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

U

University of Granada (UGR)

Status

Completed

Conditions

Endometriosis

Treatments

Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT03979183
Physio-EndEA

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

Intervention
Experimental group
Description:
Therapeutic exercise
Treatment:
Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises
Control
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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