Prehypertension
Conditions
Keywords
Prehypertension, aerobic exercise, Dietary management
Brief summary
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.
Detailed description
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.
Interventions
OTHERActive dietary management and aerobic exercise training.
Active dietary management and aerobic exercise training.
Sponsors
The Korean Vascular Research Working Group
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Experimental group versus Control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-80 years * Prehypertension or grade 1 hypertension, defined as a systolic blood pressure of 130 to 159 mm Hg and/or a diastolic blood pressure of 85 to 99 mm Hg * Patients without previous use of anti-hypertensive medication
Exclusion criteria
* Patients under anti-hypertensive medications * Patients with suspected or confirmed secondary hypertension * Patients with abnormal liver function tests (transaminases more than three times the upper limit of normal) * Patients without aerobic exercise tolerance * Patients under hormone replacement therapy or other steroids * Patients with peripheral edemas and/or baseline serum creatinine level above 2.0 mg/dL * Patients with medical conditions that potentially affect blood pressure, including neurological disorders, gastrointestinal diseases, or malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in office systolic and diastolic blood pressure | from baseline to 12 weeks | Change in office systolic and diastolic blood pressure |
| Change in 24-hour ambulatory systolic blood pressure | from baseline to 12 weeks | Change in 24-hour ambulatory systolic blood pressure |
| Change in 24-hour ambulatory diastolic blood pressure | from baseline to 12 weeks | Change in 24-hour ambulatory diastolic blood pressure |
| Change in daytime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks | Change in daytime ambulatory systolic and diastolic blood pressure |
| Change in nighttime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks | Change in nighttime ambulatory systolic and diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum renin level | from baseline to 12 weeks | Change in serum renin level |
| Change in serum angiotensin converting enzyme (ACE) level | from baseline to 12 weeks | Change in serum angiotensin converting enzyme (ACE) level |
| Change in circulating endothelial and inflammatory biomarkers | from baseline to 12 weeks | interleukin-6 |
| Change in arterial stiffness | from baseline to 12 weeks | augmentation index |
Countries
South Korea
Outcome results
None listed