An interventional study of Active dietary management and aerobic exercise training. in Prehypertension, sponsored by Korea University Anam Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Prevention
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.
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Korea University Anam Hospital is the lead sponsor of 112 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Subjects will not receive education and recommendation of dietary management and aerobic exercise training.
Active dietary management and aerobic exercise training.
Change in 24-hour ambulatory systolic blood pressure
Change in 24-hour ambulatory systolic blood pressure
Time frame: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
Change in daytime ambulatory systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
Change in nighttime ambulatory systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
Change in office systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in arterial stiffness
augmentation index
Time frame: from baseline to 12 weeks
Change in arterial stiffness
pulse wave velocity
Time frame: from baseline to 12 weeks
Change in serum renin level
Change in serum renin level
Time frame: from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
Change in serum angiotensin converting enzyme (ACE) level
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
interleukin-6
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
interleukin-18
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Tumour Necrosis Factor alpha
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
high sensitivity-C-reactive protein
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Soluble intercellular adhesion molecule-1 (sICAM-1)
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Plasminogen activator inhibitor-1
Time frame: from baseline to 12 weeks
Plan to share: Undecided
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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