Quality and Behavior of Pelvic Floor in Runner Women

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders; Sport Injury
• Intervention / Treatment: Other: Runners with educational training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio I Cuesta Vargas, PhD, PT; Phone Number: 0034951952852; Email: acuesta@uma.es
• Study Contact Backup: Name: Natividad Giraldo Ortega, PhD candidate; Phone Number: 0034627191002; Email: nati.fisio15@gmail.com

Study Locations

• Spain
  • Malaga, Spain, 29009
    • University of Malaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 44 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Assesment Runners; Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week.
EXPERIMENTAL: 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.	Other: Runners with educational training; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaga

Publications and helpful links

General Publications

• 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. Erratum In: Int J Sports Med. 2017 Mar;38(3):e1.
• 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.
• 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.
• 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.
• 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.
• Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: athletes; pelvic floor
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Wounds and Injuries; Urination Disorders; Pregnancy Complications; Urinary Incontinence; Urinary Incontinence, Stress; Pelvic Floor Disorders; Athletic Injuries
• Other Study ID Numbers: corredorasSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No