NCT07848451

Brief Summary

This study evaluated the effects of a 12-week physiotherapy exercise programme on pelvic floor and abdominopelvic function in healthy young nulliparous women. Participants were randomly allocated to an intervention group or a control group. The intervention included supervised and home-based exercises focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control. The control group continued their usual activities without receiving the study intervention. Pelvic floor muscle function, abdominopelvic functional responses, respiratory function, and health-related quality of life were assessed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Subumbilical Cough Test

    Qualitative assessment of abdominal wall response during coughing. The outcome was categorized as no bulging or bulging of the abdominal wall. Bulging was defined as caudal bulging of the umbilicopubic region during the cough maneuver, indicating insufficient abdominal muscle activation.

    Baseline and after the 12-week intervention

Secondary Outcomes (9)

  • Pelvic Floor Muscle Strength - Modified Oxford Scale

    Baseline and after the 12-week intervention

  • Pelvic Floor Muscle Endurance

    Baseline and after the 12-week intervention

  • Pelvic Floor Muscle Contraction Pressure

    Baseline and after the 12-week intervention

  • Abdominal Diastasis Functional Test

    Baseline and after the 12-week intervention

  • Transversus Abdominis Activation Test

    Baseline and after the 12-week intervention

  • +4 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants assigned to this group completed a 12-week physiotherapy exercise programme focused on postural organization, breathing coordination, and lumbopelvic-abdominal muscle control, combining supervised sessions with home-based exercise.

Behavioral: Multimodal Physiotherapy Exercise Programme

Control group

NO INTERVENTION

Participants assigned to this group continued their usual activities and did not receive the study exercise programme during the 12-week study period.

Interventions

Participants completed a 12-week exercise programme combining postural organization, breathing coordination, and lumbopelvic-abdominal motor control. The programme included a 20-minute supervised session once weekly, complemented by home-based exercise.

Intervention Group

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female university students aged 18 to 26 years.
  • Nulliparous.
  • No gynecological pathology.
  • No respiratory pathology.
  • History of sexual intercourse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sirvent-Pinar MA, Iglesias-Comesaña A, Guerrero-Rubio MA, Alarcón-Alarcón D, Rodríguez-Blanco N, Pérez de Arrilucea Le Floc'h U. Development and reproducible description of a multimodal physiotherapy intervention for pelvic floor health: a methodological report. BMC Women's Health. 2026. doi:10.1186/s12905-026-04779-3.

    BACKGROUND

Study Officials

  • Luís Gómez Pérez, PhD

    Universidad Miguel Hernández

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and the statistician were blinded to group allocation. Participants and the physiotherapist supervising the intervention were not blinded due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No prospective plan for individual participant data sharing was established for this study.