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Blood Flow Restriction Training for The Shoulder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540367
Recruitment Status : Completed
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick McCulloch, The Methodist Hospital System

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Device: Blood flow restriction therapy Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomized to either perform exercises with blood flow restriction therapy or without
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020
Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Intervention: Control
Participants in this group performed the exercises without the blood flow restriction therapy cuff
Experimental: Experimental: BFR
Participants in this group performed the exercises with the blood flow restriction therapy cuff
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Determine if BFR changes loss of LE lean muscle mass [ Time Frame: Baseline and 8 weeks ]
    LE lean muscle mass was measured in grams using DEXA

  2. Isometric rotator cuff strength [ Time Frame: Baseline and 8 weeks ]
    Peak strength was measured using a hand-held dunamometer


Secondary Outcome Measures :
  1. Strength endurance [ Time Frame: Baseline and 8 weeks ]
    repetitions to fatigue (RTF) were performed for 3 exercises

  2. Electromyography [ Time Frame: Twice a week for 8 weeks ]
    wireless surface electromyography (EMG, Trigno, Delsys®, Natick, Massachusetts, USA) was recorded


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540367


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Investigators
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Principal Investigator: Patrick C McCulloch, MD The Methodist Hospital System
More Information
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Publications:
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.
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.
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
Sawilowsky SS. New effect size rules of thumb. J Mod Appl Stat Method. 2009;8(2):26.

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Responsible Party: Patrick McCulloch, Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT04540367    
Other Study ID Numbers: Pro00017362
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No