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

Primary Purpose

Whole Body Vibration, Osteo Arthritis Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sub Acute Whole Body Vibration Training
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whole Body Vibration

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole Body Training (12 week)

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain Pressure Threshold assessed using the Jtech Medical Echo Algometer
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

Change in Pulse Wave Velocity (PWV)
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.
Change in IL-6
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.

Full Information

First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT06058169
Brief Title
Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)
Official Title
Pilot Investigation on the Effects of Sub Acute (12 Week) Home Base Whole-body Vibration Training in Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whole Body Vibration, Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Training (12 week)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sub Acute Whole Body Vibration Training
Intervention Description
Participants will be given a personal vibration plate (equipped with stabilizing bars) to take home for training which will last for up 12 weeks. For this test the participant will be asked to stand on a vibration plate for up to 20 minutes. Participants will be instructed to remove any footwear and stand mid-center on the platform in a standing position with feet shoulder width apart. The participant will be asked to step on and off of the vibration plate. During the first four weeks, participants will be asked to complete 5-10 minutes of WBV per day, at least 4-5 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 15 minutes and/or reduce the duration of rest. Beginning at week 9, based on how the participant feels, the study team may adjust the WBV time/duration up to 20 minutes per session, 4-5 days per week.
Primary Outcome Measure Information:
Title
Change in Pain Pressure Threshold assessed using the Jtech Medical Echo Algometer
Description
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.
Time Frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Secondary Outcome Measure Information:
Title
Change in Pulse Wave Velocity (PWV)
Description
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.
Time Frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Title
Change in IL-6
Description
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.
Time Frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reva Crandall, BS
Phone
7067215483
Email
rcrandall@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Harris, PhD
Phone
7067215998
Email
ryharris@augusta.edu
Facility Information:
Facility Name
Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

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

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