Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes (PFMT-UI-FFT)

September 29, 2024 updated by: Celia Rodríguez Longobardo, Universidad Politecnica de Madrid
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Politécnica de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PFM strength
This group carries out a 12-week training intervention based on Kegel exercises to improve strength and muscle activation
Other: Pelvic floor muscle training intervention
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.
No Intervention: Control Group
This group is used as a control group. They keep training their sports discipline but don't join the 12-week PFM training protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From the enrollment to the end of treatment at 12 weeks
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.
From the enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
From the enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Politecnica de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPM20221125
  • 20221125 (Other Identifier: Universidad Politécnica de Madrid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be analyzed anonymously

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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