Muscle Mass
Conditions
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
Interventions
The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
DEVICEBlood 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.
Sponsors
Fairview Health Services
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One Repetition Maximum | 6 weeks | One repetition maximum on the single leg press. Isometric quadriceps extension strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Thickness | 6 weeks | Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Flow Restriction Cuff This group will receive an active cuff that partially restricts blood flow to the experimental limb.
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. | 8 |
| Blood Flow Restriction Cuff-Placebo This group will wear a placebo cuff, of which will not restrict blood flow at all.
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. | 0 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Blood Flow Restriction Cuff | Blood Flow Restriction Cuff-Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 0 Participants | 8 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 6.2 | — | 28.1 years STANDARD_DEVIATION 6.2 |
| One Repetition Maximum | 267.1 pounds STANDARD_DEVIATION 63.2 | — | 267.1 pounds STANDARD_DEVIATION 63.2 |
| Quadriceps Muscle Thickness | 42.4 centimeters STANDARD_DEVIATION 10.2 | — | 42.4 centimeters STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 0 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | — | 8 participants |
| Sex: Female, Male Female | 7 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 0 |
| other Total, other adverse events | 0 / 8 | 0 / 0 |
| serious Total, serious adverse events | 0 / 8 | 0 / 0 |
Outcome results
Primary
One Repetition Maximum
One repetition maximum on the single leg press. Isometric quadriceps extension strength.
Time frame: 6 weeks
Population: No participants completed the placebo arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Cuff | One Repetition Maximum | 302.9 pounds | Standard Deviation 67.1 |
Secondary
Quadriceps Muscle Thickness
Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.
Time frame: 6 weeks
Population: No participants completed the placebo arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Cuff | Quadriceps Muscle Thickness | 45 centimeters | Standard Deviation 13.4 |