Low Intensity Blood Flow Restriction Training Study

NCT03055260 | Completed Results FDA Device

• 1 other identifier: 1612M02121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Mass

Outcome Measures

Primary Outcomes (1)

• One Repetition Maximum

  One repetition maximum on the single leg press. Isometric quadriceps extension strength.

  6 weeks

Secondary Outcomes (1)

• Quadriceps Muscle Thickness

  6 weeks

Study Arms (2)

Blood flow restriction cuff

EXPERIMENTAL

This group will receive an active cuff that partially restricts blood flow to the experimental limb.

Device: Blood flow restriction cuff

Blood Flow restriction Cuff-Placebo

PLACEBO COMPARATOR

This group will wear a placebo cuff, of which will not restrict blood flow at all.

Device: Blood Flow restriction Cuff-Placebo

Interventions

Blood flow restriction cuff DEVICE

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

Blood Flow restriction Cuff-Placebo DEVICE

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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-49

You may not qualify if:

• Pregnant
• Hypertensive
• Recent back or lower extremity injury
• History of blood clotting
• Varicose veins
• Adults lacking the capacity to consent for themselves

Sponsors & Collaborators

• University of Minnesota: lead
• Fairview Health Services: collaborator

Study Sites (1)

Fairview Health Services

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (2)

• 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.

  PMID: 21922259 BACKGROUND

• 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.

  PMID: 26463594 BACKGROUND

Results Point of Contact

• Title: Russel Giveans
• Organization: University of Minenesota

russell.giveans@gmail.com

5042314007

Study Officials

• Jon Schoenecker, DPT

  Fairview Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 16, 2017
• Study Start: May 23, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)