Diet and Exercise on Ambulatory Blood Pressure

NCT ID: NCT05274971

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2024-02-01

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.

Conditions

Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Active management group

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.

Group Type: EXPERIMENTAL

Active dietary management and aerobic exercise training.

Intervention Type: OTHER

Active dietary management and aerobic exercise training.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active dietary management and aerobic exercise training.

Active dietary management and aerobic exercise training.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Korean Vascular Research Working Group

UNKNOWN

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soon Jun Hong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ki-Chul Sung

Role: STUDY_CHAIR

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea

Locations

Korea University Anam Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

Daphne

Identifier Type: -

Identifier Source: org_study_id