Clinical trial NCT04457141: Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.
Official title: Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Pelvic floor
Electromyography
Barefoot
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized clinical trial
Primary purpose: PREVENTION

Brief summary: JUSTIFICATION:

Urinary incontinence is highly prevalent among women who play high impact sports such as running. that observed one of the possible reasons for this high prevalence is delayed activation of the pelvic floor in relation to the abdominal muscles.

The use of minimalist shoes during the race produces changes in muscle and joint biomechanics and efficiency in the race. However, to date no studies evaluating the influence of footwear in the musculature of the pelvic floor during the race.

OBJECTIVE: Describe and compare the electromyographic activity of the muscles of the pelvic floor and abdominal during the race with conventional shoes and minimalist.

DESIGN: cross-over study experimental, analytical and prospective. METHODOLOGY: conventional and minimalist: 50 healthy young women, 6- randomly distributed in two groups will be included to characterise the electromyographic activity of the pelvic floor muscles before and during running at 6-9-11 km/h with the two types of running shoes.

A baseline assessment will be performed to confirm that the women meet the inclusion and exclusion criteria. The ability to run a 10-minute treadmill at a speed of 6-9-11 km/h will be assessed, as well as the ability to adequately contract the pelvic floor muscles.

The group of 50 women will initially run randomly with conventional running shoes or with minimalist running shoes, and then, after a 10-minute washout period, will run with the other type of running shoe, i.e. if a participant in the first phase used conventional running shoes, she will run with a minimalist running shoe in the second phase.

The cadence of step, the range of movement of the femur and the EMG recording with electromyographic sensors of the pelvic floor musculature (using an intravaginal probe of the germproof brand), abdominal (internal and external oblique), spinal erectors and gluteus (using a surface sensor) in relation to the cycling gait will be collected and recorded with barographic sensors. The variables to be included in the electromyography for each muscle in relation to the gait cycle will be: onset of activation, duration, intensity and synergy with their corresponding standard deviation.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 to 38 years.
* Nulliparous.
* Clinically healthy at the time of the study.
* Physically able for the requirement of the race on tape.
* Body Mass Index (BMI) 20-25 kg / m2
* Having signed the informed consent.

Exclusion Criteria:

* Pregnant women.
* urogynecological dysfunction.
* Lower limb surgeries performed in the last six months.
* Not be able to make voluntary contractions of the pelvic floor standardized according to the Modified Oxford Scale

Primary outcomes:
measure: Electrical activation of the pelvic floor musculature, abdominal, gluteus maximus and lumbar erectors during the race in nulliparous women with sneakers traditional and minimalist
timeFrame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
Secondary outcomes:
measure: Cadence and Range of motion in the sagittal plane of the femur during running at different speeds in nulliparous women with conventional and minimalist shoes.
timeFrame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
measure: Maximum voluntary contraction (MVIC), minimum peak, maximum peak and total average of the muscles of the sp, abdominal (LE), gluteus maximus and erectors during running at different speeds in nulliparous women with conventional shoes and minimalist
timeFrame: Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Radiology, Rehabilitation and Physiotherapy
Study officials:
affiliation: universidad complutense
name: Maria Garcia
role: PRINCIPAL_INVESTIGATOR
References: