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

February 27, 2023 updated by: Dr. Murat Sezer, Istanbul University

Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Name: Murat Sezer, Professor, MD
  • Phone Number: +90 533 237 93 43
  • Email: sezermr@gmail.com

Study Locations

  • Turkey
      • Istanbul, Turkey, 34290
        • Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local Vibration Application Following Flow-Mediated Dilation Application
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.
Device: Local Vibration Application Following Flow Mediated Dilation
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.
Experimental: Flow-Mediated Dilation Application
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
Other: Flow mediated dilation
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial Artery Diameter
Time Frame: Up to 10 minutes after vibration application initiation
vessel diameter in millimeters
Up to 10 minutes after vibration application initiation
Brachial Artery Mean Flow Velocity
Time Frame: Up to 10 minutes after vibration application initiation
Mean flow velocity ( cm/sec) measured with Doppler
Up to 10 minutes after vibration application initiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 10 minutes after vibration application initiation
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
Up to 10 minutes after vibration application initiation
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
Up to 10 minutes after vibration application initiation
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
Up to 10 minutes after vibration application initiation

Collaborators and Investigators

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

Sponsor

Istanbul University

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)

August 8, 2022

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/755

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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