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

January 22, 2019 updated by: Jason Brumitt, George Fox University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • George Fox University School of Physical Therapy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular Strength as Measured by Dynamometry
Time Frame: 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
Change from Baseline to 8-weeks
Tendon Size as Measured by Diagnostic Ultrasound
Time Frame: Change from Baseline to 8-weeks
Ultrasound images are capture at pre- and post-test sessions
Change from Baseline to 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Fox University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

May 30, 2019

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe