- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637909
Korean Life-Style Modification Effects on Blood Pressure
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 120-752
- Yonsei universty medical center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: general management
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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.
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Experimental: The treatment group1
Korean DASH diet with sodium reduction intervention
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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.
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Experimental: The treatment group2
Korean DASH diet with sodium reduction intervention and excersize intervention
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of blood pressure after intervention
Time Frame: after 1 week, 4weeks, 8weeks intervention for each group intervention
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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.
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after 1 week, 4weeks, 8weeks intervention for each group intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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