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

Endometriosis Clinical Trial

— Physio-EndEA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979183
• Other study ID #: Physio-EndEA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Behavioral:
• Lumbopelvic, stretching, aerobic and relaxation exercises
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)

Locations

Country	Name	City	State
Spain	Francisco Artacho Cordón	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pressure pain threshold (PPT)	Algometry will be used to measure PPT levels in abdomen, pelvis and lower back regions through an electronic algometer. For this purpose, an approximate rate of 30 kilopascal/s will be applied with a 1cm2 probe. Seven points from the abdominal and pelvic area, and two additional points from the lower back region will be tested. Prior PPT assessment, assessor will ask for participants to press the switch when they first feel a change from pressure to pain. The mean of three tests, spaced by 30 s, will be used for the analysis.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Pain intensity	Visual Analogue Scale will be used to identify self-reported levels of chronic pelvic pain, dysmenorrhea, dyspareunia, dyschezia and dysuria.. Scores range from 0 to 10. Higher scores represent increased pain intensity	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Catastrophizing thoughts	The Pain Catastrophizing Scale (PCS) will be also used to assess catastrophic thinking related to pain. Scores of this 13-item scale range from 0 to 52. Higher scores represent higher catastrophic thoughts.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Muscle thickness	Images of the abdominal wall, lumbar multifidus and quadriceps will be obtained using an ultrasound device with a 12 megahertz linear probe and a depth of 5 cm. The thicknesses of the external and internal oblique, the transversus abdominal muscles and the lumbar multifidus, as well as the width of the lumbar multifidus will be assessed. Three measurements of both right and left muscles diameters will be recorded with a 2-minute interval between trials.; Lumbar multifidus assessment will be performed at, the fifth lumbar vertebra, marking its spinal process.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Muscle trunk flexor and extensor endurance	Muscle trunk flexor endurance test will be used to assess the endurance strength of abdominal muscles by isometric endurance of trunk flexors. Time (in seconds) is measured, and higher scores represent better performance.; Muscle trunk extensor endurance test will be used to assess the endurance strength of back extensor muscles by isometric endurance of trunk extensors.Time (in seconds) is measured, and higher scores represent better performance.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Flexibility of the lumbar spine	Original Schöber test will be used to assess lumbar spine flexibility. The assessor will determine the location of the lumbosacral junction and marks it with a horizontal line. A second mark will be drown 10cm above the first line. The difference between the measurements in erect and flexion positions will be recorded. Higher differences represent better flexibility.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Body Balance	Total body balance will be assessed with the Flamingo test. In standing position without shoes, participants will be asked to stay on one leg. Assessor will record the number of trials needed to complete 30 seconds of this static position. The average of both legs will be used. Lower scores represent better performance	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Functional capacity	It will be assessed with theThe 6-min walk test (6MWT) to determine the maximum distance that each patient is able to walk within 6 min (in metres). Patients are instructed to walk as far as they can in 6 min, without stopping and without running, but increasing and decreasing the speed voluntarily. Higher scores represent better performance	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Chronic fatigue	Muscular fatigue will be assessed with the Piper Fatigue Scale-Revised (PFS-R), originally developed to assess cancer-related fatigue, but also used to assess fatigue in other musculoskeletal disorders such as heart failure. It contains 22 items scoring from 0 to 10. Total score is average score of these 22 items (0-10). Lower scores reflect better performance. PFS-R has high reliability (Cronbach's a=0.96).	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Body mass index	Height (in centimeters) and weight (in kilograms) will be assessed and then combined to report body mass index (BMI) in kg/m^2.	Baseline
Secondary	Skeletal muscle mass	Skeletal muscle mass (in kilograms) will be recorded with an impedance meter	Baseline
Secondary	Body fat	Body fat (in percentage) will be recorded with an impedance meter	Baseline
Secondary	Sexual function	It will be assessed with the Female Sexual Function Index questionnaire (FSFI) (19 item) divided in 6 domains:desire, arousal, lubrication, orgasm, satisfaction and pain.; Items are answered on a 6-point Likert-type scale (with the exception of items 1 and 2, answered on a 5-point Likert-type scale). Scores of individual items from each domain are summed and multiplied by the domain factor. The global score is obtained by the sum of all domain scores, ranging from 2 to 36. Higher values correspond to better sexual function	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Gastrointestinal function	It will be assessed with the Gastrointestinal Quality of Life Index (GLQI) (36 items) grouped in 5 domains: digestive symptoms, physical status, emotions, social dysfunction and effects of medical treatment. Each item is scored from 0 (worst appreciation) to 4 (best appreciation). Scores of items are summed to obtain the global score, which ranges from 0 (worst) to 144 (best quality of life).	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Sleep quality	It will be assessed with the Pittsburgh Sleep Quality Index (PSQI) (19 items), grouped in seven "components": subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component ranges from 0 (lowest dysfunction) to 3 (greatest dysfunction), and the PSQI global score is obtained by the sum of component's scores, and thus, ranges from 0 to 21, with higher scores indicating poor sleep quality.	Baseline, inmediately after intervention and 1-year post-intervention
Secondary	Self-perceived physical fitness	Regular physical activity will be estimated through the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ), that has shown a moderate reliability to indirectly estimate physical activity (Spearman rank correlation coefficient > 0.69). During an interview, the assessor will ask each women the number of days per week and the amount of time (in minutes) per day that they spent doing each of the 63 activities listed in the questionnaire. Finally, an activity metabolic index is calculated by multiplying the number of days per week, the amount of time per day and the standard intensity codes assigned to each activity. This score approximates Kcal/day of energy expenditure.	Baseline