Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-07 @ 10:23 AM
Study NCT ID:
NCT03815760
Status:
UNKNOWN
Last Update Posted:
2019-01-24
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-22', 'releaseDate': '2019-10-03'}], 'estimatedResultsFirstSubmitDate': '2019-10-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessors are blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-22', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscular Strength as Measured by Dynamometry', 'timeFrame': 'Change from Baseline to 8-weeks', 'description': 'Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus'}, {'measure': 'Tendon Size as Measured by Diagnostic Ultrasound', 'timeFrame': 'Change from Baseline to 8-weeks', 'description': 'Ultrasound images are capture at pre- and post-test sessions'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['infraspinatus, external rotators, blood flow restriction'], 'conditions': ['Muscular Weakness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ability of blood flow restriction therapy to improve strength of shoulder muscles during the sidelying external rotation (ER) exercise versus a control group who only performs the sidelying ER exercise.', 'detailedDescription': 'The purpose of this study is to determine if blood flow restriction (BFR) therapy is superior at increasing strength of the shoulder (supraspinatus, infraspinatus, posterior deltoid, and middle deltoid) and increasing tendon size of the supraspinatus and infraspinatus (as determined by diagnostic ultrasound) while performing the sidelying external rotation exercise compared to those who only perform the sideyling external rotation exercise without BFR.\n\nSubjects will be randomized to one of two treatment groups: exercise with BFR or exercise alone. Recruitment will be a sample of convenience consisting of healthy adults (age range 22 to 45). Subjects will perform the sidelying external rotation exercise 2 times a week for an 8 week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Healthy adult (age 18 and older) with no current shoulder pathology\n\nExclusion Criteria:\n\n1. Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology\n2. Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period\n3. Cervical/thoracic spine surgery during the prior 1 year\n4. Subject having one or more contraindications for BFR training.'}, 'identificationModule': {'nctId': 'NCT03815760', 'briefTitle': 'Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone', 'organization': {'class': 'OTHER', 'fullName': 'George Fox University'}, 'officialTitle': 'Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone', 'orgStudyIdInfo': {'id': '2181055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise with Blood Flow Restriction', 'description': 'Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks.\n\nThe BFR cuff will be applied to the upper arm. Arterial occlusion will be set to 50%.\n\nSubjects will perform 4 sets (30, 15, 15, 15 reps) with a 30 sec rest period between reps. The occlusion will be maintained for the 8 min treatment period.', 'interventionNames': ['Device: Blood Flow Restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise without Blood Flow Restriction', 'description': 'Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks.\n\nThis group will not have BFR applied. Subjects will perform 4 sets (30, 15, 15, 15 reps) with a 30 sec rest period between reps.', 'interventionNames': ['Device: Blood Flow Restriction']}], 'interventions': [{'name': 'Blood Flow Restriction', 'type': 'DEVICE', 'otherNames': ['Exercise'], 'description': 'Subjects will perform sidelying external rotation exercise', 'armGroupLabels': ['Exercise with Blood Flow Restriction', 'Exercise without Blood Flow Restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97132', 'city': 'Newberg', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Brumitt, PhD', 'role': 'CONTACT', 'email': 'jbrumitt@georgefox.edu', 'phone': '503-554-2461'}, {'name': 'Jason Brumitt, PhD', 'role': 'CONTACT', 'email': 'jbrumitt@georgefox.edu', 'phone': '5035542461'}], 'facility': 'George Fox University School of Physical Therapy', 'geoPoint': {'lat': 45.30012, 'lon': -122.97316}}], 'centralContacts': [{'name': 'Jason Brumitt, PhD', 'role': 'CONTACT', 'email': 'jbrumitt@georgefox.edu', 'phone': '5035542461'}, {'name': 'Tyler Cuddeford, PhD', 'role': 'CONTACT', 'email': 'tcuddeford@georgefox.edu', 'phone': '5035542452'}], 'overallOfficials': [{'name': 'Jason Brumitt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Fox University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Fox University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physical Therapy', 'investigatorFullName': 'Jason Brumitt', 'investigatorAffiliation': 'George Fox University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-10-03', 'type': 'RELEASE'}, {'date': '2019-10-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jason Brumitt, Assistant Professor of Physical Therapy, George Fox University'}}}}