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

NCT01841840 | Completed

• 1 other identifier: 2012.7712
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis; Pre-Hypertension; Hypertension

Keywords

Stroke; Hemiparetic; Passive Vibration; Arterial Stiffness; Pulse Wave Velocity; Wave Reflection; Body Composition; Autonomic Function

Outcome Measures

Primary Outcomes (3)

• Blood Pressures

  Non-invasive measures of brachial blood pressure

  30 minutes

• Arterial Stiffness

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

  30 minutes

• Pressure Wave Reflection

  Using the augmentation index from radial tonometry

  30 minutes

Secondary Outcomes (2)

• Body Composition

  30 minutes

• Autonomic Function

  30 minutes

Study Arms (3)

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.

Other: Low-Frequency Passive Vibration

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.

Other: High-Frequency Pasive Vibration

Interventions

Low-Frequency Passive Vibration OTHER

10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs

Also known as: Power Plate Pro5 AIRdaptive

Low-Frequency Pasive Vibration

High-Frequency Pasive Vibration OTHER

10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs

Also known as: Power Plate Pro5 AIRdaptive

High-Frequency Passive Vibration

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Stroke; Paresis; Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arturo Figueroa, M.D., Ph.D

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 29, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)