Whole Body Vibration Training for Pelvic Floor Muscle

Healthy Clinical Trial

Official title:

Study of Pelvic Floor Muscle and Urinary Sphincter Activity by Electromyography During Whole Body Vibration Training

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02341976
• Other study ID #: 1405M50481
• Status: Withdrawn
• Phase: N/A
• First received: May 27, 2014
• Last updated: October 25, 2016
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Urinary incontinence is a common problem due to a weak pelvic floor muscle associated with decrease quality of life. The vibration exercises have been associated with improvements of the muscle component. Due to this, some researches have proposed that this technique could be applied to weak pelvic floor. However, it is unknown which vibration trainings have the highest impact on the pelvic floor muscle and urinary sphincter, more objectives studies to validate these data are necessary.

The purpose of our research is to evaluate the activity in the urinary sphincter and the pelvic floor muscle by vibratory platform training in women.

Subjects will be recruited, criteria exclusion will be evaluated, age, and BMI will be recorded. Each subject will exercise on the vibratory platform in 3 different positions, each one with 2 different frequencies and 1 minute each position and frequency. Pelvic electromyography (EMG) will assess the activity of the urinary sphincter and pelvic floor muscle with vibratory exercise. Data will be collected during all procedures.

According to our purpose and anticipating the impact of this research extrapolating whole body vibration (WBV) training as program to improve the strength of the pelvic floor muscle elaborating a guided plan to improve clinical outcomes and quality of life of patients suffering from urinary incontinence with this new nonsurgical treatment approach to women with mild to moderate stress urinary incontinence, as well as this research allow us to increase our knowledge in urinary continence and the pelvic floor.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Women over 18 years of age

Exclusion Criteria:

Criteria exclusion like unhealthy condition, acute thrombosis, acute inflammations, implants, fractures, acute tendinopathies, kidney or bladder stones, gallstones, lung disease, heart disease, skin disease, hypertension, any medication or disease known to affect muscle mass or strength and pregnant will be evaluated

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Vibratory platform exercises
Different positions on vibratory platform with different frequencies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

References & Publications (5)

Machado A, García-López D, González-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. — View Citation

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. Epub 2005 Sep 21. — View Citation

Marín PJ, Ferrero CM, Menéndez H, Martín 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. — View Citation

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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	The second assessment that will also be reported will evaluate the proportion of the MVC peak average reached by the peak average of the muscle contraction with each WBV exercise. A positive impact of the exercise will be considered if this reaches over 60% of the MVC. On the other hand, the investigators will define as no impact when below 60% of the MVC is reached.	1 year	No