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

NCT ID: NCT06786182

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pelvic Floor Abdominal Muscles Abdominal Muscles/ultrasonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a randomized controlled trial (RCT) design with a parallel-group model. Participants are allocated to either a control group or an intervention group using a 1:1 ratio. The intervention group receives a structured educational program delivered via telematic resources, covering topics such as pelvic floor muscle (PFM) anatomy, function, and proper muscle activation techniques. The control group does not receive this educational intervention. Both groups undergo baseline and post-intervention ultrasound assessments to measure abdominal and PFM activation during various maneuvers, including resting, PFM contraction, the Active Straight Leg Raise (ASLR) test, and the hollowing maneuver. This model aims to evaluate the impact of the educational intervention on muscle co-contraction and activation patterns.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Blinding will apply to the study evaluators. The evaluators will have no knowledge about the assignment of the participants, which ensures that the evaluation of the results is unbiased and not influenced by the group to which they belong.

Study Groups

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EDUCATION

Participants receive an educational program focused on improving awareness and activation of the pelvic floor muscles and abdominal muscle synergy through telematic resources.

Group Type EXPERIMENTAL

PFM Educational Program

Intervention Type BEHAVIORAL

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.

Control

Participants in this group receive no educational intervention and participate only in baseline and follow-up assessments of abdominal and PFM activation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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European University of Madrid

OTHER

Sponsor Role lead

Responsible Party

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Marta de la Plaza

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Angel Gonzalez de la Flor

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 11135380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35876473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21599840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25891335 (View on PubMed)

Other Identifiers

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2024-442

Identifier Type: -

Identifier Source: org_study_id

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