Pelvic Floor Muscle WeaknessFFT-PFMNCT06626841
Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes
An observational study of Pelvic Floor Muscle Weakness and Strength, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Strength, Muscle Tone
- What is being tested?
- Pelvic floor muscles contractile capacity and activation
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 21 Apr 2023to 3 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Madrid, members of a FFT facility.
Who may be able to join
- 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
Who cannot join
- Any criterion that fails to meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Functional Fitness Training Workout Significantly Affects Pelvic Floor Strength and Muscle Activation in Female Nulliparous Athletes
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.
- Conditions
- Pelvic Floor Muscle Weakness, Strength, Muscle Tone
- Being tested
- Pelvic floor muscles contractile capacity and activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscles contractile capacity and activationDiagnostic test
Also called pelvic floor muscles force production, pelvic floor strength, pelvic floor muscles activation
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Pelvic floor muscles contractile capacity and activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to the end of the workout, around 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start21 Apr 2023
- Primary completion3 Jun 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celia Rodríguez Longobardo, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626841
- Sponsor's protocol ID
- 20221125
- Other IDs
- 20221125
- Acronym
- FFT-PFM
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used in anonymous form.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Fitness Training Workout Significantly Affects Pelvic Floor Strength and Muscle Activation in Female Nulliparous Athletes
- ClinicalTrials.gov ID
- NCT06626841
- Acronym / sponsor ID
- FFT-PFM / 20221125
- Conditions
- Pelvic Floor Muscle Weakness, Strength, Muscle Tone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female athletes | – | Diagnostic Test: Pelvic floor muscles contractile capacity and activationFemale 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Madrid, members of a FFT facility.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any criterion that fails to meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscles contractile capacity and activationAlso: pelvic floor muscles force production, pelvic floor strength, pelvic floor muscles activationAn 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). | Diagnostic test | Female athletes |
Primary outcome
Muscle activation
Time frame: Change from baseline to the end of the workout, around 1 hour.
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.
Strength
Time frame: Change from baseline to the end of the workout, around 1 hour.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No. Data will be used in anonymous form.
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Muscle Weakness and Strength, run by Universidad Politecnica de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activation (time frame: Change from baseline to the end of the workout, around 1 hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.