Korean Life-Style Modification Effects on Blood Pressure
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|ClinicalTrials.gov Identifier: NCT01637909|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : November 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prehypertension Hypertension||Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention. Dietary Supplement: Treatment group 1(Dietary intervention) Other: Treatment group 2(dietary and exercise intervention)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
|Active Comparator: general management||
Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.
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.
Experimental: The treatment group1
Korean DASH diet with sodium reduction intervention
Dietary Supplement: Treatment group 1(Dietary intervention)
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.
Experimental: The treatment group2
Korean DASH diet with sodium reduction intervention and excersize intervention
Other: Treatment group 2(dietary and exercise intervention)
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.
- changes of blood pressure after intervention [ Time Frame: after 1 week, 4weeks, 8weeks intervention for each group 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637909
|Korea, Republic of|
|Yonsei universty medical center|
|Seoul, Korea, Republic of, 120-752|