Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedStudy Start
First participant enrolled
January 18, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedJanuary 24, 2019
January 1, 2019
4 months
January 17, 2019
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Tendon Size as Measured by Diagnostic Ultrasound
Ultrasound images are capture at pre- and post-test sessions
Change from Baseline to 8-weeks
Study Arms (2)
Exercise with Blood Flow Restriction
EXPERIMENTALSubjects 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
ACTIVE COMPARATORSubjects 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.
Interventions
Subjects will perform sidelying external rotation exercise
Eligibility Criteria
You may qualify if:
- \. Healthy adult (age 18 and older) with no current shoulder pathology
You may not qualify if:
- 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
- Cervical/thoracic spine surgery during the prior 1 year
- Subject having one or more contraindications for BFR training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George Fox University School of Physical Therapy
Newberg, Oregon, 97132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Brumitt, PhD
George Fox University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors are blinded to group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Physical Therapy
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 24, 2019
Study Start
January 18, 2019
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
January 24, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share