Clinical trial NCT06814743: A Mobile Application for Female Athletes with Pelvic Floor Dysfunctions (ACTITUD2.0)
Official title: Analysis, Awareness and Tele-rehabilitation of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: Female
Athletes
e-Health
Exercises
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia, Innovación y Universidades, Spain
First posted: 2025-02-07
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* To train and compete in any sport.
* To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).

Exclusion Criteria:

* To have recurrent infections of urinary tract during the last three months.
* To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
* To have been pregnant during the year prior to the start of the study.

Primary outcomes:
measure: Functional characteristics of pelvic floor musculature
timeFrame: 12 weeks
measure: Functional characteristics of pelvic floor musculature with manometry I
timeFrame: 12 weeks
measure: Functional characteristics of pelvic floor musculature with manometry II
timeFrame: 12 weeks
measure: Functional characteristics of pelvic floor musculature with manometry III
timeFrame: 12 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound I
timeFrame: 12 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound II
timeFrame: 12 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound III
timeFrame: 12 weeks
measure: Sports performance through maximal vertical jump I
timeFrame: 12 weeks
measure: Sports performance through maximal vertical jump II
timeFrame: 12 weeks
measure: Occurrence of urinary incontinence symptomatology
timeFrame: 12 weeks
measure: Sexual dysfunction symptomatology
timeFrame: 12 weeks
measure: Occurrence of ano-rectal incontinence
timeFrame: 12 weeks
measure: Level of quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Compliance to the proposed pelvic floor exercise program
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Palma de Mallorca
state: Balearic Islands
Study officials:
affiliation: University of the Balearic Islands
name: Natalia Romero-Franco
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Balearic Islands
name: Natalia Romero-Franco, PhD
role: PRINCIPAL_INVESTIGATOR
References: