Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Device: BFR
* Other: Stanard strengthening program.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - Standard strengthening group (no BFR)<br>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) | Other: Stanard strengthening program.<br>* 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)<br>|
| Experimental: Group 2 - Low-load BFR group<br>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) | Device: BFR<br>* 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).<br>Other: Stanard strengthening program.<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Flow Restriction (BFR), Healthy Volunteers