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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05868304
• Other study ID #: STUDY00002454
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• BFR
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).

Other:
• Stanard strengthening program.
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)

Locations

Country	Name	City	State
United States	Cedar Sinai Kerlan jobe orthopedic institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Force plate measures from baseline to 16 weeks	Force (N)	Measured at 4, 6, 8, 12, and 16 weeks.
Primary	The change in Force plate measures from baseline to 16 weeks	Power (W)	Measured at 4,6,8,12 and 16 weeks.
Primary	The change in Force plate measures from baseline to 16 weeks	Velocity M/Se	Measured at 4,6,8,12 and 16 weeks.
Primary	the changes in Force plate measures from baseline to 16 weeks	Relative strength index (RSI)	Measured at 4,6,8,12 and 16 weeks.
Primary	the change in Force plate measures from baseline to 16 weeks	Displacement	Measured at 4,6,8,12 and 16 weeks.
Primary	the changes in Force Frame measures from baseline to 16 weeks	Force (N)	Measured at 4,6,8,12 and 16 weeks.
Primary	the changes in Force Frame measures from baseline to 16 weeks	power (W)	Measured at 4,6,8,12 and 16 weeks.
Primary	the changes in Force Frame measure from baseline to 16 weeks	Velocity M/sec	Measured at 4,6,8,12 and 16 weeks.