Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or non-BFR group. Both groups will do the same training program: 1) first sitting unilateral knee extension and standing unilateral knee curls (w/ or w/o BFR; 4 sets, 30/15/15/15 reps) and 2) scaption and sidelying external rotation (no BFR for either group; 3 sets x 15 reps each).

Study Overview

• Status: Unknown
• Conditions: Muscle Weakness; Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff
• Intervention / Treatment: Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)

Detailed Description

This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or a non-BFR group. Both groups will perform the same training program 2 times a week over 8 weeks with one group performing the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant leg).

Prior to starting the study the subjects will have their strength assessed by a blinded physical therapist using a hand held dynamometer. The muscles assessed will be the: quadriceps, the hamstrings, the supraspinatus, and the external rotators of the shoulder. Another blinded physical therapist will assess the cross-sectional area of the quadriceps and the supraspinatus tendon using ultrasonography. These tests will be repeated at the conclusion of the study.

Subjects' training weight will be 30% of their 1 repetition max (1RM). 1RM will be determined using hand held dumbbells for the shoulder exercises and machines (knee extension, knee curl machines) for the lower extremity exercises.

Subjects will be randomized to either the BFR or non-BFR group. Subjects in the BFR group will perform the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant lower extremity). Both groups will perform 4 sets of each lower extremity exercise for 30/15/15/15 reps. After completing the lower extremity exercises the subjects will perform the shoulder exercises (scaption, sidelying external rotation) for 3 sets of 15 repetitions each. The shoulder exercises will not be performed with BFR in either group.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Newberg, Oregon, United States, 97132
      • Recruiting
      • George Fox University
      • Contact: Jason Brumitt, PhD; Phone Number: 504-554-2461; Email: jbrumitt@georgefox.edu
      • Principal Investigator: Jason Brumitt, PhD
      • Sub-Investigator: Marcey Keefer Hutchison, DPT
      • Sub-Investigator: Dan Kang, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects aged 18 and over

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;
• Current lower extremity injury and/or having had a lower extremity surgery during the prior 6-month time period;
• Cervical/thoracic spine surgery during the prior 1-year;
• Subject having 1 or more contraindications for BFR training;
• Under the age of 18 years.

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: Blood Flow Restriction Group; This group will perform 2 lower extremity exercises (sitting unilateral knee extension, standing unilateral knee curl) under occlusion (i.e., BFR) for 4 sets (30/15/15/15 reps) each followed by 2 shoulder exercises (scaption and sidelying external rotation) 3 sets x 15 reps each. Exercises will be performed at 30% of 1RM.	Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit); Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit; Other Names: Non-Blood Flow Restriction Group (exercise without blood flow restriction)
Active Comparator: Non-Blood Flow Restriction Group; This group will perform the same exercises for the same volume without the use of BFR.	Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit); Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit; Other Names: Non-Blood Flow Restriction Group (exercise without blood flow restriction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength Assessment	Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions	Change in Baseline Strength (Newtons) at 8 weeks
Ultrasonography	Diagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus	Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks

Collaborators and Investigators

• Sponsor: George Fox University
• Investigators: Principal Investigator: Jason Brumitt, PhD, College of Physical Therapy, George Fox University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): December 7, 2020
• Study Completion (Anticipated): December 7, 2020

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: shoulder; 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: 2183025

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: No