Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

NCT06014021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Pelvic Floor Disorders

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Pelvic floor muscle training

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

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.

Sponsors & Collaborators

  • Fundació d'investigació Sanitària de les Illes Balears

    collaborator OTHER_GOV
  • Consejo Superior de Deportes, Spain

    collaborator OTHER
  • University of the Balearic Islands

    lead OTHER

Principal Investigators

  • Natalia Romero-Franco · University of the Balearic Islands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2023-10-05
Completion
2023-11-20

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014021 on ClinicalTrials.gov