Low Intensity Blood Flow Restriction Training Study

Not Applicable

Completed

• Conditions: Muscle Mass

• Registration Number: NCT03055260
• Lead Sponsor: University of Minnesota

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.

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 Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-05-23
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-02
• Results First Submitted: 2020-02-13
• Results First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Results First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
One Repetition Maximum	6 weeks	One repetition maximum on the single leg press. Isometric quadriceps extension strength.

Secondary Outcome Measures

Name	Time	Method
Quadriceps Muscle Thickness	6 weeks	Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.

Trial Locations

Locations (1)

Fairview Health Services; 🇺🇸 Minneapolis, Minnesota, United States