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Quality and Behavior of Pelvic Floor in Runner Women

Quality and Behavior of Pelvic Floor in Runner Women

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03934996
Enrollment
0
Registered
2019-05-02
Start date
2021-06-01
Completion date
2026-12-01
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders, Sport Injury, Stress Urinary Incontinence

Keywords

pelvic floor, athletes

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.

Interventions

OTHERRunners 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

Sponsors

University of Malaga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

The researcher will not know who belongs to each group

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 44 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of electromyography of Pelvic Floor MusclesPrior and after intervention, an average of 12 weeksChange of electromyography of Pelvic Floor Muscles
Perineometry of MCVbaseline, prior and after intervention, an average of 12 weeksperineometry of MCV using PFX
Intravaginal manual palpationbaseline, prior and after intervention, an average of 12 weeksmanual testing of the levator ani muscles using scale of Daniels
Change %MVCPrior and after intervention, an average of 12 weeksChange % of Maximun voluntary contraction
Change of Base Tone of Pelvic Floor Muscles (EMG)baseline, prior and after intervention, an average of 12 weeksElectromyography of base tone of Pelvic Floor Muscles
Change of step lengthPrior and after intervention, an average of 12 weeksMetres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of cadencePrior and after intervention, an average of 12 weekssteps/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.
Change of ground reaction forcePrior and after intervention, an average of 12 weeksNewton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of accelerationPrior and after intervention, an average of 12 weeksChange of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.
Change of displacementPrior and after intervention, an average of 12 weeksmetres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of accumulated fatiguePrior and after intervention, an average of 12 weeksUsing Lactate Pro 2. Mmol/Litres
Change of heart ratePrior and after intervention, an average 12 weeksHeart Rate

Secondary

MeasureTime frameDescription
Quality of life scorePrior and after intervention, an average of 12 weeksUsing 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 capacityPrior and after intervention, an average of 12 weeksDifference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026