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

Primary Purpose

Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff, Muscle Weakness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)
Sponsored by
George Fox University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff focused on measuring blood flow restriction, shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • George Fox UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Flow Restriction Group

Non-Blood Flow Restriction Group

Arm Description

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.

This group will perform the same exercises for the same volume without the use of BFR.

Outcomes

Primary Outcome Measures

Strength Assessment
Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions
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

Secondary Outcome Measures

Full Information

First Posted
October 8, 2020
Last Updated
October 15, 2020
Sponsor
George Fox University
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1. Study Identification

Unique Protocol Identification Number
NCT04596020
Brief Title
Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
Official Title
Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Anticipated)
Study Completion Date
December 7, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Fox University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff, Muscle Weakness
Keywords
blood flow restriction, shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessors will not be aware of group allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Blood Flow Restriction Group
Arm Type
Active Comparator
Arm Description
This group will perform the same exercises for the same volume without the use of BFR.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)
Other Intervention Name(s)
Non-Blood Flow Restriction Group (exercise without blood flow restriction)
Intervention Description
Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit
Primary Outcome Measure Information:
Title
Strength Assessment
Description
Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions
Time Frame
Change in Baseline Strength (Newtons) at 8 weeks
Title
Ultrasonography
Description
Diagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus
Time Frame
Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Brumitt, PhD
Phone
15045542461
Email
jbrumitt@georgefox.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
Organizational Affiliation
College of Physical Therapy, George Fox University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Fox University
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
Phone
504-554-2461
Email
jbrumitt@georgefox.edu
First Name & Middle Initial & Last Name & Degree
Jason Brumitt, PhD
First Name & Middle Initial & Last Name & Degree
Marcey Keefer Hutchison, DPT
First Name & Middle Initial & Last Name & Degree
Dan Kang, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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

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