Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)

NCT03979183 | Completed

• 1 other identifier: Physio-EndEA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Given (1) the high volume of women on reproductive age that have a clinical diagnosis of endometriosis and (2) the poor management of symptoms that medical treatment usually achieves, new therapeutic interventions need to be evaluated in order to improve pain and quality of life in those patients. Therefore, 'Physio-EndEA' study has been designed to evaluate whether therapeutic exercise could help on the management of endometriosis-related symptoms

Conditions

Endometriosis

Keywords

Pain; Therapeutic exercise; Physiotherapy; Rehabilitation; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in quality of life assessed by EHP-30

  It will be assessed using the Endometriosis Health Profile-30 (EHP-30). It is a self-administered disease-specific instrument to measure QoL in women with endometriosis. The 30-item EHP, referred to the last 4 weeks, is comprised of five domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Items within each subscale, answered on a 5-point Likert-type scale, are summed and then transformed to a percentage scale ranging from 0 (best health status) to 100 (worse health status) by dividing the raw score of all items by the maximum possible raw score, multiplied by 100

  Baseline, inmediately after intervention and 1-year post-intervention

Secondary Outcomes (16)

• Pressure pain threshold (PPT)

  Baseline, inmediately after intervention and 1-year post-intervention

• Pain intensity

  Baseline, inmediately after intervention and 1-year post-intervention

• Catastrophizing thoughts

  Baseline, inmediately after intervention and 1-year post-intervention

• Muscle thickness

  Baseline, inmediately after intervention and 1-year post-intervention

• Muscle trunk flexor and extensor endurance

  Baseline, inmediately after intervention and 1-year post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Therapeutic exercise

Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises

Control

NO INTERVENTION

Usual care

Interventions

Lumbopelvic, stretching, aerobic and relaxation exercises BEHAVIORAL

Intervention program will comprises brisk walks and small choreographies, global and analytical stretching exercises, as well as lumbopelvic stabilization exercises (with intensity and volume progression)

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal status
• Clinical diagnosis of endometriosis by laparoscopy, magnetic resonance imaging or ultrasound imaging
• History of clinical symptoms
• To be able to walk without assistance
• To be able to read and write enough
• To be capable and willing to provide consent
• Interested in improving lifestyle

You may not qualify if:

• Acute or terminal illness
• Presence of any chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program
• Unwillingness to complete the study requirements
• Be registered in other exercise program

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Francisco Artacho Cordón

Granada, 18016, Spain

Location

Related Publications (2)

• Salinas-Asensio MDM, Alvarez-Salvago F, Mundo-Lopez A, Ocon-Hernandez O, Lozano-Lozano M, Lopez-Garzon M, Postigo-Martin P, Arroyo-Morales M, Rodriguez-Ruiz A, Fernandez-Lao C, Artacho-Cordon F. Changes in fatigue, health-related fitness, sleep quality, mental health, gastrointestinal complaints and sexual function after a multimodal supervised therapeutic exercise program in women with endometriosis unresponsive to conventional therapy: a secondary analysis of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114083. doi: 10.1016/j.ejogrb.2025.114083. Epub 2025 May 24.

  PMID: 40440865 DERIVED

• Artacho-Cordon F, Salinas-Asensio MDM, Galiano-Castillo N, Ocon-Hernandez O, Peinado FM, Mundo-Lopez A, Lozano-Lozano M, Alvarez-Salvago F, Arroyo-Morales M, Fernandez-Lao C, Cantarero-Villanueva I. Effect of a Multimodal Supervised Therapeutic Exercise Program on Quality of Life, Pain, and Lumbopelvic Impairments in Women With Endometriosis Unresponsive to Conventional Therapy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Nov;104(11):1785-1795. doi: 10.1016/j.apmr.2023.06.020. Epub 2023 Jul 17.

  PMID: 37467936 DERIVED

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco Artacho-Cordón, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: June 7, 2019
• Study Start: September 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)