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Completed

NCT Number: NCT05868304

Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedar Sinai Kerlan jobe orthopedic institute

Los Angeles, California, 90035, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers without history of knee pathology requiring physical therapy or surgery
  • Individuals between 18 and 40 years old

Exclusion criteria

  • History of venous thromboembolism or other hematologic disorder Pregnant
  • Coronary artery disease, peripheral arterial disease, or hypertension (> 140/90 mmHg)

Treatment and study plan

BFR

Device

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)

Primary outcomes

  1. The change in Force plate measures from baseline to 16 weeks

    Time frame: Measured at 4, 6, 8, 12, and 16 weeks.

    Force (N)

  2. The change in Force plate measures from baseline to 16 weeks

    Time frame: Measured at 4,6,8,12 and 16 weeks.

    Power (W)

  3. 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

  4. 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)

  5. the change in Force plate measures from baseline to 16 weeks

    Time frame: Measured at 4,6,8,12 and 16 weeks.

    Displacement

  6. the changes in Force Frame measures from baseline to 16 weeks

    Time frame: Measured at 4,6,8,12 and 16 weeks.

    Force (N)

  7. the changes in Force Frame measures from baseline to 16 weeks

    Time frame: Measured at 4,6,8,12 and 16 weeks.

    power (W)

  8. 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 22, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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