StrokeNCT01841840
The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke
A study testing Low-Frequency Passive Vibration and High-Frequency Pasive Vibration in people with Stroke and Hemiparesis, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis, Pre-Hypertension
- What is being tested?
- Low-Frequency Passive Vibration and High-Frequency Pasive Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Stroke, Hemiparesis, Pre-Hypertension, Hypertension
- Being tested
- Low-Frequency Passive Vibration, High-Frequency Pasive Vibration
- Keywords
- Stroke, Hemiparetic, Passive Vibration, Arterial Stiffness, Pulse Wave Velocity, Wave Reflection, Body Composition, Autonomic Function
- Medical subject headings
- Stroke, Paresis, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Frequency Passive VibrationOther
Also called Power Plate Pro5 AIRdaptive
10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs
High-Frequency Pasive VibrationOther
Also called Power Plate Pro5 AIRdaptive
10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High-Frequency Pasive Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressures
Non-invasive measures of brachial blood pressure
Measured: 30 minutes
Arterial Stiffness
Using pulse wave velocity of the aorta, systemic, and legs
Measured: 30 minutes
Pressure Wave Reflection
Using the augmentation index from radial tonometry
Measured: 30 minutes
Secondary outcomes (2)
Body Composition
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Measured: 30 minutes
Autonomic Function
Heart rate variability will be assessed from electrocardiogram
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Figueroa, Florida State University
- Investigators
- Arturo Figueroa, M.D., Ph.D, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841840
- Sponsor's protocol ID
- 2012.7712
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT01841840
- Acronym / sponsor ID
- 2012.7712
- Conditions
- Stroke, Hemiparesis, Pre-Hypertension, Hypertension
- Keywords
- Stroke, Hemiparetic, Passive Vibration, Arterial Stiffness, Pulse Wave Velocity, Wave Reflection, Body Composition, Autonomic Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Low-Frequency Passive VibrationThis 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 | Experimental | Other: High-Frequency Pasive VibrationThis arm involves exposing the subject to a 10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Frequency Passive VibrationAlso: Power Plate Pro5 AIRdaptive10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs | Other | Low-Frequency Pasive Vibration |
| High-Frequency Pasive VibrationAlso: Power Plate Pro5 AIRdaptive10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs | Other | High-Frequency Passive Vibration |
Primary outcome
Blood Pressures
Time frame: 30 minutes
Non-invasive measures of brachial blood pressure
Arterial Stiffness
Time frame: 30 minutes
Using pulse wave velocity of the aorta, systemic, and legs
Pressure Wave Reflection
Time frame: 30 minutes
Using the augmentation index from radial tonometry
2 secondary outcomes
Body Composition
Time frame: 30 minutes
Autonomic Function
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Figueroa, M.D., Ph.D principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Frequency Passive Vibration and High-Frequency Pasive Vibration in people with Stroke and Hemiparesis, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressures (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.