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The effects of Tai Chi on Grade 1 Hypertension patient : Randomized controlled trial

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    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
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    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
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    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
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Woosuk University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Woosuk University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    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 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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I10.9)Other and unspecified primary hypertension 

    Stage 1 hypertensive patients
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    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 of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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