Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2023-11-20

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The design of this study does not allow to mask participants or care providers. Investigators or outcomes assessors will not know which group athletes belong.

Study Groups

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Experimental group 1

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.

Group Type EXPERIMENTAL

Pelvic floor muscle training with biofeedback device

Intervention Type BEHAVIORAL

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.

Information about pelvic floor and communication with health professionals

Intervention Type BEHAVIORAL

Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.

Experimental group 2

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.

Group Type ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type BEHAVIORAL

Use of the Smartphone application to perform a strengthening program for pelvic floor musculature.

Information about pelvic floor and communication with health professionals

Intervention Type BEHAVIORAL

Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.

Control group

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

Group Type ACTIVE_COMPARATOR

Information about pelvic floor and communication with health professionals

Intervention Type BEHAVIORAL

Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.

Interventions

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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.

Intervention Type BEHAVIORAL

Pelvic floor muscle training

Use of the Smartphone application to perform a strengthening program for pelvic floor musculature.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No