NCT06014021

Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (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 6-weeks strengthening PF program by using tele-rehabilitation, with or without intracavitary biofeedback, in the PF anatomo-functional characteristics, quality of life and sports performance of female athletes with PFD. To this end, 45 female athletes with self-reported PFD who train and compete in athletic in Spain will be recruited and randomly distributed in three groups of the experimental study. During 6 weeks, all participants will use an specifically developed Smartphone 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 strengthening program for PF, which will be instructed by 3D avatars, while using an intracavitary biofeedback device that will inform about vaginal pressure; the experimental group 2 (EG2) will be similar to EG1, but they will not use the intracavitary biofeedback device. Before and after these 6 weeks, anatomo-functional PF characteristics, quality of life, PFD symptoms and sports performance of all participants will be evaluated. As an additional outcome, the level of engagement of the athletes from experimental groups to complete the training program will be registered.

Detailed description

Female athletes from EG1 and EG2 will complete the strengthening program for PF three times per week, during six 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 muscle training with biofeedback device	Use of the Smartphone application to perform a strengthening program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure.
BEHAVIORAL	Pelvic floor muscle training	Use of the Smartphone application to perform a strengthening program for pelvic floor musculature.
BEHAVIORAL	Information about pelvic floor and communication with health professionals	Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-10-05
• Completion: 2023-11-20
• First posted: 2023-08-28
• Last updated: 2024-04-02

Locations

1 site across 1 country: Spain