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

NCT06776627 | Completed

• 2 other identifiers: 24_RIPH2-032024-A01875-42
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Adapted physical activity; Quality of life

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness at 12 weeks of an adapted physical activity program on the health-related quality of life of patients with endometriosis.

  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 Outcomes (10)

• To evaluate the effectiveness at 9 weeks of an adapted physical activity program in patients with endometriosis on health-related quality of life.

  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

  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

  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

  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

  12 weeks

Study Arms (2)

Routine care

NO INTERVENTION

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)

Routine care + adapted physical activity (APA)

EXPERIMENTAL

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.

Other: Adapted physical activity (APA)

Interventions

Adapted physical activity (APA) 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.

Routine care + adapted physical activity (APA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• ECM Rénovbat: collaborator
• ARGOS (Association pour la Recherche en Gynécologie Obstétrique et Stérilité): collaborator
• SAPHYR Martinique (Association Santé par l'activité physique régulière): collaborator
• Agence Régionale de Santé de la Martinique: collaborator

Study Sites (1)

University Hospital Center of Martinique

Fort-de-France, Martinique, 97261, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 15, 2025
• Study Start: December 11, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)