Quality and Behavior of Pelvic Floor in Runner Women

Study Overview
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Brief Summary
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The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race.

Detailed Description
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Introduction: Women are more likely to suffer injuries in the Pelvic Floor (PF) and Urinary Incontinence (UI) because of their anatomical characteristics. Their participation in the sports field has been more active recently. There are studies that correlate the race with presenting weakness of the SP muscles and Stress Urinary Incontinence (SUI), so the race is considers as a risk factor for these affectations. However, there are few studies of real-time measurements during running. Some runners may even present SUI during daily activities (ADL). The UI is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity. Objectives: The purpose of this study is to perform measurements of different variables in real time while running and in their ADL. The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. The secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of PF and abdominal girdle (AG) according to the type of stroke, duration, intensity and distance. And compare results between both group (interventional group and no interventional group). Material and method: Randomized clinical trial will be performed with 59 female runners aged 25-44 years. The sample will be divided into two groups randomly. The study will be carried out health center called Tiro de Pichón in Málaga.

Official Title
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Quality and Behavior of Pelvic Floor in Runner Women

Conditions
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Pelvic Floor Disorders, Sport Injury, Stress Urinary Incontinence

Intervention / Treatment
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* Other: Runners with educational training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy woman between 25 and 44 years old. Women not pregnant. Women who run at least 10 km / week. In case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding. Exclusion Criteria: Women Pregnant or suspected of it. Postpartum less than one year. Having the period during the exploration for the classification in groups or during the day of the measurements. Present operation in the urogenital region as well as any visceral or spinal operation. Urinary tract and/or vaginal infections. Vaginal lesions; anorectal lesions or bleeding. Women with gynecological bleeding; urethral obstruction; fistulas; malformations (ectopic ureter, etc); genital prolapse. Women with pain in Pelvic Floor or lower limbs or back. Pain during the race. Allergy to silver, nickel and/or latex.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assesment Runners<br>Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week. | |
| Experimental: Runners with educational training<br>Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles. | Other: Runners with educational training<br>* Intervention will consist of an educational talk to know the anatomy and function of the Pelvic Floor Muscles and 20 minutes of both strength and endurance exercises with biofeedback. An exercise protocol will be carried out. The participants will be instruct to contract and maintain maximum force for a mean period of 6 seconds (endurance training) and rest for twice the length of the endurance training time, followed by three fast contractions in a row as strength training. It will be done twice a week, during 12 weeks. Pelvic floor assesment: Perineometry, manual palpation, electromyography Trunk and lower limbs electromyography and kinematics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change %MVC | Change % of Maximun voluntary contraction | Prior and after intervention, an average of 12 weeks | 
| Change of Base Tone of Pelvic Floor Muscles (EMG) | Electromyography of base tone of Pelvic Floor Muscles | baseline, prior and after intervention, an average of 12 weeks | 
| Change of step length | Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias. | Prior and after intervention, an average of 12 weeks | 
| Change of cadence | steps/secons. It will measure with two cinematic shimmers wich will be placed on both tibias.It will measure with a cinematic shimmer wich will be placed on both tibias. | Prior and after intervention, an average of 12 weeks | 
| Change of ground reaction force | Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias. | Prior and after intervention, an average of 12 weeks | 
| Change of acceleration | Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun. | Prior and after intervention, an average of 12 weeks | 
| Change of displacement | metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias. | Prior and after intervention, an average of 12 weeks | 
| Change of accumulated fatigue | Using Lactate Pro 2. Mmol/Litres | Prior and after intervention, an average of 12 weeks | 
| Change of heart rate | Heart Rate | Prior and after intervention, an average 12 weeks | 
| Perineometry of MCV | perineometry of MCV using PFX | baseline, prior and after intervention, an average of 12 weeks | 
| Intravaginal manual palpation | manual testing of the levator ani muscles using scale of Daniels | baseline, prior and after intervention, an average of 12 weeks | 
| Change of electromyography of Pelvic Floor Muscles | Change of electromyography of Pelvic Floor Muscles | Prior and after intervention, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Pelvic floor functional capacity | Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG) | Prior and after intervention, an average of 12 weeks | 
| Quality of life score | Using SF-12 health survey scoring demonstration. It provides a profile of the state of health and is one of the most commonly used generic scales in the evaluation of clinical outcomes. It is a self-administered instrument of 12 items from the 8 dimensions of the SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1) ), Corporal Pain (1), General Health (1). For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health). Validated by Ware J Jr, Kosinki M, Meller SD. and the Spanish version by Vilagut et al., 2008, who obtained an internal consistency coefficient of about 0.9 for Sf-36 and lower light for SF-12. The Cronbach alpha coefficients of the summary components of the SF-12 exceeded the proposed minimum of 0.7 for group comparisons. | Prior and after intervention, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor, athletes