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

Обзор

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.

Вмешательства

• Процедура 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.
• Комбинированный продукт 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

Первичные конечные точки

• Quality of Life - Sexual Function [Срок оценки: 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 [Срок оценки: 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).]

Вторичные конечные точки (3)

• Quality of Life - Pleasure [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Laura Fuentes Aparicio — Valencia
• University of Valencia — Valencia

Идентификаторы

NCT: NCT06810297 · SEX-ENDOMETRIO-UV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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