Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)

Not Applicable

Not yet recruiting

• Conditions: Osteo Arthritis Knee; Whole Body Vibration
• Interventions: Device: Sub Acute Whole Body Vibration Training

• Registration Number: NCT06058169
• Lead Sponsor: Augusta University

Brief Summary

The purpose of this proposal is to understand how the Vibrant Health Ultimate whole-body vibration (WBV) machine affects pain and inflammation in older adults. The investigators' hypothesize that sub-acute (12 weeks) WBV will lead to improvement in the level of knee pain and improve vascular function via a decrease in systemic inflammation.

Detailed Description

Knee osteoarthritis (KO) is a leading cause of disability and medical cost. Whole body vibration (WBV) has emerged as an exercise alternative that may be more tolerable than traditional forms of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise, research supports that WBV can be very beneficial for your health. In fact, a single bout of WBV increases circulating concentrations of inflammatory markers. WBV is safe and effective, WBV training has been conducted in obesity, elderly, patients with diabetes, patients with lung disease, as well as patients with knee osteoarthritis.

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Start: 2025-03-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Symptomatic Osteoarthritic knee pain for at least 6 months.
• Mean and women
• Ages 40-75 years old

Exclusion Criteria

• <40 years old or >75 years old
• History of balance issues
• History of falls
• Epilepsy
• Pregnancy
• The use of whole-body vibration in the past 6 months
• Previous knee surgery within last 3 years
• Unable to stand for at least 20 minutes (for whole body vibration training)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Whole Body Training (12 week)	Sub Acute Whole Body Vibration Training	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Pressure Threshold assessed using the Jtech Medical Echo Algometer	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration	change from baseline pain pressure threshold at 12 weeks. Pain Pressure Threshold (PPT) will be assessed using the Jtech Medical Echo Algometer. PPT is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing non-painful pressure stimulus turns into an uncomfortable or painful pressure sensation. The subject will lie supine. An investigator will assess PPT at the following sites: a) 2 cm below the medial edge of the patella and b) 2 cm below the lateral edge of the patella. Using the 1 cm2 probe, the investigator will place it perpendicular to each site and apply pressure at a rate of 0.5 kg/cm2/s. Each trial will stop when the subject reports pain. The investigator will take 3 trials at each site; the average of the 3 trials, recorded in kg/cm2, will be used for statistical analysis.

Secondary Outcome Measures

Name	Time	Method
Change in Pulse Wave Velocity (PWV)	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 IL-6	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.

Trial Locations

Locations (1)

Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology; 🇺🇸 Augusta, Georgia, United States