Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

Cedars-Sinai Medical Center16 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

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)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Cedar Sinai Kerlan jobe orthopedic institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

The change in Force plate measures from baseline to 16 weeks

Force (N)

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

The change in Force plate measures from baseline to 16 weeks

Power (W)