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

Sleep Disturbances Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Body Constitution
• Dao-in Exercise
• Dyssomnias
• Parasomnias
• Peri-menopausal Women
• Sleep Disorders
• Sleep Disturbances

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