Blood Flow Restriction TrainingNCT05342909
Two Time a Week vs. Five Time a Week Blood Flow Restriction Training Program for the Lower Extremity.
A study testing 5x a week BFR training group and 2x a week BFR training group in people with Blood Flow Restriction Training, run by George Fox University at 2 sites in United States.
Trial summary
This study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Training
- What is being tested?
- 5x a week BFR training group and 2x a week BFR training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2020to 30 Jun 2022
- 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
Inclusion Criteria: healthy adults 18 years of age who currently perform weight-lifting (i.e., resistance training) exercise 2x a week.
-
Exclusion Criteria: current musculoskeletal injury; surgery to the low back or lower extremities during the prior year; one or more contraindications to blood flow restriction training.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 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
- Recruiting
George Fox University
Newberg, Oregon, 97132
JASON BRUMITT, PhD, 503-554-2461, jbrumitt@georgefox.edu
About this study
Official title: Blood Flow Restriction Training for the Quad: Comparing Daily Training vs. Training Twice a Week
This study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any additional BFR exercise. Those randomized to the BFR groups will perform the unilateral 90-0 knee extension exercise followed by the bilateral squat. Subjects will have the BFR applied to their dominant lower extremity and will perform 4 sets (30/15/15/15 reps) per exercise. Training will initial start at 30% of 1RM with training intensity increased by 5% every 2 weeks. The training program will last 8 weeks.
Pre- and posttests include ultrasound imaging of the dominant leg rectus femoris and strength testing via hand held dynamometry.
- Conditions
- Blood Flow Restriction Training
- Being tested
- 5x a week BFR training group, 2x a week BFR training group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5x a week BFR training groupOther
This group will perform the two exercises 5x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh.
2x a week BFR training groupOther
This group will perform the two exercises 2x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh.
| Study group | Role | What they receive |
|---|---|---|
| 5x a week BFR training group | Experimental | Subjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh daily (5x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program. Receives: Other: 5x a week BFR training group |
| 2x a week BFR training group | Experimental | Subjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh twice a week (2x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program. Receives: Other: 2x a week BFR training group |
| Control group | No intervention | This group will not perform any BFR exercises. They are to continue with their regular independent exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Hand held dynamometry will be used to assess changes in strength (bilaterally) for the quadricep, hip extensors, and hip abductors.
Measured: 8 weeks
Cross-sectional area of the rectus femoris
Ultrasound imaging will measure the cross-sectional area of the rectus femoris
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction TrainingStudies 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
- 55 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
- NCT05342909
- Sponsor's protocol ID
- GeorgeFoxU
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 25 Apr 2022
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training for the Quad: Comparing Daily Training vs. Training Twice a Week
- ClinicalTrials.gov ID
- NCT05342909
- Acronym / sponsor ID
- GeorgeFoxU
- Conditions
- Blood Flow Restriction Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Apr 2022 (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 study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any additional BFR exercise. Those randomized to the BFR groups will perform the unilateral 90-0 knee extension exercise followed by the bilateral squat. Subjects will have the BFR applied to their dominant lower extremity and will perform 4 sets (30/15/15/15 reps) per exercise. Training will initial start at 30% of 1RM with training intensity increased by 5% every 2 weeks. The training program will last 8 weeks.
Pre- and posttests include ultrasound imaging of the dominant leg rectus femoris and strength testing via hand held dynamometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5x a week BFR training group | Experimental | Other: 5x a week BFR training groupSubjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh daily (5x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program. |
| 2x a week BFR training group | Experimental | Other: 2x a week BFR training groupSubjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh twice a week (2x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program. |
| Control group | No intervention | –This group will not perform any BFR exercises. They are to continue with their regular independent exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 5x a week BFR training groupThis group will perform the two exercises 5x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh. | Other | 5x a week BFR training group |
| 2x a week BFR training groupThis group will perform the two exercises 2x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh. | Other | 2x a week BFR training group |
Primary outcome
Muscular strength
Time frame: 8 weeks
Hand held dynamometry will be used to assess changes in strength (bilaterally) for the quadricep, hip extensors, and hip abductors.
Cross-sectional area of the rectus femoris
Time frame: 8 weeks
Ultrasound imaging will measure the cross-sectional area of the rectus femoris
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- 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
College of Physical Therapy; George Fox University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5x a week BFR training group and 2x a week BFR training group in people with Blood Flow Restriction Training, run by George Fox University at 2 sites 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?
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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (time frame: 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 25 Apr 2022.