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出境医 / 临床实验 / Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study) (Physio-EndEA)

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

Study Description
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

Condition or disease Intervention/treatment Phase
Endometriosis Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises Not Applicable

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 40 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=20) or usual care group (n=20). 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
Therapeutic exercise
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)

No Intervention: Control
Usual care
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pressure pain threshold (PPT) [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.

  2. Pain intensity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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

  3. Catastrophizing thoughts [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.

  4. Muscle thickness [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]

    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.


  5. Muscle trunk flexor and extensor endurance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]

    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.


  6. Flexibility of the lumbar spine [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.

  7. Body Balance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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

  8. Functional capacity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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

  9. Chronic fatigue [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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 α=0.96).

  10. Body mass index [ Time Frame: Baseline ]
    Height (in centimeters) and weight (in kilograms) will be assessed and then combined to report body mass index (BMI) in kg/m^2.

  11. Skeletal muscle mass [ Time Frame: Baseline ]
    Skeletal muscle mass (in kilograms) will be recorded with an impedance meter

  12. Body fat [ Time Frame: Baseline ]
    Body fat (in percentage) will be recorded with an impedance meter

  13. Sexual function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]

    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


  14. Gastrointestinal function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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).

  15. Sleep quality [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.

  16. Self-perceived physical fitness [ Time Frame: Baseline ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Francisco Artacho-Cordón, PhD 0034-958-249-983 fartacho@ugr.es
Contact: Olga Ocón-Hernández, PhD 0034-958-242-865 ooconh@ugr.es

Sponsors and Collaborators
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: Francisco Artacho-Cordón, PhD Universidad de Granada
Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 11, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Pressure pain threshold (PPT) [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Pain intensity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Catastrophizing thoughts [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Muscle thickness [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Muscle trunk flexor and extensor endurance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Flexibility of the lumbar spine [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Body Balance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Functional capacity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Chronic fatigue [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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 α=0.96).
  • Body mass index [ Time Frame: Baseline ]
    Height (in centimeters) and weight (in kilograms) will be assessed and then combined to report body mass index (BMI) in kg/m^2.
  • Skeletal muscle mass [ Time Frame: Baseline ]
    Skeletal muscle mass (in kilograms) will be recorded with an impedance meter
  • Body fat [ Time Frame: Baseline ]
    Body fat (in percentage) will be recorded with an impedance meter
  • Sexual function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Gastrointestinal function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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).
  • Sleep quality [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Self-perceived physical fitness [ Time Frame: Baseline ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Pressure pain threshold (PPT) [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Pain intensity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Catastrophizing thoughts [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Muscle thickness [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Muscle trunk flexor and extensor endurance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Flexibility of the lumbar spine [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Body Balance [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Functional capacity [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Chronic fatigue [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    It will be assessed with the Piper Fatigue Scale-Revised (PFS-R). It contains 22 items scoring from 0 to 10. The average of all items is calculated, and lower scores reflect better performance.
  • Body mass index [ Time Frame: Baseline ]
    Height (in centimeters) and weight (in kilograms) will be assessed and then combined to report body mass index (BMI) in kg/m^2.
  • Body composition [ Time Frame: Baseline ]
    Skeletal muscle mass, and percentage of body fat will be recorded with an impedance meter
  • Sexual function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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
  • Gastrointestinal function [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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).
  • Sleep quality [ Time Frame: Baseline, inmediately after intervention and 1-year post-intervention ]
    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.
  • Self-perceived physical fitness [ Time Frame: Baseline ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)
Official Title  ICMJE '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
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 40 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=20) or usual care group (n=20). 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Endometriosis
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Experimental: Intervention
    Therapeutic exercise
    Intervention: Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises
  • No Intervention: Control
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979183
Other Study ID Numbers  ICMJE Physio-EndEA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francisco Artacho Cordón, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco Artacho-Cordón, PhD Universidad de Granada
PRS Account Universidad de Granada
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP