Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions (ACTITUD2)

University of the Balearic Islands

Status: Completed

Conditions: Pelvic Floor Disorders

Treatments: Behavioral: Pelvic floor muscle training; Behavioral: Pelvic floor muscle training with biofeedback device; Behavioral: Information about pelvic floor and communication with health professionals

Study type: Interventional

Funder types: Other

Identifiers

NCT06014021

124CER19_

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Experimental group 1

Experimental group

Description:

All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF, while using an intracavitary biofeedback device.

Treatment:

Behavioral: Pelvic floor muscle training with biofeedback device

Behavioral: Information about pelvic floor and communication with health professionals

Experimental group 2

Active Comparator group

Description:

All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF.

Treatment:

Behavioral: Pelvic floor muscle training

Behavioral: Information about pelvic floor and communication with health professionals

Control group

Active Comparator group

Description:

All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team.

Treatment:

Behavioral: Information about pelvic floor and communication with health professionals