<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03251755</url>
  </required_header>
  <id_info>
    <org_study_id>CE17071B</org_study_id>
    <nct_id>NCT03251755</nct_id>
  </id_info>
  <brief_title>Exercise Using Chinese Yoga Improving Insomnia</brief_title>
  <acronym>Yoga</acronym>
  <official_title>The Effectiveness of Dao-in (Chinese Yoga) on Insomnia in Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the data from WHO, currently there are 350 million people with diabetes mellitus&#xD;
      in the world, and the amount of which is still increasing. Among all types of diabetes&#xD;
      mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in&#xD;
      Taiwan is 98%. One third of the group suffers from sleep disorder. The prevalence rate is&#xD;
      33.7-52%, similar with the abroad prevalence rate (38.4%), but it's much higher than the&#xD;
      prevalence rate of the general public(20.8%). As a result, people with diabetes mellitus are&#xD;
      at high risk of sleep disorder. Not having enough sleep or sleep badly tend to cause abnormal&#xD;
      metabolism, which influence the control of glycemia and worsen the disease. Currently&#xD;
      investigations emphasize prevalence rate, risk factors and diabetes mellitus, increasing&#xD;
      glycemia, complications which result from lack of sleep. Primary improving methods include&#xD;
      the improvement of sleeping environment, recommendation of healthy diet, exercise and getting&#xD;
      oriental medicine treatment. At the present time, WHO is actively promoting the combination&#xD;
      of oriental treatment. Consequently, expecting the intervention of Dao-in(Chinese Yoga) could&#xD;
      help to improve sleep quality, HbA1c rate and oriental medicine constitution, in order to&#xD;
      decrease the incidence of complications and improve the quality of life, which could also&#xD;
      decrease the expense of medication and act as a health care for diabetes mellitus patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the World Health Organization (WHO), diabetes is a rapidly growing chronic&#xD;
      disease. Type II diabetes mellitus (DM) accounted for 98% of diabetics in Taiwan, and 40.0%&#xD;
      of them have sleep disturbance similar as other country's 38.4%, but it is much higher than&#xD;
      the people who did not have diabetics (20.8%). The metabolism and physiological status of DM&#xD;
      patient are easily affected by poor quality of sleep, resulting in poor blood sugar control&#xD;
      and easy to lead complications. It is a very huge impact on health. So the insomnia in DM&#xD;
      patient is a very important care issue for medical health team. Previous studies have found&#xD;
      that long-term practice tai chi, Ba Duan Jin and other traditional Chinese medicine qigong&#xD;
      can improve sleep quality, glycosylated hemoglobin and physiological indicators of type 2 DM&#xD;
      insomnia. Therefore, the aim of this study is to investigate the effect of the Duo-in on&#xD;
      improving sleeping quality, glycated hemoglobin (HbA1c) and Traditional Chinese Medical (TCM)&#xD;
      body constitution in insomnia of type 2 DM patient. It is expected that the results of this&#xD;
      study could provide medical health team with reference and guidance of clinical care and home&#xD;
      care of the patients with type 2 DM insomnia, and prevent the occurrence of complications and&#xD;
      improve their quality of life, thereby, to reducing the cost of medical expenses.&#xD;
&#xD;
      An experimental study is designed, there will recruit 60 type 2 DM participants come from an&#xD;
      outpatient department of a medical central in central of Taiwan, randomly assigned to&#xD;
      experimental or control group each of 30 participants. The participants are enrolled should&#xD;
      meet: (1) type 2 DM with diagnosis of insomnia; (2) Pittsburgh Sleep Quality Inventory&#xD;
      Assessment score (PSQI)&gt; 5; (3) willing to participate in and complete the consent form. The&#xD;
      intervention method: Teach Duo-in practice (give guidance Duo-in CD disc) and the DM health&#xD;
      education for 20 minutes in experimental group, while the control group only give the DM&#xD;
      health education in the first 12weeks, after that the control group will give them the same&#xD;
      intervention as experimental group for 12weeks. The experimental group performed Duo-in three&#xD;
      times a week, each time for 20 minutes for 12 weeks at home. Daily bedtime diaries will be&#xD;
      recorded in both groups. The tools in this study are: the scale of participant's demographic&#xD;
      data and interference factors of sleep, PSQI, TCM body constitution questionnaire (BCQ),&#xD;
      HbA1C and daily bedtime diaries. Data collection will be before intervention and 4th, 8th,&#xD;
      12th, 16th, 20th and 24th weeks, with PSQI, TCM body constitution, Glycated Hemoglobin&#xD;
      (HbA1C) and daily bedtime diaries. The data collection on 4th, 8th, 16th and 20th week will&#xD;
      mail the PSQI to the participants and ask them to answer. Data will analyze by descriptive&#xD;
      and inferential statistical analysis, including frequency distribution, percentage, mean,&#xD;
      standard deviation, Paired t-test, t-test, Chi -square test, the generalized estimation&#xD;
      equation (GEE; to analyze the repeated measurement of different time and group) verification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open-labelled, randomized, study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PSQI</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pittsburgh Sleep Quality Inventory Assessment score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BCQ</measure>
    <time_frame>12 weeks</time_frame>
    <description>body constitution questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDNF</measure>
    <time_frame>12 weeks</time_frame>
    <description>serum brain-derived neurotrophic factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABI</measure>
    <time_frame>12 weeks</time_frame>
    <description>ankle-brachial index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Exercise Promotion</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise promotion using Dao-in (Chinese Yoga)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usually clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Exercise promotion using Chinese Yoga</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. type 2 DM with diagnosis of insomnia;&#xD;
&#xD;
          2. Pittsburgh Sleep Quality Inventory Assessment score (PSQI)&gt; 5;&#xD;
&#xD;
          3. willing to participate in and complete the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CKD&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  Mental illness&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Te Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Endocrinology and Metabolism in Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 4, 2020</last_update_submitted>
  <last_update_submitted_qc>January 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taichung Veterans General Hospital</investigator_affiliation>
    <investigator_full_name>TCVGH</investigator_full_name>
    <investigator_title>Deputy head nurse</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>insomnia</keyword>
  <keyword>Dao-in</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251755
org study id: CE17071B
nct id: NCT03251755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-labelled, randomized, study
primary purpose: Treatment
masking: None (Open Label)
measure: PSQI
time frame: 12 weeks
description: Pittsburgh Sleep Quality Inventory Assessment score
measure: BCQ
time frame: 12 weeks
description: body constitution questionnaire
measure: BDNF
time frame: 12 weeks
description: serum brain-derived neurotrophic factor
measure: ABI
time frame: 12 weeks
description: ankle-brachial index
arm group label: Exercise
arm group type: Experimental
description: Exercise promotion using Dao-in (Chinese Yoga)
arm group label: Control
arm group type: No Intervention
description: Usually clinical practice
intervention type: Behavioral
intervention name: Yoga
description: Exercise promotion using Chinese Yoga
arm group label: Exercise
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: I-Te Lee, MD, PhD
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taichung Veterans General Hospital
investigator full name: TCVGH
investigator title: Deputy head nurse
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Undecided