| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometriosis | Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises | Not Applicable |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention
Therapeutic exercise
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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
|
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 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.
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
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Francisco Artacho-Cordón, PhD | 0034-958-249-983 | fartacho@ugr.es | |
| Contact: Olga Ocón-Hernández, PhD | 0034-958-242-865 | ooconh@ugr.es |
| 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 |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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. |
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| 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 |
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| 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)
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Francisco Artacho Cordón, Universidad de Granada | ||||
| Study Sponsor ICMJE | Universidad de Granada | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Universidad de Granada | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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