Diet and Exercise on Ambulatory Blood Pressure

Korea University Anam Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Prehypertension

Interventions

Active dietary management and aerobic exercise training.OTHER

Active dietary management and aerobic exercise training.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea