Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.

NCT04457141 | Completed DMC

• 1 other identifier: 19/570-E_TFM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Pelvic floor; Electromyography; Barefoot

Outcome Measures

Primary Outcomes (1)

• Electrical activation of the pelvic floor musculature, abdominal, gluteus maximus and lumbar erectors during the race in nulliparous women with sneakers traditional and minimalist

  PeriformTM vaginal probe Will collect the EMG activity of the muscles of the pelvic also register with superficial electrodes EMG abdominal, gluteus maximus and lumbar erectors. Records are made in a single session with washout periods in accordance with previous studies that have collected the activity of the EMG activity PF during treadmill running different speeds.

  Basal, 0.5, 1.0, 1.5 minutes after the start of the test.

Secondary Outcomes (2)

• 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.

  Basal, 0.5, 1.0, 1.5 minutes after the start of the test.

• 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

  Basal, 0.5, 1.0, 1.5 minutes after the start of the test.

Study Arms (2)

first:shod ,second:minimalist shoes

OTHER

The first group will race with conventional shoes and then minimalist shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9 km/h and 30 seconds at 11km/h. They have a washout period of 10 minutes between both interventions.

Combination Product: Effect of pelvic floor for the use of minimalist shoes versus shod in woman.

first:minimalist shoes ,second:shod

OTHER

The second group will race with minimalist shoes and then conventional shoes. The group run 5 minutes for warming and then 30 seconds at 6km/h, 30 seconds at 9km/h and 30 seconds at 11km/h. They have a washout period of 10 minutes between both interventions.

Combination Product: Effect of pelvic floor for the use of minimalist shoes versus shod in woman.

Interventions

Effect of pelvic floor for the use of minimalist shoes versus shod in woman. COMBINATION_PRODUCT

Measure the activity of the pelvic floor and others muscles with EMG during treadmill running with different speeds and different shoes: minimalist and shod.

first:minimalist shoes ,second:shod; first:shod ,second:minimalist shoes

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Department of Radiology, Rehabilitation and Physiotherapy

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Garcia

  universidad complutense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: July 7, 2020
• Study Start: February 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 3, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)