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

Muscular Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03815760
• Other study ID #: 2181055
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: January 2019
• Source: George Fox University
• Contact: Jason Brumitt, PhD
• Phone: 5035542461
• Email: jbrumitt[@]georgefox.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Muscular Weakness

Intervention

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

Locations

Country	Name	City	State
United States	George Fox University School of Physical Therapy	Newberg	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
George Fox University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tendon Size as Measured by Diagnostic Ultrasound	Ultrasound images are capture at pre- and post-test sessions	Change from Baseline to 8-weeks