Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy
Phase: NA
Conditions: Muscle Mass
Sponsor: University of Minnesota

NCT03055260 
Low Intensity Blood Flow Restriction Training Study 
PI: Russel Giveans 
Document Date: 2/1/2017 

Effect of low intensity blood flow restriction training on lower extremity strength and hypertrophy 
 
Jon Schoenecker, DPT – Fairview/Institute for Athletic Medicine 
 
Protocol v3.0 – February 1, 2017 
Project Summary 
This study is looking at the effect of blood flow resctriction in the leg on overall strength gain 
and muscle increase. Subjects will complete baseline testing that will measure quadriceps muscle 
cross-sectional area via ultrasound technology, as well as complete 6 weeks of sessions (2 times 
per week) in which they perform controlled exercises, one leg at a time.  
Subjects will be assigned to one of two groups: either the 1.) experimental group or 2.) control 
group. The experimental group will exercise with a blood flow restriction cuff around their right 
leg inflated to 100-250 mmHg (depending on participant size), and the control group will also 
exercise with a cuff on their right leg but with a pressure much less than that of the experimental 
group. Both groups however will complete the exact same protocol throughout the entirety of the 
study. Once the 6 weeks of training is up, muscle cross sectional area via ultrasound and 1RM 
will be re-tested and compared to the initial measurements. 
 
Background 
Physically active individuals with the goal of increasing muscle mass and enhancing 
performance often turn to resistance training. Per the American College of Sports Medicine’s 
recommendations, 70% of a person’s 1 repetition maximum, for 6-12 repetitions, is required to 
induce hypertrophy in human skeletal muscle. Muscle loading below this 70% 1RM has shown 
to less effective for muscle hypertrophy. Recent research over the past 5-10 years has shown that 
low load resistance training (30% of 1RM) combined with moderate blood flow restriction has 
resulted in muscle hypertrophy gains similar to the traditional high load training. Blood flow 
restriction consists of using blood pressure-like cuffs at the proximal portion of arms or legs with 
the purpose of restricting ~80% of arterial flow to the muscle and 100% of the venous return. 
This short-term (~5 minutes for entire protocol) decrease in blood flow has been theorized work 
via increased: acute muscle cellular swelling, metabolic accumulation resulting in increased 
muscle fiber recruitment, growth hormone release, proliferation for myogenic stem cells, and 
enhanced signaling of protein synthesis. BFR has shown favorable results across populations, 
including elderly, trained athletes, and those recovering from injury who are not able to load 
their joints at 70% of their 1RM. It is currently being used in rehabilitation settings as well as in 
professional sports. 
 
Study Purpose/Objective 
The purpose of this study is to investigate whether the addition of blood flow restriction to low 
load exercise, will result in changes in quadriceps hypertrophy or lower extremity strength. 

 
Inclusion Criteria 
Male or female ages 18-49 
 
Exclusion Criteria 
Pregnant, hypertensive, recent back or lower extremity injury, history of blood clotting, varicose 
veins, adults lacking the capacity to consent for themselves 
Methods and Procedures 
Session 1: baseline testing 
 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press 
machine; cross-sectional measurement of both right and left quadriceps muscle using 
ultrasound technology. 
 After day 1 testing; randomly allocate subjects to either control group or experimental 
group 
Sessions 2-9: 6 weeks of exercise protocol, 2x/week 
Both the experimental and control groups will complete the same protocol for the entirety of the 
study: 
 5- minute warm up 
 Using a single-leg press exercise machine: Subjects complete the testing protocol with 
either blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) 
or no blood flow restriction (placebo inflation) on right limb.  
o Protocol: 30 repetitions – 15 repetitions – 15 repetitions – 15 repetitions with each 
set separated by ~30 seconds. 
o Right and left legs will be alternating, but only right leg will have the occlusion 
cuff 
Session 10: Re-test 
- 
Re check 1RM, cross sectional area of quadriceps with ultrasound 
Data Safety and Monitoring Plan 
The PI will be responsible for monitoring and handling any potential problems that arise, 
including, but not limited to, informing the IRB immediately of any safety issues or concerns. 
Injury 
In the event that this research activity results in an injury, treatment will be available, including 
first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed 
in the ordinary manner to you or your insurance company. If you think that you have suffered a 

research related injury, let the study administrators know right away. If serious injury were to 
occur, the PI will see to it that immediate medical attention is provided, including having the PI 
transport the subject to the nearest appropriate medical facility and/or contacting the appropriate 
emergency services. 
Statistical Analyses 
Independent Samples t-tests, Paired samples t-test, repeated measures ANOVAs and two-way 
ANOVAs will all be employed to determine difference within and between groups, across trials 
and conditions. SPSS v23 will be utilized for all statistical analyses. 
Data and Record Keeping 
The PI will be responsible for collecting and maintaining all data, and storing said data on a 
password-protected computer that will remained locked in a Fairview clinic office. 
References 
Loenneke, J. P., Wilson, J. M., Marín, P. J., Zourdos, M. C., & Bemben, M. G. (2011). Low 
intensity blood flow restriction training: A meta-analysis. European Journal of Applied 
Physiology, 112(5), 1849-1859. doi:10.1007/s00421-011-2167-x