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

• Sponsor: Istanbul University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05492071
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arm: 1
• Anticipated Duration (Days): 24
• Patients Per Site Per Month: 114.1

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Vasodilation; Diabetes Mellitus, Type 2	Device: Local Vibration Application Following Flow Mediated Dilation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
• Actual Study Start Date: Aug 8, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Brachial Artery Diameter [Up to 10 minutes after vibration application initiation]

   vessel diameter in millimeters

2. Brachial Artery Mean Flow Velocity [Up to 10 minutes after vibration application initiation]

   Mean flow velocity ( cm/sec) measured with Doppler

Other Outcome Measures

1. Magnitude of Maximum Blood Flow Change [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 [Up to 10 minutes after vibration application initiation]

   Magnitude of Maximum Diameter Change in Diabetic and Nondiabetic subgroups

3. Magnitude of Maximum Resistance Change [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 [Up to 10 minutes after vibration application initiation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology	Istanbul		Turkey	34290

Sponsors and Collaborators

• Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Herrero AJ, Menéndez H, Gil L, Martín J, Martín T, García-López D, Gil-Agudo A, Marín 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.
• 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.

• Responsible Party: Dr. Murat Sezer, Professor, MD, Istanbul University
• ClinicalTrials.gov Identifier: NCT05492071
• Other Study ID Numbers: 2020/755
• First Posted: Aug 8, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• 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
• Keywords provided by Dr. Murat Sezer, Professor, MD, Istanbul University: Vibration; Peripheral Artery Hemodynamics; Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 10, 2022