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| Name | Class |
|---|---|
| The Korean Vascular Research Working Group | UNKNOWN |
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This is a multicenter, randomized, single-blinded clinical trial investigating the effect of dietary management and active aerobic exercise training on reduction of 24-hour ambulatory blood pressure in subjects with prehypertension and drug-naïve stage 1 hypertension.
Most guidelines recommend lifestyle modifications such as exercise or dietary programs for stage 1 hypertension or prehypertension, before initiation of antihypertensive drug treatment. Epidemiological and observational studies have shown that cardiovascular risk increases progressively from blood pressure levels as low as 115/75 mmHg and that patients with prehypertension or stage 1 hypertension are likely to progress to hypertension requiring medications. From a previous clinical trial, a 12-week aerobic exercise program reduced 24-hour and daytime ambulatory blood pressure in patients with resistant hypertension. Aerobic exercise and DASH (Dietary Approaches to Stop Hypertension) diet are currently recommended in subjects with prehypertension and stage 1 hypertension without a clear randomized, controlled clinical trial. The present trial, thus, seeks to evaluate the effect of dietary management and active aerobic exercise training, preferably moderate-intensity exercise, on 24-hour ambulatory blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active management group | Experimental | Active dietary management and aerobic exercise training. Subjects will receive assessment and education of DASH diet (0, 4, and 8 weeks), with active aerobic exercise training (1 hour everyday exercise, at least 5 times per week for 12 weeks) (aerobic exercise education at baseline, 4, and 8 weeks after randomization). Each set of aerobic exercise consists of 10 minutes warm-up, 40 minutes moderate-intensity treadmill trotting, and 10 minutes cooldown. Telephone counseling at 2, 6, and 10 weeks after randomization. |
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| Control group | No Intervention | Subjects will not receive education and recommendation of dietary management and aerobic exercise training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active dietary management and aerobic exercise training. | Other | Active dietary management and aerobic exercise training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour ambulatory systolic blood pressure | Change in 24-hour ambulatory systolic blood pressure | from baseline to 12 weeks |
| Change in 24-hour ambulatory diastolic blood pressure | Change in 24-hour ambulatory diastolic blood pressure | from baseline to 12 weeks |
| Change in daytime ambulatory systolic and diastolic blood pressure | Change in daytime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks |
| Change in nighttime ambulatory systolic and diastolic blood pressure | Change in nighttime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks |
| Change in office systolic and diastolic blood pressure | Change in office systolic and diastolic blood pressure | from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial stiffness | augmentation index | from baseline to 12 weeks |
| Change in arterial stiffness | pulse wave velocity | from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki-Chul Sung | Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | Seoul | 136705 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41462029 | Derived | Lim S, Hong SJ, Kim JH, Cha JJ, Joo HJ, Park JH, Yu CW, Lim DS, Shin JH, Lee JY, Lim YH, Kim SH, Sung KC. Dietary management and aerobic exercise counselling on blood pressure control in subjects with prehypertension and drug-naive stage 1 hypertension: a randomized clinical trial. Sci Rep. 2025 Dec 29;15(1):45683. doi: 10.1038/s41598-025-20828-7. |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Experimental group versus Control group
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| Change in serum renin level | Change in serum renin level | from baseline to 12 weeks |
| Change in serum angiotensin converting enzyme (ACE) level | Change in serum angiotensin converting enzyme (ACE) level | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | interleukin-6 | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | interleukin-18 | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | Tumour Necrosis Factor alpha | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | high sensitivity-C-reactive protein | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | Soluble intercellular adhesion molecule-1 (sICAM-1) | from baseline to 12 weeks |
| Change in circulating endothelial and inflammatory biomarkers | Plasminogen activator inhibitor-1 | from baseline to 12 weeks |