NCT05097885 · Augusta University
Health Benefits of Whole-body Vibration
(VIBE-Rx)
What this study is about
The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.
View original scientific description
The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.
Interventions
OTHER
Sub Acute Whole Body Vibration Training
Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and/or reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and/or reduce the duration of rest.
Primary outcome measures
Change in VO2 Peak
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
change from baseline relative (mL/kg/min) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks
Change in Flow-Mediated Dilation (FMD)
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
change from baseline brachial artery flow mediated dilation at 12 weeks.
Change in Skeletal Muscle Mitochondrial Function
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
change from baseline skeletal muscle mitochondrial function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1)
Change in Pulse Wave Velocity (PWV)
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.
Change in Post Occlusive Reactive Hyperemia (PORH)
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI).
Change in IL-6
Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women (\> 18 yrs old)
Exclusion criteria
- \<18 years old
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- Direct vasoactive medications (i.e. nitrates)
Where
- Augusta, Georgia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2025 · Source of record for eligibility and locations