Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers
NCT ID: NCT05868304
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2023-02-08
2025-09-25
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 - Standard strengthening group (no BFR)
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)
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)
Group 2 - Low-load BFR group
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)
BFR
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.
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)
Interventions
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BFR
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.
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)
Eligibility Criteria
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Inclusion Criteria
* Individuals between 18 and 40 years old
Exclusion Criteria
* Coronary artery disease, peripheral arterial disease, or hypertension (\> 140/90 mmHg)
18 Years
ALL
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Orr Limpisvasti
Principal Investigator
Locations
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Cedar Sinai Kerlan jobe orthopedic institute
Los Angeles, California, United States
Countries
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Other Identifiers
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STUDY00002454
Identifier Type: -
Identifier Source: org_study_id
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