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OpenTrials
Completed

NCT Number: NCT06626841

Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes

Functional Fitness Training (FFT) is a modality that seeks to improve physical fitness and performance within several functional tasks by conducting a variety of training activities such as aerobic and metabolic conditioning, resistance training, and high impact exercises. Although there are many benefits of FFT for improving fitness and body composition, their effects on the pelvic floor are not clear, as high-impact exercises performed in FFT have been shown to cause an increase in intra-abdominal pressure. When these exercises are performed repeatedly, fatigue can occur within the pelvic floor muscles (PFM), which can increase the risk of developing pelvic floor dysfunctions. However, currently little is known about how FFT activities acutely affect the PFM and whether such training regimes may contribute to long-term urinary incontinence in female FFT athletes. Therefore, this study aimed to analyse the acute effects of a FFT.workout on pelvic floor strength and muscle activation in nulliparous female FFT athletes. It is hypothesized that both strength and PFM activation of the female athletes would be reduced after a FFT workout due to PFM fatigue.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

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
  • Have been practicing FFT or weightlifting for at least 2 years
  • Train a minimum of 3 days/week that did not include pelvic floor exercises
  • Have no medical contraindications or previous pelvic floor surgeries

Exclusion criteria

  • Any criterion that fails to meet the inclusion criteria

Treatment and study plan

Pelvic floor muscles contractile capacity and activation

Diagnostic Test

An initial assessment of the pelvic floor is carried out when athletes arrive at the facility. Participants then complete a FFT workout, which consists of performing as many rounds as possible (AMRAP type) of 20 wallballs, 15 box jumps, and 10 burpees within 15 minutes. These plyometrics and load lifting exercises are chosen to fatigue the PFM and are simple to execute. The pelvic floor assessment is performed again at 3 minutes following the FFT workout.

Measurements of the pelvic floor parameters are conducted by a specialist physiotherapist. The muscle activation and strength of the PFM are obtained using a vaginal dynamometer (i.e. pelvimeter probe fixed at a vertex with two arms that can be separated by up to 25°), connected to the Phenix USB2, Vivaltis (Pelvimètre Phenix, Vivaltis).

Other names: pelvic floor muscles force production, pelvic floor strength, pelvic floor muscles activation

Primary outcomes

  1. Muscle activation

    Time frame: Change from baseline to the end of the workout, around 1 hour.

    To assess muscle activation, a vaginal dynamometer (pelvimeter probe fixed at a vertex with two arms that can be separated by up to 25°), connected to the Phenix USB2, Vivaltis (Pelvimètre Phenix, Vivaltis) is used. For the pelvic floor examination the physiotherapist introduces the closed pelvimeter inside the vagina with the supporting arm against the posterior face of the symphysis pubis. Once introduced, the probe is opened by 5º and the basal muscle activation (initial inertia index) and shock absorption (the capacity of the pelvic floor to withstand stress) are recorded.

  2. Strength

    Time frame: Change from baseline to the end of the workout, around 1 hour.

    Maximal, minimum and medium force production of the pelvic floor muscles. The physiotherapist introduces the closed pelvimeter inside the vagina with the supporting arm against the posterior face of the symphysis pubis. Once introduced, the physiotherapist fixed the arms of the probe at 5º with the athlete performing a pelvic floor contraction for 10 seconds against the arms (isometric contraction). A follow-up 10-second contraction is performed after a 20-second rest to assess PFM submaximal force.

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Registry information

Official study title

A Functional Fitness Training Workout Significantly Affects Pelvic Floor Strength and Muscle Activation in Female Nulliparous Athletes

Acronym: FFT-PFM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2024
Registry last updated
Oct 4, 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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