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Completed

NCT Number: NCT05451641

Blood Flow Restriction Resistance Training Intervention on Vascular Function

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Aging Research Laboratory

Austin, Texas, 78705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood flow restriction resistance training

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. Change from baseline grip strength at 2 weeks

    Time frame: Baseline measurement and measurement at 2 weeks

    Measured by a hand dynamometer

Secondary outcomes

  1. 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

  2. Change from baseline fat mass at 2 weeks

    Time frame: Baseline measurement and measurement at 2 weeks

    Measured by a bioelectrical impedance analysis machine

  3. Change from baseline lean body mass at 2 weeks

    Time frame: Baseline measurement and measurement at 2 weeks

    Measured by a bioelectrical impedance analysis machine

  4. Blood flow responses to different types of cuff

    Time frame: Baseline measurement

    Measured by an ultrasound machine

  5. Blood flow responses to different types of cuff

    Time frame: At 2 weeks

    Measured by an ultrasound machine

  6. Change from baseline arterial stiffness at 2 weeks

    Time frame: Baseline measurement and measurement at 2 weeks

    Evaluated by the Omron VP-1000plus device (Non-invasive measurement)

  7. 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

    Measured by a lactometer

  8. 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

    Measured by a heart rate monitor

  9. 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

    Measured by an Omron digital blood pressure monitor

  10. Change of the perceived exertion

    Time frame: At 10 minutes, 20 minutes, and 30 minutes during the training sessions

    Borg rating of perceived exertion scale

Sponsors and collaborators

Lead sponsor

Hirofumi Tanaka

Other

Registry information

Official study title

The Effect of Blood Flow Restriction Resistance Training on Vascular Function: Wide-Rigid Cuffs vs. Narrow-Elastic Bands

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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