Health Benefits of Whole-body Vibration (VIBE-Rx)

Pilot Investigation on the Health Benefits of Sub Acute (12 Week) Whole-body Vibration Training

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.

Study Overview

• Status: Recruiting
• Conditions: Whole-body Vibration
• Intervention / Treatment: Other: Sub Acute Whole Body Vibration Training

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Looney, MS; Phone Number: 7067215483; Email: jlooney@augusta.edu
• Study Contact Backup: Name: Ryan Harris, PhD; Phone Number: 7067215998; Email: ryharris@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
      • Contact: Ryan Harris, PhD, CEP; Phone Number: 706-721-5998; Email: ryharris@augusta.edu
      • Contact: Casey Derella, BS; Phone Number: 706-721-5483; Email: cderella@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women (> 18 yrs old)
• All races

Exclusion Criteria:

• <18 years old
• Clinical diagnosis of hepatic, cardiovascular, or renal disease
• Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
• Pregnancy
• Direct vasoactive medications (i.e. nitrates)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sub Acute (12 week) Whole Body Training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VO2 Peak	change from baseline relative (mL/kg/min) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change in Flow-Mediated Dilation (FMD)	change from baseline brachial artery flow mediated dilation at 12 weeks.	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change in Skeletal Muscle Mitochondrial Function	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)	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change in Pulse Wave Velocity (PWV)	Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change in Post Occlusive Reactive Hyperemia (PORH)	Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI).	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Change in IL-6	change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1818010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No