Clinical trial NCT02541318: Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
Official title: Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-menopausal Women
Sleep Disturbances
Dao-in Exercise
Body Constitution
Keywords: peri-menopausal women
sleep disturbances
Dao-in exercise
body constitution
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2015-09-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: 2 months after practicing Duo-In
measure: Body Constitution Questionnaire (BCQ)
timeFrame: 2 months after practicing Duo-In
Secondary outcomes:
measure: Peri-menopausal disturbance scale
timeFrame: 2 months after practicing Duo-In
measure: Peri-menopausal fatigue scale
timeFrame: 2 months after practicing Duo-In
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Dr. Chen's Obstetrics and Gynecology Clinic
city: Taichung
country: Taiwan
facility: Taiwan Society of Health Promotion-Taichung Branch
city: Taichung
country: Taiwan
facility: China Medical Universuty
city: Taipei
country: Taiwan
facility: Taiwan Society of Health Promotion-Taipei Branch
Study officials:
affiliation: China Medical University, China
name: Yi-Chang Su, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: