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
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
-
-
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Madrid, Spain, 28029
- Angel Gonzalez de la Flor
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-
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.
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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).
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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
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
- Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.
- Notenboom-Nas FJM, Knol-de Vries GE, Beijer L, Tolsma Y, Slieker-Ten Hove MCP, Dekker JH, van Koeveringe GA, Blanker MH. Exploring pelvic floor muscle function in men with and without pelvic floor symptoms: A population-based study. Neurourol Urodyn. 2022 Nov;41(8):1739-1748. doi: 10.1002/nau.24996. Epub 2022 Jul 25.
- Tuckett AG, Hodgkinson B, Hegney DG, Paterson J, Kralik D. Effectiveness of educational interventions to raise men's awareness of bladder and bowel health. Int J Evid Based Healthc. 2011 Jun;9(2):81-96. doi: 10.1111/j.1744-1609.2011.00208.x.
- Richter LA, Gutman RE, Tefera E, Estep A, Iglesia CB. Knowledge of erectile dysfunction and pelvic floor disorders among young adults: a cross-sectional study. Can J Urol. 2015 Apr;22(2):7715-9.
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.