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Qigong for pre & stage 1 hypertension : A randomized controlled trial

Status Approved

First Submitted Date

2015/02/09
Registered Date

2015/02/27
Last Updated Date

2017/10/18

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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	KCT0001397
Unique Protocol ID	KI1401
Public/Brief Title	Qigong for pre & stage 1 hypertension
Scientific Title	Qigong for pre & stage 1 hypertension : A randomized controlled trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	djomc-117
Approval Date	2014-07-07
Institutional Review Board Name	Institutional Review Board of Daejeon University Oriental Medical Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

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	Jung-hyo Cho
Title	Associate Professor
Telephone	+82-42-229-6806
Affiliation	Daejeon University
Address	62 Daehangno, Dong-gu, Daejeon
Contact Person for Public Queries
Name	Jung-hyo Cho
Title	Associate Professor
Telephone	+82-42-229-6806
Affiliation	Daejeon University
Address	62 Daehangno, Dong-gu, Daejeon
Contact Person for Updating Information
Name	Jung-Eun Kim
Title	Senior Researcher
Telephone	+82-42-223-4054
Affiliation	Korea Institute of Oriental Medicine
Address	1672 Yuseongdae-ro, Yuseong-gu, Daejeon

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2014-09-18 Actual
Target Number of Participant	52
Primary Completion Date	2015-10-22 , Actual
Study Completion Date	2015-10-22 , Actual
Name of Study	Daejeon Korean Medicine Hospital of Daejeon University
Recruitment Status	Completed
Date of First Enrollment	2014-09-18 ,

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	Korea Institute of Oriental Medicine
Organization Type	Research Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Institute of Oriental Medicine
Organization Type	Research Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a randomized, controlled, parallel group trial whose participants are patients with prehypertension or stage 1 hypertension. The aim of this study is to assess the effectiveness and safety of qigong treatment.

Study Summary Information

Lay Summary

This study is a randomized, controlled, parallel group trial whose participants are patients with prehypertension or stage 1 hypertension. The aim of this study is to assess the effectiveness and safety of qigong treatment.

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	Behavioral
Intervention Description	Each qigong class lasts about 50 min, including 15-min warm-up and 10-min cool-down sessions.
Number of Arms	2
Arm 1	Arm Label Usual care control group
	Target Number of Participant 26
	Arm Type No intervention
	Arm Description Participants in the control group will not receive qigong treatment and continue usual care for 12 weeks.
Arm 2	Arm Label Qigong treatment group
	Target Number of Participant 26
	Arm Type Experimental
	Arm Description Participants in the treatment group will practice qigong at home by watching the provided digital video disc, more than 5 times a week for 12 weeks; additionally, they will write a self-reported diary about whether to continue performing qigong. They will visit the clinical trial center and attend the qigong class every other week.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I10.9)Other and unspecified primary hypertension
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description 1. Men and women, aged 19 to 65 years 2. Blood pressure is in the prehypertension stage or at stage 1 hypertension (systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg) (by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure criteria) 3. Provide consent to participate in this trial and sign an informed consent statement
Exclusion Criteria	1. Taking medicine for blood pressure control, such as prescription or over the counter drug or herb/supplements 2. Secondary hypertension 3. Previous cerebrovascular or heart disease such as myocardial infarction, angina and valvular disease 4. Wasting disease 5. Insulin or diabetes medication in diabetic patients 6. Previous kidney, liver or hyperthyroidism 7. Active tuberculosis and other infectious disease 8. Systemic steroids or immunosuppressive therapy 9. Oral contraceptives, central nervous system inhibitors or stimulants, such as taking medication that affects blood pressure 10. Pregnant women, lactating and pregnant women who plan on 11. Others whose clinical trials conductors are considered inappropriate for participating in this trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	The average systolic blood pressure
Timepoint	12 weeks after randomization
Secondary Outcome(s) 1
Outcome	Measure Yourself Medical Outcome Profile 2 (MYMOP2)
Timepoint	12 and 16 weeks after randomization
Secondary Outcome(s) 2
Outcome	The average systolic blood pressure
Timepoint	16 weeks after randomization
Secondary Outcome(s) 3
Outcome	The average diastolic blood pressure
Timepoint	12 and 16 weeks after randomization
Secondary Outcome(s) 4
Outcome	Body mass index (BMI)
Timepoint	12 and 16 weeks after randomization
Secondary Outcome(s) 5
Outcome	Lipid profile
Timepoint	12 weeks after randomization
Secondary Outcome(s) 6
Outcome	Adverse events
Timepoint	Every visit
Secondary Outcome(s) 7
Outcome	Quality of life (EuroQol-5 Dimension, EQ-5D)
Timepoint	12 and 16 weeks after randomization

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

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	Not provided at time of Registration

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Qigong for pre &amp; stage 1 hypertension : A randomized controlled trial

Qigong for pre & stage 1 hypertension : A randomized controlled trial