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

Not Applicable

Completed

• Conditions: Vasodilation; Diabetes Mellitus, Type 2
• Interventions: Device: Local Vibration Application Following Flow Mediated Dilation; Other: Flow mediated dilation

• Registration Number: NCT05492071
• Lead Sponsor: Istanbul University

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:

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.

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 Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-05
• Study Start: 2022-08-08
• Study First Posted: 2022-08-08
• Primary Completion: 2022-09-10
• Study Completion: 2022-09-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Local Vibration Application Following Flow-Mediated Dilation Application	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.
Flow-Mediated Dilation Application	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology; 🇹🇷 Istanbul, Turkey