'Physio-EndEA' Study: a Randomized Controlled Trial to Evaluate the Effect of a Supervised and Adapted Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in quality of life assessed by EHP-30
Study Overview
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
Detailed Description
Background: Prevalence of endometriosis is approximately 10% of women of childbearing age. Pain, considered in its multiple versions (dysmenorrhea, dyspareunia, dyschezia, dysuria and, in general, chronic pelvic pain) is the most common and disabilitating symptom in affected women. Usual care, consisting on palliative pharmacological treatment in combination with surgery, is clearly insufficient and physical therapies need to be explored in order to reduce pain and to improve quality of life in affected women.
Objective
The overall objective of 'Physio-EndEA' study will be to explore potential short and mid-term benefits of a rehabilitation program on the quality of life of symptomatic women.
Methods: A total of 26 symptomatic endometriosis women will be recruited. Inclusion criteria includes: aged 18-50, clinical diagnosis of endometriosis and interested in improving lifestyle while exclusion criteria includes: diagnosed chronic disease or orthopaedic issues that would interfere with ability to participate in a physical activity program. Women will be randomized to either intervention (n=13) or usual care group (n=13). Intervention group will receive twice weekly session for 9 weeks and control group will receive recommendations about healthy lifestyle and usual care.
Discussion: This study attempts to improve the quality of life of symptomatic endometriosis women by reducing musculoskeletal and occupational impairments. Findings will offer a new therapeutic approach for a better pain control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Intervention
Therapeutic exercise
Intervention: Lumbopelvic, stretching, aerobic and relaxation exercises (Behavioral)
Control
Usual care
Outcomes
Primary Outcomes
Change in quality of life assessed by EHP-30
Time Frame: Baseline, inmediately after intervention and 1-year post-intervention
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
Secondary Outcomes
- Pain intensity(Baseline, inmediately after intervention and 1-year post-intervention)
- Muscle thickness(Baseline, inmediately after intervention and 1-year post-intervention)
- Body mass index(Baseline)
- Self-perceived physical fitness(Baseline)
- Pressure pain threshold (PPT)(Baseline, inmediately after intervention and 1-year post-intervention)
- Catastrophizing thoughts(Baseline, inmediately after intervention and 1-year post-intervention)
- Muscle trunk flexor and extensor endurance(Baseline, inmediately after intervention and 1-year post-intervention)
- Functional capacity(Baseline, inmediately after intervention and 1-year post-intervention)
- Body Balance(Baseline, inmediately after intervention and 1-year post-intervention)
- Flexibility of the lumbar spine(Baseline, inmediately after intervention and 1-year post-intervention)
- Skeletal muscle mass(Baseline)
- Gastrointestinal function(Baseline, inmediately after intervention and 1-year post-intervention)
- Sleep quality(Baseline, inmediately after intervention and 1-year post-intervention)
- Body fat(Baseline)
- Chronic fatigue(Baseline, inmediately after intervention and 1-year post-intervention)
- Sexual function(Baseline, inmediately after intervention and 1-year post-intervention)
Investigators
Francisco Artacho Cordón
Principal Investigator
Universidad de Granada