Whole Body Vibration Training for Pelvic Floor Muscle

October 25, 2016 updated by: University of Minnesota

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vibratory platform exercises
Vibratory platform exercises: different positions on a vibratory platform in different frequencies
Other: Vibratory platform exercises
Different positions on vibratory platform with different frequencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak average of the pelvic floor activity (measured by Electromyography (EMG)
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Nissrine Nakib, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1405M50481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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