Low Intensity Blood Flow Restriction Training Study

Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy

The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. After baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested and compared to the initial measurements.

Study Overview

• Status: Completed
• Conditions: Muscle Mass
• Intervention / Treatment: Device: Blood flow restriction cuff; Device: Blood Flow restriction Cuff-Placebo

Detailed Description

Session 1 - baseline testing

• 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements 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 2-13 - 6 weeks of exercise protocol, 2x/per 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 partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb.

  • Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by ~30-90 seconds.
  • Right and left legs will be alternating, but only one leg will have the occlusion cuff

Session 14 - Re-test

- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Fairview Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction cuff; This group will receive an active cuff that partially restricts blood flow to the experimental limb.	Device: Blood flow restriction cuff; The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Placebo Comparator: Blood Flow restriction Cuff-Placebo; This group will wear a placebo cuff, of which will not restrict blood flow at all.	Device: Blood Flow restriction Cuff-Placebo; The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One Repetition Maximum	One repetition maximum on the single leg press. Isometric quadriceps extension strength.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Muscle Thickness	Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.	6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Fairview Health Services
• Investigators: Principal Investigator: Jon Schoenecker, DPT, Fairview Health Services

Publications and helpful links

General Publications

• Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
• Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1612M02121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No