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Completed

NCT Number: NCT05492071

Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics

Application of vibration has been previously shown to affect tissue perfusion and utilized in different branches of medicine. Little is known about the acute impact of vibration application on peripheral artery hemodynamics. In this study, investigators intend to assess:

1. vibration induced hemodynamic changes in brachial artery in non-diabetic patients and compare the characteristics of these alterations with flow mediated dilation mediated changes in same cohort. 2. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

About this study

Background and Rationale:

Vibration application has been previously shown to affect tissue perfusion and utilized in different branches of medicine. However, previous studies have mainly focused on the impact of vibration on skin perfusion or vibration with active muscle contractions, therefore couldn't truly demonstrate acute impact of local vibration application on peripheral arteries. In addition to that, as a population that is prone to develop vascular problems, it is not known whether diabetic patients have comparable response to vibration application with non-diabetic population.

Objectives:

In this study, investigators aim to demonstrate and compare hemodynamic alterations in brachial artery with paired measurements pre- and post- vibration application and compare the characteristics of these changes with those of flow-mediated dilation in a non-diabetic cohort. Additionally, differences and similarities in vascular hemodynamic response to vibration in diabetic and non-diabetic subgroups are intended to be elucidated.

Methods:

Flow mediated dilatation and vibration will be applied after the participants will abstain from alcohol, caffeine and nicotine for 24 hours. Flow mediated dilatation (FMD) will be induced via 5 min cuff inflation below left elbow at supra-systolic pressures (50mmHg above pre-application systolic pressure). Vibration will be applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD. Left Brachial artery flow will be measured with pulsed Doppler and diameter will be measured via 2D ultrasonographic imaging at 0th, 2nd, 4th, 6th, 8th minutes.Throughout the entire application and measurement periods, patients will be continuously monitored with electrocardiogram.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 - 80
  • Sinus Rhythm in ECG
  • Ejection Fraction > %35
  • Informed Consent

Exclusion criteria

  • Unstabile angina
  • Certain or suspected subclavian artery or brachial artery atherosclerotic disease (assessed with USG)
  • Heart failure ( New York Heart Association III - IV)
  • Atrial fibrillation or frequent extrasystoles in ECG.

Treatment and study plan

Local Vibration Application Following Flow Mediated Dilation

Device

Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). Vibration is applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD.

Flow mediated dilation

Other

Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).

Primary outcomes

  1. Brachial Artery Diameter

    Time frame: Up to 10 minutes after vibration application initiation

    vessel diameter in millimeters

  2. Brachial Artery Mean Flow Velocity

    Time frame: Up to 10 minutes after vibration application initiation

    Mean flow velocity ( cm/sec) measured with Doppler

Other outcomes

  1. Magnitude of Maximum Blood Flow Change

    Time frame: Up to 10 minutes after vibration application initiation

    Magnitude of Maximum Blood Flow Change in Diabetic and Nondiabetic subgroups

  2. Magnitude of Maximum Diameter Change

    Time frame: Up to 10 minutes after vibration application initiation

    Magnitude of Maximum Diameter Change in Diabetic and Nondiabetic subgroups

  3. Magnitude of Maximum Resistance Change

    Time frame: Up to 10 minutes after vibration application initiation

    Magnitude of Maximum Resistance Change in Diabetic and Nondiabetic subgroups

  4. Magnitude of Maximum Mean Flow Velocity Change

    Time frame: Up to 10 minutes after vibration application initiation

    Magnitude of Maximum Mean Flow Velocity Change in Diabetic and Nondiabetic subgroups

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Acronym: VMD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Mar 1, 2023

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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