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

Primary Purpose

Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Duo-in exercise
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peri-menopausal Women focused on measuring peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Dr. Chen's Obstetrics and Gynecology ClinicRecruiting
  • Taiwan Society of Health Promotion-Taichung BranchRecruiting
  • China Medical UniversutyRecruiting
  • Taiwan Society of Health Promotion-Taipei BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Practice-from Beginning Group

Practice-2 month Later Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Body Constitution Questionnaire (BCQ)

Secondary Outcome Measures

Peri-menopausal disturbance scale
Peri-menopausal fatigue scale

Full Information

First Posted
August 4, 2015
Last Updated
September 2, 2015
Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02541318
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise, Body Constitution
Keywords
peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Practice-from Beginning Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Practice-2 month Later Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Duo-in exercise
Intervention Description
Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.
Primary Outcome Measure Information:
Title
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Time Frame
2 months after practicing Duo-In
Title
Body Constitution Questionnaire (BCQ)
Time Frame
2 months after practicing Duo-In
Secondary Outcome Measure Information:
Title
Peri-menopausal disturbance scale
Time Frame
2 months after practicing Duo-In
Title
Peri-menopausal fatigue scale
Time Frame
2 months after practicing Duo-In

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny Jui-Shan Lin, Ph.D.
Phone
+886-4-22053366
Ext
3105
Email
taco423@ms26.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Chang Su, Ph.D.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Chen's Obstetrics and Gynecology Clinic
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Ming Chan, Master
Phone
+886-3-5337789
Email
drcmc.obs@gmail.com
Facility Name
Taiwan Society of Health Promotion-Taichung Branch
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Chen, Master
Phone
886-4-2310-6675
Email
miiitiiigg@gmail.com
Facility Name
China Medical Universuty
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Jui-Shan Lin, Ph.D.
Phone
+886-4-22053366
Ext
3105
Email
taco423@ms26.hinet.net
Facility Name
Taiwan Society of Health Promotion-Taipei Branch
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Kuei Lin, Master
Phone
+886-2-2711-0936
Email
chikueilin@gmail.com

12. IPD Sharing Statement

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

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