Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
2 other identifiers
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 4, 2015
September 1, 2015
1.1 years
August 4, 2015
September 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Peri-menopausal disturbance scale
2 months after practicing Duo-In
Peri-menopausal fatigue scale
2 months after practicing Duo-In
Study Arms (2)
Practice-from Beginning Group
EXPERIMENTALThe "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.
Practice-2 month Later Group
OTHERThe "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.
Interventions
Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.
Eligibility Criteria
You may qualify if:
- peri-menopausal women who have sleep disturbances.
- peri-menopausal women who can walk freely and without any disable.
You may not qualify if:
- peri-menopausal women who have cancer and other life-threatening diseases.
- peri-menopausal women who have psychological diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dr. Chen's Obstetrics and Gynecology Clinic
Hsinchu, Taiwan, 300, Taiwan
Taiwan Society of Health Promotion-Taichung Branch
Taichung, Taiwan, 403, Taiwan
China Medical Universuty
Taichung, Taiwan, 404, Taiwan
Taiwan Society of Health Promotion-Taipei Branch
Taipei, Taiwan, 106, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Chang Su, Ph.D.
China Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
September 4, 2015
Study Start
August 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
September 4, 2015
Record last verified: 2015-09