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

NCT ID: NCT03815760

Last Updated: 2019-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2019-05-30

Brief Summary

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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

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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.

Conditions

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Muscular Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors are blinded to group allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

Blood Flow Restriction

Intervention Type DEVICE

Subjects will perform sidelying external rotation exercise

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.

Group Type ACTIVE_COMPARATOR

Blood Flow Restriction

Intervention Type DEVICE

Subjects will perform sidelying external rotation exercise

Interventions

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Blood Flow Restriction

Subjects will perform sidelying external rotation exercise

Intervention Type DEVICE

Other Intervention Names

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Exercise

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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George Fox University

OTHER

Sponsor Role lead

Responsible Party

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Jason Brumitt

Assistant Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Brumitt, PhD

Role: PRINCIPAL_INVESTIGATOR

George Fox University

Locations

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George Fox University School of Physical Therapy

Newberg, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Brumitt, PhD

Role: CONTACT

5035542461

Tyler Cuddeford, PhD

Role: CONTACT

5035542452

Facility Contacts

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Jason Brumitt, PhD

Role: primary

503-554-2461

Jason Brumitt, PhD

Role: backup

5035542461

Other Identifiers

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2181055

Identifier Type: -

Identifier Source: org_study_id

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