Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis

NCT06810297 | Enrolling By Invitation

• 1 other identifier: SEX-ENDOMETRIO-UV
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program. The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.

Conditions

Endometriosis; Sexual Function; Sex Behavior

Keywords

Endometriosis; Sexual Function; Sexual Experience

Outcome Measures

Primary Outcomes (2)

• Quality of Life - Sexual Function

  The Index of Female Sexual Function (IFSF) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function. The scores for the same domain are added together and multiplied by the factor that corresponds to each domain. The total score is obtained by adding the scores for the 6 domains. A score of 0 in any of the domains indicates a lack of sexual activity in the last month.The maximum total score will be 36 points and the minimum 2. The higher the score, the better the sexual function.

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

• Quality of Life - Sexual self-concept

  Multidimensional Scale of Sexual Concept (MSSCQ) will be used. It is a multidimensional self-reported instrument for the evaluation of sexual self- concept. Each answer has a score of 0 to 4 points. The higher the score, the better the sexual assertiveness and sexual self-concept. There are a total of 16 questions. The maximum score is 64 points and the minimum is 0.

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

Secondary Outcomes (3)

• Quality of Life - Pleasure

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

• Physical-Funcionality - Motor control

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

• Physical-Funcionality- Pelvic floor and abdominal ultrasound

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

Other Outcomes (3)

• Excitation

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

• Excitation

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

• Excitation

  Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).

Study Arms (2)

Therapeutic Exercise

ACTIVE COMPARATOR

They will recive the therapeutic exercise program.

Procedure: Therapeutic Exercise

Therapeutic exercise and sexual education

EXPERIMENTAL

They will receive ta combined program, which will combine therapeutic exercise with a sexual education classes.

Combination Product: Therapeutic exercise and sexual education

Interventions

Therapeutic Exercise PROCEDURE

It will consist of an 8-week intervention divided into 2 weekly sessions, in which functional exercise will be combined with aerobic exercise. A progressive protocol will be carried out.The sessions will last approximately 60 minutes divided into a first aerobic part which will serve as a warm-up for the functional part, then a main part with approximately 6 exercises and, finally, a cool-down of 3 to 5 minutes with relaxation exercises and stretching.

Therapeutic Exercise

Therapeutic exercise and sexual education COMBINATION_PRODUCT

The sexual education part will consist of a 4-week intervention divided into 1 session every two weeks in an online format, in which topics related to the pathology and self-knowledge will be addressed. The sessions will last approximately 60 minutes, divided into a first part of reception and welcome of the group (lasting approximately 5-10 minutes), then the main content will be divided differently in each session (the explicit content of each session will be detailed later) and will end with a farewell and closing of the online session (lasting approximately 5-10 minutes) together with the explanation of the homework. In addition, they will also carry out the therapeutic exercise protocol.

Therapeutic exercise and sexual education

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• People of legal age (over 18 years old)
• Not older than 50 years old
• Currently residing in Spain
• Spanish speakers
• With a medical diagnosis of endometriosis
• Without any other associated gynecological pathology

You may not qualify if:

• Minors
• People over 50 years old
• Those with cognitive limitations that prevent them from completing the different questionnaires used
• People who are involved in litigation processes
• People with gynecological pathologies other than endometriosis

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Laura Fuentes Aparicio

Valencia, 46010, Spain

Location

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Endometriosis; Sexual Behavior

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 5, 2025
• Study Start: October 18, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)