<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815760</url>
  </required_header>
  <id_info>
    <org_study_id>2181055</org_study_id>
    <nct_id>NCT03815760</nct_id>
  </id_info>
  <brief_title>Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone</brief_title>
  <official_title>Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Fox University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Fox University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the ability of blood flow restriction therapy to&#xD;
      improve strength of shoulder muscles during the sidelying external rotation (ER) exercise&#xD;
      versus a control group who only performs the sidelying ER exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if blood flow restriction (BFR) therapy is superior&#xD;
      at increasing strength of the shoulder (supraspinatus, infraspinatus, posterior deltoid, and&#xD;
      middle deltoid) and increasing tendon size of the supraspinatus and infraspinatus (as&#xD;
      determined by diagnostic ultrasound) while performing the sidelying external rotation&#xD;
      exercise compared to those who only perform the sideyling external rotation exercise without&#xD;
      BFR.&#xD;
&#xD;
      Subjects will be randomized to one of two treatment groups: exercise with BFR or exercise&#xD;
      alone. Recruitment will be a sample of convenience consisting of healthy adults (age range 22&#xD;
      to 45). Subjects will perform the sidelying external rotation exercise 2 times a week for an&#xD;
      8 week period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Anticipated">May 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessors are blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Muscular Strength as Measured by Dynamometry</measure>
    <time_frame>Change from Baseline to 8-weeks</time_frame>
    <description>Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tendon Size as Measured by Diagnostic Ultrasound</measure>
    <time_frame>Change from Baseline to 8-weeks</time_frame>
    <description>Ultrasound images are capture at pre- and post-test sessions</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Muscular Weakness</condition>
  <arm_group>
    <arm_group_label>Exercise with Blood Flow Restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks.&#xD;
The BFR cuff will be applied to the upper arm. Arterial occlusion will be set to 50%.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise without Blood Flow Restriction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will perform the sidelying external rotation exercise 2x a week for 8 weeks.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood Flow Restriction</intervention_name>
    <description>Subjects will perform sidelying external rotation exercise</description>
    <arm_group_label>Exercise with Blood Flow Restriction</arm_group_label>
    <arm_group_label>Exercise without Blood Flow Restriction</arm_group_label>
    <other_name>Exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Healthy adult (age 18 and older) with no current shoulder pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology&#xD;
&#xD;
          2. Shoulder surgery (or general upper extremity surgery) during the prior 6-month time&#xD;
             period&#xD;
&#xD;
          3. Cervical/thoracic spine surgery during the prior 1 year&#xD;
&#xD;
          4. Subject having one or more contraindications for BFR training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Brumitt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Fox University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jason Brumitt, PhD</last_name>
    <phone>5035542461</phone>
    <email>jbrumitt@georgefox.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tyler Cuddeford, PhD</last_name>
    <phone>5035542452</phone>
    <email>tcuddeford@georgefox.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>George Fox University School of Physical Therapy</name>
      <address>
        <city>Newberg</city>
        <state>Oregon</state>
        <zip>97132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Brumitt, PhD</last_name>
      <phone>503-554-2461</phone>
      <email>jbrumitt@georgefox.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jason Brumitt, PhD</last_name>
      <phone>5035542461</phone>
      <email>jbrumitt@georgefox.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Fox University</investigator_affiliation>
    <investigator_full_name>Jason Brumitt</investigator_full_name>
    <investigator_title>Assistant Professor of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>infraspinatus, external rotators, blood flow restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 3, 2019</submitted>
    <returned>October 22, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815760
org study id: 2181055
nct id: NCT03815760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessors are blinded to group allocation.
measure: Muscular Strength as Measured by Dynamometry
time frame: Change from Baseline to 8-weeks
description: Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus
measure: Tendon Size as Measured by Diagnostic Ultrasound
time frame: Change from Baseline to 8-weeks
description: Ultrasound images are capture at pre- and post-test sessions
arm group label: Exercise with Blood Flow Restriction
arm group type: Experimental
description: 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.
arm group label: Exercise without Blood Flow Restriction
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Blood Flow Restriction
description: Subjects will perform sidelying external rotation exercise
arm group label: Exercise with Blood Flow Restriction
arm group label: Exercise without Blood Flow Restriction
other name: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Brumitt, PhD
role: Principal Investigator
affiliation: George Fox University
last name: Jason Brumitt, PhD
phone: 5035542461
email: jbrumitt@georgefox.edu
last name: Tyler Cuddeford, PhD
phone: 5035542452
email: tcuddeford@georgefox.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: George Fox University
investigator full name: Jason Brumitt
investigator title: Assistant Professor of Physical Therapy
mesh term: Muscle Weakness
sharing ipd: No
submitted: October 3, 2019
returned: October 22, 2019