Diet and Exercise on Ambulatory Blood Pressure

Korea University

Status: Completed

Conditions: Prehypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05274971

Daphne

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Active management group

Experimental group

Description:

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.

Treatment:

Other: Active dietary management and aerobic exercise training.

Control group

No Intervention group

Description:

Subjects will not receive education and recommendation of dietary management and aerobic exercise training.