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Low Intensity Blood Flow Restriction Training Study

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ClinicalTrials.gov Identifier: NCT03055260
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
Fairview Health Services
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Muscle Mass Device: Blood flow restriction cuff Device: Blood Flow restriction Cuff-Placebo Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Blood flow restriction cuff
This group will receive an active cuff that partially restricts blood flow to the experimental limb.
 Device: 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.
Placebo Comparator: Blood Flow restriction Cuff-Placebo
This group will wear a placebo cuff, of which will not restrict blood flow at all.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. One Repetition Maximum [ Time Frame: 6 weeks ]
    One repetition maximum on the single leg press. Isometric quadriceps extension strength.


Secondary Outcome Measures :
  1. Quadriceps Muscle Thickness [ Time Frame: 6 weeks ]
    Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055260


Locations
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United States, Minnesota
Fairview Health Services
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Fairview Health Services
Investigators
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Principal Investigator: Jon Schoenecker, DPT Fairview Health Services
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] February 1, 2017

More Information
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Publications:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03055260    
Other Study ID Numbers: 1612M02121
First Posted: February 16, 2017    Key Record Dates
Results First Posted: February 28, 2020
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No