Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator CuffNCT04596020
Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
A study testing Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit) in people with Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff and Muscle Weakness, run by George Fox University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff, Muscle Weakness
- What is being tested?
- Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to 7 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 and over
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;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
George Fox University
Newberg, Oregon, 97132
Jason Brumitt, PhD, 504-554-2461, jbrumitt@georgefox.edu
Jason Brumitt, PhD
About this study
Official title: 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).
Read the 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.
- Conditions
- Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff, Muscle Weakness
- Being tested
- Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)
- Keywords
- blood flow restriction, shoulder
- 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 Restriction Group (exercise with blood flow restriction using a Delfi unit)Other
Also called Non-Blood Flow Restriction Group (exercise without blood flow restriction)
Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Group | Experimental | 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. Receives: Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit) |
| Non-Blood Flow Restriction Group | Active comparator | This group will perform the same exercises for the same volume without the use of BFR. Receives: Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength Assessment
Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions
Measured: 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
Measured: Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start10 Oct 2020
- Primary completion7 Dec 2020 (estimated)
- Study completion7 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator CuffStudies 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
- 40 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, College of Physical Therapy, George Fox University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596020
- Sponsor's protocol ID
- 2183025
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
- ClinicalTrials.gov ID
- NCT04596020
- Acronym / sponsor ID
- 2183025
- Conditions
- Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff, Muscle Weakness
- Keywords
- blood flow restriction, shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 7 Dec 2020 (estimated)
- Study completion
- 7 Dec 2020 (estimated)
- First posted
- 22 Oct 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Group | Experimental | Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)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. |
| Non-Blood Flow Restriction Group | Active comparator | Other: Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)This group will perform the same exercises for the same volume without the use of BFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects aged 18 and over
Key exclusion criteria (6 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;
- 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;
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 Restriction Group (exercise with blood flow restriction using a Delfi unit)Also: Non-Blood Flow Restriction Group (exercise without blood flow restriction)Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit | Other | Blood Flow Restriction Group, Non-Blood Flow Restriction Group |
Primary outcome
Strength Assessment
Time frame: Change in Baseline Strength (Newtons) at 8 weeks
Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions
Ultrasonography
Time frame: Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks
Diagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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
College of Physical Therapy, 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 Group (exercise with blood flow restriction using a Delfi unit) in people with Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff and Muscle 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 6 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 22 Oct 2020. 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 (15045542461, jbrumitt@georgefox.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength Assessment (time frame: Change in Baseline Strength (Newtons) at 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 22 Oct 2020.