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CompletedNCT06626841FFT-PFMUpdated Oct 4, 2024

Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes

An observational study in Pelvic Floor Muscle Weakness, Strength and Muscle Tone, sponsored by Universidad Politecnica de Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Universidad Politecnica de Madrid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pelvic Floor Muscle Weakness
  • Strength
  • Muscle Tone

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03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 23 is below the median of 98 across 144 observational studies indexed under Muscle Weakness.

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Lead sponsor

Universidad Politecnica de Madrid is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents of Madrid, members of a FFT facility.

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

Exclusion Criteria:

  • Any criterion that fails to meet the inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Female athletes

    Female functional fitness training athletes. The participants had to be nulliparous, had been practicing FFT or weightlifting for at least 2 years, trained a minimum of 3 days/week that did not include pelvic floor exercises, and had no medical contraindications or previous pelvic floor surgeries

    Diagnostic Test: Pelvic floor muscles contractile capacity and activation

Interventions

  • Diagnostic testPelvic floor muscles contractile capacity and activation

    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).

    Also known as: pelvic floor muscles force production, pelvic floor strength, pelvic floor muscles activation

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What researchers measure

Primary outcomes

  1. Muscle activation

    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.

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

  2. Strength

    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.

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

07

Study locations

1 site
  • Universidad Politécnica de Madrid
    Madrid, 28040, Spain
08

References and documents

Individual participant data

Plan to share: No — Data will be used in anonymous form.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06626841
Lead sponsor
Universidad Politecnica de Madrid
Responsible party
Celia Rodríguez Longobardo (Principal Investigator, Universidad Politecnica de Madrid) — Principal investigator
First posted
Oct 4, 2024
Start date
Apr 21, 2023
Primary completion
Jun 3, 2023
Completion
Jun 3, 2023
Last update
Oct 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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