Peri-menopausal WomenNCT02541318
Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
A study testing Duo-in exercise in people with Peri-menopausal Women and Sleep Disturbances, run by China Medical University Hospital at 4 sites in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Peri-menopausal Women, Sleep Disturbances, Dao-in Exercise
- What is being tested?
- Duo-in exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesTaiwan
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- peri-menopausal women who have sleep disturbances.
- peri-menopausal women who can walk freely and without any disable.
Who cannot join
- peri-menopausal women who have cancer and other life-threatening diseases.
- peri-menopausal women who have psychological diseases.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites, 4 recruiting
- Recruiting
Dr. Chen's Obstetrics and Gynecology Clinic
Hsinchu, Taiwan, 300
Chien-Ming Chan, Master, +886-3-5337789, drcmc.obs@gmail.com
- Recruiting
Taiwan Society of Health Promotion-Taichung Branch
Taichung, Taiwan, 403
Michelle Chen, Master, 886-4-2310-6675, miiitiiigg@gmail.com
- Recruiting
China Medical Universuty
Taichung, Taiwan, 404
Sunny Jui-Shan Lin, Ph.D., +886-4-22053366 ext. 3105, taco423@ms26.hinet.net
- Recruiting
Taiwan Society of Health Promotion-Taipei Branch
Taipei, Taiwan, 106
Chi-Kuei Lin, Master, +886-2-2711-0936, chikueilin@gmail.com
About this study
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.
- Being tested
- Duo-in exercise
- Keywords
- peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duo-in exerciseBehavioural
Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.
| Study group | Role | What they receive |
|---|---|---|
| Practice-from Beginning Group | Experimental | 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. Receives: Behavioral: Duo-in exercise |
| Practice-2 month Later Group | Other | 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. Receives: Behavioral: Duo-in exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Measured: 2 months after practicing Duo-In
Body Constitution Questionnaire (BCQ)
Measured: 2 months after practicing Duo-In
Secondary outcomes (2)
Peri-menopausal disturbance scale
Measured: 2 months after practicing Duo-In
Peri-menopausal fatigue scale
Measured: 2 months after practicing Duo-In
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-menopausal WomenStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yi-Chang Su, Ph.D., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541318
- Sponsor's protocol ID
- MOST 103-2410-H-039-011
- Other IDs
- Dao-In for Women with Insomnia
- Status last verified
- Sep 2015
- First submitted
- 4 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance
- ClinicalTrials.gov ID
- NCT02541318
- Acronym / sponsor ID
- MOST 103-2410-H-039-011
- Keywords
- peri-menopausal women, sleep disturbances, Dao-in exercise, body constitution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice-from Beginning Group | Experimental | Behavioral: Duo-in exerciseThe "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 | Other | Behavioral: Duo-in exerciseThe "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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- peri-menopausal women who have sleep disturbances.
- peri-menopausal women who can walk freely and without any disable.
Key exclusion criteria (2 listed)
- peri-menopausal women who have cancer and other life-threatening diseases.
- peri-menopausal women who have psychological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duo-in exerciseDuo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases. | Behavioural | Practice-2 month Later Group, Practice-from Beginning Group |
Primary outcome
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Time frame: 2 months after practicing Duo-In
Body Constitution Questionnaire (BCQ)
Time frame: 2 months after practicing Duo-In
2 secondary outcomes
Peri-menopausal disturbance scale
Time frame: 2 months after practicing Duo-In
Peri-menopausal fatigue scale
Time frame: 2 months after practicing Duo-In
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chang Su, Ph.D. principal investigator
China Medical University, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duo-in exercise in people with Peri-menopausal Women and Sleep Disturbances, run by China Medical University Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunny Jui-Shan Lin, Ph.D. (+886-4-22053366 ext. 3105, taco423@ms26.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) (time frame: 2 months after practicing Duo-In). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.