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Completed

NCT Number: NCT06623045

Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes

Functional fitness training (FFT) is a prominent exercise regimen, that has emerged as the dominant fitness trend of the 21st century , advocating high-intensity exercises with repetitive, impactful movements that often result in increased intra-abdominal pressure (IAP) and neuromuscular fatigue. This demanding training pattern, characterized by minimal rest pauses, has been associated with potential health concerns, particularly urinary incontinence (UI). In athletes, UI is intricately connected to the frequency of exposure to increased IAP during high-impact activities. These activities assume even greater significance in sports, particularly in FFT, where there is an increased frequency of impactful foot contact on the ground and intensive abdominal exercises, potentially correlating with the overload of the pelvic floor muscles and the emergence of dysfunctions. Therefore, this study aims to examine the effects of a 12-week training program focused on Kegel exercises performed with diaphragmatic breathing in nulliparous female FFT athletes. The central hypothesis postulates that after the 12-week intervention, these women will exhibit enhancements in both the muscular activation and contractile capacity of their pelvic floor, leading to a reduction in instances of urine leakage.

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Key information

Conditions

Strength Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Muscle Activation Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence (UI) Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Politécnica de Madrid

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous FFT female athletes
  • had been practicing FFT or weightlifting for at least 2 years
  • train a minimum of 3 days/week
  • had not previously performed pelvic floor exercises
  • had no medical contraindications or previous pelvic floor surgeries

Exclusion criteria

  • Any criterion that does not meet the inclusion criteria

Treatment and study plan

Pelvic floor muscle training intervention

Other

The training program consisted of 12 weeks of PFM exercises, 3 times per week, with each session lasting between 10 and 15 minutes. The program followed different stages through the weeks: (1) proprioception of pelvic floor muscles activation and integration with diaphragmatic breathing, (2) stabilization and strengthening of the pelvic floor musculature through progressive overloading, and (3) transference of these exercises to FFT practice. During the 12 weeks, short contractions (2") were combined with longer ones (5 to 10"), carrying out the progressive overload by increasing the number of contractions, the duration of the contraction, or by evolving the execution position towards more upright postures and sporting movements.

Primary outcomes

  1. Strength

    Time frame: From the enrollment to the end of treatment at 12 weeks

    Maximal, medium and minimal force generated of the pelvic floor muscles, measured with a vaginal dynamometer, which involves a pelvimeter probe with two arms that could be separated up to 25°, connected to the Phenix USB2 device (Pelvimètre Phenix, Vivaltis). The closed pelvimeter is inserted into the vagina with one arm positioned against the posterior side of the symphysis pubis. Once in place, to evaluate the contractile force of the PFM, the participant performes a pelvic floor contraction for 10 seconds against the arms of the probe fixed at 5º (an isometric contraction).

  2. muscle activation

    Time frame: From the enrollment to the end of treatment at 12 weeks

    Measured as tone or initial inertia index (III) using a vaginal dynamometer, which involves a pelvimeter probe with two arms that could be separated up to 25°, connected to the Phenix USB2 device (Pelvimètre Phenix, Vivaltis). The closed pelvimeter is inserted into the vagina with one arm positioned against the posterior side of the symphysis pubis. Once in place, the probe is opened by 5° to measure basal muscle activation (initial inertia index) and shock absorption, which assesses the pelvic floor ability to withstand stress.

Secondary outcomes

  1. Urinary incontinence (UI)

    Time frame: From the enrollment to the end of treatment at 12 weeks

    Measured with the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF), which evaluates the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women (in the female athletes in this case). It encompasses 4 items (frequency or urinary incontinence, amount of leakage, overall impact of urinary incontinence and self-diagnostic item) with a scoring scale of 0-21 reflecting the degree of urinary incontinence as slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Registry information

Acronym: PFMT-UI-FFT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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