search
Back to results

Quality and Behavior of Pelvic Floor in Runner Women

Primary Purpose

Pelvic Floor Disorders, Sport Injury, Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Runners with educational training
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring pelvic floor, athletes

Eligibility Criteria

25 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Malaga

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assesment Runners

Runners with educational training

Arm Description

Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week.

Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles.

Outcomes

Primary Outcome Measures

Change %MVC
Change % of Maximun voluntary contraction
Change of Base Tone of Pelvic Floor Muscles (EMG)
Electromyography of base tone of Pelvic Floor Muscles
Change of step length
Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
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.
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.
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.
Change of displacement
metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Change of accumulated fatigue
Using Lactate Pro 2. Mmol/Litres
Change of heart rate
Heart Rate
Perineometry of MCV
perineometry of MCV using PFX
Intravaginal manual palpation
manual testing of the levator ani muscles using scale of Daniels
Change of electromyography of Pelvic Floor Muscles
Change of electromyography of Pelvic Floor Muscles

Secondary Outcome Measures

Change Pelvic floor functional capacity
Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)
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.

Full Information

First Posted
April 22, 2019
Last Updated
June 8, 2020
Sponsor
University of Malaga
search

1. Study Identification

Unique Protocol Identification Number
NCT03934996
Brief Title
Quality and Behavior of Pelvic Floor in Runner Women
Official Title
Quality and Behavior of Pelvic Floor in Runner Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Sport Injury, Stress Urinary Incontinence
Keywords
pelvic floor, athletes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The researcher will not know who belongs to each group
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assesment Runners
Arm Type
No Intervention
Arm Description
Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week.
Arm Title
Runners with educational training
Arm Type
Experimental
Arm Description
Healthy woman between 25 and 44 years old, not pregnant and running at least 10 km/week with educational training about pelvic floor muscles.
Intervention Type
Other
Intervention Name(s)
Runners with educational training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change %MVC
Description
Change % of Maximun voluntary contraction
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of Base Tone of Pelvic Floor Muscles (EMG)
Description
Electromyography of base tone of Pelvic Floor Muscles
Time Frame
baseline, prior and after intervention, an average of 12 weeks
Title
Change of step length
Description
Metres of the step length. It will measure with two cinematic shimmers wich will be placed on both tibias.
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of cadence
Description
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.
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of ground reaction force
Description
Newton of the ground reaction force. It will measure with two cinematic shimmers wich will be placed on both tibias.
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of acceleration
Description
Change of Acceleration (m/s2 axes X, Y, Z). It will measure with a EXG shimmer wich will be placed on the sternun.
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of displacement
Description
metres of displacement. It will measure with two cinematic shimmers wich will be placed on both tibias.
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of accumulated fatigue
Description
Using Lactate Pro 2. Mmol/Litres
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Change of heart rate
Description
Heart Rate
Time Frame
Prior and after intervention, an average 12 weeks
Title
Perineometry of MCV
Description
perineometry of MCV using PFX
Time Frame
baseline, prior and after intervention, an average of 12 weeks
Title
Intravaginal manual palpation
Description
manual testing of the levator ani muscles using scale of Daniels
Time Frame
baseline, prior and after intervention, an average of 12 weeks
Title
Change of electromyography of Pelvic Floor Muscles
Description
Change of electromyography of Pelvic Floor Muscles
Time Frame
Prior and after intervention, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Change Pelvic floor functional capacity
Description
Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)
Time Frame
Prior and after intervention, an average of 12 weeks
Title
Quality of life score
Description
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.
Time Frame
Prior and after intervention, an average of 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio I Cuesta Vargas, PhD, PT
Phone
0034951952852
Email
acuesta@uma.es
First Name & Middle Initial & Last Name or Official Title & Degree
Natividad Giraldo Ortega, PhD candidate
Phone
0034627191002
Email
nati.fisio15@gmail.com
Facility Information:
Facility Name
University of Malaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28212587
Citation
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. Erratum In: Int J Sports Med. 2017 Mar;38(3):e1.
Results Reference
background
PubMed Identifier
25420756
Citation
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.
Results Reference
background
PubMed Identifier
27794169
Citation
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.
Results Reference
background
PubMed Identifier
26193953
Citation
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.
Results Reference
background
PubMed Identifier
23687004
Citation
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.
Results Reference
background
PubMed Identifier
15233598
Citation
Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
Results Reference
background
PubMed Identifier
30326528
Citation
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.
Results Reference
background

Learn more about this trial

Quality and Behavior of Pelvic Floor in Runner Women

We'll reach out to this number within 24 hrs