HealthyNCT02341976
Whole Body Vibration Training for Pelvic Floor Muscle
A study testing Vibratory platform exercises in people with Healthy, run by University of Minnesota.
Trial summary
To study which position on the whole body vibrator machine would stimulate the pelvic floor muscles. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vibratory platform exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over 18 years of age
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Vibratory platform exercises
- Keywords
- whole body vibration, pelvic floor muscle, urinary incontinence, Urinary sphincter
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory platform exercisesOther
Different positions on vibratory platform with different frequencies
| Study group | Role | What they receive |
|---|---|---|
| Vibratory platform exercises | Other | Vibratory platform exercises: different positions on a vibratory platform in different frequencies Receives: Other: Vibratory platform exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Why it stopped: PI left University and no study was ever done
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nissrine Nakib, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341976
- Sponsor's protocol ID
- 1405M50481
- Status last verified
- Oct 2016
- First submitted
- 27 May 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8108659Marin 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.
PubMed 23636085Maikala 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.
PubMed 16175416Mikhael 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.
PubMed 20171817Machado 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.
PubMed 19422657
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pelvic Floor Muscle and Urinary Sphincter Activity by Electromyography During Whole Body Vibration Training
- ClinicalTrials.gov ID
- NCT02341976
- Acronym / sponsor ID
- 1405M50481
- Conditions
- Healthy
- Keywords
- whole body vibration, pelvic floor muscle, urinary incontinence, Urinary sphincter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left University and no study was ever done
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study which position on the whole body vibrator machine would stimulate the pelvic floor muscles.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibratory platform exercises | Other | Other: Vibratory platform exercisesVibratory platform exercises: different positions on a vibratory platform in different frequencies |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women over 18 years of age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibratory platform exercisesDifferent positions on vibratory platform with different frequencies | Other | Vibratory platform exercises |
Primary outcome
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 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Results publication: PubMed 8108659Petros 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.
- Results publication: PubMed 23636085Marin 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.
- Results publication: PubMed 16175416Maikala 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.
- Results publication: PubMed 20171817Mikhael 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.
- Results publication: PubMed 19422657Machado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nissrine Nakib, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Vibratory platform exercises in people with Healthy, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak average of the pelvic floor activity (measured by Electromyography (EMG) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341976, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.