Clinical trial NCT03934996: Quality and Behavior of Pelvic Floor in Runner Women
Official title: Quality and Behavior of Pelvic Floor in Runner Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Floor Disorders
Sport Injury
Stress Urinary Incontinence
Keywords: pelvic floor
athletes
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change %MVC
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of Base Tone of Pelvic Floor Muscles (EMG)
timeFrame: baseline, prior and after intervention, an average of 12 weeks
measure: Change of step length
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of cadence
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of ground reaction force
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of acceleration
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of displacement
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of accumulated fatigue
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Change of heart rate
timeFrame: Prior and after intervention, an average 12 weeks
measure: Perineometry of MCV
timeFrame: baseline, prior and after intervention, an average of 12 weeks
measure: Intravaginal manual palpation
timeFrame: baseline, prior and after intervention, an average of 12 weeks
measure: Change of electromyography of Pelvic Floor Muscles
timeFrame: Prior and after intervention, an average of 12 weeks
Secondary outcomes:
measure: Change Pelvic floor functional capacity
timeFrame: Prior and after intervention, an average of 12 weeks
measure: Quality of life score
timeFrame: Prior and after intervention, an average of 12 weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: University of Malaga
Study officials:
References:
citation: Hagovska M, Svihra J, Bukova A, Horbacz A, Drackova D, Svihrova V, Kraus L. Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises. Int J Sports Med. 2017 Mar;38(3):210-216. doi: 10.1055/s-0042-123045. Epub 2017 Feb 17.
citation: Chevalier F, Fernandez-Lao C, Cuesta-Vargas AI. Normal reference values of strength in pelvic floor muscle of women: a descriptive and inferential study. BMC Womens Health. 2014 Nov 25;14:143. doi: 10.1186/s12905-014-0143-4.
citation: Leitner M, Moser H, Eichelberger P, Kuhn A, Radlinger L. Evaluation of pelvic floor muscle activity during running in continent and incontinent women: An exploratory study. Neurourol Urodyn. 2017 Aug;36(6):1570-1576. doi: 10.1002/nau.23151. Epub 2016 Oct 29.
citation: Luginbuehl H, Naeff R, Zahnd A, Baeyens JP, Kuhn A, Radlinger L. Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study. Arch Gynecol Obstet. 2016 Jan;293(1):117-124. doi: 10.1007/s00404-015-3816-9. Epub 2015 Jul 21.
citation: Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
citation: Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
citation: Carvalhais A, Da Roza T, Vilela S, Jorge RN, Bo K. Association Between Physical Activity Level and Pelvic Floor Muscle Variables in Women. Int J Sports Med. 2018 Dec;39(13):995-1000. doi: 10.1055/a-0596-7531. Epub 2018 Oct 16.