Muscular WeaknessNCT03815760
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
A study testing Blood Flow Restriction in people with Muscular Weakness, run by George Fox University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Weakness
- What is being tested?
- Blood Flow Restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy adult (age 18 and older) with no current shoulder pathology
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
George Fox University School of Physical Therapy
Newberg, Oregon, 97132
Jason Brumitt, PhD, 503-554-2461, jbrumitt@georgefox.edu
Jason Brumitt, PhD, 5035542461, jbrumitt@georgefox.edu
About this study
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.
Read the 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.
- Conditions
- Muscular Weakness
- Being tested
- Blood Flow Restriction
- Keywords
- infraspinatus, external rotators, blood flow restriction
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
Also called Exercise
Subjects will perform sidelying external rotation exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise with Blood Flow Restriction | Experimental | 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. Receives: Device: Blood Flow Restriction |
| Exercise without Blood Flow Restriction | Active comparator | 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. Receives: Device: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline to 8-weeks
Tendon Size as Measured by Diagnostic Ultrasound
Ultrasound images are capture at pre- and post-test sessions
Measured: Change from Baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start18 Jan 2019
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Fox University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Brumitt, George Fox University
- Investigators
- Jason Brumitt, PhD, Principal investigator, George Fox University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815760
- Sponsor's protocol ID
- 2181055
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone
- ClinicalTrials.gov ID
- NCT03815760
- Acronym / sponsor ID
- 2181055
- Conditions
- Muscular Weakness
- Keywords
- infraspinatus, external rotators, blood flow restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with Blood Flow Restriction | Experimental | Device: Blood Flow RestrictionSubjects 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 comparator | Device: Blood Flow RestrictionSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy adult (age 18 and older) with no current shoulder pathology
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow RestrictionAlso: ExerciseSubjects will perform sidelying external rotation exercise | Device | Exercise with Blood Flow Restriction, Exercise without Blood Flow Restriction |
Primary outcome
Muscular Strength as Measured by Dynamometry
Time frame: 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
Time frame: Change from Baseline to 8-weeks
Ultrasound images are capture at pre- and post-test sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Brumitt, PhD principal investigator
George Fox University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction in people with Muscular Weakness, run by George Fox University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Brumitt, PhD (5035542461, jbrumitt@georgefox.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular Strength as Measured by Dynamometry (time frame: Change from Baseline to 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.