Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Stanard strengthening program.; Device: BFR

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90035
      • Cedar Sinai Kerlan jobe orthopedic institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Other: 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)
Experimental: 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)	Other: 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); Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Force plate measures from baseline to 16 weeks	Force (N)	Measured at 4, 6, 8, 12, and 16 weeks.
The change in Force plate measures from baseline to 16 weeks	Power (W)	Measured at 4,6,8,12 and 16 weeks.
The change in Force plate measures from baseline to 16 weeks	Velocity M/Se	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 at 4,6,8,12 and 16 weeks.
the change in Force plate measures from baseline to 16 weeks	Displacement	Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measures from baseline to 16 weeks	Force (N)	Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measures from baseline to 16 weeks	power (W)	Measured at 4,6,8,12 and 16 weeks.
the changes in Force Frame measure from baseline to 16 weeks	Velocity M/sec	Measured at 4,6,8,12 and 16 weeks.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): September 25, 2025
• Study Completion (Actual): September 25, 2025

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Blood Flow Restriction (BFR)
• Other Study ID Numbers: STUDY00002454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No