Low Intensity Blood Flow Restriction Training Study

Muscle Mass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055260
• Other study ID #: 1612M02121
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Mass

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fairview Health Services	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Fairview Health Services

Country where clinical trial is conducted

United States, 

References & Publications (2)

Loenneke JP, Wilson JM, Marín 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One Repetition Maximum	One repetition maximum on the single leg press. Isometric quadriceps extension strength.	6 weeks
Secondary	Quadriceps Muscle Thickness	Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.	6 weeks