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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/01/28
    • Registered Date : 2019/03/18
    • Last Updated Date : 2019/06/19
Background Information
1.Background  
CRIS Registration Number KCT0003632 
Unique Protocol ID 2018014 
Public/Brief Title The effects of Tai Chi on Grade 1 Hypertension patient 
Scientific Title The effects of Tai Chi on Grade 1 Hypertension patient : Randomized controlled trial  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number 2018014 
Approval Date 2019-01-16 
Institutional Review Board  
- Name Pusan National University Korean Medicine Hospital Institutional Review Board  
- Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do 
- Telephone 055-360-5902 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Eui-Hyoung Hwang 
- Title associate professor 
- Telephone +82-55-360-5951 
- Affiliation Pusan National University 
- Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 
Contact Person for Public Queries
- Name Eui-Hyoung Hwang 
- Title associate professor 
- Telephone +82-55-360-5951 
- Affiliation Pusan National University 
- Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 
Contact Person for Updating Information
- Name Eui-Hyoung Hwang 
- Title associate professor 
- Telephone +82-55-360-5951 
- Affiliation Pusan National University 
- Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2019-04-17 , Actual
Target Number of Participant 80
Primary Completion Date 2019-09-30 , Anticipated
Study Completion Date 2019-12-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Pusan National University Korean Medicine Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2019-04-17 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Woosuk University 
- Organization Type University  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Woosuk University 
- Organization Type University  
Study Summary
7. Study Summary  
Lay Summary Treatment and management of hypertension, as well as drug therapy, are widely used for a healthy diet, exercise, non-smoking, and non-pharmacic treatments.
Recently, interest in Qi gong and Tai Chi has increased as a way to treat hypertension in traditional Korean medicine clinic.
This study aims to verify the efficancy of the Tai Chi by comparing the randomized and usual care group of high blood pressure patients with primary hypertension (ages 19 to 70).
The Tai Chi group, which operates the Tai Chi twice a week (80 percent compliance and more than 13 times in total), will receive 8 weeks of exercise, and the usual care group will receive training at the hospital about salt intake restriction, weight loss, alcohol consumption, exercise, and meal control, and they are administered by themselves for 8 weeks. Since then, both will be monitored in four weeks.
The primary outcome is the difference between the systolic and the relaxation period blood pressure, and the secondary outcome include comparing the body components before and after, changes in heart rate per minute, and evaluation of motor strength and difficulty of exercise for the Tai Chi.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Others  
Intervention Description The Tai Chi group, which operates the Tai Chi three twice a week (80 percent compliance and more than 13 times in total), will receive 8 weeks of exercise, and the usual care group will receive training at the hospital about salt intake restriction, weight loss, alcohol consumption, exercise, and meal control, and they are administered by themselves for 8 weeks. Since then, both will be monitored in four weeks. Since the intervention of the control group and the experimental group of the study is not possible to perform participant blind, this study does not perform participant blind but only assessor blind.  
Number of Arms
Arm 1 Arm Label The Tai Chi group 
Target Number of Participant 40 
Arm Type Experimental 
Arm Description The Tai Chi group, which operates the Tai Chi twice a week (80 percent compliance and more than 13 times in total), will receive 8 weeks of exercise. Since then, both will be monitored in four weeks. 
Arm 2 Arm Label The usual care group 
Target Number of Participant 40 
Arm Type Active comparator 
Arm Description The usual care group will receive training at the hospital about salt intake restriction, weight loss, alcohol consumption, exercise, and meal control, and they are administered by themselves for 8 weeks. Since then, both will be monitored in four weeks. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the circulatory system
Stage 1 hypertensive patients  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 70 Year
Description 1) Stage 1 hypertensive patients who were diagnosed at the health checkup and hospital or were screened for systolic blood pressure of 140 to 159 mmHg or diastolic blood pressure of 90 to 99 mmHg
2) A person who can communicate normally
3) Participants who signed a study agreement with a voluntary participation intention  
Exclusion Criteria 1) Individuals who participated in another trial within a month
2) A person who is deemed difficult to treat exercise for high blood pressure through the judgment of a doctor, such as a severe pain condition or joint deformation
3) A person who is unable to communicate properly due to dementia or mild cognitive impairment
4) A person who is pregnant
5) A person who is difficult to include in this study in accordance with the investigator's judgment  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Difference in systolic pressure change before and after treatment, difference in diastolic blood pressure change after treatment 
- Timepoint First visit, 4weeks, 8weeks, 12weeks after first visit 
Secondary Outcome(s) 1 
- Outcome Changes in heart rate during 1 minute 
- Timepoint First visit, 4weeks, 8weeks, 12weeks after first visit 
Secondary Outcome(s) 2 
- Outcome body mass index 
- Timepoint First visit, 8weeks, 12weeks after first visit 
Secondary Outcome(s) 3 
- Outcome Strength of exercise and difficulty of exercise 
- Timepoint 8weeks after first visit 
Secondary Outcome(s) 4 
- Outcome Adverse reaction 
- Timepoint 8weeks, 12weeks after first visit 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No