Clinical trial NCT03979183: Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)
Official title: '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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Pain
Therapeutic exercise
Physiotherapy
Rehabilitation
Quality of life
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life assessed by EHP-30
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
Secondary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Pain intensity
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Catastrophizing thoughts
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Muscle thickness
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Muscle trunk flexor and extensor endurance
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Flexibility of the lumbar spine
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Body Balance
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Functional capacity
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Chronic fatigue
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Body mass index
timeFrame: Baseline
measure: Skeletal muscle mass
timeFrame: Baseline
measure: Body fat
timeFrame: Baseline
measure: Sexual function
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Gastrointestinal function
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Sleep quality
timeFrame: Baseline, inmediately after intervention and 1-year post-intervention
measure: Self-perceived physical fitness
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Francisco Artacho Cordón
Study officials:
affiliation: Universidad de Granada
name: Francisco Artacho-Cordón, PhD
role: PRINCIPAL_INVESTIGATOR
References: