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

Not Applicable

• Conditions: Muscular Weakness
• Interventions: Device: Blood Flow Restriction

• Registration Number: NCT03815760
• Lead Sponsor: George Fox University

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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-17
• Study Start: 2019-01-18
• Study First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Study First Posted: 2019-01-24
• Last Update Posted: 2019-01-24
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise with Blood Flow Restriction	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.
Exercise without Blood Flow Restriction	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.

Primary Outcome Measures

Name	Time	Method
Muscular Strength as Measured by Dynamometry	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
Tendon Size as Measured by Diagnostic Ultrasound	Change from Baseline to 8-weeks	Ultrasound images are capture at pre- and post-test sessions

Trial Locations

Locations (1)

George Fox University School of Physical Therapy; 🇺🇸 Newberg, Oregon, United States