Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 10:18 AM
Study NCT ID:
NCT05868304
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: