Clinical trial NCT06014021: Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions
Official title: Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: Female
Athletes
Track and Field
Tele-rehabilitation
Strengthening
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
name: Consejo Superior de Deportes, Spain
First posted: 2023-08-28
Enrollment: 45
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 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.

Eligibility criteria: Inclusion Criteria:

* To train and compete in any of the Track and Field modalities
* To have sports license from regional or national Track and Field Federation in the season when study starts.
* To have a self-reported pelvic floor disorder (urinary incontinence, fecal incontinence, sexual dysfunction or pelvic organ prolapse).

Exclusion Criteria:

* To have pelvic pain during the last three months.
* 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 with perineometer
timeFrame: 6 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound I
timeFrame: 6 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound II
timeFrame: 6 weeks
measure: Anatomical characteristics of pelvic floor structures with ultrasound III
timeFrame: 6 weeks
measure: Sports performance through maximal vertical jump
timeFrame: 6 weeks
measure: Presence of pelvic floor disorders symptomatology
timeFrame: 6 weeks
measure: Frequency of pelvic floor disorders symptomatology
timeFrame: 6 weeks
measure: Sexual dysfunction symptomatology
timeFrame: 6 weeks
measure: Level of quality of life
timeFrame: 6 weeks
Secondary outcomes:
measure: Engagement to training program
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
affiliation: University of the Balearic Islands
name: Natalia Romero-Franco
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Lopez ES, Acevedo-Gomez MB, Romero-Franco N, Basas-Garcia A, Ramirez-Parenteau C, Calvo-Moreno SO, Fernandez-Dominguez JC. Urinary Incontinence Among Elite Track and Field Athletes According to Their Event Specialization: A Cross-Sectional Study. Sports Med Open. 2022 Jun 15;8(1):78. doi: 10.1186/s40798-022-00468-1.
citation: Romero-Franco N, Molina-Mula J, Bosch-Donate E, Casado A. Therapeutic exercise to improve pelvic floor muscle function in a female sporting population: a systematic review and meta-analysis. Physiotherapy. 2021 Dec;113:44-52. doi: 10.1016/j.physio.2021.04.006. Epub 2021 Apr 29.