Exercise PromotionYogaNCT03251755
Exercise Using Chinese Yoga Improving Insomnia
A study testing Yoga in people with Exercise Promotion, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
According to the data from WHO, currently there are 350 million people with diabetes mellitus in the world, and the amount of which is still increasing. Among all types of diabetes mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in Taiwan is 98%. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Promotion
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 May 2017to 30 Nov 2018
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 2 DM with diagnosis of insomnia;
- Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5;
- willing to participate in and complete the consent form.
Who cannot join
- CKD
- COPD
- Mental illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407
About this study
Official title: The Effectiveness of Dao-in (Chinese Yoga) on Insomnia in Type 2 Diabetes Mellitus
According to the data from WHO, currently there are 350 million people with diabetes mellitus in the world, and the amount of which is still increasing. Among all types of diabetes mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in Taiwan is 98%. One third of the group suffers from sleep disorder. The prevalence rate is 33.7-52%, similar with the abroad prevalence rate (38.4%), but it's much higher than the prevalence rate of the general public(20.8%). As a result, people with diabetes mellitus are at high risk of sleep disorder. Not having enough sleep or sleep badly tend to cause abnormal metabolism, which influence the control of glycemia and worsen the disease. Currently investigations emphasize prevalence rate, risk factors and diabetes mellitus, increasing glycemia, complications which result from lack of sleep. Primary improving methods include the improvement of sleeping environment, recommendation of healthy diet, exercise and getting oriental medicine treatment. At the present time, WHO is actively promoting the combination of oriental treatment. Consequently, expecting the intervention of Dao-in(Chinese Yoga) could help to improve sleep quality, HbA1c rate and oriental medicine constitution, in order to decrease the incidence of complications and improve the quality of life, which could also decrease the expense of medication and act as a health care for diabetes mellitus patients.
Read the detailed description
According to the World Health Organization (WHO), diabetes is a rapidly growing chronic disease. Type II diabetes mellitus (DM) accounted for 98% of diabetics in Taiwan, and 40.0% of them have sleep disturbance similar as other country's 38.4%, but it is much higher than the people who did not have diabetics (20.8%). The metabolism and physiological status of DM patient are easily affected by poor quality of sleep, resulting in poor blood sugar control and easy to lead complications. It is a very huge impact on health. So the insomnia in DM patient is a very important care issue for medical health team. Previous studies have found that long-term practice tai chi, Ba Duan Jin and other traditional Chinese medicine qigong can improve sleep quality, glycosylated hemoglobin and physiological indicators of type 2 DM insomnia. Therefore, the aim of this study is to investigate the effect of the Duo-in on improving sleeping quality, glycated hemoglobin (HbA1c) and Traditional Chinese Medical (TCM) body constitution in insomnia of type 2 DM patient. It is expected that the results of this study could provide medical health team with reference and guidance of clinical care and home care of the patients with type 2 DM insomnia, and prevent the occurrence of complications and improve their quality of life, thereby, to reducing the cost of medical expenses.
An experimental study is designed, there will recruit 60 type 2 DM participants come from an outpatient department of a medical central in central of Taiwan, randomly assigned to experimental or control group each of 30 participants. The participants are enrolled should meet: (1) type 2 DM with diagnosis of insomnia; (2) Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5; (3) willing to participate in and complete the consent form. The intervention method: Teach Duo-in practice (give guidance Duo-in CD disc) and the DM health education for 20 minutes in experimental group, while the control group only give the DM health education in the first 12weeks, after that the control group will give them the same intervention as experimental group for 12weeks. The experimental group performed Duo-in three times a week, each time for 20 minutes for 12 weeks at home. Daily bedtime diaries will be recorded in both groups. The tools in this study are: the scale of participant's demographic data and interference factors of sleep, PSQI, TCM body constitution questionnaire (BCQ), HbA1C and daily bedtime diaries. Data collection will be before intervention and 4th, 8th, 12th, 16th, 20th and 24th weeks, with PSQI, TCM body constitution, Glycated Hemoglobin (HbA1C) and daily bedtime diaries. The data collection on 4th, 8th, 16th and 20th week will mail the PSQI to the participants and ask them to answer. Data will analyze by descriptive and inferential statistical analysis, including frequency distribution, percentage, mean, standard deviation, Paired t-test, t-test, Chi -square test, the generalized estimation equation (GEE; to analyze the repeated measurement of different time and group) verification.
- Conditions
- Exercise Promotion
- Being tested
- Yoga
- Keywords
- type 2 diabetes mellitus, insomnia, Dao-in
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Exercise promotion using Chinese Yoga
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise promotion using Dao-in (Chinese Yoga) Receives: Behavioral: Yoga |
| Control | No intervention | Usually clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQI
Pittsburgh Sleep Quality Inventory Assessment score
Measured: 12 weeks
Secondary outcomes (3)
BCQ
body constitution questionnaire
Measured: 12 weeks
BDNF
serum brain-derived neurotrophic factor
Measured: 12 weeks
ABI
ankle-brachial index
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start24 May 2017
- Primary completion31 May 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PromotionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-labelled, randomized, study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TCVGH, Taichung Veterans General Hospital
- Investigators
- I-Te Lee, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251755
- Sponsor's protocol ID
- CE17071B
- Acronym
- Yoga
- Status last verified
- Jan 2020
- First submitted
- 13 Aug 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dao-in (Chinese Yoga) on Insomnia in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03251755
- Acronym / sponsor ID
- Yoga / CE17071B
- Conditions
- Exercise Promotion
- Keywords
- type 2 diabetes mellitus, insomnia, Dao-in
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
According to the data from WHO, currently there are 350 million people with diabetes mellitus in the world, and the amount of which is still increasing. Among all types of diabetes mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in Taiwan is 98%. One third of the group suffers from sleep disorder. The prevalence rate is 33.7-52%, similar with the abroad prevalence rate (38.4%), but it's much higher than the prevalence rate of the general public(20.8%). As a result, people with diabetes mellitus are at high risk of sleep disorder. Not having enough sleep or sleep badly tend to cause abnormal metabolism, which influence the control of glycemia and worsen the disease. Currently investigations emphasize prevalence rate, risk factors and diabetes mellitus, increasing glycemia, complications which result from lack of sleep. Primary improving methods include the improvement of sleeping environment, recommendation of healthy diet, exercise and getting oriental medicine treatment. At the present time, WHO is actively promoting the combination of oriental treatment. Consequently, expecting the intervention of Dao-in(Chinese Yoga) could help to improve sleep quality, HbA1c rate and oriental medicine constitution, in order to decrease the incidence of complications and improve the quality of life, which could also decrease the expense of medication and act as a health care for diabetes mellitus patients.
Detailed description
According to the World Health Organization (WHO), diabetes is a rapidly growing chronic disease. Type II diabetes mellitus (DM) accounted for 98% of diabetics in Taiwan, and 40.0% of them have sleep disturbance similar as other country's 38.4%, but it is much higher than the people who did not have diabetics (20.8%). The metabolism and physiological status of DM patient are easily affected by poor quality of sleep, resulting in poor blood sugar control and easy to lead complications. It is a very huge impact on health. So the insomnia in DM patient is a very important care issue for medical health team. Previous studies have found that long-term practice tai chi, Ba Duan Jin and other traditional Chinese medicine qigong can improve sleep quality, glycosylated hemoglobin and physiological indicators of type 2 DM insomnia. Therefore, the aim of this study is to investigate the effect of the Duo-in on improving sleeping quality, glycated hemoglobin (HbA1c) and Traditional Chinese Medical (TCM) body constitution in insomnia of type 2 DM patient. It is expected that the results of this study could provide medical health team with reference and guidance of clinical care and home care of the patients with type 2 DM insomnia, and prevent the occurrence of complications and improve their quality of life, thereby, to reducing the cost of medical expenses.
An experimental study is designed, there will recruit 60 type 2 DM participants come from an outpatient department of a medical central in central of Taiwan, randomly assigned to experimental or control group each of 30 participants. The participants are enrolled should meet: (1) type 2 DM with diagnosis of insomnia; (2) Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5; (3) willing to participate in and complete the consent form. The intervention method: Teach Duo-in practice (give guidance Duo-in CD disc) and the DM health education for 20 minutes in experimental group, while the control group only give the DM health education in the first 12weeks, after that the control group will give them the same intervention as experimental group for 12weeks. The experimental group performed Duo-in three times a week, each time for 20 minutes for 12 weeks at home. Daily bedtime diaries will be recorded in both groups. The tools in this study are: the scale of participant's demographic data and interference factors of sleep, PSQI, TCM body constitution questionnaire (BCQ), HbA1C and daily bedtime diaries. Data collection will be before intervention and 4th, 8th, 12th, 16th, 20th and 24th weeks, with PSQI, TCM body constitution, Glycated Hemoglobin (HbA1C) and daily bedtime diaries. The data collection on 4th, 8th, 16th and 20th week will mail the PSQI to the participants and ask them to answer. Data will analyze by descriptive and inferential statistical analysis, including frequency distribution, percentage, mean, standard deviation, Paired t-test, t-test, Chi -square test, the generalized estimation equation (GEE; to analyze the repeated measurement of different time and group) verification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-labelled, randomized, study
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: YogaExercise promotion using Dao-in (Chinese Yoga) |
| Control | No intervention | –Usually clinical practice |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 DM with diagnosis of insomnia;
- Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5;
- willing to participate in and complete the consent form.
Key exclusion criteria (4 listed)
- CKD
- COPD
- Mental illness
- pregnancy
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 |
|---|---|---|
| YogaExercise promotion using Chinese Yoga | Behavioural | Exercise |
Primary outcome
PSQI
Time frame: 12 weeks
Pittsburgh Sleep Quality Inventory Assessment score
3 secondary outcomes
BCQ
Time frame: 12 weeks
BDNF
Time frame: 12 weeks
ABI
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
I-Te Lee, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Exercise Promotion, run by Taichung Veterans General Hospital at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI (time frame: 12 weeks). 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 7 Jan 2020.