NCT06626841

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

September 29, 2024

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Study Arms (1)

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

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
Female athletes

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Madrid, members of a FFT facility.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, Madrid, 28040, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 4, 2024

Study Start

April 21, 2023

Primary Completion

June 3, 2023

Study Completion

June 3, 2023

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Data will be used in anonymous form.

Locations