Low Intensity Blood Flow Restriction Training Study

University of Minnesota (UMN)

Status: Completed

Conditions: Muscle Mass

Treatments: Device: Blood flow restriction cuff; Device: Blood Flow restriction Cuff-Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03055260

1612M02121

Details and patient eligibility

About

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.

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups, including a placebo group

Blood flow restriction cuff

Experimental group

Description:

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

Treatment:

Device: Blood flow restriction cuff

Blood Flow restriction Cuff-Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Blood Flow restriction Cuff-Placebo