Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
69 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-11-10
Study Completion Date
2020-08-01
Brief Summary
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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.
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Detailed Description
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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).
Pitchers: 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).
Pitchers: 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).
Conditions
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Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants were randomized to either perform exercises with blood flow restriction therapy or without
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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No Intervention: Control
Participants in this group performed the exercises without the blood flow restriction therapy cuff
Group Type
NO_INTERVENTION
No interventions assigned to this group
Experimental: BFR
Participants in this group performed the exercises with the blood flow restriction therapy cuff
Group Type
EXPERIMENTAL
Blood flow restriction therapy
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Healthy, untrained volunteers
Exclusion Criteria
1. Previous history of shoulder injury occurring in the laterality of choice
2. Current painful dysfunction resulting in exercise limitation
3. Any health-related exercise limitation as ordered by physician
4. Vascular compromise or previous vascular surgery
5. Ages outside of 18-65
6. Inability to access clinic and equipment
7. Currently involved in structured strength training regimen of the upper extremity
2. Current painful dysfunction resulting in exercise limitation
3. Any health-related exercise limitation as ordered by physician
4. Vascular compromise or previous vascular surgery
5. Ages outside of 18-65
6. Inability to access clinic and equipment
7. Currently involved in structured strength training regimen of the upper extremity
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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The Methodist Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Patrick McCulloch,MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Patrick C McCulloch, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. Epub 2014 Apr 13.
Reference Type
BACKGROUND
Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
Reference Type
BACKGROUND
Cornish SM, Bugera EM, Duhamel TA, Peeler JD, Anderson JE. A focused review of myokines as a potential contributor to muscle hypertrophy from resistance-based exercise. Eur J Appl Physiol. 2020 May;120(5):941-959. doi: 10.1007/s00421-020-04337-1. Epub 2020 Mar 6.
Reference Type
BACKGROUND
Counts BR, Dankel SJ, Barnett BE, Kim D, Mouser JG, Allen KM, Thiebaud RS, Abe T, Bemben MG, Loenneke JP. Influence of relative blood flow restriction pressure on muscle activation and muscle adaptation. Muscle Nerve. 2016 Mar;53(3):438-45. doi: 10.1002/mus.24756. Epub 2015 Dec 29.
Reference Type
BACKGROUND
Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
Reference Type
BACKGROUND
Figueiredo VC, de Salles BF, Trajano GS. Volume for Muscle Hypertrophy and Health Outcomes: The Most Effective Variable in Resistance Training. Sports Med. 2018 Mar;48(3):499-505. doi: 10.1007/s40279-017-0793-0.
Reference Type
BACKGROUND
Glowacki SP, Martin SE, Maurer A, Baek W, Green JS, Crouse SF. Effects of resistance, endurance, and concurrent exercise on training outcomes in men. Med Sci Sports Exerc. 2004 Dec;36(12):2119-27. doi: 10.1249/01.mss.0000147629.74832.52.
Reference Type
BACKGROUND
Hollman JH, Berling TA, Crum EO, Miller KM, Simmons BT, Youdas JW. Do Verbal and Tactile Cueing Selectively Alter Gluteus Maximus and Hamstring Recruitment During a Supine Bridging Exercise in Active Females? A Randomized Controlled Trial. J Sport Rehabil. 2018 Mar 1;27(2):138-143. doi: 10.1123/jsr.2016-0130. Epub 2018 Mar 1.
Reference Type
BACKGROUND
Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
Reference Type
BACKGROUND
Hughes L, Rosenblatt B, Gissane C, Paton B, Patterson SD. Interface pressure, perceptual, and mean arterial pressure responses to different blood flow restriction systems. Scand J Med Sci Sports. 2018 Jul;28(7):1757-1765. doi: 10.1111/sms.13092. Epub 2018 Apr 30.
Reference Type
BACKGROUND
Illyes A, Kiss RM. Shoulder muscle activity during pushing, pulling, elevation and overhead throw. J Electromyogr Kinesiol. 2005 Jun;15(3):282-9. doi: 10.1016/j.jelekin.2004.10.005.
Reference Type
BACKGROUND
Lambert B, Hedt C, Epner E, et al. BFR For Proximal Benefit: Blood Flow Restriction Therapy For The Shoulder?: 3527: Board# 215 June 1 9: 30 AM-11: 00 AM. Med Sci Sports Exerc. 2019;51(6):972-973.
Reference Type
BACKGROUND
Lambert B, Hedt CA, Jack RA, et al. Blood Flow Restriction Therapy Preserves Whole Limb Bone and Muscle Following ACL Reconstruction. Orthop J Sports Med. 2019;7(3_suppl2):2325967119S2325900196.
Reference Type
BACKGROUND
Lambert BS, Hedt C, Moreno M, Harris JD, McCulloch P. Blood Flow Restriction Therapy for Stimulating Skeletal Muscle Growth: Practical Considerations for Maximizing Recovery in Clinical Rehabilitation Settings. Tech Orthop. 2018;33(2):89-97
Reference Type
BACKGROUND
Lambert BS, Shimkus KL, Fluckey JD, Riechman SE, Greene NP, Cardin JM, Crouse SF. Anabolic responses to acute and chronic resistance exercise are enhanced when combined with aquatic treadmill exercise. Am J Physiol Endocrinol Metab. 2015 Feb 1;308(3):E192-200. doi: 10.1152/ajpendo.00689.2013. Epub 2014 Nov 25.
Reference Type
BACKGROUND
Loenneke JP, Kim D, Fahs CA, Thiebaud RS, Abe T, Larson RD, Bemben DA, Bemben MG. Effects of exercise with and without different degrees of blood flow restriction on torque and muscle activation. Muscle Nerve. 2015 May;51(5):713-21. doi: 10.1002/mus.24448.
Reference Type
BACKGROUND
Madarame H, Neya M, Ochi E, Nakazato K, Sato Y, Ishii N. Cross-transfer effects of resistance training with blood flow restriction. Med Sci Sports Exerc. 2008 Feb;40(2):258-63. doi: 10.1249/mss.0b013e31815c6d7e.
Reference Type
BACKGROUND
Mattocks KT, Jessee MB, Counts BR, Buckner SL, Grant Mouser J, Dankel SJ, Laurentino GC, Loenneke JP. The effects of upper body exercise across different levels of blood flow restriction on arterial occlusion pressure and perceptual responses. Physiol Behav. 2017 Mar 15;171:181-186. doi: 10.1016/j.physbeh.2017.01.015. Epub 2017 Jan 11.
Reference Type
BACKGROUND
Oishi Y, Tsukamoto H, Yokokawa T, Hirotsu K, Shimazu M, Uchida K, Tomi H, Higashida K, Iwanaka N, Hashimoto T. Mixed lactate and caffeine compound increases satellite cell activity and anabolic signals for muscle hypertrophy. J Appl Physiol (1985). 2015 Mar 15;118(6):742-9. doi: 10.1152/japplphysiol.00054.2014. Epub 2015 Jan 8.
Reference Type
BACKGROUND
Oliver JM, Kreutzer A, Jenke SC, Phillips MD, Mitchell JB, Jones MT. Velocity Drives Greater Power Observed During Back Squat Using Cluster Sets. J Strength Cond Res. 2016 Jan;30(1):235-43. doi: 10.1519/JSC.0000000000001023.
Reference Type
BACKGROUND
Paddon-Jones D, Sheffield-Moore M, Cree MG, Hewlings SJ, Aarsland A, Wolfe RR, Ferrando AA. Atrophy and impaired muscle protein synthesis during prolonged inactivity and stress. J Clin Endocrinol Metab. 2006 Dec;91(12):4836-41. doi: 10.1210/jc.2006-0651. Epub 2006 Sep 19.
Reference Type
BACKGROUND
Ploughman M, Shears J, Quinton S, Flight C, O'brien M, MacCallum P, Kirkland MC, Byrne JM. Therapists' cues influence lower limb muscle activation and kinematics during gait training in subacute stroke. Disabil Rehabil. 2018 Dec;40(26):3156-3163. doi: 10.1080/09638288.2017.1380720. Epub 2017 Oct 17.
Reference Type
BACKGROUND
Rome S, Forterre A, Mizgier ML, Bouzakri K. Skeletal Muscle-Released Extracellular Vesicles: State of the Art. Front Physiol. 2019 Aug 9;10:929. doi: 10.3389/fphys.2019.00929. eCollection 2019.
Reference Type
BACKGROUND
Salles JI, Velasques B, Cossich V, Nicoliche E, Ribeiro P, Amaral MV, Motta G. Strength training and shoulder proprioception. J Athl Train. 2015 Mar;50(3):277-80. doi: 10.4085/1062-6050-49.3.84. Epub 2015 Jan 16.
Reference Type
BACKGROUND
Sawilowsky SS. New effect size rules of thumb. J Mod Appl Stat Method. 2009;8(2):26.
Reference Type
BACKGROUND
Scheuermann BW, Tripse McConnell JH, Barstow TJ. 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00017362
Identifier Type: -
Identifier Source: org_study_id
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