Influence of Bodily Practices on the Quality of Life of Women With Endometriosis (PCKendo)

October 24, 2024 updated by: Fondation Hôpital Saint-Joseph

Influence of Bodily Practices on the Quality of Life of Women

This research focuses on understanding how physical activity can improve the quality of life for women with endometriosis by enhancing their self-perception, particularly regarding their physical abilities and appearance. The study is based on the idea that improving internal perceptions can lead to better overall well-being for these women. Previous studies, suggest that physical self-perception plays a crucial role in shaping an individual's quality of life. There is also evidence supporting a reciprocal relationship between physical self-concept and participation in physical activity

In this context, the research aims to explore how physical activity could positively influence the self-concept of women suffering from endometriosis, which in turn could enhance their quality of life. By focusing on improving both physical abilities and body image through regular exercise, this study seeks to offer insights into potential therapeutic approaches for managing the physical and psychological impacts of endometriosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Menstruating women aged 18 to 55;
  • proven diagnosis of endometriosis (pelvic ultrasound or MRI)
  • Having endometriosis-related pain of a level higher than 3 on the VAS scale and/or chronic incapacitating symptoms related to endometriosis;
  • Patient without treatment or with stable endometriosis treatment (pill and/or ATG) who has not undergone treatment during the last 6 months;
  • Patient affiliated to a health insurance scheme;
  • French-speaking patient;
  • Patient having given free, informed and express oral consent.

Exclusion Criteria:

  • Any patient whose endometriosis treatment has been modified for less than 6 months;
  • Having endometriosis-related pain greater than or equal to 8 on the VAS scale;
  • Cardiovascular risks related to physical training;
  • Inability to perform proposed exercises;
  • Patient under guardianship;
  • Patient deprived of liberty;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: physical activity
Other: physical activity
40 min circuit training session
Active Comparator: analgesic physical therapy
Other: analgesic physical therapy
physical therapy with massage and Transcutaneous Electrical Nerve Stimulation in a 40min session
Experimental: analgesic physical therapy AND physical activity
Other: analgesic physical therapy AND physical activity
25 min circuit training session and 15 min physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life
Time Frame: 6months
EHP-30 questionnaire
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Frederique PERROTTE, Fondation Hôpital Saint-Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

March 20, 2025

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 665-PCKendo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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