Status Approved
First Submitted Date
2019/01/28
Registered Date
2019/03/18
Last Updated Date
2021/06/24
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003632 |
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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 |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2018014 |
Approval Date | 2019-01-16 |
Institutional Review Board Name | Pusan National University Korean Medicine Hospital Institutional Review Board |
Institutional Review Board Address | 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
Institutional Review Board Telephone | 055-360-5902 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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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 |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-04-17 Actual | |
Target Number of Participant | 80 | |
Primary Completion Date | 2020-04-29 , Actual | |
Study Completion Date | 2021-04-30 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Pusan National University Korean Medicine Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-04-17 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Woosuk University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Woosuk University |
Organization Type | University |
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. |
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8. Study Design
Study Type | Interventional Study |
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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 | 2 |
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. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I10.9)Other and unspecified primary hypertension Stage 1 hypertensive patients |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~70Year |
|
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 |
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 |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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Final Enrollment Number | 41 |
Number of Publication | 0 |
Results Upload | 태극권 임상연구 결과보고서.hwp |
Date of Posting Results | 2021/06/03 |
Protocol URL or File Upload | Effects of taichi on grade 1 hypertension A study protocol for a randomized controlled trial.pdf |
Brief Summary | 41 participants were recruited out of a total of 80. There was no difference between the experimental group and the control group in the difference of systolic blood pressure before and after treatment, and in the change of diastolic blood pressure before and after treatment. The difference in heart rate per minute and body composition, which were secondary outcomes, also showed no difference between the experimental group and the control group. Intensity and difficulty of the exercises, which were other secondary outcome, did not have a significant correlation with changes in blood pressure. No adverse events were reported. |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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