HealthyNCT05868304
Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers
A study testing BFR and Stanard strengthening program. in people with Healthy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BFR and Stanard strengthening program.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 25 Sep 2025
- 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
- Healthy volunteers without history of knee pathology requiring physical therapy or surgery
- Individuals between 18 and 40 years old
Who cannot join
- History of venous thromboembolism or other hematologic disorder Pregnant
- Coronary artery disease, peripheral arterial disease, or hypertension (> 140/90 mmHg)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedar Sinai Kerlan jobe orthopedic institute
Los Angeles, California, 90035
About this study
Official title: Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.
Read the detailed description
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. The primary research procedures are:
Subjects will be randomized into either BFR or conventional strengthening groups.
BFR and conventional strengthening programs will be implemented. Force plate and force frame data will be collected at baseline, 4, 6, 8, 12, and 16 weeks.
Subject Population. The study will enroll 18 healthy volunteers. The study includes 6 visits.
The total study duration for each subject is 16 weeks.
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act
- Conditions
- Healthy
- Being tested
- BFR, Stanard strengthening program.
- Keywords
- Blood Flow Restriction (BFR), Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRDevice
Exercises may involve warm up on a stationary bike for 5 minutes, application of a BFR cuff (a cuff that often uses air to inflate around a limb) on the selected extremity, and exercise sets (e.g. banded squats, step ups, Romanian dead lifts). We will record metrics on an iPad. Testing will be done with ForceDecks and ForceFrames (system for measuring muscle strength and imbalance).
Stanard strengthening program.Other
The exercise program will be completed 3 times per week Participants will warm up on a stationary bike for 5 minutes
The program will consist of the following exercises using a 30,15,15,15 rep scheme:
Banded squats Step ups (8 inch) Romanian dead lifts (RDL)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Standard strengthening group (no BFR) | Active comparator | Participants will warm up on a stationary bike for 5 minutes
The program will consist of the following exercises using a 30,15,15,15 rep scheme:
Banded squats Step ups (8 inch) Romanian dead lifts (RDL) Receives: Other: Stanard strengthening program. |
| Group 2 - Low-load BFR group | Experimental | Participants will warm up on a stationary bike for 5 minutes BFR will be applied to non-dominant limb (dominant limb is determined as the preferred leg for kicking a ball)
The program will consist of the following exercises using a 30,15,15,15 rep scheme:
Banded squats Step ups (8 inch) Romanian dead lifts (RDL) Receives: Device: BFR; Other: Stanard strengthening program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Force plate measures from baseline to 16 weeks
Force (N)
Measured: Measured at 4, 6, 8, 12, and 16 weeks.
The change in Force plate measures from baseline to 16 weeks
Power (W)
Measured: Measured at 4,6,8,12 and 16 weeks.
The change in Force plate measures from baseline to 16 weeks
Velocity M/Se
Measured: Measured at 4,6,8,12 and 16 weeks.
the changes in Force plate measures from baseline to 16 weeks
Relative strength index (RSI)
Measured: Measured at 4,6,8,12 and 16 weeks.
the change in Force plate measures from baseline to 16 weeks
Displacement
Measured: Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measures from baseline to 16 weeks
Force (N)
Measured: Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measures from baseline to 16 weeks
power (W)
Measured: Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measure from baseline to 16 weeks
Velocity M/sec
Measured: Measured at 4,6,8,12 and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start8 Feb 2023
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orr Limpisvasti, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868304
- Sponsor's protocol ID
- STUDY00002454
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2023
- Last updated
- 25 Nov 2025
- 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 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05868304
- Acronym / sponsor ID
- STUDY00002454
- Conditions
- Healthy
- Keywords
- Blood Flow Restriction (BFR), Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 22 May 2023 (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 research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.
Detailed description
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. The primary research procedures are:
Subjects will be randomized into either BFR or conventional strengthening groups.
BFR and conventional strengthening programs will be implemented. Force plate and force frame data will be collected at baseline, 4, 6, 8, 12, and 16 weeks.
Subject Population. The study will enroll 18 healthy volunteers. The study includes 6 visits.
The total study duration for each subject is 16 weeks.
The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Standard strengthening group (no BFR) | Active comparator | Other: Stanard strengthening program.Participants will warm up on a stationary bike for 5 minutes The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL) |
| Group 2 - Low-load BFR group | Experimental | Device: BFR, Other: Stanard strengthening program.Participants will warm up on a stationary bike for 5 minutes BFR will be applied to non-dominant limb (dominant limb is determined as the preferred leg for kicking a ball) The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers without history of knee pathology requiring physical therapy or surgery
- Individuals between 18 and 40 years old
Key exclusion criteria (2 listed)
- History of venous thromboembolism or other hematologic disorder Pregnant
- Coronary artery disease, peripheral arterial disease, or hypertension (> 140/90 mmHg)
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 |
|---|---|---|
| BFRExercises may involve warm up on a stationary bike for 5 minutes, application of a BFR cuff (a cuff that often uses air to inflate around a limb) on the selected extremity, and exercise sets (e.g. banded squats, step ups, Romanian dead lifts). We will record metrics on an iPad. Testing will be done with ForceDecks and ForceFrames (system for measuring muscle strength and imbalance). | Device | Group 2 - Low-load BFR group |
| Stanard strengthening program.The exercise program will be completed 3 times per week Participants will warm up on a stationary bike for 5 minutes The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL) | Other | Group 1 - Standard strengthening group (no BFR), Group 2 - Low-load BFR group |
Primary outcome
The change in Force plate measures from baseline to 16 weeks
Time frame: Measured at 4, 6, 8, 12, and 16 weeks.
Force (N)
The change in Force plate measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Power (W)
The change in Force plate measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Velocity M/Se
the changes in Force plate measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Relative strength index (RSI)
the change in Force plate measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Displacement
the changes in Force Frame measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Force (N)
the changes in Force Frame measures from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
power (W)
the changes in Force Frame measure from baseline to 16 weeks
Time frame: Measured at 4,6,8,12 and 16 weeks.
Velocity M/sec
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR and Stanard strengthening program. in people with Healthy, run by Cedars-Sinai Medical Center 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Force plate measures from baseline to 16 weeks (time frame: Measured at 4, 6, 8, 12, and 16 weeks.). The study lists 8 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 Nov 2025.