A Mobile Application for Female Athletes With Pelvic Floor Dysfunctions (ACTITUD2.0)

NCT06814743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-12-24

No results posted yet for this study

Summary

Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.

This study will evaluate the effects of a 12-weeks program with exercises focused on PF awareness and strengthening by using a mobile application supervised by physiotherapists, with or without intracavitary biofeedback, on the PF anatomical and functional characteristics, symptomatology and sports performance of female athletes with PFD.

To this end, 105 female athletes with self-reported PFD who train and compete in sport in Spain will be recruited and randomly distributed in three groups of the experimental study. During 12 weeks, all participants will use the mobile application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a the exercise program for PF; the experimental group 2 (EG2) will be similar to EG1, but they will use an intravaginal biofeedback device during exercises to receive information about their intra-vaginal pressure.

Before and after these 12 weeks, anatomical and functional PF characteristics, PF symptoms and sports performance of all participants will be evaluated. As additional outcome, the compliance of the athletes from experimental groups to complete the training program will be registered (in %).

Conditions

  • Pelvic Floor Disorders

Interventions

BEHAVIORAL

Pelvic floor exercises program guided with an intravaginal biofeedback device

Use of the mobile application to perform a exercise program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure. Behavioral: mobile application with access to information about pelvic floor and direct communication with healthcare team.

BEHAVIORAL

Pelvic floor exercises program

Use of the mobile application to perform a exercise program for pelvic floor musculature. Behavioral: Information about pelvic floor and communication with health professionals Use of the mobile application with access to information about pelvic floor and direct communication with healthcare team.

BEHAVIORAL

Information about pelvic floor and communication with health professionals

Use of the mobile application with access to information about pelvic floor and direct communication with healthcare team.

Sponsors & Collaborators

  • Ministerio de Ciencia, Innovación y Universidades, Spain

    collaborator UNKNOWN
  • University of the Balearic Islands

    lead OTHER

Principal Investigators

  • Natalia Romero-Franco · University of the Balearic Islands

  • Natalia Romero-Franco, PhD · University of the Balearic Islands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814743 on ClinicalTrials.gov