NCT05097885

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Feb 2022Jan 2028

First Submitted

Initial submission to the registry

October 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4.8 years

First QC Date

October 15, 2021

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

Sub Acute (12 week) Whole Body Training

EXPERIMENTAL
Other: Sub Acute Whole Body Vibration Training

Interventions

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.

Sub Acute (12 week) Whole Body Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Augusta, Georgia, 30912, United States

RECRUITING

Central Study Contacts

Jacob Looney, MS

CONTACT

Ryan Harris, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 28, 2021

Study Start

February 28, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations