The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses
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ClinicalTrials.gov Identifier: NCT03540147 |
Recruitment Status :
Terminated
(The number of subjects in this study was overestimated in the initial assessment.)
First Posted : May 30, 2018
Results First Posted : January 28, 2021
Last Update Posted : February 18, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exercise Training Hemodynamic Response | Device: Hokanson Cuffs Device: BStrong Bands | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Each participant will undergo five visits to the laboratory for repeated testing under five different conditions. The sessions will be randomized and will take 2.5 hours to complete. |
Masking: | Single (Participant) |
Masking Description: | The participants will not know which condition they will receive on the day of testing. |
Primary Purpose: | Basic Science |
Official Title: | The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses |
Actual Study Start Date : | January 26, 2018 |
Actual Primary Completion Date : | May 26, 2019 |
Actual Study Completion Date : | May 26, 2019 |

Arm | Intervention/treatment |
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Experimental: Exercise with Hokanson cuffs
Participants will walk on the treadmill with Hokanson cuffs inflated.
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Device: Hokanson Cuffs
Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant. |
Experimental: Exercise with BStrong Bands
Participants will walk on the treadmill with BStrong bands inflated.
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Device: BStrong Bands
Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
Sham Comparator: Exercise without inflated bands/cuffs
Participants will walk on the treadmill with non-inflated BStrong bands.
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Device: BStrong Bands
Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
Experimental: Yoga poses with BStrong bands inflated
Participants will perform 15-20 yoga poses with BStrong bands inflated.
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Device: BStrong Bands
Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
Sham Comparator: Yoga poses with BStrong bands uninflated
Participants will perform 15-20 yoga poses with uninflated BStrong bands.
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Device: BStrong Bands
Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
- Systolic Blood Pressure [ Time Frame: Measurements were taken at Baseline (before Experimental Arm Participation) and after Experimental Arm Participation. ]Arterial blood pressure was measured using the automatic oscillometric methods.
- Flow-mediated Dilation [ Time Frame: Before and after the exercise interventions ]After 20 minutes of supine rest, endothelial function was measured via flow-mediated dilation (FMD) technique by measuring the brachial artery's diameter increase following a brief period of occlusion using an automated diagnostic ultrasound system. A blood pressure cuff was placed on the forearm with the proximal edge of the cuff above with the participant's antecubital fossa. Two cross-sectional images of the artery were acquired utilizing the automated ultrasound probe proximal to the antecubital fossa. Following baseline metrics, the cuff was inflated to 50 mmHg above resting systolic blood pressure for 5 minutes to occlude blood flow. After 5 minutes of occlusion, the cuff was deflated, and both brachial artery diameter and blood flow velocity were measured simultaneously and continuously for two-minutes immediately post occlusion. FMD was calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion.

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Pregnancy
- A recent illness, recent surgery, or any medical intervention
- history of diabetes, heart disease, or other cardiovascular problems

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): NCT03540147
United States, Texas | |
Cardiovascular Aging Research Lab at UT Austin | |
Austin, Texas, United States, 78712 |
Principal Investigator: | Hirofumi Tanaka, PhD | University of Texas at Austin |
Documents provided by Hirofumi Tanaka, University of Texas at Austin:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hirofumi Tanaka, Professor, University of Texas at Austin |
ClinicalTrials.gov Identifier: | NCT03540147 |
Other Study ID Numbers: |
2017-10-0074 |
First Posted: | May 30, 2018 Key Record Dates |
Results First Posted: | January 28, 2021 |
Last Update Posted: | February 18, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
blood flow restriction blood pressure yoga |