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

NCT ID: NCT04457141

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

first:shod ,second:minimalist shoes

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.

Group Type: OTHER

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

Intervention Type: 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

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Garcia

Role: PRINCIPAL_INVESTIGATOR

universidad complutense

Locations

Department of Radiology, Rehabilitation and Physiotherapy

Madrid, , Spain

Countries

Spain

Other Identifiers

19/570-E_TFM

Identifier Type: -

Identifier Source: org_study_id