Clinical trial NCT05492071: Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics
Official title: Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasodilation
Diabetes Mellitus, Type 2
Keywords: Vibration
Peripheral Artery Hemodynamics
Diabetes Mellitus
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Brachial Artery Diameter
timeFrame: Up to 10 minutes after vibration application initiation
measure: Brachial Artery Mean Flow Velocity
timeFrame: Up to 10 minutes after vibration application initiation
Secondary outcomes:
Other outcomes:
measure: Magnitude of Maximum Blood Flow Change
timeFrame: Up to 10 minutes after vibration application initiation
measure: Magnitude of Maximum Diameter Change
timeFrame: Up to 10 minutes after vibration application initiation
measure: Magnitude of Maximum Resistance Change
timeFrame: Up to 10 minutes after vibration application initiation
measure: Magnitude of Maximum Mean Flow Velocity Change
timeFrame: Up to 10 minutes after vibration application initiation
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study officials:
References:
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.
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.
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.