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Exercise Using Chinese Yoga Improving Insomnia (Yoga)

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ClinicalTrials.gov Identifier: NCT03251755
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
TCVGH, Taichung Veterans General Hospital

Tracking Information
First Submitted Date  ICMJE August 13, 2017
First Posted Date  ICMJE August 16, 2017
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
PSQI [ Time Frame: 12 weeks ]
Pittsburgh Sleep Quality Inventory Assessment score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • BCQ [ Time Frame: 12 weeks ]
    body constitution questionnaire
  • BDNF [ Time Frame: 12 weeks ]
    serum brain-derived neurotrophic factor
  • ABI [ Time Frame: 12 weeks ]
    ankle-brachial index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Using Chinese Yoga Improving Insomnia
Official Title  ICMJE The Effectiveness of Dao-in (Chinese Yoga) on Insomnia in Type 2 Diabetes Mellitus
Brief 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%. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open-labelled, randomized, study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Exercise Promotion
Intervention  ICMJE Behavioral: Yoga
Exercise promotion using Chinese Yoga
Study Arms  ICMJE
  • Experimental: Exercise
    Exercise promotion using Dao-in (Chinese Yoga)
    Intervention: Behavioral: Yoga
  • No Intervention: Control
    Usually clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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.

Exclusion Criteria:

  • CKD
  • COPD
  • Mental illness
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03251755
Other Study ID Numbers  ICMJE CE17071B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party TCVGH, Taichung Veterans General Hospital
Study Sponsor  ICMJE Taichung Veterans General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: I-Te Lee, MD, PhD Taichung Veterans General Hospital
PRS Account Taichung Veterans General Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP