Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes
PFMT-UI-FFT
2 other identifiers
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 2, 2024
CompletedOctober 2, 2024
September 1, 2024
2 months
September 23, 2024
September 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Strength
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
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 Outcomes (1)
Urinary incontinence (UI)
From the enrollment to the end of treatment at 12 weeks
Study Arms (2)
PFM strength
EXPERIMENTALThis group carries out a 12-week training intervention based on Kegel exercises to improve strength and muscle activation
Control Group
NO INTERVENTIONThis group is used as a control group. They keep training their sports discipline but don't join the 12-week PFM training protocol.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Politécnica de Madrid
Madrid, Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 23, 2024
First Posted
October 2, 2024
Study Start
April 23, 2023
Primary Completion
July 6, 2023
Study Completion
September 10, 2023
Last Updated
October 2, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
Data will be analyzed anonymously