Diet and Exercise on Ambulatory Blood Pressure

Not Applicable

Completed

Interventions: Other: Active dietary management and aerobic exercise training.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Active management group	Active dietary management and aerobic exercise training.	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.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour ambulatory systolic blood pressure	from baseline to 12 weeks	Change in 24-hour ambulatory systolic blood pressure
Change in office systolic and diastolic blood pressure	from baseline to 12 weeks	Change in office systolic and 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 24-hour ambulatory diastolic blood pressure	from baseline to 12 weeks	Change in 24-hour ambulatory 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 Outcome Measures

Name	Time	Method
Change in arterial stiffness	from baseline to 12 weeks	pulse wave velocity
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	Plasminogen activator inhibitor-1