- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05451641
Blood Flow Restriction Resistance Training Intervention on Vascular Function
The Effect of Blood Flow Restriction Resistance Training on Vascular Function: Wide-Rigid Cuffs vs. Narrow-Elastic Bands
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lin-Sheng Chen
- Phone Number: 765-775-3257
- Email: samas9944@gmail.com
Study Locations
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Texas
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Austin, Texas, United States, 78705
- Recruiting
- Cardiovascular Aging Research Laboratory
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Contact:
- Lin-Sheng Chen, MS
- Phone Number: +1 765 775 3257
- Email: linsheng.chen@utexas.edu
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Contact:
- Hirofumi Tanaka, PhD
- Phone Number: 512-232-4801
- Email: htanaka@austin.utexas.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Apparently healthy, sedentary or recreationally active young adults aged between 18 - 40 years old and signed the informed consent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wide-rigid cuff
The wide-rigid cuff will be randomly assigned to one of the subject's arms.
|
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.
|
Experimental: Narrow-elastic band
The narrow-elastic band will be randomly assigned to another arm of the subject.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline vascular function at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
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Flow-mediated dilation evaluated by an ultrasound machine
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Baseline measurement and measurement at 2 weeks
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Change from baseline muscle strength at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
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Measured by a cable machine in the gym
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Baseline measurement and measurement at 2 weeks
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Change from baseline grip strength at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
|
Measured by a hand dynamometer
|
Baseline measurement and measurement at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline body fat percentage at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
|
Measured by a bioelectrical impedance analysis machine
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Baseline measurement and measurement at 2 weeks
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Change from baseline fat mass at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
|
Measured by a bioelectrical impedance analysis machine
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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
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Measured by a bioelectrical impedance analysis machine
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Baseline measurement and measurement at 2 weeks
|
Blood flow responses to different types of cuff
Time Frame: Baseline measurement
|
Measured by an ultrasound machine
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Baseline measurement
|
Blood flow responses to different types of cuff
Time Frame: At 2 weeks
|
Measured by an ultrasound machine
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At 2 weeks
|
Change from baseline arterial stiffness at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
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Evaluated by the Omron VP-1000plus device (Non-invasive measurement)
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Baseline measurement and measurement at 2 weeks
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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
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Measured by a lactometer
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At 10 minutes before the training sessions (baseline measurement) and at 10 minutes after the training sessions
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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
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Measured by a heart rate monitor
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At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
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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
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Measured by an Omron digital blood pressure monitor
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At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
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Change of the perceived exertion
Time Frame: At 10 minutes, 20 minutes, and 30 minutes during the training sessions
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Borg rating of perceived exertion scale
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At 10 minutes, 20 minutes, and 30 minutes during the training sessions
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hirofumi Tanaka, PhD, The University of Texas at Austin
Publications and helpful links
General 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.
- Pearson 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.
- Early 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.
- Hunt 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.
- Horiuchi 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.
- Alhejily 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.
- Thijssen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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