Low Intensity Blood Flow Restriction Training Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Muscle Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Blood flow restriction cuff

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

Group Type EXPERIMENTAL

Blood flow restriction cuff

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Blood Flow restriction Cuff-Placebo

Intervention Type DEVICE

The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.

Interventions

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Blood flow restriction cuff

The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.

Intervention Type DEVICE

Blood Flow restriction Cuff-Placebo

The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes