NCT02341976

Brief Summary

To study which position on the whole body vibrator machine would stimulate the pelvic floor muscles.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

May 27, 2014

Last Update Submit

October 25, 2016

Conditions

Keywords

whole body vibrationpelvic floor muscleurinary incontinenceUrinary sphincter

Outcome Measures

Primary Outcomes (1)

  • Peak average of the pelvic floor activity (measured by Electromyography (EMG)

    The primary assessment that will be reported will evaluate the mean of the peak activity measured by Electromyography (EMG) reached by the different exercises

    1 year

Secondary Outcomes (1)

  • Proportion of the Maximum Voluntary contraction (MVC) peak average reached by the peak average of the muscle contraction with each Whole Body Vibration (WBV) exercise

    1 year

Study Arms (1)

Vibratory platform exercises

OTHER

Vibratory platform exercises: different positions on a vibratory platform in different frequencies

Other: Vibratory platform exercises

Interventions

Different positions on vibratory platform with different frequencies

Vibratory platform exercises

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl. 1993;153:1-93. No abstract available.

  • Marin PJ, Ferrero CM, Menendez H, Martin J, Herrero AJ. Effects of whole-body vibration on muscle architecture, muscle strength, and balance in stroke patients: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Oct;92(10):881-8. doi: 10.1097/PHM.0b013e318292336c.

  • Maikala RV, King S, Bhambhani YN. Acute physiological responses in healthy men during whole-body vibration. Int Arch Occup Environ Health. 2006 Feb;79(2):103-14. doi: 10.1007/s00420-005-0029-8. Epub 2005 Sep 21.

  • Mikhael M, Orr R, Fiatarone Singh MA. The effect of whole body vibration exposure on muscle or bone morphology and function in older adults: a systematic review of the literature. Maturitas. 2010 Jun;66(2):150-7. doi: 10.1016/j.maturitas.2010.01.013. Epub 2010 Feb 19.

  • Machado A, Garcia-Lopez D, Gonzalez-Gallego J, Garatachea N. Whole-body vibration training increases muscle strength and mass in older women: a randomized-controlled trial. Scand J Med Sci Sports. 2010 Apr;20(2):200-7. doi: 10.1111/j.1600-0838.2009.00919.x. Epub 2009 Apr 20.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nissrine Nakib, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-10