NCT05868304

Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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).
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)

Timeline

• Start date: 2023-02-08
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2023-05-22
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States