Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04540367
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2020-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Blood Flow Restriction Training for The Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bslambert@houstonmethodist.org', 'phone': '8326872483', 'title': 'Bradley Lambert', 'organization': 'Houston Methodist Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks.', 'description': 'It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.', 'eventGroups': [{'id': 'EG000', 'title': 'No Intervention: Control (General Population)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental: BFR (General Population)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises. Additionally, these participants are considered part of the general population.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'No Intervention: Control (Pitchers)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff.\n\nAdditionally, these participants are considered the pitchers.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Experimental: BFR (Pitchers)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff Blood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.\n\nAdditionally, these participants are considered the pitchers.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Other', 'notes': 'The subject had an arm muscle strain from having an untrained arm. They were treated with ibuprofen, cleared by the PI and were able to complete the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine if BFR Changes UE Lean Muscle Mass in the General Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Population, No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'id': 'OG001', 'title': 'General Population, Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.'}], 'classes': [{'title': 'Upper extremity lean muscle mass at 8 weeks', 'categories': [{'measurements': [{'value': '-17', 'spread': '77', 'groupId': 'OG000'}, {'value': '175', 'spread': '54', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder region lean muscle mass at 8 weeks', 'categories': [{'measurements': [{'value': '96', 'spread': '61', 'groupId': 'OG000'}, {'value': '278', 'spread': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'UE lean muscle mass was measured in grams using DEXA. These data are reported as an average of both the left and right side.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Isometric Rotator Cuff Strength in General Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'id': 'OG001', 'title': 'Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.'}], 'classes': [{'title': 'Pre Flexion', 'categories': [{'measurements': [{'value': '12.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Flexion', 'categories': [{'measurements': [{'value': '11.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Pre Scaption', 'categories': [{'measurements': [{'value': '12', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Post Scaption', 'categories': [{'measurements': [{'value': '12.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 0', 'categories': [{'measurements': [{'value': '13.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 0', 'categories': [{'measurements': [{'value': '13.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 0', 'categories': [{'measurements': [{'value': '20.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 0', 'categories': [{'measurements': [{'value': '20.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 90', 'categories': [{'measurements': [{'value': '15.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '16', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 90', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 90', 'categories': [{'measurements': [{'value': '17.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 90', 'categories': [{'measurements': [{'value': '18.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitchers, No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'id': 'OG001', 'title': 'Pitchers, Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.'}], 'classes': [{'title': 'Shoulder Lean Muscle Mass in Throwing Arm at Baseline', 'categories': [{'measurements': [{'value': '4291.8', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '4279', 'spread': '52', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder Lean Muscle Mass in Non-Throwing Arm at Baseline', 'categories': [{'measurements': [{'value': '4284.1', 'spread': '55.9', 'groupId': 'OG000'}, {'value': '4272.1', 'spread': '55.5', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder Lean Muscle Mass in Throwing Arm at 8 Weeks', 'categories': [{'measurements': [{'value': '4307.3', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '4410.1', 'spread': '52', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder Lean Muscle Mass in Non-Throwing Arm at 8 Weeks', 'categories': [{'measurements': [{'value': '4347.3', 'spread': '56', 'groupId': 'OG000'}, {'value': '4346.2', 'spread': '55.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Shoulder lean muscle mass was measured in grams using DEXA. These data are reported for each arm.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Isometric Rotator Cuff Strength in Pitchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitchers, No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'id': 'OG001', 'title': 'Pitchers, Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.'}], 'classes': [{'title': 'Pre Flexion in Throwing Arm', 'categories': [{'measurements': [{'value': '14.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Post Flexion in Throwing Arm', 'categories': [{'measurements': [{'value': '13.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Pre Flexion in Non-throwing arm', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Post flexion in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '14.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Pre Scaption in Throwing Arm', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Post Scaption in Throwing Arm', 'categories': [{'measurements': [{'value': '14.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Pre Scaption in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Post Scaption in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 0 in Throwing Arm', 'categories': [{'measurements': [{'value': '16.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 0 in Throwing Arm', 'categories': [{'measurements': [{'value': '16.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 0 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '16.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 0 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '16.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 0 in Throwing Arm', 'categories': [{'measurements': [{'value': '24.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 0 in Throwing Arm', 'categories': [{'measurements': [{'value': '21.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 0 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '24.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 0 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '22.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 90 in Throwing Arm', 'categories': [{'measurements': [{'value': '19.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 90 in Throwing Arm', 'categories': [{'measurements': [{'value': '18.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Pre ER at 90 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '20.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Post ER at 90 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '21.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 90 in Throwing Arm', 'categories': [{'measurements': [{'value': '20.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 90 in Throwing Arm', 'categories': [{'measurements': [{'value': '20.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Pre IR at 90 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '19.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Post IR at 90 in Non-Throwing Arm', 'categories': [{'measurements': [{'value': '21.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Strength Endurance in General Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'id': 'OG001', 'title': 'Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.'}], 'classes': [{'title': 'Cable ER - Pre at 50% LOP', 'categories': [{'measurements': [{'value': '97.3', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '94.1', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Cable ER Post at 50% LOP', 'categories': [{'measurements': [{'value': '155.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '155.1', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Cable IR - Pre at 50% LOP', 'categories': [{'measurements': [{'value': '230.7', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '230.9', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': 'Cable IR - Post at 50% LOP', 'categories': [{'measurements': [{'value': '305.9', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '389.5', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Scaption - Pre at 50% LOP', 'categories': [{'measurements': [{'value': '134.8', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '137', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Scaption - Post at 50% LOP', 'categories': [{'measurements': [{'value': '211.2', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '240.3', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Cable ER - Pre without LOP', 'categories': [{'measurements': [{'value': '99.5', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '96.2', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Cable ER Post without LOP', 'categories': [{'measurements': [{'value': '157.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '155.9', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Cable IR - Pre at without LOP', 'categories': [{'measurements': [{'value': '249.1', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '249.3', 'spread': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Cable IR - Post at without LOP', 'categories': [{'measurements': [{'value': '342.2', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '407', 'spread': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Scaption - Pre at without LOP', 'categories': [{'measurements': [{'value': '138.6', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '140.2', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Scaption - Post without LOP', 'categories': [{'measurements': [{'value': '222.7', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '231.7', 'spread': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'repetitions to fatigue (RTF) were performed for 3 exercises. Volume (repetitions x resistance, kg) was calculated for each trial as is common for strength training investigations.\n\nAfter strength testing, participants were asked to perform the first of 2 endurance tests separated by 48 to 72 hours. On both occasions, a single set of repetitions to fatigue (RTF) were performed for 3 exercises in the following order: standing cable ER at 0 of shoulder abduction, standing cable IR at 0, and dumbbell scaption with each exercise separated by a 2-minute rest period and alternating between arms (order randomized). This test was performed in both groups with and without 50% limb occlusion pressure (LOP) applied by an automated tourniquet system. A nylon cuff was placed around the most proximal portion of the upper extremity for all testing. The order of testing was randomized between the 2 testing days for each participant.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Intervention: Control (General Population)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff.\n\nAdditionally, these participants are considered part of the general population.'}, {'id': 'FG001', 'title': 'Experimental: BFR (General Population)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.\n\nAdditionally, these participants are considered part of the general population.'}, {'id': 'FG002', 'title': 'No Intervention: Control (Pitchers)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff.\n\nAdditionally, these participants are considered the pitchers.'}, {'id': 'FG003', 'title': 'Experimental: BFR (Pitchers)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.\n\nAdditionally, these participants are considered the pitchers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'COVID-19 Contact Tracing Protocols prevented completion of study activities', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'No Intervention: Control (General Population)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population.'}, {'id': 'BG001', 'title': 'Experimental: BFR (General Population)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff\n\nBlood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises. Additionally, these participants are considered part of the general population.'}, {'id': 'BG002', 'title': 'No Intervention: Control (Pitchers)', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff.\n\nAdditionally, these participants are considered the pitchers.'}, {'id': 'BG003', 'title': 'Experimental: BFR (Pitchers)', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff Blood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.\n\nAdditionally, these participants are considered the pitchers.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '25.8', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '19.7', 'spread': '1.2', 'groupId': 'BG003'}, {'value': '26.7', 'spread': '8.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-19', 'size': 258501, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-22T10:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized to either perform exercises with blood flow restriction therapy or without'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2020-08-26', 'resultsFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-07', 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if BFR Changes UE Lean Muscle Mass in the General Population', 'timeFrame': 'Baseline and 8 weeks', 'description': 'UE lean muscle mass was measured in grams using DEXA. These data are reported as an average of both the left and right side.'}, {'measure': 'Isometric Rotator Cuff Strength in General Population', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.'}, {'measure': 'Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Shoulder lean muscle mass was measured in grams using DEXA. These data are reported for each arm.'}, {'measure': 'Isometric Rotator Cuff Strength in Pitchers', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.'}], 'secondaryOutcomes': [{'measure': 'Strength Endurance in General Population', 'timeFrame': 'Baseline and 8 weeks', 'description': 'repetitions to fatigue (RTF) were performed for 3 exercises. Volume (repetitions x resistance, kg) was calculated for each trial as is common for strength training investigations.\n\nAfter strength testing, participants were asked to perform the first of 2 endurance tests separated by 48 to 72 hours. On both occasions, a single set of repetitions to fatigue (RTF) were performed for 3 exercises in the following order: standing cable ER at 0 of shoulder abduction, standing cable IR at 0, and dumbbell scaption with each exercise separated by a 2-minute rest period and alternating between arms (order randomized). This test was performed in both groups with and without 50% limb occlusion pressure (LOP) applied by an automated tourniquet system. A nylon cuff was placed around the most proximal portion of the upper extremity for all testing. The order of testing was randomized between the 2 testing days for each participant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '12183514', 'type': 'BACKGROUND', 'citation': 'Adams GR. Invited Review: Autocrine/paracrine IGF-I and skeletal muscle adaptation. J Appl Physiol (1985). 2002 Sep;93(3):1159-67. doi: 10.1152/japplphysiol.01264.2001.'}, {'pmid': '20581041', 'type': 'BACKGROUND', 'citation': 'Burd NA, Holwerda AM, Selby KC, West DW, Staples AW, Cain NE, Cashaback JG, Potvin JR, Baker SK, Phillips SM. Resistance exercise volume affects myofibrillar protein synthesis and anabolic signalling molecule phosphorylation in young men. J Physiol. 2010 Aug 15;588(Pt 16):3119-30. doi: 10.1113/jphysiol.2010.192856. Epub 2010 Jun 25.'}, {'pmid': '19285766', 'type': 'BACKGROUND', 'citation': 'Cifrek M, Medved V, Tonkovic S, Ostojic S. Surface EMG based muscle fatigue evaluation in biomechanics. Clin Biomech (Bristol). 2009 May;24(4):327-40. doi: 10.1016/j.clinbiomech.2009.01.010. Epub 2009 Mar 13.'}, {'pmid': '17909396', 'type': 'BACKGROUND', 'citation': 'Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.'}, {'pmid': '24726484', 'type': 'BACKGROUND', 'citation': 'Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014 Oct;23(10):1454-61. doi: 10.1016/j.jse.2014.01.006. 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EMG and oxygen uptake responses during slow and fast ramp exercise in humans. Exp Physiol. 2002 Jan;87(1):91-100. doi: 10.1113/eph8702246.'}, {'pmid': '20360434', 'type': 'BACKGROUND', 'citation': 'Suga T, Okita K, Morita N, Yokota T, Hirabayashi K, Horiuchi M, Takada S, Omokawa M, Kinugawa S, Tsutsui H. Dose effect on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. J Appl Physiol (1985). 2010 Jun;108(6):1563-7. doi: 10.1152/japplphysiol.00504.2009. Epub 2010 Apr 1.'}, {'pmid': '22415101', 'type': 'BACKGROUND', 'citation': 'Suga T, Okita K, Takada S, Omokawa M, Kadoguchi T, Yokota T, Hirabayashi K, Takahashi M, Morita N, Horiuchi M, Kinugawa S, Tsutsui H. Effect of multiple set on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. Eur J Appl Physiol. 2012 Nov;112(11):3915-20. doi: 10.1007/s00421-012-2377-x. Epub 2012 Mar 14.'}, {'pmid': '15959798', 'type': 'BACKGROUND', 'citation': 'Takano H, Morita T, Iida H, Asada K, Kato M, Uno K, Hirose K, Matsumoto A, Takenaka K, Hirata Y, Eto F, Nagai R, Sato Y, Nakajima T. Hemodynamic and hormonal responses to a short-term low-intensity resistance exercise with the reduction of muscle blood flow. Eur J Appl Physiol. 2005 Sep;95(1):65-73. doi: 10.1007/s00421-005-1389-1. Epub 2005 Jun 15.'}, {'pmid': '11128848', 'type': 'BACKGROUND', 'citation': 'Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.'}, {'pmid': '10846023', 'type': 'BACKGROUND', 'citation': 'Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.'}, {'pmid': '18490165', 'type': 'BACKGROUND', 'citation': 'Troiano A, Naddeo F, Sosso E, Camarota G, Merletti R, Mesin L. Assessment of force and fatigue in isometric contractions of the upper trapezius muscle by surface EMG signal and perceived exertion scale. Gait Posture. 2008 Aug;28(2):179-86. doi: 10.1016/j.gaitpost.2008.04.002. Epub 2008 May 19.'}, {'pmid': '20618358', 'type': 'BACKGROUND', 'citation': 'Yasuda T, Fujita S, Ogasawara R, Sato Y, Abe T. Effects of low-intensity bench press training with restricted arm muscle blood flow on chest muscle hypertrophy: a pilot study. Clin Physiol Funct Imaging. 2010 Sep;30(5):338-343. doi: 10.1111/j.1475-097X.2010.00949.x. Epub 2010 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if BFR-LIX promotes greater increases in shoulder lean mass, rotator cuff strength, endurance, and acute increases in shoulder muscle activation compared to LIX alone.', 'detailedDescription': "Healthy Volunteers: Thirty-two healthy adults were randomized into two groups (BFRm=13,f=3, NoBFRm=10,f=6) that performed 8wks of shoulder LIX \\[2/wk, 4 sets (30/15/15/fatigue), 20%max\\] using common rotator cuff exercises \\[cable external rotation (ER), cable internal rotation (IR), dumbbell scaption (SCAP), and side-lying dumbbell ER (SLER)\\]. The BFR group also trained with an automated tourniquet placed at the proximal arm (50%-occlusion). Regional lean mass (dual-energy-xray-absorptiometry), isometric strength, and muscular endurance (repetitions-to-fatigue, RTF, 20%max, with and without 50%-occlusion) was measured before and after training. Electromyographic amplitude (EMGa) was also recorded from target shoulder muscles during endurance testing. A mixed-model ANCOVA (covaried on baseline measures) was used to detect within and between-group differences in primary outcome measures (α=0.05).\n\nPitchers: Twenty-eight collegiate baseball pitchers were randomized into 2 groups (BFRN=15, NOBFRN=13) that, in conjunction with offseason training, performed 8wks of shoulder LIX \\[Throwing arm only; 2/wk, 4 sets (30/15/15/fatigue), 20%isometric max\\] using 4 exercises \\[cable external and internal rotation (ER/IR), dumbbell scaption, and side-lying dumbbell ER\\]. The BFR group also trained with an automated tourniquet on the proximal arm (50%-occlusion). Regional lean mass (dual-energy x-ray absorptiometry), rotator cuff strength (dynamometry: IR0\\&90, ° ER0\\&90, ° Scaption, Flexion), and fastball biomechanics were assessed pre- and post-training. Achievable workload (sets × reps × resistance) was also recorded. An ANCOVA (covaried on baseline measures) repeated on training timepoint was used to detect within-group and between-group differences in outcome measures (α=0.05). For significant pairwise comparisons, effect size (ES) was calculated using a Cohen's d statistic and interpreted as: 0-0.1, negligible(N); 0.1-0.3, small(S); 0.3-0.5, moderate(M); 0.5-0.7, large(L); \\>0.7, very large(VL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, untrained volunteers\n\nExclusion Criteria:\n\n1. Previous history of shoulder injury occurring in the laterality of choice\n2. Current painful dysfunction resulting in exercise limitation\n3. Any health-related exercise limitation as ordered by physician\n4. Vascular compromise or previous vascular surgery\n5. Ages outside of 18-65\n6. Inability to access clinic and equipment\n7. Currently involved in structured strength training regimen of the upper extremity'}, 'identificationModule': {'nctId': 'NCT04540367', 'briefTitle': 'Blood Flow Restriction Training for The Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit', 'orgStudyIdInfo': {'id': 'Pro00017362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control', 'description': 'Participants in this group performed the exercises without the blood flow restriction therapy cuff'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: BFR', 'description': 'Participants in this group performed the exercises with the blood flow restriction therapy cuff', 'interventionNames': ['Device: Blood flow restriction therapy']}], 'interventions': [{'name': 'Blood flow restriction therapy', 'type': 'DEVICE', 'description': 'The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.', 'armGroupLabels': ['Experimental: BFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Patrick C McCulloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patrick McCulloch,MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}