NCT05451641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

June 22, 2022

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline vascular function 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

    Measured by a cable machine in the gym

    Baseline measurement and measurement at 2 weeks

  • Change from baseline grip strength at 2 weeks

    Measured by a hand dynamometer

    Baseline measurement and measurement at 2 weeks

Secondary Outcomes (10)

  • Change from baseline body fat percentage at 2 weeks

    Baseline measurement and measurement at 2 weeks

  • Change from baseline fat mass at 2 weeks

    Baseline measurement and measurement at 2 weeks

  • Change from baseline lean body mass at 2 weeks

    Baseline measurement and measurement at 2 weeks

  • Blood flow responses to different types of cuff

    Baseline measurement

  • Blood flow responses to different types of cuff

    At 2 weeks

  • +5 more secondary outcomes

Study Arms (2)

Wide-rigid cuff

EXPERIMENTAL

The wide-rigid cuff will be randomly assigned to one of the subject's arms.

Behavioral: Blood flow restriction resistance training

Narrow-elastic band

EXPERIMENTAL

The narrow-elastic band will be randomly assigned to another arm of the subject.

Behavioral: Blood flow restriction resistance training

Interventions

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.

Narrow-elastic bandWide-rigid cuff

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy, sedentary or recreationally active young adults aged between 18 - 40 years old and signed the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Aging Research Laboratory

Austin, Texas, 78705, United States

Location

Related Publications (7)

  • 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.

    PMID: 29043659BACKGROUND
  • 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.

    PMID: 25249278BACKGROUND
  • 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.

    PMID: 33344005BACKGROUND
  • 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.

    PMID: 23703116BACKGROUND
  • 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.

    PMID: 23133756BACKGROUND
  • 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.

    PMID: 23719421BACKGROUND
  • 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.

    PMID: 19380611BACKGROUND

Study Officials

  • Hirofumi Tanaka, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 11, 2022

Study Start

September 20, 2022

Primary Completion

September 1, 2024

Study Completion

September 19, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations