Clinical trial NCT05274971: Diet and Exercise on Ambulatory Blood Pressure
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Keywords: Prehypertension
aerobic exercise
Dietary management
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Vascular Research Working Group
First posted: 2022-03-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group versus Control group
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 24-hour ambulatory systolic blood pressure
timeFrame: from baseline to 12 weeks
measure: Change in 24-hour ambulatory diastolic blood pressure
timeFrame: from baseline to 12 weeks
measure: Change in daytime ambulatory systolic and diastolic blood pressure
timeFrame: from baseline to 12 weeks
measure: Change in nighttime ambulatory systolic and diastolic blood pressure
timeFrame: from baseline to 12 weeks
measure: Change in office systolic and diastolic blood pressure
timeFrame: from baseline to 12 weeks
Secondary outcomes:
measure: Change in arterial stiffness
timeFrame: from baseline to 12 weeks
measure: Change in arterial stiffness
timeFrame: from baseline to 12 weeks
measure: Change in serum renin level
timeFrame: from baseline to 12 weeks
measure: Change in serum angiotensin converting enzyme (ACE) level
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
measure: Change in circulating endothelial and inflammatory biomarkers
timeFrame: from baseline to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
name: Ki-Chul Sung
role: STUDY_CHAIR
References: