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Completed

NCT Number: NCT06776627

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Center of Martinique

Fort-de-France, Martinique, 97261, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Collaborators

  • ARGOS (Association pour la Recherche en Gynécologie Obstétrique et Stérilité)
  • Agence Régionale de Santé de la Martinique
  • ECM Rénovbat
  • SAPHYR Martinique (Association Santé par l'activité physique régulière)

Registry information

Acronym: APAENDO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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