An interventional study of Runners with educational training in Pelvic Floor Disorders, Sport Injury and Stress Urinary Incontinence, sponsored by University of Malaga. Withdrawn at 1 site in Spain. Open to female participants aged 25 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
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Exclusion Criteria:
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.
Other: Runners with educational training
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
Change %MVC
Change % of Maximun voluntary contraction
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Prior and after intervention, an average of 12 weeks
Change of accumulated fatigue
Using Lactate Pro 2. Mmol/Litres
Time frame: Prior and after intervention, an average of 12 weeks
Change of heart rate
Heart Rate
Time frame: Prior and after intervention, an average 12 weeks
Perineometry of MCV
perineometry of MCV using PFX
Time frame: baseline, prior and after intervention, an average of 12 weeks
Intravaginal manual palpation
manual testing of the levator ani muscles using scale of Daniels
Time frame: baseline, prior and after intervention, an average of 12 weeks
Change of electromyography of Pelvic Floor Muscles
Change of electromyography of Pelvic Floor Muscles
Time frame: Prior and after intervention, an average of 12 weeks
Change Pelvic floor functional capacity
Difference between Perineometry of MCV and Base Tone of Pelvic Floor Muscles (EMG)
Time frame: 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.
Time frame: Prior and after intervention, an average of 12 weeks
Plan to share: No
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