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NCT05492071 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— VMD  

Official title:
Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05492071
Other study ID # 2020/755
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2022
Est. completion date September 20, 2022

Study information
Verified date February 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 20, 2022
Est. primary completion date September 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
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).

Locations
Country Name City State
Turkey Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Magnitude of Maximum Blood Flow Change Magnitude of Maximum Blood Flow Change in Diabetic and Nondiabetic subgroups Up to 10 minutes after vibration application initiation
Other Magnitude of Maximum Diameter Change Magnitude of Maximum Diameter Change in Diabetic and Nondiabetic subgroups Up to 10 minutes after vibration application initiation
Other Magnitude of Maximum Resistance Change Magnitude of Maximum Resistance Change in Diabetic and Nondiabetic subgroups Up to 10 minutes after vibration application initiation
Other Magnitude of Maximum Mean Flow Velocity Change Magnitude of Maximum Mean Flow Velocity Change in Diabetic and Nondiabetic subgroups Up to 10 minutes after vibration application initiation
Primary Brachial Artery Diameter vessel diameter in millimeters Up to 10 minutes after vibration application initiation
Primary Brachial Artery Mean Flow Velocity Mean flow velocity ( cm/sec) measured with Doppler Up to 10 minutes after vibration application initiation
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