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

Primary Purpose

Pelvic Floor Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pelvic floor muscle training with biofeedback device
Pelvic floor muscle training
Information about pelvic floor and communication with health professionals
Sponsored by
University of the Balearic Islands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Female, Athletes, Track and Field, Tele-rehabilitation, Strengthening

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of the Balearic Islands

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental group 1

Experimental group 2

Control group

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Functional characteristics of pelvic floor musculature with perineometer
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a perineometer (in mmHg) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal contraction of pelvic floor musculature during 3 seconds (three trials with 60 seconds apart). The best trial (the highest pressure) will be collected, as well as the rest vaginal pressure before the first trial of MVC.
Anatomical characteristics of pelvic floor structures with ultrasound I
Change in the levator hiatus length (in mm) after the intervention period and compared to the athletes from the rest of groups. This variable will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Anatomical characteristics of pelvic floor structures with ultrasound II
Change in the anorectal angle (in degrees) and pubourethral angle (in degrees) after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Anatomical characteristics of pelvic floor structures with ultrasound III
Change in the symmetry of the bladder base (in mm) at rest and bladder base displacement (in mm) while participants perform a MVC of the pelvic floor musculature (PFM) and also during straining, after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using a transabdominal approach with transducer, in transverse orientation.
Sports performance through maximal vertical jump
Change in the maximal height that athletes reach with a vertical jump (in meters) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal countermovement jump (three trials with 30 seconds apart). It will be collected the average of the three trials.
Presence of pelvic floor disorders symptomatology
Change in self-reported PFD symptoms through the PFD-SENTINEL questionnaire, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed PFD-SENTINEL tool consisting of 5 symptoms (urinary incontinence, anal incontinence, pelvic pain, pelvic organ prolapse, and overactive bladder syndrome) and 28 items. The responses to each item are categorized in yes or no. One point will be assigned for the affirmative response to each item. It will be considered the symptom score (presence or not of PFD symptoms),and total score (from 0 to 28 points).
Frequency of pelvic floor disorders symptomatology
In case of affirmative response to the presence of one or more PFD symptoms, it will be explore the frequency of the existing symptom. The responses will be graded on a 4-point scale indicating how often women have each symptom (1 = rarely, 2 = sometimes, 3 = often, and 4 = always). It will be explored the change after the intervention period and compared to the athletes from the rest of groups.
Sexual dysfunction symptomatology
Change in self-reported sexual dysfunction symptoms through The Female Sexual Function Index (FSFI), after the intervention period and compared to the athletes from the rest of groups. This scale consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The responses to each item are graded as follows: 1 = never or very low, 2 = rarely or low, 3 = sometimes or moderate, 4 = often or high, 5 = always or very high. It will be consider individual score for each area (max 6 points) and total score (max 36 points).
Level of quality of life
It will be explore the change in quality of life due to the pelvic floor disorders symptoms (according to a scale from 0, no affection, to 10, maximal affection) after the intervention period and compared to the athletes from the rest of groups.

Secondary Outcome Measures

Engagement to training program
Percentage of training program sessions that athletes from experimental groups completed during the six weeks of intervention, according to the number of proposed sessions (three times per week).

Full Information

First Posted
August 22, 2023
Last Updated
August 29, 2023
Sponsor
University of the Balearic Islands
Collaborators
Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes
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1. Study Identification

Unique Protocol Identification Number
NCT06014021
Brief Title
Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions
Acronym
ACTITUD2
Official Title
Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Balearic Islands
Collaborators
Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Female, Athletes, Track and Field, Tele-rehabilitation, Strengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm 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.
Arm Title
Experimental group 2
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training with biofeedback device
Intervention Description
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
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
Use of the Smartphone application to perform a strengthening program for pelvic floor musculature.
Intervention Type
Behavioral
Intervention Name(s)
Information about pelvic floor and communication with health professionals
Intervention Description
Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.
Primary Outcome Measure Information:
Title
Functional characteristics of pelvic floor musculature with perineometer
Description
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a perineometer (in mmHg) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal contraction of pelvic floor musculature during 3 seconds (three trials with 60 seconds apart). The best trial (the highest pressure) will be collected, as well as the rest vaginal pressure before the first trial of MVC.
Time Frame
6 weeks
Title
Anatomical characteristics of pelvic floor structures with ultrasound I
Description
Change in the levator hiatus length (in mm) after the intervention period and compared to the athletes from the rest of groups. This variable will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Time Frame
6 weeks
Title
Anatomical characteristics of pelvic floor structures with ultrasound II
Description
Change in the anorectal angle (in degrees) and pubourethral angle (in degrees) after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Time Frame
6 weeks
Title
Anatomical characteristics of pelvic floor structures with ultrasound III
Description
Change in the symmetry of the bladder base (in mm) at rest and bladder base displacement (in mm) while participants perform a MVC of the pelvic floor musculature (PFM) and also during straining, after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using a transabdominal approach with transducer, in transverse orientation.
Time Frame
6 weeks
Title
Sports performance through maximal vertical jump
Description
Change in the maximal height that athletes reach with a vertical jump (in meters) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal countermovement jump (three trials with 30 seconds apart). It will be collected the average of the three trials.
Time Frame
6 weeks
Title
Presence of pelvic floor disorders symptomatology
Description
Change in self-reported PFD symptoms through the PFD-SENTINEL questionnaire, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed PFD-SENTINEL tool consisting of 5 symptoms (urinary incontinence, anal incontinence, pelvic pain, pelvic organ prolapse, and overactive bladder syndrome) and 28 items. The responses to each item are categorized in yes or no. One point will be assigned for the affirmative response to each item. It will be considered the symptom score (presence or not of PFD symptoms),and total score (from 0 to 28 points).
Time Frame
6 weeks
Title
Frequency of pelvic floor disorders symptomatology
Description
In case of affirmative response to the presence of one or more PFD symptoms, it will be explore the frequency of the existing symptom. The responses will be graded on a 4-point scale indicating how often women have each symptom (1 = rarely, 2 = sometimes, 3 = often, and 4 = always). It will be explored the change after the intervention period and compared to the athletes from the rest of groups.
Time Frame
6 weeks
Title
Sexual dysfunction symptomatology
Description
Change in self-reported sexual dysfunction symptoms through The Female Sexual Function Index (FSFI), after the intervention period and compared to the athletes from the rest of groups. This scale consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The responses to each item are graded as follows: 1 = never or very low, 2 = rarely or low, 3 = sometimes or moderate, 4 = often or high, 5 = always or very high. It will be consider individual score for each area (max 6 points) and total score (max 36 points).
Time Frame
6 weeks
Title
Level of quality of life
Description
It will be explore the change in quality of life due to the pelvic floor disorders symptoms (according to a scale from 0, no affection, to 10, maximal affection) after the intervention period and compared to the athletes from the rest of groups.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Engagement to training program
Description
Percentage of training program sessions that athletes from experimental groups completed during the six weeks of intervention, according to the number of proposed sessions (three times per week).
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Romero-Franco, PhD
Phone
971172916
Ext
2916
Email
natalia.romero@uib.es
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Fernández-Domínguez, PhD
Phone
971259513
Ext
9513
Email
jcarlos.fernandez@uib.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Romero-Franco
Organizational Affiliation
University of the Balearic Islands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Balearic Islands
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35704136
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.
Results Reference
result
PubMed Identifier
34555673
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.
Results Reference
result

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Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

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