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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 : March 11, 2021
Sponsor:
Collaborators:
Savannah Wooten
Sten Stray-Gundersen
Information provided by (Responsible Party):
Hirofumi Tanaka, University of Texas at Austin

Study Description
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Brief Summary:
The impact of blood flow restriction (BFR) on exercise and hemodynamic responses will be studied. The use of BFR will be studied during yoga and low-intensity aerobic exercise in healthy subjects with no history of chronic illness ranging from 18-40 years of age. This study will evaluate several conditions related to cardiovascular physiology in order to determine the safety and efficacy of this type of exercise training. First, the effects of two distinct types of BFR cuffs (BStrong and Hokanson) will be studied during low-intensity aerobic exercise on vascular function. Second, the effect of yoga will be studied with and without the use of BStrong bands on vascular function. Outcome measures include acute effects on endothelial function i.e. flow-mediated dilation, arterial stiffness, beat-by-beat blood pressure, heart rate, RPE (rate of perceived exertion), and blood lactate. For this intervention, the BFR cuffs will be used during exercise to evaluate its safety and efficacy. Since BFR is becoming a widely popular method of exercise, it is important to study its safety and hemodynamic effects.

Condition or disease Intervention/treatment Phase
Exercise Training Hemodynamic Response Device: Hokanson Cuffs Device: BStrong Bands Not Applicable

Detailed Description:
Participants will be tested a total of 5 times; twice for the yoga portion and thrice for the aerobic exercise (walking) portion. Outcome measures will be consistent across the five visits and will take approximately 2.5 hours to complete. The order of the five separate sessions will be randomized such that the participant cannot expect which condition they will be performing.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise with Hokanson cuffs
Participants will walk on the treadmill with Hokanson cuffs inflated.
 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.
 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.
 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.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation. ]
    Arterial blood pressure was measured using the automatic oscillometric methods.

  2. Flow-mediated Dilation [ Time Frame: Before (baseline) 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT03540147


Locations
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United States, Texas
Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Savannah Wooten
Sten Stray-Gundersen
Investigators
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Principal Investigator: Hirofumi Tanaka, PhD University of Texas at Austin
  Study Documents (Full-Text)

Documents provided by Hirofumi Tanaka, University of Texas at Austin:
Study Protocol and Statistical Analysis Plan  [PDF] February 7, 2019

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD without identifying information will be shared with other investigators with a reasonable request to the investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The information is available now.
Access Criteria: They will be available with a reasonable request to the investigators.

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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
Keywords provided by Hirofumi Tanaka, University of Texas at Austin:
blood flow restriction
blood pressure
yoga