Endothelial FunctionNCT05451641
Blood Flow Restriction Resistance Training Intervention on Vascular Function
A study testing Blood flow restriction resistance training in people with Endothelial Function, run by Hirofumi Tanaka at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of blood flow restriction (BFR) resistance training on vascular function. The investigators aim to compare the effects of different BFR devices (wide-rigid cuffs and narrow elastic bands) on vascular function. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Blood flow restriction resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Apparently healthy, sedentary or recreationally active young adults aged between 18 - 40 years old and signed the informed consent.
Who cannot join
- A current COVID-19 diagnosis
- morbid obesity
- hypertension
- smoking
- overt cardiovascular disease
- using any medication that might affect the cardiovascular system
- current participation in resistance training.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Laboratory
Austin, Texas, 78705
About this study
Official title: The Effect of Blood Flow Restriction Resistance Training on Vascular Function: Wide-Rigid Cuffs vs. Narrow-Elastic Bands
The purpose of this study is to investigate the effect of blood flow restriction (BFR) resistance training on vascular function. The investigators aim to compare the effects of different BFR devices (wide-rigid cuffs and narrow elastic bands) on vascular function. The investigators hypothesize that BFR resistance training with wide-rigid cuffs might have a minor negative effect (short-term and reversible) on vascular function, while BFR resistance training with narrow-elastic bands may improve vascular function. Both training methods are equally effective in increasing muscle strength.
Read the detailed description
Blood flow restriction (BFR) resistance training has been proven to be effective in increasing muscle mass and strength. During BFR training, cuffs (similar to blood pressure cuffs) are placed on the proximal ends of the extremities to partially occlude arterial blood flow to the working muscles and fully restrict venous outflow from the working muscle. The metabolites produced by the working muscle during exercise are trapped in the working muscle, which causes metabolic stress to augment muscle adaptation. Typically, two types of cuffs are used in the BFR training: the narrow-elastic bands and wide-rigid nylon cuffs adapted from surgical tourniquets and blood pressure cuffs.
Currently, the effect of BFR training on vascular function remains unclear. When the cuffs are removed after BFR training, there will be a reactive hyperemic blood flow to wash out all the metabolites produced during exercise. This reactive hyperemic blood flow also will impose shear stress on the arterial vessel wall. The shear stress will lead to an increase in vasodilator factors, which lead to an improvement in vascular function. However, other studies have pointed out that BFR training might cause a negative effect on vascular function when the occlusion pressure was too high. The possible mechanisms of the negative effect might be ischemia-reperfusion injury and retrograde shear stress in the artery. The wide-rigid cuffs are easily available but have the potential to inhibit the expansion of muscle upon increased blood flow accompanying exercise and muscle contraction while the narrow-elastic bands do not prevent the expansion. To the investigators' best knowledge, there is no study directly comparing different BFR cuffs on vascular function. Thus, the aim of the present study is to compare the effects of different BFR cuffs on vascular function (evaluated by flow-mediated dilation, a non-invasive measure of endothelial-derived vasodilation).
- Conditions
- Endothelial Function
- Being tested
- Blood flow restriction resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction resistance trainingBehavioural
The participants will receive a 2-week exercise training program (3 times per week). Each training session will consist of 3 resistance training exercises with two blood flow restriction devices (wide-rigid cuff and narrow-elastic band). For both arms, the participants will perform the same exercise with different BFR devices.
| Study group | Role | What they receive |
|---|---|---|
| Wide-rigid cuff | Experimental | The wide-rigid cuff will be randomly assigned to one of the subject's arms. Receives: Behavioral: Blood flow restriction resistance training |
| Narrow-elastic band | Experimental | The narrow-elastic band will be randomly assigned to another arm of the subject. Receives: Behavioral: Blood flow restriction resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline vascular function at 2 weeks
Flow-mediated dilation evaluated by an ultrasound machine
Measured: Baseline measurement and measurement at 2 weeks
Change from baseline muscle strength at 2 weeks
Measured by a cable machine in the gym
Measured: Baseline measurement and measurement at 2 weeks
Change from baseline grip strength at 2 weeks
Measured by a hand dynamometer
Measured: Baseline measurement and measurement at 2 weeks
Secondary outcomes (10)
Change from baseline body fat percentage at 2 weeks
Measured by a bioelectrical impedance analysis machine
Measured: Baseline measurement and measurement at 2 weeks
Change from baseline fat mass at 2 weeks
Measured by a bioelectrical impedance analysis machine
Measured: Baseline measurement and measurement at 2 weeks
Change from baseline lean body mass at 2 weeks
Measured by a bioelectrical impedance analysis machine
Measured: Baseline measurement and measurement at 2 weeks
Blood flow responses to different types of cuff
Measured by an ultrasound machine
Measured: Baseline measurement
Blood flow responses to different types of cuff
Measured by an ultrasound machine
Measured: At 2 weeks
Change from baseline arterial stiffness at 2 weeks
Evaluated by the Omron VP-1000plus device (Non-invasive measurement)
Measured: Baseline measurement and measurement at 2 weeks
Change from baseline blood lactate concentration
Measured by a lactometer
Measured: At 10 minutes before the training sessions (baseline measurement) and at 10 minutes after the training sessions
Changes from baseline heart rate at the end of each exercise during all the training sessions
Measured by a heart rate monitor
Measured: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Change from baseline blood pressure at the end of each exercise during all the training sessions
Measured by an Omron digital blood pressure monitor
Measured: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Change of the perceived exertion
Borg rating of perceived exertion scale
Measured: At 10 minutes, 20 minutes, and 30 minutes during the training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start20 Sep 2022
- Primary completion1 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hirofumi Tanaka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hirofumi Tanaka, University of Texas at Austin
- Investigators
- Hirofumi Tanaka, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451641
- Sponsor's protocol ID
- STUDY00002999
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lixandrao ME, Ugrinowitsch C, Berton R, Vechin FC, Conceicao MS, Damas F, Libardi CA, Roschel H. Magnitude of Muscle Strength and Mass Adaptations Between High-Load Resistance Training Versus Low-Load Resistance Training Associated with Blood-Flow Restriction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Feb;48(2):361-378. doi: 10.1007/s40279-017-0795-y.
PubMed 29043659Pearson SJ, Hussain SR. A review on the mechanisms of blood-flow restriction resistance training-induced muscle hypertrophy. Sports Med. 2015 Feb;45(2):187-200. doi: 10.1007/s40279-014-0264-9.
PubMed 25249278Early KS, Rockhill M, Bryan A, Tyo B, Buuck D, McGinty J. EFFECT OF BLOOD FLOW RESTRICTION TRAINING ON MUSCULAR PERFORMANCE, PAIN AND VASCULAR FUNCTION. Int J Sports Phys Ther. 2020 Dec;15(6):892-900. doi: 10.26603/ijspt20200892.
PubMed 33344005Hunt JE, Galea D, Tufft G, Bunce D, Ferguson RA. Time course of regional vascular adaptations to low load resistance training with blood flow restriction. J Appl Physiol (1985). 2013 Aug 1;115(3):403-11. doi: 10.1152/japplphysiol.00040.2013. Epub 2013 May 23.
PubMed 23703116Horiuchi M, Okita K. Blood flow restricted exercise and vascular function. Int J Vasc Med. 2012;2012:543218. doi: 10.1155/2012/543218. Epub 2012 Oct 22.
PubMed 23133756Alhejily W, Aleksi A, Martin BJ, Anderson TJ. The effect of ischemia-reperfusion injury on measures of vascular function. Clin Hemorheol Microcirc. 2014;56(3):265-71. doi: 10.3233/CH-131741.
PubMed 23719421Thijssen DH, Dawson EA, Tinken TM, Cable NT, Green DJ. Retrograde flow and shear rate acutely impair endothelial function in humans. Hypertension. 2009 Jun;53(6):986-92. doi: 10.1161/HYPERTENSIONAHA.109.131508. Epub 2009 Apr 20.
PubMed 19380611
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Resistance Training on Vascular Function: Wide-Rigid Cuffs vs. Narrow-Elastic Bands
- ClinicalTrials.gov ID
- NCT05451641
- Acronym / sponsor ID
- STUDY00002999
- Conditions
- Endothelial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hirofumi TanakaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of blood flow restriction (BFR) resistance training on vascular function. The investigators aim to compare the effects of different BFR devices (wide-rigid cuffs and narrow elastic bands) on vascular function. The investigators hypothesize that BFR resistance training with wide-rigid cuffs might have a minor negative effect (short-term and reversible) on vascular function, while BFR resistance training with narrow-elastic bands may improve vascular function. Both training methods are equally effective in increasing muscle strength.
Detailed description
Blood flow restriction (BFR) resistance training has been proven to be effective in increasing muscle mass and strength. During BFR training, cuffs (similar to blood pressure cuffs) are placed on the proximal ends of the extremities to partially occlude arterial blood flow to the working muscles and fully restrict venous outflow from the working muscle. The metabolites produced by the working muscle during exercise are trapped in the working muscle, which causes metabolic stress to augment muscle adaptation. Typically, two types of cuffs are used in the BFR training: the narrow-elastic bands and wide-rigid nylon cuffs adapted from surgical tourniquets and blood pressure cuffs.
Currently, the effect of BFR training on vascular function remains unclear. When the cuffs are removed after BFR training, there will be a reactive hyperemic blood flow to wash out all the metabolites produced during exercise. This reactive hyperemic blood flow also will impose shear stress on the arterial vessel wall. The shear stress will lead to an increase in vasodilator factors, which lead to an improvement in vascular function. However, other studies have pointed out that BFR training might cause a negative effect on vascular function when the occlusion pressure was too high. The possible mechanisms of the negative effect might be ischemia-reperfusion injury and retrograde shear stress in the artery. The wide-rigid cuffs are easily available but have the potential to inhibit the expansion of muscle upon increased blood flow accompanying exercise and muscle contraction while the narrow-elastic bands do not prevent the expansion. To the investigators' best knowledge, there is no study directly comparing different BFR cuffs on vascular function. Thus, the aim of the present study is to compare the effects of different BFR cuffs on vascular function (evaluated by flow-mediated dilation, a non-invasive measure of endothelial-derived vasodilation).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide-rigid cuff | Experimental | Behavioral: Blood flow restriction resistance trainingThe wide-rigid cuff will be randomly assigned to one of the subject's arms. |
| Narrow-elastic band | Experimental | Behavioral: Blood flow restriction resistance trainingThe narrow-elastic band will be randomly assigned to another arm of the subject. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Apparently healthy, sedentary or recreationally active young adults aged between 18 - 40 years old and signed the informed consent.
Key exclusion criteria (7 listed)
- A current COVID-19 diagnosis
- morbid obesity
- hypertension
- smoking
- overt cardiovascular disease
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 |
|---|---|---|
| Blood flow restriction resistance trainingThe participants will receive a 2-week exercise training program (3 times per week). Each training session will consist of 3 resistance training exercises with two blood flow restriction devices (wide-rigid cuff and narrow-elastic band). For both arms, the participants will perform the same exercise with different BFR devices. | Behavioural | Narrow-elastic band, Wide-rigid cuff |
Primary outcome
Change from baseline vascular function at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Flow-mediated dilation evaluated by an ultrasound machine
Change from baseline muscle strength at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Measured by a cable machine in the gym
Change from baseline grip strength at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Measured by a hand dynamometer
10 secondary outcomes
Change from baseline body fat percentage at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Change from baseline fat mass at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Change from baseline lean body mass at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Blood flow responses to different types of cuff
Time frame: Baseline measurement
Blood flow responses to different types of cuff
Time frame: At 2 weeks
Change from baseline arterial stiffness at 2 weeks
Time frame: Baseline measurement and measurement at 2 weeks
Change from baseline blood lactate concentration
Time frame: At 10 minutes before the training sessions (baseline measurement) and at 10 minutes after the training sessions
Changes from baseline heart rate at the end of each exercise during all the training sessions
Time frame: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Change from baseline blood pressure at the end of each exercise during all the training sessions
Time frame: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Change of the perceived exertion
Time frame: At 10 minutes, 20 minutes, and 30 minutes during the training sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 29043659Lixandrao ME, Ugrinowitsch C, Berton R, Vechin FC, Conceicao MS, Damas F, Libardi CA, Roschel H. Magnitude of Muscle Strength and Mass Adaptations Between High-Load Resistance Training Versus Low-Load Resistance Training Associated with Blood-Flow Restriction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Feb;48(2):361-378. doi: 10.1007/s40279-017-0795-y.
- Background: PubMed 25249278Pearson SJ, Hussain SR. A review on the mechanisms of blood-flow restriction resistance training-induced muscle hypertrophy. Sports Med. 2015 Feb;45(2):187-200. doi: 10.1007/s40279-014-0264-9.
- Background: PubMed 33344005Early KS, Rockhill M, Bryan A, Tyo B, Buuck D, McGinty J. EFFECT OF BLOOD FLOW RESTRICTION TRAINING ON MUSCULAR PERFORMANCE, PAIN AND VASCULAR FUNCTION. Int J Sports Phys Ther. 2020 Dec;15(6):892-900. doi: 10.26603/ijspt20200892.
- Background: PubMed 23703116Hunt JE, Galea D, Tufft G, Bunce D, Ferguson RA. Time course of regional vascular adaptations to low load resistance training with blood flow restriction. J Appl Physiol (1985). 2013 Aug 1;115(3):403-11. doi: 10.1152/japplphysiol.00040.2013. Epub 2013 May 23.
- Background: PubMed 23133756Horiuchi M, Okita K. Blood flow restricted exercise and vascular function. Int J Vasc Med. 2012;2012:543218. doi: 10.1155/2012/543218. Epub 2012 Oct 22.
- Background: PubMed 23719421Alhejily W, Aleksi A, Martin BJ, Anderson TJ. The effect of ischemia-reperfusion injury on measures of vascular function. Clin Hemorheol Microcirc. 2014;56(3):265-71. doi: 10.3233/CH-131741.
- Background: PubMed 19380611Thijssen DH, Dawson EA, Tinken TM, Cable NT, Green DJ. Retrograde flow and shear rate acutely impair endothelial function in humans. Hypertension. 2009 Jun;53(6):986-92. doi: 10.1161/HYPERTENSIONAHA.109.131508. Epub 2009 Apr 20.
- Individual participant dataSharing planned: No
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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
The 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 Blood flow restriction resistance training in people with Endothelial Function, run by Hirofumi Tanaka 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 7 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: finished, as of the sponsor's last update on 10 Jun 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline vascular function at 2 weeks (time frame: Baseline measurement and measurement at 2 weeks). The study lists 3 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 NCT05451641, 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 10 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.