Quality and Behavior of Pelvic Floor in Runner Women

NCT03934996 | Withdrawn

• 1 other identifier: corredorasSP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Floor Disorders; Sport Injury; Stress Urinary Incontinence

Keywords

pelvic floor; athletes

Outcome Measures

Primary Outcomes (12)

• Change %MVC

  Change % of Maximun voluntary contraction

  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

  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.

  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.

  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.

  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.

  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.

  Prior and after intervention, an average of 12 weeks

• Change of accumulated fatigue

  Using Lactate Pro 2. Mmol/Litres

  Prior and after intervention, an average of 12 weeks

• Change of heart rate

  Heart Rate

  Prior and after intervention, an average 12 weeks

• Perineometry of MCV

  perineometry of MCV using PFX

  baseline, prior and after intervention, an average of 12 weeks

• Intravaginal manual palpation

  manual testing of the levator ani muscles using scale of Daniels

  baseline, prior and after intervention, an average of 12 weeks

• Change of electromyography of Pelvic Floor Muscles

  Change of electromyography of Pelvic Floor Muscles

  Prior and after intervention, an average of 12 weeks

Secondary Outcomes (2)

• Change Pelvic floor functional capacity

  Prior and after intervention, an average of 12 weeks

• Quality of life score

  Prior and after intervention, an average of 12 weeks

Study Arms (2)

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.

Other: Runners with educational training

Interventions

Runners with educational training OTHER

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

Runners with educational training

Eligibility Criteria

• Age: 25 Years - 44 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

University of Malaga

Málaga, 29009, Spain

Location

Related Publications (7)

• 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.

  PMID: 28212587 BACKGROUND

• Chevalier 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.

  PMID: 25420756 BACKGROUND

• Leitner 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.

  PMID: 27794169 BACKGROUND

• Luginbuehl 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.

  PMID: 26193953 BACKGROUND

• Goldstick 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.

  PMID: 23687004 BACKGROUND

• Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.

  PMID: 15233598 BACKGROUND

• Carvalhais 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.

  PMID: 30326528 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher will not know who belongs to each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher of CTS631 University of Malaga

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 2, 2019
• Study Start: June 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)