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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise, Body Constitution

Intervention / Treatment
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* Behavioral: Duo-in exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peri-menopausal women who have sleep disturbances. peri-menopausal women who can walk freely and without any disable. Exclusion Criteria: peri-menopausal women who have cancer and other life-threatening diseases. peri-menopausal women who have psychological diseases.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice-from Beginning Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|
| Other: Practice-2 month Later Group<br>The Practice-from Beginning Group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the Practice-2 month Later Group. Then, after 2 weeks, the participants of Practice-from Beginning Group and Practice-2 month Later Group will crossover. The Practice-from Beginning Group has no intervention, but the Practice-2 month Later Group will practice Duo-in exercise for 2 months. | Behavioral: Duo-in exercise<br>* Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) |  | 2 months after practicing Duo-In | 
| Body Constitution Questionnaire (BCQ) |  | 2 months after practicing Duo-In | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-menopausal disturbance scale |  | 2 months after practicing Duo-In | 
| Peri-menopausal fatigue scale |  | 2 months after practicing Duo-In | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution