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| Name | Class |
|---|---|
| Fairview Health Services | OTHER |
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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.
Session 1 - baseline testing
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.
Session 14 - Re-test
- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood flow restriction cuff | Experimental | This group will receive an active cuff that partially restricts blood flow to the experimental limb. |
|
| Blood Flow restriction Cuff-Placebo | Placebo Comparator | This group will wear a placebo cuff, of which will not restrict blood flow at all. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| One Repetition Maximum | One repetition maximum on the single leg press. Isometric quadriceps extension strength. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Muscle Thickness | Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Schoenecker, DPT | Fairview Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairview Health Services | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21922259 | Background | Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16. | |
| 26463594 | Background | Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28. |
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Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No participants completed the placebo arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | One Repetition Maximum | One repetition maximum on the single leg press. Isometric quadriceps extension strength. | No participants completed the placebo arm. | Posted | Mean | Standard Deviation | pounds | 6 weeks |
|
6 weeks
No participants completed the placebo arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russel Giveans | University of Minenesota | 5042314007 | russell.giveans@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2017 | Jan 30, 2020 | Prot_SAP_000.pdf |
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| 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. |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| One Repetition Maximum | 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure. | Mean | Standard Deviation | pounds |
|
| Quadriceps Muscle Thickness | 8 participants were enrolled. 1 participants dropped-out prior to collection of this data measure. | Mean | Standard Deviation | centimeters |
|
|
|
| Secondary | Quadriceps Muscle Thickness | Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound. | No participants completed the placebo arm. | Posted | Mean | Standard Deviation | centimeters | 6 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|