Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04596020
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessors will not be aware of group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strength Assessment', 'timeFrame': 'Change in Baseline Strength (Newtons) at 8 weeks', 'description': 'Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions'}, {'measure': 'Ultrasonography', 'timeFrame': 'Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks', 'description': 'Diagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood flow restriction', 'shoulder'], 'conditions': ['Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or non-BFR group. Both groups will do the same training program: 1) first sitting unilateral knee extension and standing unilateral knee curls (w/ or w/o BFR; 4 sets, 30/15/15/15 reps) and 2) scaption and sidelying external rotation (no BFR for either group; 3 sets x 15 reps each).', 'detailedDescription': "This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or a non-BFR group. Both groups will perform the same training program 2 times a week over 8 weeks with one group performing the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant leg).\n\nPrior to starting the study the subjects will have their strength assessed by a blinded physical therapist using a hand held dynamometer. The muscles assessed will be the: quadriceps, the hamstrings, the supraspinatus, and the external rotators of the shoulder. Another blinded physical therapist will assess the cross-sectional area of the quadriceps and the supraspinatus tendon using ultrasonography. These tests will be repeated at the conclusion of the study.\n\nSubjects' training weight will be 30% of their 1 repetition max (1RM). 1RM will be determined using hand held dumbbells for the shoulder exercises and machines (knee extension, knee curl machines) for the lower extremity exercises.\n\nSubjects will be randomized to either the BFR or non-BFR group. Subjects in the BFR group will perform the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant lower extremity). Both groups will perform 4 sets of each lower extremity exercise for 30/15/15/15 reps. After completing the lower extremity exercises the subjects will perform the shoulder exercises (scaption, sidelying external rotation) for 3 sets of 15 repetitions each. The shoulder exercises will not be performed with BFR in either group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Male or female subjects aged 18 and over\n\nExclusion Criteria:\n\n* Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology;\n* Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period;\n* Current lower extremity injury and/or having had a lower extremity surgery during the prior 6-month time period;\n* Cervical/thoracic spine surgery during the prior 1-year;\n* Subject having 1 or more contraindications for BFR training;\n* Under the age of 18 years.'}, 'identificationModule': {'nctId': 'NCT04596020', 'briefTitle': 'Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?', 'organization': {'class': 'OTHER', 'fullName': 'George Fox University'}, 'officialTitle': 'Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?', 'orgStudyIdInfo': {'id': '2183025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Flow Restriction Group', 'description': 'This group will perform 2 lower extremity exercises (sitting unilateral knee extension, standing unilateral knee curl) under occlusion (i.e., BFR) for 4 sets (30/15/15/15 reps) each followed by 2 shoulder exercises (scaption and sidelying external rotation) 3 sets x 15 reps each. Exercises will be performed at 30% of 1RM.', 'interventionNames': ['Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Blood Flow Restriction Group', 'description': 'This group will perform the same exercises for the same volume without the use of BFR.', 'interventionNames': ['Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)']}], 'interventions': [{'name': 'Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)', 'type': 'OTHER', 'otherNames': ['Non-Blood Flow Restriction Group (exercise without blood flow restriction)'], 'description': 'Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit', 'armGroupLabels': ['Blood Flow Restriction Group', 'Non-Blood Flow Restriction Group']}]}, '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': '504-554-2461'}, {'name': 'Jason Brumitt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marcey Keefer Hutchison, DPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dan Kang, DPT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'George Fox University', 'geoPoint': {'lat': 45.30012, 'lon': -122.97316}}], 'centralContacts': [{'name': 'Jason Brumitt, PhD', 'role': 'CONTACT', 'email': 'jbrumitt@georgefox.edu', 'phone': '15045542461'}], 'overallOfficials': [{'name': 'Jason Brumitt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Physical Therapy, George Fox University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Fox University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Therapy', 'investigatorFullName': 'Jason Brumitt', 'investigatorAffiliation': 'George Fox University'}}}}