Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT03055260
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Intensity Blood Flow Restriction Training Study
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: