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

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: Muscular Weakness
• Intervention / Treatment: Device: Blood Flow Restriction

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

• Study Contact: Name: Jason Brumitt, PhD; Phone Number: 5035542461; Email: jbrumitt@georgefox.edu
• Study Contact Backup: Name: Tyler Cuddeford, PhD; Phone Number: 5035542452; Email: tcuddeford@georgefox.edu

Study Locations

• United States
  • Oregon
    • Newberg, Oregon, United States, 97132
      • Recruiting
      • George Fox University School of Physical Therapy
      • Contact: Jason Brumitt, PhD; Phone Number: 5035542461; Email: jbrumitt@georgefox.edu
      • Contact: Jason Brumitt, PhD; Phone Number: 503-554-2461; Email: jbrumitt@georgefox.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Ultrasound images are capture at pre- and post-test sessions	Change from Baseline to 8-weeks

Collaborators and Investigators

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

Study record dates

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: infraspinatus, external rotators, blood flow restriction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• 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