Diet and Exercise on Ambulatory Blood Pressure

NCT05274971 | Completed

• 1 other identifier: Daphne
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension

Keywords

Prehypertension; aerobic exercise; Dietary management

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Change in arterial stiffness

  from baseline to 12 weeks

• Change in arterial stiffness

  from baseline to 12 weeks

• Change in serum renin level

  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

  from baseline to 12 weeks

Study Arms (2)

Active management group

EXPERIMENTAL

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.

Control group

NO INTERVENTION

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

Interventions

Active dietary management and aerobic exercise training. OTHER

Active dietary management and aerobic exercise training.

Active management group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• The Korean Vascular Research Working Group: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 136705, South Korea

Location

Related Publications (1)

• Lim S, Hong SJ, Kim JH, Cha JJ, Joo HJ, Park JH, Yu CW, Lim DS, Shin JH, Lee JY, Lim YH, Kim SH, Sung KC. Dietary management and aerobic exercise counselling on blood pressure control in subjects with prehypertension and drug-naive stage 1 hypertension: a randomized clinical trial. Sci Rep. 2025 Dec 29;15(1):45683. doi: 10.1038/s41598-025-20828-7.

  PMID: 41462029 DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ki-Chul Sung

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Experimental group versus Control group

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: March 11, 2022
• Study Start: May 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-04

Locations

KR (1)