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Completed

NCT Number: NCT03055260

Low Intensity Blood Flow Restriction Training Study

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.

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Key information

Conditions

Muscle Mass

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fairview Health Services

Minneapolis, Minnesota, 55414, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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.

Primary outcomes

  1. One Repetition Maximum

    Time frame: 6 weeks

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

Secondary outcomes

  1. Quadriceps Muscle Thickness

    Time frame: 6 weeks

    Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Fairview Health Services

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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