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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02541318
Other study ID # MOST 103-2410-H-039-011
Secondary ID Dao-In for Women
Status Recruiting
Phase N/A
First received August 4, 2015
Last updated September 2, 2015
Start date August 2014
Est. completion date October 2015

Study information

Verified date September 2015
Source China Medical University Hospital
Contact Sunny Jui-Shan Lin, Ph.D.
Phone +886-4-22053366
Email taco423@ms26.hinet.net
Is FDA regulated No
Health authority Taiwan: National Science Council
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
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.

Locations

Country Name City State
Taiwan Dr. Chen's Obstetrics and Gynecology Clinic Hsinchu
Taiwan China Medical Universuty Taichung
Taiwan Taiwan Society of Health Promotion-Taichung Branch Taichung
Taiwan Taiwan Society of Health Promotion-Taipei Branch Taipei

Sponsors (2)

Lead Sponsor Collaborator
China Medical University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) 2 months after practicing Duo-In No
Primary Body Constitution Questionnaire (BCQ) 2 months after practicing Duo-In No
Secondary Peri-menopausal disturbance scale 2 months after practicing Duo-In No
Secondary Peri-menopausal fatigue scale 2 months after practicing Duo-In No
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