Diet and Exercise on Ambulatory Blood Pressure

October 23, 2024 updated by: Soon Jun Hong, Korea University Anam Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 24-hour ambulatory systolic blood pressure
Time Frame: from baseline to 12 weeks
Change in 24-hour ambulatory systolic blood pressure
from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
Time Frame: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
Time Frame: from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
Time Frame: from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
Time Frame: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in arterial stiffness
Time Frame: from baseline to 12 weeks
augmentation index
from baseline to 12 weeks
Change in arterial stiffness
Time Frame: from baseline to 12 weeks
pulse wave velocity
from baseline to 12 weeks
Change in serum renin level
Time Frame: from baseline to 12 weeks
Change in serum renin level
from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
Time Frame: from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
interleukin-6
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
interleukin-18
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
Tumour Necrosis Factor alpha
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
high sensitivity-C-reactive protein
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
Soluble intercellular adhesion molecule-1 (sICAM-1)
from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time Frame: from baseline to 12 weeks
Plasminogen activator inhibitor-1
from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Korean Vascular Research Working Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ki-Chul Sung, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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