Whole-body Vibration for Exercise and Vascular Health Improvement

(VIBE-Rx Trial)

Overseen By Ryan Harris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Must not be taking: Nitrates

Disqualifiers: Hepatic, Cardiovascular, Renal, Diabetes, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether whole-body vibration (WBV) training can enhance exercise ability, blood vessel health, and muscle function. Participants will use a vibration device at home for 12 weeks. It suits adults without liver, heart, or kidney disease and those not taking certain blood pressure medications. This study targets individuals interested in innovative methods to improve fitness and health. As an unphased trial, it provides a unique opportunity to explore cutting-edge fitness techniques in a supportive research environment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking direct vasoactive medications (like nitrates).

What prior data suggests that this whole-body vibration training is safe for exercise and vascular health improvement?

Research has shown that whole-body vibration (WBV) training might pose some safety concerns. One study found that certain WBV machines can exceed safe limits, highlighting the need for caution when using them. Another study indicated that the risk of WBV causing blood clots in veins is not fully understood.

Additionally, while some research suggests WBV might benefit conditions like heart disease, there is limited evidence regarding its safety and effectiveness for other issues, such as long-term back pain. Overall, although WBV is under study for its potential benefits, careful consideration of its safety is necessary, especially with prolonged use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Whole-body vibration training is unique because it offers a non-invasive and potentially low-impact way to improve vascular health and exercise capacity. Unlike traditional exercise regimens that may require intense physical activity, this method uses mechanical vibrations to stimulate muscle and blood vessel function, which could be particularly beneficial for individuals who have limitations in performing regular exercises. Researchers are excited about this approach because it could provide a new option for enhancing vascular health without the need for strenuous workouts, making it accessible to a wider range of people, including those who might struggle with conventional exercise routines.

What evidence suggests that Whole Body Vibration Training is effective for improving exercise and vascular health?

Research shows that whole-body vibration (WBV), which participants in this trial will undergo, can strengthen muscles, improve balance, and increase blood flow. It also enhances arterial flexibility, benefiting heart and blood vessel health. Studies have shown that WBV training can improve movement, flexibility, and coordination. These benefits suggest that WBV could enhance exercise performance and blood vessel health. Overall, early findings support its potential to improve muscle and blood vessel health. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 years of age from any racial background. It's not suitable for those under 18, pregnant individuals, people taking direct vasoactive medications like nitrates, or anyone with a clinical diagnosis of liver, heart, kidney disease or complications from diabetes.

Inclusion Criteria

I am over 18 years old.

People of any race are eligible.

Exclusion Criteria

I am under 18 years old.

I am not taking any medications that directly affect blood vessel function.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of home-based whole-body vibration training to assess improvements in exercise capacity, vascular function, and skeletal muscle function.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sub Acute Whole Body Vibration Training

Trial Overview The study is testing the effects of home-based Whole Body Vibration (WBV) training to see if it can improve exercise capacity, blood vessel function in both large vessels and small capillaries, as well as muscle function.

How Is the Trial Designed?

Group I: Sub Acute (12 week) Whole Body Training Experimental Treatment 1 Intervention

Sub Acute Whole Body Vibration Training is already approved in European Union, United States, China for the following indications:

Approved in European Union as Whole Body Vibration Training for:

• Rehabilitation for stroke patients
• Improvement of muscle strength and balance
• Treatment of osteoporosis
• Management of spasticity in cerebral palsy and multiple sclerosis

Approved in United States as Whole Body Vibration Training for:

• Rehabilitation for stroke patients
• Improvement of muscle strength and balance
• Treatment of osteoporosis
• Management of spasticity in cerebral palsy and multiple sclerosis

Approved in China as Whole Body Vibration Training for:

• Rehabilitation for stroke patients
• Improvement of muscle strength and balance
• Treatment of osteoporosis
• Management of spasticity in cerebral palsy and multiple sclerosis

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

Whole body vibration training (WBV) significantly reduced myocardial infarct size in rats subjected to ischemia-reperfusion injury, indicating improved cardiac tolerance to such injuries.

Rats that underwent WBV experienced fewer and shorter episodes of ventricular tachycardia and had a lower mortality rate from ventricular fibrillation compared to the control group, suggesting enhanced cardiac safety during stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Training Increases Myocardial Salvage Against Acute Ischemia in Adult Male Rats. Shekarforoush, S., Naghii, MR.[2020]

Low-frequency whole-body vibration (WBV) training significantly increased the activity of the gastrocnemius muscle during squat exercises at specific frequencies (4, 8, 12, 16, 24, and 30 Hz), indicating its efficacy in enhancing muscle activation.

The study, involving 20 healthy adults, found no significant changes in oxygen consumption (VO2) or lactate levels, suggesting that low-frequency WBV is safe and does not adversely affect fatigue recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Low-Frequency Whole-Body Vibration on Muscle Activation, Fatigue, and Oxygen Consumption in Healthy Young Adults: A Single-Group Repeated-Measures Controlled Trial. Yoon, JY., Kang, SR., Kim, HS., et al.[2022]

In a study involving 15 individuals with multiple sclerosis, high-frequency whole-body vibration (26 Hz) showed a consistent trend of higher isometric muscle torque in the quadriceps and hamstrings compared to low-frequency vibration (2 Hz), although these differences were not statistically significant.

The results suggest that while high-frequency WBV may enhance muscle performance, further research is needed to explore its potential as a treatment option and to assess its long-term effects and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of whole-body vibration on lower extremity muscle performance in persons with multiple sclerosis. Jackson, KJ., Merriman, HL., Vanderburgh, PM., et al.[2009]

Whole-body vibration (WBV) training has shown potential benefits in improving bone density in the hip and tibia, but not in the lumbar spine, indicating its specific effects on certain areas of the body.

While some studies suggest that WBV can enhance muscle performance, balance, and functional mobility in older adults, the overall quality of the research is variable, and more rigorous studies are needed to establish safe and effective training parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of whole-body vibration training in aging adults: a systematic review. Merriman, H., Jackson, K.[2019]

A 3-minute session of whole-body vibration (WBV) therapy significantly increased muscle microvascular blood flow in healthy adults, showing its potential as an exercise mimetic.

While knee extension exercise (KEX) resulted in a greater increase in microvascular blood flow compared to WBV, the findings suggest that WBV could be beneficial for improving blood flow in individuals with microvascular dysfunction, such as those with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Stimulates Microvascular Blood Flow in Skeletal Muscle. Betik, AC., Parker, L., Kaur, G., et al.[2023]

Whole-body vibration training (WBVT) did not significantly improve exercise capacity in COPD patients compared to conventional training, as measured by sit-to-stand and 6-minute walk tests over a 3-month program involving 28 participants.

Despite the lack of improvement in exercise capacity, WBVT showed some benefits in quality of life measures, with significant improvements in three out of four categories of the chronic respiratory disease questionnaire (CRQ) and a trend towards better scores in the COPD assessment test (CAT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Training During a Low Frequency Outpatient Exercise Training Program in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Trial. Spielmanns, M., Gloeckl, R., Gropp, JM., et al.[2023]

Whole-body vibration (WBV) exercise training for 12 weeks significantly reduced arterial stiffness and blood pressure in postmenopausal women with prehypertension and hypertension, indicating potential cardiovascular benefits.

Participants in the WBV group also experienced a notable increase in leg muscle strength by 21%, suggesting that this type of exercise can enhance physical function and reduce disability risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body vibration exercise training reduces arterial stiffness in postmenopausal women with prehypertension and hypertension. Figueroa, A., Kalfon, R., Madzima, TA., et al.[2014]

Whole-body vibration (WBV) significantly reduces arterial stiffness in healthy men, as indicated by a decrease in brachial-ankle pulse wave velocity (baPWV) measured 20 and 40 minutes after the WBV session.

The study involved 10 healthy men performing WBV sessions, which showed that while heart rate and blood pressure remained stable, arterial stiffness decreased acutely, suggesting WBV could be a beneficial adjunct to exercise training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial stiffness acutely decreases after whole-body vibration in humans. Otsuki, T., Takanami, Y., Aoi, W., et al.[2022]

Whole-body vibration training (WBVT) can lead to potentially harmful levels of vibration exposure, exceeding safety standards set by ISO 2631-1, even with just 10 minutes of training per day.

The study found that performing slow, unloaded squats during WBVT with vertical forces (VV) resulted in greater head acceleration and mechanical impedance compared to using upward forces on one foot at a time (RV), suggesting that RV may pose a lower risk of adverse health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration exposure and biodynamic responses during whole-body vibration training. Abercromby, AF., Amonette, WE., Layne, CS., et al.[2022]

Acute whole-body vibration (WBV) exercise significantly increased oxygen uptake (Vo2) in both young (mean age 21.5 years) and older participants (mean age 69.2 years), indicating a physiological response to this type of exercise.

While WBV improved Vo2 levels, the increase was not sufficient to enhance cardiovascular fitness, suggesting that WBV alone may not be an effective standalone exercise for improving heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the physiologic effects of acute whole-body vibration exercise in young and older people. Cochrane, DJ., Sartor, F., Winwood, K., et al.[2015]

In a study involving 11 prehypertensive adults, whole-body vibration combined with resistance exercise (WBV + RE) led to significantly lower postexercise blood pressure compared to resistance exercise alone and a control condition, indicating enhanced cardiovascular benefits.

WBV + RE also resulted in a higher excess postexercise oxygen consumption (EPOC) at 15 minutes postexercise compared to resistance exercise alone, suggesting improved metabolic responses following this combined exercise approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of whole-body vibration with resistance exercise on postexercise blood pressure and oxygen consumption in prehypertensive adults. Zeigler, ZS., Swan, PD.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11396361/

The Clinical Utility of Whole Body Vibration - PubMed Central This review will provide an overview of the different types of WBV and the dose parameters that contribute to the efficacy of use in metabolic disease.

2. withpower.com withpower.com/trial/phase-11-2021-29c43

Whole-body Vibration for Exercise and Vascular Health ... Research shows that whole-body vibration (WBV) can improve muscle strength, balance, and blood flow, and reduce arterial stiffness, which is beneficial for ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859223000748

Whole-body vibration exercise in the management of ... This study aims to investigate the effects of WBV in isolation or associated with other types of exercises in the management of CVDs.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04611451

Effect of Whole Body Vibration Exercises for Patients wıth ... There are few studies and limited evidence evaluating the effectiveness of WBV exercises in chronic nonspecific low back pain. Different protocols are used for ...

5. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2024.1295776/full

Effects of whole-body vibration training on physical function ... Numerous studies have demonstrated the effectiveness of WBVT in enhancing muscle strength, physiological parameters, flexibility, balance, and coordination ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3688642/

Safety and severity of accelerations delivered from whole ... This work indicates that readily accessible WBV devices markedly exceed ISO guidelines for safety, and extreme caution must be practiced when considering their ...

7. nature.com nature.com/articles/s41526-023-00338-4

Effects of whole-body vibration or resistive ... The safety of the interventions, in terms of the risk of inducing undesired blood clotting and venous thrombosis, is not clear. We therefore ...