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临床试验/NCT02541318
NCT02541318Unknown不适用

Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance

China Medical University Hospital8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
8
主要终点
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

研究概览

简要总结

Among health problems of peri-menopausal women, sleep disturbances is very common complaint. The aim of this study is to realize the body constitution of the peri-menopausal women with sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see if this intervention can decrease the dosage of hormone replacement therapy.

Quasi-experimental design and convenient sampling are both adopted. Participants will be recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of participants who are willing to try Duo-in exercise to improve their sleep quality will be randomly assigned into experiment group and control group. The experiment group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the control group. Then, after 2 weeks, the participants of experiment and control group will crossover. The experiment group has no intervention, but the control group will practice Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI), Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal fatigue scale will be used in the assessment at each time point. According to previous experience, a total of 70 participants will completed the whole observation course. Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of different time and groups.

This study will provide the evidence for Duo-in exercise as complementary treatment for hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in exercise into mainstream treatment for other patients with sleep disturbance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • peri-menopausal women who have sleep disturbances.
  • peri-menopausal women who can walk freely and without any disable.

排除标准

  • peri-menopausal women who have cancer and other life-threatening diseases.
  • peri-menopausal women who have psychological diseases.

结局指标

主要结局

Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

时间窗: 2 months after practicing Duo-In

Body Constitution Questionnaire (BCQ)

时间窗: 2 months after practicing Duo-In

次要结局

  • Peri-menopausal disturbance scale(2 months after practicing Duo-In)
  • Peri-menopausal fatigue scale(2 months after practicing Duo-In)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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