NCT04457141: minimalwomen

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

Completed NA Last updated 3 June 2022

What this trial tests

NA trial testing Effect of pelvic floor for the use of minimalist shoes versus shod in woman. in Stress Urinary Incontinence in 50 participants. Completed in 1 April 2022.

Timeline

1 February 2021

Primary endpoint
1 March 2022

1 April 2022

Quick facts

Lead sponsor	Universidad Complutense de Madrid
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	50
Start date	1 February 2021
Primary completion	1 March 2022
Estimated completion	1 April 2022
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Universidad Complutense de Madrid — full company profile →

Who can join

Adults 18 to 38, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of minimalist shoes on pelvic floor activity in nulliparous women during running at different velocities: a randomized cross-over clinical trial.
   García-Arrabe M, García-Fernández P, Ruiz-Ruiz B, Del Prado-Álvarez R, et al · · 2022 · cited 6× · PMID 36481768 · DOI 10.1038/s41598-022-25344-6
2. Effects of Minimalist vs. Traditional Running Shoes on Abdominal Lumbopelvic Muscle Activity in Women Running at Different Speeds: A Randomized Cross-Over Clinical Trial.
   García-Arrabé M, de la Plaza San Frutos M, Bermejo-Franco A, Del Prado-Álvarez R, et al · · 2024 · cited 2× · PMID 38257403 · DOI 10.3390/s24020310
3. Electromyographic Patterns of Muscle Activation During Running with Different Footwear at Different Speeds in Nulliparous Women: A Secondary Analysis.
   García-Arrabé M, Guerineau F, Ruiz-Ruiz B, López-Ruiz J, et al · · 2025 · PMID 40431811 · DOI 10.3390/s25103016