Diet and Exercise on Ambulatory Blood Pressure

Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects with Prehypertension and Drug-naïve Stage 1 Hypertension: Randomized, Single-blinded Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Prehypertension
• Intervention / Treatment: Other: Active dietary management and aerobic exercise training.

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136705
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Active dietary management and aerobic exercise training.; Active dietary management and aerobic exercise training.
No Intervention: Control group; Subjects will not receive education and recommendation of dietary management and aerobic exercise training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-hour ambulatory systolic blood pressure	Change in 24-hour ambulatory systolic blood pressure	from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure	Change in 24-hour ambulatory diastolic blood pressure	from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure	Change in daytime ambulatory systolic and diastolic blood pressure	from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure	Change in nighttime ambulatory systolic and diastolic blood pressure	from baseline to 12 weeks
Change in office systolic and diastolic blood pressure	Change in office systolic and diastolic blood pressure	from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in arterial stiffness	augmentation index	from baseline to 12 weeks
Change in arterial stiffness	pulse wave velocity	from baseline to 12 weeks
Change in serum renin level	Change in serum renin level	from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level	Change in serum angiotensin converting enzyme (ACE) level	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	interleukin-6	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	interleukin-18	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	Tumour Necrosis Factor alpha	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	high sensitivity-C-reactive protein	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	Soluble intercellular adhesion molecule-1 (sICAM-1)	from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers	Plasminogen activator inhibitor-1	from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: The Korean Vascular Research Working Group
• Investigators: Study Chair: Ki-Chul Sung, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Prehypertension; aerobic exercise; Dietary management
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Prehypertension
• Other Study ID Numbers: DAPHNE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No