Exercise TrainingNCT03540147

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

A study testing Hokanson Cuffs and BStrong Bands in people with Exercise Training and Hemodynamic Response, run by University of Texas at Austin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Exercise Training, Hemodynamic Response
What is being tested?: Hokanson Cuffs and BStrong Bands
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 26 Jan 2018to 26 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults

Who cannot join

Pregnancy
A recent illness, recent surgery, or any medical intervention
history of diabetes, heart disease, or other cardiovascular problems

Trial locations and contacts

1 site in 1 country.

United States1 site

Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, 78712

Other trials in United States

About this study

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.

Read the 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.

Conditions: Exercise Training, Hemodynamic Response
Being tested: Hokanson Cuffs, BStrong Bands
Keywords: blood flow restriction, blood pressure, yoga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hokanson CuffsDevice
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.
BStrong BandsDevice
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.

Study groups in NCT03540147
Study group	Role	What they receive
Exercise with Hokanson cuffs	Experimental	Participants will walk on the treadmill with Hokanson cuffs inflated. Receives: Device: Hokanson Cuffs
Exercise with BStrong Bands	Experimental	Participants will walk on the treadmill with BStrong bands inflated. Receives: Device: BStrong Bands
Exercise without inflated bands/cuffs	Sham comparator	Participants will walk on the treadmill with non-inflated BStrong bands. Receives: Device: BStrong Bands
Yoga poses with BStrong bands inflated	Experimental	Participants will perform 15-20 yoga poses with BStrong bands inflated. Receives: Device: BStrong Bands
Yoga poses with BStrong bands uninflated	Sham comparator	Participants will perform 15-20 yoga poses with uninflated BStrong bands. Receives: Device: BStrong Bands

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic Blood Pressure
Arterial blood pressure was measured using the automatic oscillometric methods.
Measured: Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.
Flow-mediated Dilation
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.
Measured: Before (baseline) and after the exercise interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 201826 May 2019

First posted30 May 2018
Study start26 Jan 2018
Primary completion26 May 2019
Study completion26 May 2019

Why it stopped: The number of subjects in this study was overestimated in the initial assessment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Exercise TrainingStudies of the same condition, open and under way.
More trials run by University of Texas at AustinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
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 blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03540147
Sponsor's protocol ID: 2017-10-0074
Status last verified: Feb 2021
First submitted: 30 Apr 2018
Last updated: 11 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: IPD without identifying information will be shared with other investigators with a reasonable request to the investigators.

Publications

Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454.
PubMed 19952840
Sugawara J, Tomoto T, Tanaka H. Impact of leg blood flow restriction during walking on central arterial hemodynamics. Am J Physiol Regul Integr Comp Physiol. 2015 Oct;309(7):R732-9. doi: 10.1152/ajpregu.00095.2015. Epub 2015 Aug 5.
PubMed 26246503
Shimizu R, Hotta K, Yamamoto S, Matsumoto T, Kamiya K, Kato M, Hamazaki N, Kamekawa D, Akiyama A, Kamada Y, Tanaka S, Masuda T. Low-intensity resistance training with blood flow restriction improves vascular endothelial function and peripheral blood circulation in healthy elderly people. Eur J Appl Physiol. 2016 Apr;116(4):749-57. doi: 10.1007/s00421-016-3328-8. Epub 2016 Jan 28.
PubMed 26822582
Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. The effect of Bikram yoga on arterial stiffness in young and older adults. J Altern Complement Med. 2013 Dec;19(12):930-4. doi: 10.1089/acm.2012.0709. Epub 2013 Jun 5.
PubMed 23738677
Miles SC, Chun-Chung C, Hsin-Fu L, Hunter SD, Dhindsa M, Nualnim N, Tanaka H. Arterial blood pressure and cardiovascular responses to yoga practice. Altern Ther Health Med. 2013 Jan-Feb;19(1):38-45.
PubMed 23341425
Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. Impact of Hot Yoga on Arterial Stiffness and Quality of Life in Normal and Overweight/Obese Adults. J Phys Act Health. 2016 Dec;13(12):1360-1363. doi: 10.1123/jpah.2016-0170. Epub 2016 Aug 24.
PubMed 27633625
Stray-Gundersen S, Wooten S, Tanaka H. Walking With Leg Blood Flow Restriction: Wide-Rigid Cuffs vs. Narrow-Elastic Bands. Front Physiol. 2020 May 29;11:568. doi: 10.3389/fphys.2020.00568. eCollection 2020.
PubMed 32547424

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses
ClinicalTrials.gov ID: NCT03540147
Acronym / sponsor ID: 2017-10-0074
Conditions: Exercise Training, Hemodynamic Response
Keywords: blood flow restriction, blood pressure, yoga
Study type: Interventional
Recruitment status: TerminatedReason stopped: The number of subjects in this study was overestimated in the initial assessment.
Enrolment: 20 participants (actual)
Lead sponsor: University of Texas at AustinUniversity, hospital or other
Collaborators: Savannah Wooten, Stray-Gundersen, Sten, Ph.D.
Study start: 26 Jan 2018 (actual)
Primary completion: 26 May 2019 (actual)
Study completion: 26 May 2019 (actual)
First posted: 30 May 2018 (actual)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5
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.

Arm	Type	Receives
Exercise with Hokanson cuffs	Experimental	Device: Hokanson CuffsParticipants will walk on the treadmill with Hokanson cuffs inflated.
Exercise with BStrong Bands	Experimental	Device: BStrong BandsParticipants will walk on the treadmill with BStrong bands inflated.
Exercise without inflated bands/cuffs	Sham comparator	Device: BStrong BandsParticipants will walk on the treadmill with non-inflated BStrong bands.
Yoga poses with BStrong bands inflated	Experimental	Device: BStrong BandsParticipants will perform 15-20 yoga poses with BStrong bands inflated.
Yoga poses with BStrong bands uninflated	Sham comparator	Device: BStrong BandsParticipants will perform 15-20 yoga poses with uninflated BStrong bands.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy adults

Key exclusion criteria (3 listed)

Pregnancy
A recent illness, recent surgery, or any medical intervention
history of diabetes, heart disease, or other cardiovascular problems

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hokanson CuffsEach 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.	Device	Exercise with Hokanson cuffs
BStrong BandsEach subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant.	Device	Exercise with BStrong Bands, Exercise without inflated bands/cuffs, Yoga poses with BStrong bands inflated, Yoga poses with BStrong bands uninflated

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blood Flow Restriction Exercise	20	20

Primary outcome: Systolic Blood Pressure

Time frame: Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.. Mean (Standard Deviation). Unit: mmHg

Measure	Exercise With Hokanson Cuffs n = 20	Exercise With BStrong Bands n = 20	Exercise Without Inflated Bands/Cuffs n = 20	Yoga Poses With BStrong Bands Inflated n = 20	Yoga Poses With BStrong Bands Uninflated n = 20
Baseline (before the experimental arm participation)	116 (11)	116 (9)	117 (7)	117 (7)	115 (8)
Immediately after	150 (16)	127 (10)	158 (14)	160 (15)	130 (15)

Population analysed: Baseline (before Experimental Arm Participation) data are reported below.

Primary outcome: Flow-mediated Dilation

Time frame: Before (baseline) and after the exercise interventions. Mean (Standard Error). Unit: percentage of resting diameter

Measure	Exercise With Hokanson Cuffs n = 20	Exercise With BStrong Bands n = 20	Exercise Without Inflated Bands/Cuffs n = 20	Yoga Poses With BStrong Bands Inflated n = 20	Yoga Poses With BStrong Bands Uninflated n = 20
Baseline (before conditions)	7.0 (2)	7.2 (2.2)	7.0 (1.8)	6.8 (1.6)	6.9 (2)
After conditions	6.8 (1.8)	7.1 (2.0)	7.1 (1.9)	7.0 (2)	6.7 (1.7)

Adverse events

Time frame: Each participants came to the laboratory twice in the span of 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise With Hokanson Cuffs	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Exercise With BStrong Bands	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Exercise Without Inflated Bands/Cuffs	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Yoga Poses With BStrong Bands Inflated	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Yoga Poses With BStrong Bands Uninflated	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19952840Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454.
Background: PubMed 26246503Sugawara J, Tomoto T, Tanaka H. Impact of leg blood flow restriction during walking on central arterial hemodynamics. Am J Physiol Regul Integr Comp Physiol. 2015 Oct;309(7):R732-9. doi: 10.1152/ajpregu.00095.2015. Epub 2015 Aug 5.
Background: PubMed 26822582Shimizu R, Hotta K, Yamamoto S, Matsumoto T, Kamiya K, Kato M, Hamazaki N, Kamekawa D, Akiyama A, Kamada Y, Tanaka S, Masuda T. Low-intensity resistance training with blood flow restriction improves vascular endothelial function and peripheral blood circulation in healthy elderly people. Eur J Appl Physiol. 2016 Apr;116(4):749-57. doi: 10.1007/s00421-016-3328-8. Epub 2016 Jan 28.
Background: PubMed 23738677Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. The effect of Bikram yoga on arterial stiffness in young and older adults. J Altern Complement Med. 2013 Dec;19(12):930-4. doi: 10.1089/acm.2012.0709. Epub 2013 Jun 5.
Background: PubMed 23341425Miles SC, Chun-Chung C, Hsin-Fu L, Hunter SD, Dhindsa M, Nualnim N, Tanaka H. Arterial blood pressure and cardiovascular responses to yoga practice. Altern Ther Health Med. 2013 Jan-Feb;19(1):38-45.
Background: PubMed 27633625Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. Impact of Hot Yoga on Arterial Stiffness and Quality of Life in Normal and Overweight/Obese Adults. J Phys Act Health. 2016 Dec;13(12):1360-1363. doi: 10.1123/jpah.2016-0170. Epub 2016 Aug 24.
Derived from this study: PubMed 32547424Stray-Gundersen S, Wooten S, Tanaka H. Walking With Leg Blood Flow Restriction: Wide-Rigid Cuffs vs. Narrow-Elastic Bands. Front Physiol. 2020 May 29;11:568. doi: 10.3389/fphys.2020.00568. eCollection 2020.
Individual participant dataSharing planned: Yes. IPD without identifying information will be shared with other investigators with a reasonable request to the investigators.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hirofumi Tanaka, PhD principal investigator

University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hokanson Cuffs and BStrong Bands in people with Exercise Training and Hemodynamic Response, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03540147, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.