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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Endometriosis; Sexual Function; Sex Behavior
• Intervention / Treatment: Procedure: Therapeutic Exercise; Combination product: Therapeutic exercise and sexual education

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • University of Valencia
  • Valencia, Spain, 46010
    • Laura Fuentes Aparicio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic Exercise; They will recive the therapeutic exercise program.	Procedure: Therapeutic Exercise; 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.
Experimental: Therapeutic exercise and sexual education; They will receive ta combined program, which will combine therapeutic exercise with a sexual education classes.	Combination product: Therapeutic exercise and sexual education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - Pleasure	Visual Analogue Scale (VAS) of pleasure will be used. Orgasmic intensity is reported through a Likert scale (0-10) and a chromatic gradation, which fluctuate from 0 (white), corresponding to the absence of orgasmic intensity, to 10 (deep red), corresponding to the highest level of orgasmic intensity.	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	Determine motor control: clinical test of lumpopelvic and thoracolumbar dissociation will be used. The clinical test assesses the ability to dissociate lumbopelvic movement from that of the thoracolumbar junction, and to evaluate the inter-rater reliability of the test in individuals with and without low back pain (LBP) when performed by experienced and novice therapists. A clinical scale was developed to characterise quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. The patient is asked to flex the trunk to see if there is lumbopelvic dissociation.	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	The ultrasound will measure muscle tone. This tone will be assessed in different situations. Measurement of basal tone, tone at maximum contraction, tone at Valsalva and tone at cough.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excitation	Sphygmomanometer will be used to measure the patients' arousal. Blood pressure will be measured to assess the level of arousal. Blood pressure is controlled by the autonomic system, which is also responsible for arousal. The higher the blood pressure, the greater the activation of the sympathetic system. Lower blood pressures indicate that the parasympathetic system is more active.	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	Electrocardiogram will be used to measure the patients' arousal. The electrocardiogram measures heart rate. It is also measured by the autonomic nervous system, so it is closely related to excitement. During excitement, a person's heart rate increases.	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	eSense skin response will be used to measure the patients' arousal. The activation of the sympathetic and parasympathetic systems is recorded through the skin. Higher values and the red colour measured with the eSense device indicate that the sympathetic system is more active. If the values tend to 0 and the colour is green, there is more activation of the parasympathetic system.	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).

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Endometriosis; Sexual Function; Sexual Experience
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Behavior; Endometriosis; Sexual Behavior; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: SEX-ENDOMETRIO-UV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No