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

Primary Purpose

Vasodilation, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Local Vibration Application Following Flow Mediated Dilation
Flow mediated dilation
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vasodilation focused on measuring Vibration, Peripheral Artery Hemodynamics, Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Local Vibration Application Following Flow-Mediated Dilation Application

Flow-Mediated Dilation Application

Arm Description

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

Outcomes

Primary Outcome Measures

Brachial Artery Diameter
vessel diameter in millimeters
Brachial Artery Mean Flow Velocity
Mean flow velocity ( cm/sec) measured with Doppler

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
February 27, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05492071
Brief Title
Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics
Acronym
VMD
Official Title
Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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

5. Study Description

Brief Summary
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: 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. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasodilation, Diabetes Mellitus, Type 2
Keywords
Vibration, Peripheral Artery Hemodynamics, Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local Vibration Application Following Flow-Mediated Dilation Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Flow-Mediated Dilation Application
Arm Type
Experimental
Arm Description
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
Intervention Type
Device
Intervention Name(s)
Local Vibration Application Following Flow Mediated Dilation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Flow mediated dilation
Intervention Description
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
Primary Outcome Measure Information:
Title
Brachial Artery Diameter
Description
vessel diameter in millimeters
Time Frame
Up to 10 minutes after vibration application initiation
Title
Brachial Artery Mean Flow Velocity
Description
Mean flow velocity ( cm/sec) measured with Doppler
Time Frame
Up to 10 minutes after vibration application initiation
Other Pre-specified Outcome Measures:
Title
Magnitude of Maximum Blood Flow Change
Description
Magnitude of Maximum Blood Flow Change in Diabetic and Nondiabetic subgroups
Time Frame
Up to 10 minutes after vibration application initiation
Title
Magnitude of Maximum Diameter Change
Description
Magnitude of Maximum Diameter Change in Diabetic and Nondiabetic subgroups
Time Frame
Up to 10 minutes after vibration application initiation
Title
Magnitude of Maximum Resistance Change
Description
Magnitude of Maximum Resistance Change in Diabetic and Nondiabetic subgroups
Time Frame
Up to 10 minutes after vibration application initiation
Title
Magnitude of Maximum Mean Flow Velocity Change
Description
Magnitude of Maximum Mean Flow Velocity Change in Diabetic and Nondiabetic subgroups
Time Frame
Up to 10 minutes after vibration application initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
City
Istanbul
ZIP/Postal Code
34290
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21042329
Citation
Herrero AJ, Menendez H, Gil L, Martin J, Martin T, Garcia-Lopez D, Gil-Agudo A, Marin PJ. Effects of whole-body vibration on blood flow and neuromuscular activity in spinal cord injury. Spinal Cord. 2011 Apr;49(4):554-9. doi: 10.1038/sc.2010.151. Epub 2010 Nov 2.
Results Reference
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PubMed Identifier
24237890
Citation
Robbins D, Yoganathan P, Goss-Sampson M. The influence of whole body vibration on the central and peripheral cardiovascular system. Clin Physiol Funct Imaging. 2014 Sep;34(5):364-9. doi: 10.1111/cpf.12103. Epub 2013 Nov 17.
Results Reference
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PubMed Identifier
31257335
Citation
Aoyama A, Yamaoka-Tojo M, Obara S, Shimizu E, Fujiyoshi K, Noda C, Matsunaga A, Ako J. Acute Effects of Whole-Body Vibration Training on Endothelial Function and Cardiovascular Response in Elderly Patients with Cardiovascular Disease. Int Heart J. 2019 Jul 27;60(4):854-861. doi: 10.1536/ihj.18-592. Epub 2019 Jun 28.
Results Reference
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Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics

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