The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke
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|ClinicalTrials.gov Identifier: NCT01841840|
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 29, 2013
Stroke is the third leading cause of death in the United States. Of those who are affected by stroke, a third becomes permanently disabled. Risk factors for stroke include, but are not limited to, advancing age, physical inactivity, arterial stiffness, and most commonly, high blood pressure. Stroke is a major form of a much boarder problem, cardiovascular disease (CVD). CVD is considered the primary cause of death in the US. Interestingly, increased arterial stiffness of elastic arteries (carotid and aorta) has been shown to be strongly correlated to CVD and stroke. Increased arterial stiffness is considered an independent risk for the development of CVD and stroke. Hence, arterial stiffness has been suggested as a potential therapeutic target for CVD and more specifically stroke.
Recently, whole-body vibration (WBV) exercise has been proposed as a new and effective method to improve muscle mass and muscle strength in younger and older individuals. It is known that systemic arterial stiffness decreased 40 min after a single WBV session in healthy men. In our laboratory, we have shown that leg arterial stiffness decreases after a session of WBV. Taken together, this data seems to suggest WBV may be used as a viable way to decrease arterial stiffness. Special populations, such as post-stroke patients, may be unwilling or unable to perform WBV exercise so an inactive form of exercise (vibration) therapy is needed.
Passive vibration (PV), allows patients to lie in an inactive, supine position, with their legs placed onto the vibration plate. This exposes the lower limbs to continuous vibration without performing voluntary muscle contraction. PV has been shown to increase skin blood flow on the vibrated extremity through vasodilation in healthy individuals and type 2 diabetics. Previous work in our laboratory has demonstrated that a 10-min session of PV on the legs decreases augmentation index (AIx) , a marker of pressure wave reflection, as well as leg and systemic PWV through decreases in local peripheral resistance in young men. However, the effects of PV on arterial function in post-stroke patients are unknown.
It is hypothesized that post-stroke patients will demonstrate a decrease in leg PWV and central AIx. However, greater responses are expected with the lower vibration frequency.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis Pre-Hypertension Hypertension||Other: Low-Frequency Passive Vibration Other: High-Frequency Pasive Vibration||Not Applicable|
The purpose of this study is to examine the effects of one acute bout of low and high frequency passive vibration on blood pressure, heart rate, arterial stiffness, wave reflection, and autonomic function in post-stroke patients.
The specific aim of this study is:
-To evaluate the effects of an acute bout of both high (40Hz/low amplitude) and low frequency (25Hz/high amplitude) passive vibration on arterial function and aortic hemodynamics by assessing blood pressures (systolic, diastolic, mean, pulse pressure), arterial stiffness (aortic, systemic, leg), aortic wave reflection (augmentation index), and autonomic function (heart rate variability).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
No Intervention: Control
This arm involves not implementing any form of intervention (passive vibration)on the subject during this visit.
Experimental: Low-Frequency Pasive Vibration
This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude.
Other: Low-Frequency Passive Vibration
10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs
Other Name: Power Plate Pro5 AIRdaptive
Experimental: High-Frequency Passive Vibration
This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude.
Other: High-Frequency Pasive Vibration
10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs
Other Name: Power Plate Pro5 AIRdaptive
- Blood Pressures [ Time Frame: 30 minutes ]Non-invasive measures of brachial blood pressure
- Arterial Stiffness [ Time Frame: 30 minutes ]Using pulse wave velocity of the aorta, systemic, and legs
- Pressure Wave Reflection [ Time Frame: 30 minutes ]Using the augmentation index from radial tonometry
- Body Composition [ Time Frame: 30 minutes ]By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
- Autonomic Function [ Time Frame: 30 minutes ]Heart rate variability will be assessed from electrocardiogram
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841840
|United States, Florida|
|Florida State University|
|Tallahassee, Florida, United States, 32306|
|Principal Investigator:||Arturo Figueroa, M.D., Ph.D||Florida State University|