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临床试验/NCT01841840
NCT01841840已完成不适用

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

Florida State University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Blood Pressures

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Younger than 40 and older than 80 years of age
  • •Resting Blood Pressure below 120/80 or above 159/99
  • •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

研究组 & 干预措施

Control

No Intervention

This arm involves not implementing any form of intervention (passive vibration)on the subject during this visit.

Low-Frequency Pasive Vibration

Experimental

This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude.

干预措施: Low-Frequency Passive Vibration (Other)

High-Frequency Passive Vibration

Experimental

This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude.

干预措施: High-Frequency Pasive Vibration (Other)

结局指标

主要结局

Blood Pressures

时间窗: 30 minutes

Non-invasive measures of brachial blood pressure

Arterial Stiffness

时间窗: 30 minutes

Using pulse wave velocity of the aorta, systemic, and legs

Pressure Wave Reflection

时间窗: 30 minutes

Using the augmentation index from radial tonometry

次要结局

  • Body Composition(30 minutes)
  • Autonomic Function(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arturo Figueroa

Associate Professor

Florida State University

研究点 (1)

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