Effectiveness of an Adapted Physical Activity Program on Improving the Health-related Quality of Life of Women With Endometriosis in Martinique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness at 12 weeks of an adapted physical activity program on the health-related quality of life of patients with endometriosis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
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.
干预措施: Adapted physical activity (APA) (Other)
结局指标
主要结局
To evaluate the effectiveness at 12 weeks of an adapted physical activity program on the health-related quality of life of patients with endometriosis.
时间窗: 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.
次要结局
- 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 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 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 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)
- 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(12 weeks)