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Diet and Exercise on Ambulatory Blood Pressure

Primary Purpose

Prehypertension

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active dietary management and aerobic exercise training.
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Prehypertension, aerobic exercise, Dietary management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-80 years
  • Prehypertension defined as a systolic blood pressure of 130 to 139 mm Hg and/or a diastolic blood pressure of 85 to 89 mm Hg
  • Patients without previous use of anti-hypertensive medication within 4 weeks of enrollment

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.

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active management group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in 24-hour ambulatory systolic blood pressure
Change in 24-hour ambulatory systolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
Change in daytime ambulatory systolic and diastolic blood pressure
Change in daytime ambulatory systolic and diastolic blood pressure
Change in nighttime ambulatory systolic and diastolic blood pressure
Change in nighttime ambulatory systolic and diastolic blood pressure
Change in office systolic and diastolic blood pressure
Change in office systolic and diastolic blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2022
Last Updated
March 20, 2023
Sponsor
Korea University Anam Hospital
Collaborators
The Korean Vascular Research Working Group
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1. Study Identification

Unique Protocol Identification Number
NCT05274971
Brief Title
Diet and Exercise on Ambulatory Blood Pressure
Official Title
Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects With Prehypertension: Randomized, Single-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
The Korean Vascular Research Working Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
While most guidelines defined arterial hypertension when office blood pressure(BP) ≥140/90 mmHg, epidemiological and observational studies showed that cardiovascular risk increases progressively from blood pressure levels as low as 115/75 mmHg and that prehypertension is likely to progress to hypertension. Regular aerobic exercise training is thought to be the cornerstone therapy for the prevention and treatment of hypertension. 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 have been also recommended in subjects with prehypertension 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Prehypertension, aerobic exercise, Dietary management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group versus Control group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active management group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects will not receive education and recommendation of dietary management and aerobic exercise training.
Intervention Type
Other
Intervention Name(s)
Active dietary management and aerobic exercise training.
Intervention Description
Active dietary management and aerobic exercise training.
Primary Outcome Measure Information:
Title
Change in 24-hour ambulatory systolic blood pressure
Description
Change in 24-hour ambulatory systolic blood pressure
Time Frame
from baseline to 12 weeks
Title
Change in 24-hour ambulatory diastolic blood pressure
Description
Change in 24-hour ambulatory diastolic blood pressure
Time Frame
from baseline to 12 weeks
Title
Change in daytime ambulatory systolic and diastolic blood pressure
Description
Change in daytime ambulatory systolic and diastolic blood pressure
Time Frame
from baseline to 12 weeks
Title
Change in nighttime ambulatory systolic and diastolic blood pressure
Description
Change in nighttime ambulatory systolic and diastolic blood pressure
Time Frame
from baseline to 12 weeks
Title
Change in office systolic and diastolic blood pressure
Description
Change in office systolic and diastolic blood pressure
Time Frame
from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in arterial stiffness
Description
augmentation index
Time Frame
from baseline to 12 weeks
Title
Change in arterial stiffness
Description
pulse wave velocity
Time Frame
from baseline to 12 weeks
Title
Change in serum renin level
Description
Change in serum renin level
Time Frame
from baseline to 12 weeks
Title
Change in serum angiotensin converting enzyme (ACE) level
Description
Change in serum angiotensin converting enzyme (ACE) level
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
interleukin-6
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
interleukin-18
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
Tumour Necrosis Factor alpha
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
high sensitivity-C-reactive protein
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
Soluble intercellular adhesion molecule-1 (sICAM-1)
Time Frame
from baseline to 12 weeks
Title
Change in circulating endothelial and inflammatory biomarkers
Description
Plasminogen activator inhibitor-1
Time Frame
from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Prehypertension defined as a systolic blood pressure of 130 to 139 mm Hg and/or a diastolic blood pressure of 85 to 89 mm Hg Patients without previous use of anti-hypertensive medication within 4 weeks of enrollment 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soon Jun Hong
Phone
82-2-920-5445, 5625
Email
psyche94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Chul Sung
Organizational Affiliation
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subin Lim

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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