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Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

Healthy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05868304
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Recruiting
Phase N/A
Start date May 2023
Completion date December 2023
View Details
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