NCT02419482已完成不适用
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Menstrual frequency
研究概览
简要总结
The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
排除标准
- •Regular high intensity endurance (two or more times per week of vigorous exercise).
- •Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
- •On-going pregnancy.
- •Breast feeding within 24 weeks
- •Cardiovascular disease or endocrine disorders
结局指标
主要结局
Menstrual frequency
时间窗: 1 year
Electronic menstrual diary
次要结局
- Body composition(16 weeks, and 36 weeks)
- Aerobic capacity(16 weeks, and 36 weeks)
- Endothelial function(16 weeks, and 36 weeks)
- Insulin sensitivity(16 weeks, and 36 weeks)
- Intima-media thickness(16 weeks, and 36 weeks)
- Oxidative capacity(16 weeks, and 36 weeks)
- Low-grade systematic inflammation(16 weeks, and 36 weeks)
- Adipose tissue morphology and function(16 weeks, (and 36 weeks if funded))
- Hormone profile, blood lipids and blood values(16 weeks, and 36 weeks)
- Pregnancy rate(16 weeks , and 36 weeks)
- Blood pressure(16 weeks, and 36 weeks)
- Quality of life(36 weeks)
- Physical activity(16 weeks, and 36 weeks)
- Adipose tissue mRNA expression(16 weeks, (and 36 weeks if funded))
- Enjoyment(weekly up to 16 weeks)
- ovarian morphology(16 weeks, and 36 weeks)
- Diet(36 weeks)
研究者
研究点 (3)
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