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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arturo Figueroa, Florida State University
ClinicalTrials.gov Identifier:
NCT01841840
First received: April 23, 2013
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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 Intervention
Stroke
Hemiparesis
Pre-Hypertension
Hypertension
Other: Low-Frequency Passive Vibration
Other: High-Frequency Pasive Vibration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Blood Pressures [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Non-invasive measures of brachial blood pressure

  • Arterial Stiffness [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Using pulse wave velocity of the aorta, systemic, and legs

  • Pressure Wave Reflection [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Using the augmentation index from radial tonometry


Secondary Outcome Measures:
  • Body Composition [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  • Autonomic Function [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Heart rate variability will be assessed from electrocardiogram


Enrollment: 11
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841840

Locations
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Investigators
Principal Investigator: Arturo Figueroa, M.D., Ph.D Florida State University
  More Information

No publications provided

Responsible Party: Arturo Figueroa, Associate Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01841840     History of Changes
Other Study ID Numbers: 2012.7712
Study First Received: April 23, 2013
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
Stroke
Hemiparetic
Passive Vibration
Arterial Stiffness
Pulse Wave Velocity
Wave Reflection
Body Composition
Autonomic Function

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hypertension
Prehypertension
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014