Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
研究概览
简要总结
The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.
详细描述
Endometriosis is an estrogen-dependent inflammatory disease, affecting almost 5% of the female population during the reproductive period. The most common symptom of women with endometriosis is dysmenorrhea. Nowadays, the main therapy is pharmacological treatment (estrogen-progestins and progestins); diet and physical exercises may represent a complementary and feasible approach to reduce the pain symptoms related to this disease.
Indeed, diet may be involved in several pathophysiological mechanisms linked to endometriosis, due to its ability to influence positively or negatively prostaglandins' metabolism, chronic inflammatory processes and circulating estrogen levels.
Among the various dietary regimes, the Mediterranean diet shows many anti-inflammatory and anti-oxidant properties.
Also regular physical activity can affect positively endometriosis, due to various etiopathogenetic mechanisms including the decrease of estrogenic levels and ovulatory frequency, the increase in SHBG levels, and the modulation of cytokines in an anti-inflammatory way.
One of the reasons of low regular physical activity is the lack of free time. For this reason, the American College of Sports Medicine developed a program designed for most of the population, called "7-minutes workout". It consists in 12 high-intensity physical exercises, lasting 30 seconds each and spaced out 10 seconds of short breaks, to be performed 2-3 times a week.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 45 years
- •body mass index between 18 and 29.9
- •women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
- •not seeking conception
排除标准
- •associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
- •patients in note for all kind of surgery
- •women who conduct a strong physical activity.
- •women who follow vegetarian-vegan diet regimens.
- •metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
- •medical contraindications to proposed physical activity.
研究组 & 干预措施
Intervention group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model
干预措施: intervention group (Behavioral)
Control group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins.
结局指标
主要结局
Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
时间窗: 12 months
The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).
次要结局
- Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity.(12 months)
- Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity(12 months)
- Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity(12 months)
- The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity(12 months)
- Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity.(12 months)