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Korean Life-Style Modification Effects on Blood Pressure

Primary Purpose

Prehypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.
Treatment group 1(Dietary intervention)
Treatment group 2(dietary and exercise intervention)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Prehypertension, Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult age >20

  2. If the subject not taken antihypertension, SBP and DBP must be the following result.

    SBP: 120~159 mmHg , DBP: 80-99 mmHg

  3. If the subject taken antihypertension, SBP and DBP must be the following result.

    SBP: 140-159mmHg ,DBP: 90-99 mmHg

  4. BMI 18.5kg/m²~44kg/m²
  5. Patients voluntarily agreed to participate in this study
  6. Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.

(not taking an oral contraceptive)

Exclusion Criteria:

  1. If the subject not taken antihypertension, SBP and DBP must be the following result.

    • 120>SBP>159 mmHg, 80>DBP>99 mmHg
  2. If the subject taken antihypertension, the number of three or more antihypertensive

  3. If the subject taken antihypertension, SBP and DBP must be the following result.

    • 140>SBP>159 mmHg, 90>DBP>99 mmHg

  4. having the target organ disease, the following disease.

    • Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
    • Brain disease: Stroke, TIA, Dementia
    • Kidney disease:
    • Pheripheral artery disease
    • Retinopathy Disease
  5. Cancer, Liver disease
  6. Regular drinking alcohol above 14 cup of during 1 week.
  7. Pregnant women, Women of childbearing age tested positive in HCG result.
  8. Pregnant women, Breastfeeding women
  9. screening test result CS
  10. illiteracy, a foreigner, the person who can't read the consent
  11. the person who had participated other study in 3 months.
  12. the person who inappropriate to participate

Sites / Locations

  • Yonsei universty medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

general management

The treatment group1

The treatment group2

Arm Description

Korean DASH diet with sodium reduction intervention

Korean DASH diet with sodium reduction intervention and excersize intervention

Outcomes

Primary Outcome Measures

changes of blood pressure after intervention
The primary outcome will be the difference in sitting brachial systolic blood pressure after 8 weeks intervention. The study population was determined by treatment group 1 will have systolic BP lowering effect of 11.5mmHg with standard deviation of 10.0mmHg and group 2 will have systolic BP lowering effect of 18.0mmHg with standard deviation of 15.0mmHg. with statistical power of 80% and drop out rate of 25%, the number needed was determined to be 32 in the control group, 22 in group 1 and 22 in group 2.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2012
Last Updated
November 10, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01637909
Brief Title
Korean Life-Style Modification Effects on Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In hypertension, lifestyle modification has been proven to be effective in reducing blood pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal to adding one antihypertensive drug. However, as the dietary pattern is different in the Korean population, the investigators cannot implement the data from Western countries directly to the Korean population. For example, the consumption of dairy products is much smaller in the Korean population when compared to the western population. Therefore, the effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean population is not well defined. In this study, the investigators sought to determine the effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood pressure lowering. The study will be performed on untreated prehypertension patients and uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension
Keywords
Prehypertension, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
general management
Arm Type
Active Comparator
Arm Title
The treatment group1
Arm Type
Experimental
Arm Description
Korean DASH diet with sodium reduction intervention
Arm Title
The treatment group2
Arm Type
Experimental
Arm Description
Korean DASH diet with sodium reduction intervention and excersize intervention
Intervention Type
Drug
Intervention Name(s)
Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.
Intervention Description
All the study subjects will undergo baseline brachial blood pressure measurement(OMRON HEM 7080IT), central aortic blood pressure measurement with Sphygmocor device(AtCor Medical), baseline laboratory, 24hr urine Na measurement, 24 hour ambulatory blood pressure and cardiopulmonary exercise test. These tests will be repeated at the 8th week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment group 1(Dietary intervention)
Intervention Description
The dietary intervention is based on active education of the enrolled subjects based on Korean modified DASH diet. The enrolled subjects are advised to substitute processed white rice with whole grains such as barley. For protein, the subjects are advised to consume chicken and fish instead of red meat. Also, consumption of nuts are recommended where as processed foods containing high fructose corn syrup are not recommended. We will recommend to reduce salt intake by advising the subjects from adding table salts to their meals as well as adding salt during cooking. We will advise the subjects from eating pickles and condiments, which are the main source of salt in the Korean population. The degree of salt reduction before and after intervention will be assessed by 24 hour recall as well as measurement of 24 hour urine Na collection at baseline and at the 8th week. The compliance of the subjects will be assessed by 24hr recall as well.
Intervention Type
Other
Intervention Name(s)
Treatment group 2(dietary and exercise intervention)
Intervention Description
The dietary intervention will be combined with exercise intervention. At baseline, the subjects will undergo evaluation for (1) cardiopulmonary function by undergoing cardiopulmonary exercise test and 3 minute step test 2) muscle strength assessment by hand grip test and 3) push ups to assess muscle endurance. After the initial evaluation, the subjects will be subjected to a course in aerobic exercise and muscle strengthening exercise developed by the Yonsei University Physical education department and will receive an educational DVD program. The subjects will each be given an electronic step counter to assess the degree of exercise. All the subjects in the treatment group 2 will be advised to undergo moderate to stenuous aerobic exercise for least 150 minutes /per week. Also, the subjects will be educated to perform muscle strengthening exercise as specificed in the educational program. The subjects will be asked to submit an exercise diary to assess the degree of compliance.
Primary Outcome Measure Information:
Title
changes of blood pressure after intervention
Description
The primary outcome will be the difference in sitting brachial systolic blood pressure after 8 weeks intervention. The study population was determined by treatment group 1 will have systolic BP lowering effect of 11.5mmHg with standard deviation of 10.0mmHg and group 2 will have systolic BP lowering effect of 18.0mmHg with standard deviation of 15.0mmHg. with statistical power of 80% and drop out rate of 25%, the number needed was determined to be 32 in the control group, 22 in group 1 and 22 in group 2.
Time Frame
after 1 week, 4weeks, 8weeks intervention for each group intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult age >20 If the subject not taken antihypertension, SBP and DBP must be the following result. SBP: 120~159 mmHg , DBP: 80-99 mmHg If the subject taken antihypertension, SBP and DBP must be the following result. SBP: 140-159mmHg ,DBP: 90-99 mmHg BMI 18.5kg/m²~44kg/m² Patients voluntarily agreed to participate in this study Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result. (not taking an oral contraceptive) Exclusion Criteria: If the subject not taken antihypertension, SBP and DBP must be the following result. 120>SBP>159 mmHg, 80>DBP>99 mmHg If the subject taken antihypertension, the number of three or more antihypertensive If the subject taken antihypertension, SBP and DBP must be the following result. 140>SBP>159 mmHg, 90>DBP>99 mmHg having the target organ disease, the following disease. Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure Brain disease: Stroke, TIA, Dementia Kidney disease: Pheripheral artery disease Retinopathy Disease Cancer, Liver disease Regular drinking alcohol above 14 cup of during 1 week. Pregnant women, Women of childbearing age tested positive in HCG result. Pregnant women, Breastfeeding women screening test result CS illiteracy, a foreigner, the person who can't read the consent the person who had participated other study in 3 months. the person who inappropriate to participate
Facility Information:
Facility Name
Yonsei universty medical center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29968437
Citation
Lee CJ, Kim JY, Shim E, Hong SH, Lee M, Jeon JY, Park S. The Effects of Diet Alone or in Combination with Exercise in Patients with Prehypertension and Hypertension: a Randomized Controlled Trial. Korean Circ J. 2018 Jul;48(7):637-651. doi: 10.4070/kcj.2017.0349.
Results Reference
derived

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Korean Life-Style Modification Effects on Blood Pressure

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