NCT06660043

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of quality of life

    EHP-30 questionnaire

    6months

Study Arms (3)

physical activity

EXPERIMENTAL
Other: physical activity

analgesic physical therapy

ACTIVE COMPARATOR
Other: analgesic physical therapy

analgesic physical therapy AND physical activity

EXPERIMENTAL
Other: analgesic physical therapy AND physical activity

Interventions

40 min circuit training session

physical activity

physical therapy with massage and Transcutaneous Electrical Nerve Stimulation in a 40min session

analgesic physical therapy

25 min circuit training session and 15 min physical therapy

analgesic physical therapy AND physical activity

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physical Therapy Studio

Chevry-Cossigny, France

RECRUITING

Hôpital Saint Joseph

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Frederique PERROTTE

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederique PERROTTE

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

March 21, 2024

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations