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NCT Number: NCT05274971

Diet and Exercise on Ambulatory Blood Pressure

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, 136705, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active dietary management and aerobic exercise training.

Other

Active dietary management and aerobic exercise training.

Primary outcomes

  1. Change in 24-hour ambulatory systolic blood pressure

    Time frame: from baseline to 12 weeks

    Change in 24-hour ambulatory systolic blood pressure

  2. Change in 24-hour ambulatory diastolic blood pressure

    Time frame: from baseline to 12 weeks

    Change in 24-hour ambulatory diastolic blood pressure

  3. 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

  4. 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

  5. Change in office systolic and diastolic blood pressure

    Time frame: from baseline to 12 weeks

    Change in office systolic and diastolic blood pressure

Secondary outcomes

  1. Change in arterial stiffness

    Time frame: from baseline to 12 weeks

    augmentation index

  2. Change in arterial stiffness

    Time frame: from baseline to 12 weeks

    pulse wave velocity

  3. Change in serum renin level

    Time frame: from baseline to 12 weeks

    Change in serum renin level

  4. Change in serum angiotensin converting enzyme (ACE) level

    Time frame: from baseline to 12 weeks

    Change in serum angiotensin converting enzyme (ACE) level

  5. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    interleukin-6

  6. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    interleukin-18

  7. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    Tumour Necrosis Factor alpha

  8. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    high sensitivity-C-reactive protein

  9. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)

  10. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    Soluble intercellular adhesion molecule-1 (sICAM-1)

  11. Change in circulating endothelial and inflammatory biomarkers

    Time frame: from baseline to 12 weeks

    Plasminogen activator inhibitor-1

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • The Korean Vascular Research Working Group

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 11, 2022
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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