Effectiveness of an Adapted Physical Activity Program on Improving the Health-related Quality of Life of Women With Endometriosis in Martinique (APAENDO)

January 28, 2026 updated by: University Hospital Center of Martinique

There is no specific treatment for endometriosis, because the pathophysiology is poorly understood.

Adapted physical activity (APA) is recognized as a beneficial supportive care for patients suffering from chronic pathology. Adapted physical activity can play a role in managing endometriosis symptoms. Studies have shown that regular physical exercise can help reduce pain, improve quality of life and alleviate symptoms related to chronic diseases.

However, it is known that few women with endometriosis have regular physical activity because of pain, chronic fatigue that lead to activity limitation or even disability.

This study provides an opportunity to evaluate the impact of regular APA practice on improving the quality of life and symptoms of women with endometriosis in Martinique.

Based on this, APA could be included in the endometriosis care pathway in Martinique.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators' hypothesis is that APA improves the overall quality of life of women with endometriosis and also has a positive impact on pain, functional abilities and sleep. The effectiveness of the proposed adapted physical activity program also improves the psycho-social and professional impact of the disease in the daily lives of patients.

Study Type

Interventional

Enrollment (Actual)

51

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 Locations

    • Martinique
      • Fort-de-France, Martinique, France, 97261
        • University Hospital Center of Martinique

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult woman of childbearing age,
  • Clinico-radiological or clinico-histological diagnosis of endometriosis: laparoscopy with biopsy or MRI,
  • History of endometriosis symptoms before diagnosis,
  • Walking without technical assistance,
  • Able to read and write,
  • Patient wishing to improve her health by optimizing her lifestyle,
  • Patient affiliated or beneficiary of a social security scheme,
  • Patient having given free, informed and written consent.

Exclusion Criteria:

  • Acute or terminal illness,
  • Recent fracture of the upper or lower limbs (< 3 months),
  • Other chronic unstable or orthopedic illness that could interfere with the ability to participate in a physical activity program,
  • Resting ECG at inclusion outside the normal range,
  • Patients who practice moderate to intense physical activity for more than 150 minutes per week,
  • Absolute contraindication to physical activity linked to severe co-morbidities,
  • Patient placed under legal protection, guardianship or curatorship,
  • Pregnant or breastfeeding woman.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care

31 patients: Routine consultation including:

  • clinical examination
  • pain scale
  • ECG
  • vital signs
  • fat and muscle mass
  • medical history
  • biological assessment
  • quality of life questionnaire (EHP-30)
  • sedentary lifestyle and physical activity test
  • sleep scale (PSQI)
Experimental: Routine care + adapted physical activity (APA)
Patients randomized to the APA group will be prescribed, at the end of the routine consultation, 12 weeks of adapted physical activity sessions, to be carried out outdoors, and coordinated by a qualified professional from the STAPS sector (Master's degree in Science and Technology of Physical and Sporting Activities). The latter will provide patients with an adapted program determined following a personalized physical condition assessment: aerobic capacity, strength, endurance, flexibility, balance and proprioception tests.
Adapted program: aerobic capacity, strength, endurance, flexibility, balance and proprioception tests. APA sessions take place over 12 weeks. There will be 2 to 3 sessions per week. Course of a session: - Warm-up: 10-15min: cycling or walking. - Moderate-intensity endurance activity: cycling, walking or swimming: 10min, the duration will be increased gradually up to a minimum of 30min at the end of the program. - Muscle strengthening: with polyarticular or monoarticular exercises targeting the upper limbs or lower limbs in alternation and sheathing. At the beginning: 8 exercises per session and 8 repetitions, 1 time per week. Objective will be to increase the number of repetitions and then integrate other exercises to reach 10 exercises with 12 repetitions, 2 times per week. - Stretching and balance: learning to stretch the muscle groups worked and then working on proprioception (bipodal, monopodal station, then double task). - Quiet time: relaxation through breathing 5 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness at 12 weeks of an adapted physical activity program on the health-related quality of life of patients with endometriosis.
Time Frame: 12 weeks

The level of health-related quality of life will be measured using the EHP-30 (Endometriosis Health Profile) questionnaire.

The minimum value is 0, and the maximum value is 100. Higher score mean a worse outcome.

12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness at 9 weeks of an adapted physical activity program in patients with endometriosis on health-related quality of life.
Time Frame: 12 weeks
The level of health-related quality of life will be measured using the EHP-30 (Endometriosis Health Profile) questionnaire. The minimum value is 0, and the maximum value is 100. Higher score mean a worse outcome.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of pain
Time Frame: 12 weeks
Pain will be assessed by the Visual Analogue Scale. The minimum value is 0 cm, and the maximum value is 10 cm. Higher score mean a worse outcome.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of functional capacities of physical condition, and activity level
Time Frame: 12 weeks
Assessed by the Ricci and Gagnon questionnaire. The minimum value is 9, and the maximum value is 45. Higher score mean a better outcome.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improving sleep quality
Time Frame: 12 weeks
Sleep quality with the questionnaire: PSQI (Pittsburgh Sleep Quality Index). The minimum value is 0, and the maximum value is 21. Higher score mean a worse outcome.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improving the professional, psychosocial impact of the disease in the daily lives of patients
Time Frame: 12 weeks
The psycho-socio-family and professional impact by using the part 2 of the EHP-30 (Endometriosis Health Profile) (section A and B).
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
Functional capacities of physical condition: measurement of blood pressure.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
Functional capacities of physical condition: measurement of heart rate.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
Functional capacities of physical condition: grip muscle strength (hand grip).
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
Functional capacities of physical condition: measurement of flexibility: with finger/ground distance.
12 weeks
To evaluate the effectiveness at 9 and 12 weeks of an adapted physical activity program in patients with endometriosis on improvement of grip muscle strength, flexibility, walking perimeter, and physical profile
Time Frame: 12 weeks
Functional capacities of physical condition: measurement of walking capacity with the 6-minute walk test.
12 weeks

Collaborators and Investigators

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

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)

December 11, 2024

Primary Completion (Actual)

July 25, 2025

Study Completion (Actual)

July 25, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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