Korea University Anam Hospital
Seoul, 136705, South Korea
NCT Number: NCT05274971
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Seoul, 136705, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active dietary management and aerobic exercise training.
Time frame: from baseline to 12 weeks
Change in 24-hour ambulatory systolic blood pressure
Time frame: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
augmentation index
Time frame: from baseline to 12 weeks
pulse wave velocity
Time frame: from baseline to 12 weeks
Change in serum renin level
Time frame: from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
Time frame: from baseline to 12 weeks
interleukin-6
Time frame: from baseline to 12 weeks
interleukin-18
Time frame: from baseline to 12 weeks
Tumour Necrosis Factor alpha
Time frame: from baseline to 12 weeks
high sensitivity-C-reactive protein
Time frame: from baseline to 12 weeks
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Time frame: from baseline to 12 weeks
Soluble intercellular adhesion molecule-1 (sICAM-1)
Time frame: from baseline to 12 weeks
Plasminogen activator inhibitor-1
Korea University Anam Hospital
Other
Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects with Prehypertension and Drug-naïve Stage 1 Hypertension: Randomized, Single-blinded Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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