Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics
VMD
Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedMarch 1, 2023
February 1, 2023
1 month
August 4, 2022
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brachial Artery Diameter
vessel diameter in millimeters
Up to 10 minutes after vibration application initiation
Brachial Artery Mean Flow Velocity
Mean flow velocity ( cm/sec) measured with Doppler
Up to 10 minutes after vibration application initiation
Other Outcomes (4)
Magnitude of Maximum Blood Flow Change
Up to 10 minutes after vibration application initiation
Magnitude of Maximum Diameter Change
Up to 10 minutes after vibration application initiation
Magnitude of Maximum Resistance Change
Up to 10 minutes after vibration application initiation
- +1 more other outcomes
Study Arms (2)
Local Vibration Application Following Flow-Mediated Dilation Application
EXPERIMENTALFlow 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
EXPERIMENTALFlow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
Interventions
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).
Eligibility Criteria
You may qualify if:
- Sinus Rhythm in ECG
- Ejection Fraction \> %35
- Informed Consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul, 34290, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 21042329BACKGROUNDRobbins 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.
PMID: 24237890BACKGROUNDAoyama 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.
PMID: 31257335BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 8, 2022
Study Start
August 8, 2022
Primary Completion
September 10, 2022
Study Completion
September 20, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02