NCT06623045

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

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 23, 2024

Last Update Submit

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

EXPERIMENTAL

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

Control Group

NO INTERVENTION

This 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.

PFM strength

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscisgender women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations