Quality and Behavior of Pelvic Floor in Runner Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change of Base Tone of Pelvic Floor Muscles (EMG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The researcher will not know who belongs to each group
入排标准
- 年龄范围
- 25 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of Base Tone of Pelvic Floor Muscles (EMG)
时间窗: baseline, prior and after intervention, an average of 12 weeks
Electromyography of base tone of Pelvic Floor Muscles
Change of acceleration
时间窗: 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 accumulated fatigue
时间窗: Prior and after intervention, an average of 12 weeks
Using Lactate Pro 2. Mmol/Litres
Change %MVC
时间窗: Prior and after intervention, an average of 12 weeks
Change % of Maximun voluntary contraction
Change of step length
时间窗: 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 heart rate
时间窗: Prior and after intervention, an average 12 weeks
Heart Rate
Perineometry of MCV
时间窗: baseline, prior and after intervention, an average of 12 weeks
perineometry of MCV using PFX
Change of ground reaction force
时间窗: 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 displacement
时间窗: 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 electromyography of Pelvic Floor Muscles
时间窗: Prior and after intervention, an average of 12 weeks
Change of electromyography of Pelvic Floor Muscles
Change of cadence
时间窗: 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.
Intravaginal manual palpation
时间窗: baseline, prior and after intervention, an average of 12 weeks
manual testing of the levator ani muscles using scale of Daniels
次要结局
- Quality of life score(Prior and after intervention, an average of 12 weeks)
- Change Pelvic floor functional capacity(Prior and after intervention, an average of 12 weeks)
研究者
Dr. Antonio I Cuesta-Vargas
Principal Researcher of CTS631 University of Malaga
University of Malaga