Diet and Exercise on Ambulatory Blood Pressure

Prehypertension Clinical Trial

Official title:

Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects With Prehypertension: Randomized, Single-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274971
• Other study ID #: Daphne
• Status: Completed
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prehypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	The Korean Vascular Research Working Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour ambulatory systolic blood pressure	Change in 24-hour ambulatory systolic blood pressure	from baseline to 12 weeks
Primary	Change in 24-hour ambulatory diastolic blood pressure	Change in 24-hour ambulatory diastolic blood pressure	from baseline to 12 weeks
Primary	Change in daytime ambulatory systolic and diastolic blood pressure	Change in daytime ambulatory systolic and diastolic blood pressure	from baseline to 12 weeks
Primary	Change in nighttime ambulatory systolic and diastolic blood pressure	Change in nighttime ambulatory systolic and diastolic blood pressure	from baseline to 12 weeks
Primary	Change in office systolic and diastolic blood pressure	Change in office systolic and diastolic blood pressure	from baseline to 12 weeks
Secondary	Change in arterial stiffness	augmentation index	from baseline to 12 weeks
Secondary	Change in arterial stiffness	pulse wave velocity	from baseline to 12 weeks
Secondary	Change in serum renin level	Change in serum renin level	from baseline to 12 weeks
Secondary	Change in serum angiotensin converting enzyme (ACE) level	Change in serum angiotensin converting enzyme (ACE) level	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	interleukin-6	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	interleukin-18	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	Tumour Necrosis Factor alpha	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	high sensitivity-C-reactive protein	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	Soluble intercellular adhesion molecule-1 (sICAM-1)	from baseline to 12 weeks
Secondary	Change in circulating endothelial and inflammatory biomarkers	Plasminogen activator inhibitor-1	from baseline to 12 weeks