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Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone

Sponsor
George Fox University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03815760
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood Flow Restriction
 N/A

Detailed Description

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.

Subjects 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessors are blinded to group allocation.
Primary Purpose:
Treatment
Official Title:
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Actual Study Start Date :
Jan 18, 2019
Anticipated Primary Completion Date :
May 30, 2019
Anticipated Study Completion Date :
May 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise with Blood Flow Restriction

Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks. The BFR cuff will be applied to the upper arm. Arterial occlusion will be set to 50%. Subjects 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.

Device: Blood Flow Restriction
Subjects will perform sidelying external rotation exercise
Other Names:
  • Exercise

    		•
    Active Comparator: Exercise without Blood Flow Restriction

    Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks. This group will not have BFR applied. Subjects will perform 4 sets (30, 15, 15, 15 reps) with a 30 sec rest period between reps.

    Device: Blood Flow Restriction
    Subjects will perform sidelying external rotation exercise
    Other Names:
  • Exercise

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Muscular Strength as Measured by Dynamometry [Change from Baseline to 8-weeks]

      Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus

    2. Tendon Size as Measured by Diagnostic Ultrasound [Change from Baseline to 8-weeks]

      Ultrasound images are capture at pre- and post-test sessions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Healthy adult (age 18 and older) with no current shoulder pathology
    Exclusion Criteria:

    1. Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology

    2. Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period

    3. Cervical/thoracic spine surgery during the prior 1 year

    4. Subject having one or more contraindications for BFR training.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George Fox University School of Physical Therapy Newberg Oregon United States 97132

    Sponsors and Collaborators

    • George Fox University

    Investigators

    • Principal Investigator: Jason Brumitt, PhD, George Fox University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Brumitt, Assistant Professor of Physical Therapy, George Fox University
    ClinicalTrials.gov Identifier:
    NCT03815760
    Other Study ID Numbers:
    • 2181055
    First Posted:
    Jan 24, 2019
    Last Update Posted:
    Jan 24, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Keywords provided by Jason Brumitt, Assistant Professor of Physical Therapy, George Fox University
    infraspinatus, external rotators, blood flow restriction
    Additional relevant MeSH terms:
    Muscle Weakness

    Study Results

    No Results Posted as of Jan 24, 2019