- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660043
Influence of Bodily Practices on the Quality of Life of Women With Endometriosis (PCKendo)
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chevry-Cossigny, France
- Physical Therapy Studio
-
Paris, France, 75014
- Hopital Saint Joseph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
|
40 min circuit training session
|
|
Active Comparator: analgesic physical therapy
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physical therapy with massage and Transcutaneous Electrical Nerve Stimulation in a 40min session
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Experimental: analgesic physical therapy AND physical activity
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25 min circuit training session and 15 min physical therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of quality of life
Time Frame: 6months
|
Endometriosis Health Profile-30 (EHP-30) questionnaire
|
6months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Self Esteem evaluation
Time Frame: at enrollement, 3 and 6 months after enrollement
|
Rosenberg questionnaire
|
at enrollement, 3 and 6 months after enrollement
|
|
evaluation of physical self esteem
Time Frame: at enrollement, at 3 and 6 months after enrollement
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Physical Self Description questionnaire - short form (PSDQ-S)
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at enrollement, at 3 and 6 months after enrollement
|
|
Pain Evaluation
Time Frame: at enrollement, 3 and 6 months after enrollement
|
Numerical pain rating scale
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at enrollement, 3 and 6 months after enrollement
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frederique PERROTTE, Fondation Hôpital Saint-Joseph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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