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

NCT ID: NCT06776627

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-11
• Study Completion Date: 2025-07-25

Brief Summary

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.

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Adapted physical activity (APA)

Intervention Type: OTHER

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.

Interventions

Adapted physical activity (APA)

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARGOS (Association pour la Recherche en Gynécologie Obstétrique et Stérilité)

UNKNOWN

Sponsor Role: collaborator

SAPHYR Martinique (Association Santé par l'activité physique régulière)

UNKNOWN

Sponsor Role: collaborator

ECM Rénovbat

UNKNOWN

Sponsor Role: collaborator

Agence Régionale de Santé de la Martinique

UNKNOWN

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Center of Martinique

Fort-de-France, Martinique, France

Countries

France

Other Identifiers

2024-A01875-42

Identifier Type: OTHER

Identifier Source: secondary_id

24_RIPH2-03

Identifier Type: -

Identifier Source: org_study_id