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

Primary Purpose

Muscular Weakness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction
Sponsored by
George Fox University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Weakness focused on measuring infraspinatus, external rotators, blood flow restriction

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • George Fox University School of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise with Blood Flow Restriction

Exercise without Blood Flow Restriction

Arm 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.

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.

Outcomes

Primary Outcome Measures

Muscular Strength as Measured by Dynamometry
Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus
Tendon Size as Measured by Diagnostic Ultrasound
Ultrasound images are capture at pre- and post-test sessions

Secondary Outcome Measures

Full Information

First Posted
January 17, 2019
Last Updated
January 22, 2019
Sponsor
George Fox University
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1. Study Identification

Unique Protocol Identification Number
NCT03815760
Brief Title
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Official Title
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Fox University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Weakness
Keywords
infraspinatus, external rotators, blood flow restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessors are blinded to group allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise with Blood Flow Restriction
Arm Type
Experimental
Arm 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 Title
Exercise without Blood Flow Restriction
Arm Type
Active Comparator
Arm 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(s)
Blood Flow Restriction
Other Intervention Name(s)
Exercise
Intervention Description
Subjects will perform sidelying external rotation exercise
Primary Outcome Measure Information:
Title
Muscular Strength as Measured by Dynamometry
Description
Use a hand held dynamometer (MicroFet 2) to measure strength of the middle and posterior deltoid, the supraspinatus, and the infraspinatus
Time Frame
Change from Baseline to 8-weeks
Title
Tendon Size as Measured by Diagnostic Ultrasound
Description
Ultrasound images are capture at pre- and post-test sessions
Time Frame
Change from Baseline to 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Healthy adult (age 18 and older) with no current shoulder pathology Exclusion Criteria: Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period Cervical/thoracic spine surgery during the prior 1 year Subject having one or more contraindications for BFR training.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Brumitt, PhD
Phone
5035542461
Email
jbrumitt@georgefox.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Cuddeford, PhD
Phone
5035542452
Email
tcuddeford@georgefox.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
Organizational Affiliation
George Fox University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Fox University School of Physical Therapy
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
Phone
503-554-2461
Email
jbrumitt@georgefox.edu
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
Phone
5035542461
Email
jbrumitt@georgefox.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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