Low Intensity Blood Flow Restriction Training Study

Not Applicable

Completed

• Conditions: Muscle Mass
• Interventions: Device: Blood flow restriction cuff; Device: Blood Flow restriction Cuff-Placebo

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood flow restriction cuff	Blood flow restriction cuff	This group will receive an active cuff that partially restricts blood flow to the experimental limb.
Blood Flow restriction Cuff-Placebo	Blood Flow restriction Cuff-Placebo	This group will wear a placebo cuff, of which will not restrict blood flow at all.

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