Diet and Exercise on Ambulatory Blood Pressure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prehypertension

Intervention / Treatment
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* Other: Active dietary management and aerobic exercise training.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group versus Control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active management group<br>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.<br>* Active dietary management and aerobic exercise training.<br>|
| No Intervention: Control group<br>Subjects will not receive education and recommendation of dietary management and aerobic exercise training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arterial stiffness | augmentation index | from baseline to 12 weeks | 
| Change in arterial stiffness | pulse wave velocity | from baseline to 12 weeks | 
| Change in serum renin level | Change in serum renin level | from baseline to 12 weeks | 
| Change in serum angiotensin converting enzyme (ACE) level | Change in serum angiotensin converting enzyme (ACE) level | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | interleukin-6 | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | interleukin-18 | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | Tumour Necrosis Factor alpha | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | high sensitivity-C-reactive protein | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | Soluble intercellular adhesion molecule-1 (sICAM-1) | from baseline to 12 weeks | 
| Change in circulating endothelial and inflammatory biomarkers | Plasminogen activator inhibitor-1 | from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehypertension, aerobic exercise, Dietary management