Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

Cedars-Sinai Medical Center

Status: Completed

Conditions: Healthy

Treatments: Other: Stanard strengthening program.; Device: BFR

Study type: Interventional

Funder types: Other

Identifiers

NCT05868304

STUDY00002454

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1 - Standard strengthening group (no BFR)

Active Comparator group

Description:

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)

Treatment:

Other: Stanard strengthening program.

Group 2 - Low-load BFR group

Experimental group

Description:

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)

Treatment:

Device: BFR

Other: Stanard strengthening program.