Effectiveness of Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students

January 15, 2025 updated by: Marta de la Plaza, European University of Madrid

Effectiveness of a Pelvic Floor Contraction and Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students: a Pilot Study

This research study investigates the effectiveness of an educational intervention aimed at improving awareness and control of pelvic floor (PF) and abdominal muscle contractions in healthy young male university students. Using ultrasound imaging, the study measures abdominal wall muscle thickness at rest and during pelvic floor contraction, Active Straight Leg Raise (ASLR) test, and hollowing maneuvers in a randomized control trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study addresses the largely overlooked area of male PF health, aiming to increase awareness and improve muscle control in healthy young men. A two-group design will be used to compare abdominal and PF muscle activation between a control group and an intervention group that receives online educational content. The intervention group will participate in a telematic program covering topics such as PF anatomy, muscle function, and the importance of proper muscle activation.

The study will use diagnostic ultrasound to measure thickness changes in the transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) muscles before and after the intervention in both groups under different conditions: PF rest, PF contraction, single-leg raise (ASLR) test, and the hollowing maneuver.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Angel Gonzalez de la Flor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men aged 18-30 years
  • Healthy men
  • Informed consent submitted, accepted and signed

Exclusion Criteria:

  • Patients undergoing abdominal cavity surgery
  • Patients with cognitive/proprioceptive impairments
  • Patients who have had physiotherapy interventions of PFM
  • Patients with low scores on the Spanish-validated SHIM sexual health questionnaire for males.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDUCATION
Participants receive an educational program focused on improving awareness and activation of the pelvic floor muscles and abdominal muscle synergy through telematic resources.
Behavioral: PFM Educational Program
A structured telematic educational program covering PFM anatomy, function, and proper activation techniques. Content includes videos, visual guides, and exercises aimed at promoting PFM co-contraction and awareness.
No Intervention: Control
Participants in this group receive no educational intervention and participate only in baseline and follow-up assessments of abdominal and PFM activation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of the Transverse Abdominal Muscle (TrA)
Time Frame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Assessed at rest, during Pelvic floor (PF) contraction and during Active Straight Leg Raise (ASRL) via ultrasound,in centimetres
Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of the External (OE) and Internal Oblique (OI) Muscles
Time Frame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Measured at rest, during PF contraction, and with the ASLR test using ultrasound, in centimeters
Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University of Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

October 26, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, we do not plan to share Individual Participant Data (IPD) with other researchers. We will publish aggregated results from the study, ensuring that all data is de-identified to protect participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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