The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses

February 17, 2021 updated by: Hirofumi Tanaka, University of Texas at Austin
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Cardiovascular Aging Research Lab at UT Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.
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.
Before (baseline) and after the exercise interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Savannah Wooten
Sten Stray-Gundersen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2018

Primary Completion (ACTUAL)

May 26, 2019

Study Completion (ACTUAL)

May 26, 2019

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-10-0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD without identifying information will be shared with other investigators with a reasonable request to the investigators.

IPD Sharing Time Frame

The information is available now.

IPD Sharing Access Criteria

They will be available with a reasonable request to the investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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