith, PT, DPT', 'role': 'CONTACT', 'email': 'megan.smith@dhha.org', 'phone': '6513191730'}, {'name': 'Mathew A Haager, PT, DPT', 'role': 'CONTACT', 'email': 'mat.haager@dhha.org', 'phone': '5639407061'}], 'overallOfficials': [{'name': 'Megan E Smith, PT, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}