NCT Number: NCT06810297
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Laura Fuentes Aparicio, Valencia, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
University of Valencia
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05059626
Endometriosis, Female Urogenital Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT05411549
Endometriosis, Female Urogenital Diseases
Hamilton, Ontario, Canada
View Trial DetailsNCT05523284
Disease, Endometriosis
Hamilton, Ontario, Canada
View Trial DetailsNCT05601596
Disease, Endometriosis
Manhasset, New York, United States
View Trial Details