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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05451641
Other study ID # STUDY00002999
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 20, 2022
Est. completion date July 2024

Study information

Verified date May 2024
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Blood flow restriction resistance training
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.

Locations

Country Name City State
United States Cardiovascular Aging Research Laboratory Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline vascular function at 2 weeks Flow-mediated dilation evaluated by an ultrasound machine Baseline measurement and measurement at 2 weeks
Primary Change from baseline muscle strength at 2 weeks Measured by a cable machine in the gym Baseline measurement and measurement at 2 weeks
Primary Change from baseline grip strength at 2 weeks Measured by a hand dynamometer Baseline measurement and measurement at 2 weeks
Secondary Change from baseline body fat percentage at 2 weeks Measured by a bioelectrical impedance analysis machine Baseline measurement and measurement at 2 weeks
Secondary Change from baseline fat mass at 2 weeks Measured by a bioelectrical impedance analysis machine Baseline measurement and measurement at 2 weeks
Secondary Change from baseline lean body mass at 2 weeks Measured by a bioelectrical impedance analysis machine Baseline measurement and measurement at 2 weeks
Secondary Blood flow responses to different types of cuff Measured by an ultrasound machine Baseline measurement
Secondary Blood flow responses to different types of cuff Measured by an ultrasound machine At 2 weeks
Secondary Change from baseline arterial stiffness at 2 weeks Evaluated by the Omron VP-1000plus device (Non-invasive measurement) Baseline measurement and measurement at 2 weeks
Secondary Change from baseline blood lactate concentration Measured by a lactometer At 10 minutes before the training sessions (baseline measurement) and at 10 minutes after the training sessions
Secondary Changes from baseline heart rate at the end of each exercise during all the training sessions Measured by a heart rate monitor At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Secondary Change from baseline blood pressure at the end of each exercise during all the training sessions Measured by an Omron digital blood pressure monitor At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
Secondary Change of the perceived exertion Borg rating of perceived exertion scale At 10 minutes, 20 minutes, and 30 minutes during the training sessions
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