- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06626841
Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes (FFT-PFM)
A Functional Fitness Training Workout Significantly Affects Pelvic Floor Strength and Muscle Activation in Female Nulliparous Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28040
- Universidad Politécnica de Madrid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle activation
Time Frame: Change from baseline to the end of the workout, around 1 hour.
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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.
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Change from baseline to the end of the workout, around 1 hour.
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Strength
Time Frame: Change from baseline to the end of the workout, around 1 hour.
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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.
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Change from baseline to the end of the workout, around 1 hour.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20221125 (Other Identifier: Universidad Politécnica de Madrid)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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