Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: BFR; Other: Stanard strengthening program.

• Registration Number: NCT05868304
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2023-03-01
• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Low-load BFR group	Stanard strengthening program.	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)
Group 2 - Low-load BFR group	BFR	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)
Group 1 - Standard strengthening group (no BFR)	Stanard strengthening program.	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 Outcome Measures

Name	Time	Method
the changes in Force plate measures from baseline to 16 weeks	Measured at 4,6,8,12 and 16 weeks.	Relative strength index (RSI)
the change in Force plate measures from baseline to 16 weeks	Measured at 4,6,8,12 and 16 weeks.	Displacement
the changes in Force Frame measure from baseline to 16 weeks	Measured at 4,6,8,12 and 16 weeks.	Velocity M/sec
The change in Force plate measures from baseline to 16 weeks	Measured at 4,6,8,12 and 16 weeks.	Velocity M/Se
the changes in Force Frame measures from baseline to 16 weeks	Measured at 4,6,8,12 and 16 weeks.	power (W)

Trial Locations

Locations (1)

Cedar Sinai Kerlan jobe orthopedic institute; 🇺🇸 Los Angeles, California, United States