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

Primary Purpose

Stroke, Hemiparesis, Pre-Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Frequency Passive Vibration
High-Frequency Pasive Vibration
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Stroke, Hemiparetic, Passive Vibration, Arterial Stiffness, Pulse Wave Velocity, Wave Reflection, Body Composition, Autonomic Function

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Low-Frequency Pasive Vibration

High-Frequency Passive Vibration

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2013
Last Updated
April 24, 2013
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT01841840
Brief Title
The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke
Official Title
The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Pre-Hypertension, Hypertension
Keywords
Stroke, Hemiparetic, Passive Vibration, Arterial Stiffness, Pulse Wave Velocity, Wave Reflection, Body Composition, Autonomic Function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm involves not implementing any form of intervention (passive vibration)on the subject during this visit.
Arm Title
Low-Frequency Pasive Vibration
Arm Type
Experimental
Arm Description
This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude.
Arm Title
High-Frequency Passive Vibration
Arm Type
Experimental
Arm Description
This arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude.
Intervention Type
Other
Intervention Name(s)
Low-Frequency Passive Vibration
Other Intervention Name(s)
Power Plate Pro5 AIRdaptive
Intervention Description
10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs
Intervention Type
Other
Intervention Name(s)
High-Frequency Pasive Vibration
Other Intervention Name(s)
Power Plate Pro5 AIRdaptive
Intervention Description
10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs
Primary Outcome Measure Information:
Title
Blood Pressures
Description
Non-invasive measures of brachial blood pressure
Time Frame
30 minutes
Title
Arterial Stiffness
Description
Using pulse wave velocity of the aorta, systemic, and legs
Time Frame
30 minutes
Title
Pressure Wave Reflection
Description
Using the augmentation index from radial tonometry
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Body Composition
Description
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Time Frame
30 minutes
Title
Autonomic Function
Description
Heart rate variability will be assessed from electrocardiogram
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, M.D., Ph.D
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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

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