A Mobile Application for Female Athletes With Pelvic Floor Dysfunctions (ACTITUD2.0)
NCT ID: NCT06814743
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2025-02-10
2025-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group 2: Exercises with biofeedback guidance
All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor, while using an intravaginal biofeedback device.
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.
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.
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.
Experimental group 1: Exercises
All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor.
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.
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.
Control group: No exercises
All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Ministerio de Ciencia, Innovación y Universidades, Spain
UNKNOWN
University of the Balearic Islands
OTHER
Responsible Party
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Principal Investigators
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Natalia Romero-Franco
Role: PRINCIPAL_INVESTIGATOR
University of the Balearic Islands
Natalia Romero-Franco, PhD
Role: PRINCIPAL_INVESTIGATOR
University of the Balearic Islands
Locations
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Palma de Mallorca
Palma, Balearic Islands, Spain
Countries
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Other Identifiers
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124CER19_2.0
Identifier Type: -
Identifier Source: org_study_id