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

Sponsor

China Medical University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02541318

Collaborator

National Science Council, Taiwan (Other)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peri-menopausal Women Sleep Disturbances Dao-in Exercise Body Constitution	Behavioral: Duo-in exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Other: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Other: Practice-2 month Later Group

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.

Outcome Measures

Primary Outcome Measures

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

Peri-menopausal disturbance scale [2 months after practicing Duo-In]
Peri-menopausal fatigue scale [2 months after practicing Duo-In]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dr. Chen's Obstetrics and Gynecology Clinic	Hsinchu	Taiwan	300
2	Taiwan Society of Health Promotion-Taichung Branch	Taichung	Taiwan	403
3	China Medical Universuty	Taichung	Taiwan	404
4	Taiwan Society of Health Promotion-Taipei Branch	Taipei	Taiwan	106