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

NCT ID: NCT02541318

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Practice-from Beginning Group

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.

Group Type EXPERIMENTAL

Duo-in exercise

Intervention Type BEHAVIORAL

Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.

Practice-2 month Later Group

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.

Group Type OTHER

Duo-in exercise

Intervention Type BEHAVIORAL

Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.

Interventions

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Duo-in exercise

Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Chang Su, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

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Dr. Chen's Obstetrics and Gynecology Clinic

Hsinchu, Taiwan, Taiwan

Site Status RECRUITING

Taiwan Society of Health Promotion-Taichung Branch

Taichung, Taiwan, Taiwan

Site Status RECRUITING

China Medical Universuty

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Taiwan Society of Health Promotion-Taipei Branch

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sunny Jui-Shan Lin, Ph.D.

Role: CONTACT

+886-4-22053366 ext. 3105

Facility Contacts

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Chien-Ming Chan, Master

Role: primary

+886-3-5337789

Michelle Chen, Master

Role: primary

886-4-2310-6675

Sunny Jui-Shan Lin, Ph.D.

Role: primary

+886-4-22053366 ext. 3105

Chi-Kuei Lin, Master

Role: primary

+886-2-2711-0936

Other Identifiers

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Dao-In for Women with Insomnia

Identifier Type: OTHER

Identifier Source: secondary_id

MOST 103-2410-H-039-011

Identifier Type: -

Identifier Source: org_study_id

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