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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Effect of pelvic floor for the use of minimalist shoes versus shod in woman.
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Urinary Incontinence focused on measuring Pelvic floor, Electromyography, Barefoot

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Radiology, Rehabilitation and Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

first:shod ,second:minimalist shoes

first:minimalist shoes ,second:shod

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Collect of the spatial displacement of the lower limb by means of an accelerometer located in the EMG sensor during the treadmill race at different speeds
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
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.

Full Information

First Posted
May 12, 2020
Last Updated
May 31, 2022
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04457141
Brief Title
Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.
Acronym
minimalwomen
Official Title
Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Pelvic floor, Electromyography, Barefoot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first:shod ,second:minimalist shoes
Arm Type
Other
Arm Description
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.
Arm Title
first:minimalist shoes ,second:shod
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Effect of pelvic floor for the use of minimalist shoes versus shod in woman.
Intervention Description
Measure the activity of the pelvic floor and others muscles with EMG during treadmill running with different speeds and different shoes: minimalist and shod.
Primary Outcome Measure Information:
Title
Electrical activation of the pelvic floor musculature, abdominal, gluteus maximus and lumbar erectors during the race in nulliparous women with sneakers traditional and minimalist
Description
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.
Time Frame
Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
Secondary Outcome Measure Information:
Title
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.
Description
Collect of the spatial displacement of the lower limb by means of an accelerometer located in the EMG sensor during the treadmill race at different speeds
Time Frame
Basal, 0.5, 1.0, 1.5 minutes after the start of the test.
Title
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
Description
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.
Time Frame
Basal, 0.5, 1.0, 1.5 minutes after the start of the test.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Garcia
Organizational Affiliation
universidad complutense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology, Rehabilitation and Physiotherapy
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the researchers will participate in all the study phases.

Learn more about this trial

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

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