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临床试验/NCT02419482
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.

Norwegian University of Science and Technology2 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
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

研究组 & 干预措施

4x4 minutes interval training

Experimental

4x4 minutes high intensity interval training with 4 minute intervals

干预措施: 4x4 minutes high intensity interval training (Behavioral)

10x1 minute interval training

Experimental

10x1 minute high intensity interval training with 1 minute intervals

干预措施: 10x1 minute high intensity interval training (Behavioral)

control

No Intervention

Physical activity recommended

结局指标

主要结局

Menstrual frequency

时间窗: 1 year

Electronic menstrual diary

次要结局

  • Aerobic capacity(16 weeks, and 36 weeks)
  • Physical activity(16 weeks, and 36 weeks)
  • Hormone profile, blood lipids and blood values(16 weeks, and 36 weeks)
  • Body composition(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))
  • Pregnancy rate(16 weeks , and 36 weeks)
  • Blood pressure(16 weeks, and 36 weeks)
  • Quality of life(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)
  • Quality of life(16 weeks)
  • Diet(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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