Clinical trial NCT05451641: Blood Flow Restriction Resistance Training Intervention on Vascular Function
Official title: The Effect of Blood Flow Restriction Resistance Training on Vascular Function: Wide-Rigid Cuffs vs. Narrow-Elastic Bands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline vascular function at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Change from baseline muscle strength at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Change from baseline grip strength at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
Secondary outcomes:
measure: Change from baseline body fat percentage at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Change from baseline fat mass at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Change from baseline lean body mass at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Blood flow responses to different types of cuff
timeFrame: Baseline measurement
measure: Blood flow responses to different types of cuff
timeFrame: At 2 weeks
measure: Change from baseline arterial stiffness at 2 weeks
timeFrame: Baseline measurement and measurement at 2 weeks
measure: Change from baseline blood lactate concentration
timeFrame: At 10 minutes before the training sessions (baseline measurement) and at 10 minutes after the training sessions
measure: Changes from baseline heart rate at the end of each exercise during all the training sessions
timeFrame: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
measure: Change from baseline blood pressure at the end of each exercise during all the training sessions
timeFrame: At 10 minutes before the training sessions (baseline measurement), at 10 minutes, 20 minutes, and 30 minutes during the training sessions
measure: Change of the perceived exertion
timeFrame: At 10 minutes, 20 minutes, and 30 minutes during the training sessions
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiovascular Aging Research Laboratory
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Hirofumi Tanaka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.