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Whole Body Vibration Training for Pelvic Floor Muscle

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ClinicalTrials.gov Identifier: NCT02341976
Recruitment Status : Withdrawn (PI left University and no study was ever done)
First Posted : January 19, 2015
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
To study which position on the whole body vibrator machine would stimulate the pelvic floor muscles.

Condition or disease Intervention/treatment Phase
Healthy Other: Vibratory platform exercises Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of Pelvic Floor Muscle and Urinary Sphincter Activity by Electromyography During Whole Body Vibration Training
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341976


Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Nissrine Nakib, MD University of Minnesota
More Information
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Publications of Results:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02341976    
Other Study ID Numbers: 1405M50481
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by University of Minnesota:
whole body vibration
pelvic floor muscle
urinary incontinence
Urinary sphincter