Blood Flow Restriction Resistance Training Intervention on Vascular Function

August 29, 2023 updated by: University of Texas at Austin

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Flow-mediated dilation evaluated by an ultrasound machine
Baseline measurement and measurement at 2 weeks
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
Baseline measurement and measurement at 2 weeks
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
Baseline measurement and measurement at 2 weeks
Change from baseline fat mass at 2 weeks
Time Frame: Baseline measurement and measurement at 2 weeks
Measured by a bioelectrical impedance analysis machine
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
Measured by a bioelectrical impedance analysis machine
Baseline measurement and measurement at 2 weeks
Blood flow responses to different types of cuff
Time Frame: Baseline measurement
Measured by an ultrasound machine
Baseline measurement
Blood flow responses to different types of cuff
Time Frame: At 2 weeks
Measured by an ultrasound machine
At 2 weeks
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)
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
Measured by a lactometer
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
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
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
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
Borg rating of perceived exertion scale
At 10 minutes, 20 minutes, and 30 minutes during the training sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hirofumi Tanaka, PhD, The University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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