Pelvic Floor DisordersNCT03934996
Quality and Behavior of Pelvic Floor in Runner Women
A study testing Runners with educational training in people with Pelvic Floor Disorders and Sport Injury, run by University of Malaga at 1 site in Spain.
Trial summary
The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. Read more about this study
- Who is it for?
- Ages 25 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Sport Injury, Stress Urinary Incontinence
- What is being tested?
- Runners with educational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Dec 2026
- Phase
- Interventional
- 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 25 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy woman between 25 and 44 years old.
- Women not pregnant.
- Women who run at least 10 km / week.
- In case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding.
Who cannot join
- Women Pregnant or suspected of it.
- Postpartum less than one year.
- Having the period during the exploration for the classification in groups or during the day of the measurements.
- Present operation in the urogenital region as well as any visceral or spinal operation.
- Urinary tract and/or vaginal infections.
- Vaginal lesions; anorectal lesions or bleeding.
Show all 10Show fewer
- Women with gynecological bleeding; urethral obstruction; fistulas; malformations (ectopic ureter, etc); genital prolapse.
- Women with pain in Pelvic Floor or lower limbs or back.
- Pain during the race.
- Allergy to silver, nickel and/or latex.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race.
Read the detailed description
Introduction: Women are more likely to suffer injuries in the Pelvic Floor (PF) and Urinary Incontinence (UI) because of their anatomical characteristics. Their participation in the sports field has been more active recently. There are studies that correlate the race with presenting weakness of the SP muscles and Stress Urinary Incontinence (SUI), so the race is considers as a risk factor for these affectations. However, there are few studies of real-time measurements during running. Some runners may even present SUI during daily activities (ADL). The UI is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity.
Objectives: The purpose of this study is to perform measurements of different variables in real time while running and in their ADL. The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. The secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of PF and abdominal girdle (AG) according to the type of stroke, duration, intensity and distance. And compare results between both group (interventional group and no interventional group).
Material and method: Randomized clinical trial will be performed with 59 female runners aged 25-44 years. The sample will be divided into two groups randomly. The study will be carried out health center called "Tiro de Pichón" in Málaga.
- Being tested
- Runners with educational training
- Keywords
- pelvic floor, athletes
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runners with educational trainingOther
Intervention will consist of an educational talk to know the anatomy and function of the Pelvic Floor Muscles and 20 minutes of both strength and endurance exercises with biofeedback. An exercise protocol will be carried out. The participants will be instruct to contract and maintain maximum force for a mean period of 6 seconds (endurance training) and rest for twice the length of the endurance training time, followed by three fast contractions in a row as strength training. It will be done twice a week, during 12 weeks.
Pelvic floor assesment: Perineometry, manual palpation, electromyography Trunk and lower limbs electromyography and kinematics
| Study group | Role | What they receive |
|---|---|---|
| Assesment Runners | No intervention | Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week. |
| Runners with educational training | Experimental | Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles. Receives: Other: Runners with educational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change %MVC
Change % of Maximun voluntary contraction
Measured: Prior and after intervention, an average of 12 weeks
Change of Base Tone of Pelvic Floor Muscles (EMG)
Electromyography of base tone of Pelvic Floor Muscles
Measured: baseline, prior and after intervention, an average of 12 weeks
Change of step length
Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
Measured: Prior and after intervention, an average of 12 weeks
Change of cadence
steps/secons. It will measure with two cinematic shimmers wich will be placed on both tibias.It will measure with a cinematic shimmer wich will be placed on both tibias.
Measured: Prior and after intervention, an average of 12 weeks
Change of ground reaction force
Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.
Measured: Prior and after intervention, an average of 12 weeks
Change of acceleration
Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.
Measured: Prior and after intervention, an average of 12 weeks
Change of displacement
metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Measured: Prior and after intervention, an average of 12 weeks
Change of accumulated fatigue
Using Lactate Pro 2. Mmol/Litres
Measured: Prior and after intervention, an average of 12 weeks
Change of heart rate
Heart Rate
Measured: Prior and after intervention, an average 12 weeks
Perineometry of MCV
perineometry of MCV using PFX
Measured: baseline, prior and after intervention, an average of 12 weeks
Intravaginal manual palpation
manual testing of the levator ani muscles using scale of Daniels
Measured: baseline, prior and after intervention, an average of 12 weeks
Change of electromyography of Pelvic Floor Muscles
Change of electromyography of Pelvic Floor Muscles
Measured: Prior and after intervention, an average of 12 weeks
Secondary outcomes (2)
Change Pelvic floor functional capacity
Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)
Measured: Prior and after intervention, an average of 12 weeks
Quality of life score
Using SF-12 health survey scoring demonstration. It provides a profile of the state of health and is one of the most commonly used generic scales in the evaluation of clinical outcomes. It is a self-administered instrument of 12 items from the 8 dimensions of the SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1) ), Corporal Pain (1), General Health (1). For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health). Validated by Ware J Jr, Kosinki M, Meller SD. and the Spanish version by Vilagut et al., 2008, who obtained an internal consistency coefficient of about 0.9 for Sf-36 and lower light for SF-12. The Cronbach alpha coefficients of the summary components of the SF-12 exceeded the proposed minimum of 0.7 for group comparisons.
Measured: Prior and after intervention, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Stopped PhD project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934996
- Sponsor's protocol ID
- corredorasSP
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2019
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagovska M, Svihra J, Bukova A, Horbacz A, Drackova D, Svihrova V, Kraus L. Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises. Int J Sports Med. 2017 Mar;38(3):210-216. doi: 10.1055/s-0042-123045. Epub 2017 Feb 17.
PubMed 28212587Chevalier F, Fernandez-Lao C, Cuesta-Vargas AI. Normal reference values of strength in pelvic floor muscle of women: a descriptive and inferential study. BMC Womens Health. 2014 Nov 25;14:143. doi: 10.1186/s12905-014-0143-4.
PubMed 25420756Leitner M, Moser H, Eichelberger P, Kuhn A, Radlinger L. Evaluation of pelvic floor muscle activity during running in continent and incontinent women: An exploratory study. Neurourol Urodyn. 2017 Aug;36(6):1570-1576. doi: 10.1002/nau.23151. Epub 2016 Oct 29.
PubMed 27794169Luginbuehl H, Naeff R, Zahnd A, Baeyens JP, Kuhn A, Radlinger L. Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study. Arch Gynecol Obstet. 2016 Jan;293(1):117-124. doi: 10.1007/s00404-015-3816-9. Epub 2015 Jul 21.
PubMed 26193953Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
PubMed 23687004Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
PubMed 15233598Carvalhais A, Da Roza T, Vilela S, Jorge RN, Bo K. Association Between Physical Activity Level and Pelvic Floor Muscle Variables in Women. Int J Sports Med. 2018 Dec;39(13):995-1000. doi: 10.1055/a-0596-7531. Epub 2018 Oct 16.
PubMed 30326528
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Behavior of Pelvic Floor in Runner Women
- ClinicalTrials.gov ID
- NCT03934996
- Acronym / sponsor ID
- corredorasSP
- Keywords
- pelvic floor, athletes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped PhD project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 May 2019 (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.
The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race.
Detailed description
Introduction: Women are more likely to suffer injuries in the Pelvic Floor (PF) and Urinary Incontinence (UI) because of their anatomical characteristics. Their participation in the sports field has been more active recently. There are studies that correlate the race with presenting weakness of the SP muscles and Stress Urinary Incontinence (SUI), so the race is considers as a risk factor for these affectations. However, there are few studies of real-time measurements during running. Some runners may even present SUI during daily activities (ADL). The UI is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity.
Objectives: The purpose of this study is to perform measurements of different variables in real time while running and in their ADL. The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. The secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of PF and abdominal girdle (AG) according to the type of stroke, duration, intensity and distance. And compare results between both group (interventional group and no interventional group).
Material and method: Randomized clinical trial will be performed with 59 female runners aged 25-44 years. The sample will be divided into two groups randomly. The study will be carried out health center called "Tiro de Pichón" in Málaga.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assesment Runners | No intervention | –Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week. |
| Runners with educational training | Experimental | Other: Runners with educational trainingHealthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy woman between 25 and 44 years old.
- Women not pregnant.
- Women who run at least 10 km / week.
- In case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding.
Key exclusion criteria (10 listed)
- Women Pregnant or suspected of it.
- Postpartum less than one year.
- Having the period during the exploration for the classification in groups or during the day of the measurements.
- Present operation in the urogenital region as well as any visceral or spinal operation.
- Urinary tract and/or vaginal infections.
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 |
|---|---|---|
| Runners with educational trainingIntervention will consist of an educational talk to know the anatomy and function of the Pelvic Floor Muscles and 20 minutes of both strength and endurance exercises with biofeedback. An exercise protocol will be carried out. The participants will be instruct to contract and maintain maximum force for a mean period of 6 seconds (endurance training) and rest for twice the length of the endurance training time, followed by three fast contractions in a row as strength training. It will be done twice a week, during 12 weeks. Pelvic floor assesment: Perineometry, manual palpation, electromyography Trunk and lower limbs electromyography and kinematics | Other | Runners with educational training |
Primary outcome
Change %MVC
Time frame: Prior and after intervention, an average of 12 weeks
Change % of Maximun voluntary contraction
Change of Base Tone of Pelvic Floor Muscles (EMG)
Time frame: baseline, prior and after intervention, an average of 12 weeks
Electromyography of base tone of Pelvic Floor Muscles
Change of step length
Time frame: Prior and after intervention, an average of 12 weeks
Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of cadence
Time frame: Prior and after intervention, an average of 12 weeks
steps/secons. It will measure with two cinematic shimmers wich will be placed on both tibias.It will measure with a cinematic shimmer wich will be placed on both tibias.
Change of ground reaction force
Time frame: Prior and after intervention, an average of 12 weeks
Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of acceleration
Time frame: Prior and after intervention, an average of 12 weeks
Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.
Change of displacement
Time frame: Prior and after intervention, an average of 12 weeks
metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of accumulated fatigue
Time frame: Prior and after intervention, an average of 12 weeks
Using Lactate Pro 2. Mmol/Litres
Change of heart rate
Time frame: Prior and after intervention, an average 12 weeks
Heart Rate
Perineometry of MCV
Time frame: baseline, prior and after intervention, an average of 12 weeks
perineometry of MCV using PFX
Intravaginal manual palpation
Time frame: baseline, prior and after intervention, an average of 12 weeks
manual testing of the levator ani muscles using scale of Daniels
Change of electromyography of Pelvic Floor Muscles
Time frame: Prior and after intervention, an average of 12 weeks
Change of electromyography of Pelvic Floor Muscles
2 secondary outcomes
Change Pelvic floor functional capacity
Time frame: Prior and after intervention, an average of 12 weeks
Quality of life score
Time frame: Prior and after intervention, an average of 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 28212587Hagovska M, Svihra J, Bukova A, Horbacz A, Drackova D, Svihrova V, Kraus L. Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises. Int J Sports Med. 2017 Mar;38(3):210-216. doi: 10.1055/s-0042-123045. Epub 2017 Feb 17.
- Background: PubMed 25420756Chevalier F, Fernandez-Lao C, Cuesta-Vargas AI. Normal reference values of strength in pelvic floor muscle of women: a descriptive and inferential study. BMC Womens Health. 2014 Nov 25;14:143. doi: 10.1186/s12905-014-0143-4.
- Background: PubMed 27794169Leitner M, Moser H, Eichelberger P, Kuhn A, Radlinger L. Evaluation of pelvic floor muscle activity during running in continent and incontinent women: An exploratory study. Neurourol Urodyn. 2017 Aug;36(6):1570-1576. doi: 10.1002/nau.23151. Epub 2016 Oct 29.
- Background: PubMed 26193953Luginbuehl H, Naeff R, Zahnd A, Baeyens JP, Kuhn A, Radlinger L. Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study. Arch Gynecol Obstet. 2016 Jan;293(1):117-124. doi: 10.1007/s00404-015-3816-9. Epub 2015 Jul 21.
- Background: PubMed 23687004Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
- Background: PubMed 15233598Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
- Background: PubMed 30326528Carvalhais A, Da Roza T, Vilela S, Jorge RN, Bo K. Association Between Physical Activity Level and Pelvic Floor Muscle Variables in Women. Int J Sports Med. 2018 Dec;39(13):995-1000. doi: 10.1055/a-0596-7531. Epub 2018 Oct 16.
- Individual participant dataSharing planned: No
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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?
A study testing Runners with educational training in people with Pelvic Floor Disorders and Sport Injury, run by University of Malaga 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 10 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: withdrawn, as of the sponsor's last update on 21 Jun 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 was withdrawn before enrolling participants, so there are no results.
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?
Change %MVC (time frame: Prior and after intervention, an average of 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934996, which also lists 7 linked publications.
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 21 Jun 2024.