Quality and Behavior of Pelvic Floor in Runner Women
- Conditions
- Pelvic Floor DisordersSport InjuryStress Urinary Incontinence
- Interventions
- Other: Runners with educational training
- Registration Number
- NCT03934996
- Lead Sponsor
- University of Malaga
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Runners with educational training Runners with educational training Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles.
- Primary Outcome Measures
Name Time Method Change of Base Tone of Pelvic Floor Muscles (EMG) baseline, prior and after intervention, an average of 12 weeks Electromyography of base tone of Pelvic Floor Muscles
Change of acceleration Prior and after intervention, an average of 12 weeks Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.
Change of accumulated fatigue Prior and after intervention, an average of 12 weeks Using Lactate Pro 2. Mmol/Litres
Change %MVC Prior and after intervention, an average of 12 weeks Change % of Maximun voluntary contraction
Change of step length Prior and after intervention, an average of 12 weeks Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of heart rate Prior and after intervention, an average 12 weeks Heart Rate
Perineometry of MCV baseline, prior and after intervention, an average of 12 weeks perineometry of MCV using PFX
Change of ground reaction force Prior and after intervention, an average of 12 weeks Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of displacement Prior and after intervention, an average of 12 weeks metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of electromyography of Pelvic Floor Muscles Prior and after intervention, an average of 12 weeks Change of electromyography of Pelvic Floor Muscles
Change of cadence Prior and after intervention, an average of 12 weeks 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.
Intravaginal manual palpation baseline, prior and after intervention, an average of 12 weeks manual testing of the levator ani muscles using scale of Daniels
- Secondary Outcome Measures
Name Time Method Quality of life score Prior and after intervention, an average of 12 weeks 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.
Change Pelvic floor functional capacity Prior and after intervention, an average of 12 weeks Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)
Trial Locations
- Locations (1)
University of Malaga
🇪🇸Malaga, Spain