Exercise Using Chinese Yoga Improving Insomnia (Yoga)
Primary Purpose
Exercise Promotion
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Promotion focused on measuring type 2 diabetes mellitus, insomnia, Dao-in
Eligibility Criteria
Inclusion Criteria:
- type 2 DM with diagnosis of insomnia;
- Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5;
- willing to participate in and complete the consent form.
Exclusion Criteria:
- CKD
- COPD
- Mental illness
- pregnancy
Sites / Locations
- Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
Exercise promotion using Dao-in (Chinese Yoga)
Usually clinical practice
Outcomes
Primary Outcome Measures
PSQI
Pittsburgh Sleep Quality Inventory Assessment score
Secondary Outcome Measures
BCQ
body constitution questionnaire
BDNF
serum brain-derived neurotrophic factor
ABI
ankle-brachial index
Full Information
NCT ID
NCT03251755
First Posted
August 13, 2017
Last Updated
January 4, 2020
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03251755
Brief Title
Exercise Using Chinese Yoga Improving Insomnia
Acronym
Yoga
Official Title
The Effectiveness of Dao-in (Chinese Yoga) on Insomnia in Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Promotion
Keywords
type 2 diabetes mellitus, insomnia, Dao-in
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-labelled, randomized, study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise promotion using Dao-in (Chinese Yoga)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usually clinical practice
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Exercise promotion using Chinese Yoga
Primary Outcome Measure Information:
Title
PSQI
Description
Pittsburgh Sleep Quality Inventory Assessment score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
BCQ
Description
body constitution questionnaire
Time Frame
12 weeks
Title
BDNF
Description
serum brain-derived neurotrophic factor
Time Frame
12 weeks
Title
ABI
Description
ankle-brachial index
Time Frame
12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
type 2 DM with diagnosis of insomnia;
Pittsburgh Sleep Quality Inventory Assessment score (PSQI)> 5;
willing to participate in and complete the consent form.
Exclusion Criteria:
CKD
COPD
Mental illness
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Te Lee, MD, PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Exercise Using Chinese Yoga Improving Insomnia
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