Diet and Exercise on Ambulatory Blood Pressure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active management group 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.
Active dietary management and aerobic exercise training.
|
| No Intervention: Control group Subjects will not receive education and recommendation of dietary management and aerobic exercise training. |
Outcome Measures
Primary Outcome Measures
- Change in 24-hour ambulatory systolic blood pressure [from baseline to 12 weeks]
Change in 24-hour ambulatory systolic blood pressure
- Change in 24-hour ambulatory diastolic blood pressure [from baseline to 12 weeks]
Change in 24-hour ambulatory diastolic blood pressure
- Change in daytime ambulatory systolic and diastolic blood pressure [from baseline to 12 weeks]
Change in daytime ambulatory systolic and diastolic blood pressure
- Change in nighttime ambulatory systolic and diastolic blood pressure [from baseline to 12 weeks]
Change in nighttime ambulatory systolic and diastolic blood pressure
- Change in office systolic and diastolic blood pressure [from baseline to 12 weeks]
Change in office systolic and diastolic blood pressure
Secondary Outcome Measures
- Change in arterial stiffness [from baseline to 12 weeks]
augmentation index
- Change in arterial stiffness [from baseline to 12 weeks]
pulse wave velocity
- Change in serum renin level [from baseline to 12 weeks]
Change in serum renin level
- Change in serum angiotensin converting enzyme (ACE) level [from baseline to 12 weeks]
Change in serum angiotensin converting enzyme (ACE) level
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
interleukin-6
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
interleukin-18
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
Tumour Necrosis Factor alpha
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
high sensitivity-C-reactive protein
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
Soluble intercellular adhesion molecule-1 (sICAM-1)
- Change in circulating endothelial and inflammatory biomarkers [from baseline to 12 weeks]
Plasminogen activator inhibitor-1
Eligibility Criteria
Criteria
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
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Patients without previous use of anti-hypertensive medication within 4 weeks of enrollment
Exclusion Criteria:
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Patients under anti-hypertensive medications
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Patients with suspected or confirmed secondary hypertension
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Patients with abnormal liver function tests (transaminases more than three times the upper limit of normal)
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Patients without aerobic exercise tolerance
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Patients under hormone replacement therapy or other steroids
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Patients with peripheral edemas and/or baseline serum creatinine level above 2.0 mg/dL
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Patients with medical conditions that potentially affect blood pressure, including neurological disorders, gastrointestinal diseases, or malignancy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Korea University Anam Hospital
- The Korean Vascular Research Working Group
Investigators
- Study Chair: Ki-Chul Sung, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Daphne