The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke

Not Applicable

Completed

• Conditions: Stroke; Hemiparesis; Pre-Hypertension; Hypertension
• Interventions: Other: Low-Frequency Passive Vibration; Other: High-Frequency Pasive Vibration

• Registration Number: NCT01841840
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-24
• Last Update Submitted: 2013-04-24
• Study First Posted: 2013-04-29
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 40-80 years of age
• Resting Blood Pressure between 120/80 and 159/99
• Non-Smoker
• Sedentary or low activity (<120 min per week)
• 25-39.9 kg/m2 BMI
• Diagnosed with stroke for at least 4 months

Exclusion Criteria

• Younger than 40 and older than 80 years of age
• Resting Blood Pressure below 120/80 or above 159/99
• Smoker
• Physically active
• BMI below 25 kg/m2 or above 39.9 kg/m2
• Diagnosed with stroke for less than 4 months
• Diagnosed with any other cardiovascular diseases besides stroke and stage-1 hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-Frequency Pasive Vibration	Low-Frequency Passive 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.
High-Frequency Passive Vibration	High-Frequency Pasive 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.

Primary Outcome Measures

Name	Time	Method
Blood Pressures	30 minutes	Non-invasive measures of brachial blood pressure
Arterial Stiffness	30 minutes	Using pulse wave velocity of the aorta, systemic, and legs
Pressure Wave Reflection	30 minutes	Using the augmentation index from radial tonometry

Secondary Outcome Measures

Name	Time	Method
Body Composition	30 minutes	By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Autonomic Function	30 minutes	Heart rate variability will be assessed from electrocardiogram

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States