NCT06814743

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

Analysis, Awareness and Tele-rehabilitation of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of the Balearic Islands · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 %).

Detailed description

Female athletes from EG1 and EG2 will complete the exercise program for PF three times per week, during 12 weeks. Each session will last about 20 minutes and exercises will be modified every two weeks to meet the principle of training progression and avoid athletes become bored.

Conditions

• Pelvic Floor Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2025-02-07
• Last updated: 2025-12-24

Locations

1 site across 1 country: Spain