PrehypertensionNCT05274971
Diet and Exercise on Ambulatory Blood Pressure
A study testing Active dietary management and aerobic exercise training. in people with Prehypertension, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Active dietary management and aerobic exercise training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prehypertension
- Being tested
- Active dietary management and aerobic exercise training.
- Keywords
- Prehypertension, aerobic exercise, Dietary management
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active dietary management and aerobic exercise training.Other
Active dietary management and aerobic exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Active management group | Experimental | 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. Receives: Other: Active dietary management and aerobic exercise training. |
| Control group | No intervention | Subjects will not receive education and recommendation of dietary management and aerobic exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour ambulatory systolic blood pressure
Change in 24-hour ambulatory systolic blood pressure
Measured: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
Measured: from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
Change in daytime ambulatory systolic and diastolic blood pressure
Measured: from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
Change in nighttime ambulatory systolic and diastolic blood pressure
Measured: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
Change in office systolic and diastolic blood pressure
Measured: from baseline to 12 weeks
Secondary outcomes (11)
Change in arterial stiffness
augmentation index
Measured: from baseline to 12 weeks
Change in arterial stiffness
pulse wave velocity
Measured: from baseline to 12 weeks
Change in serum renin level
Change in serum renin level
Measured: from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
Change in serum angiotensin converting enzyme (ACE) level
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
interleukin-6
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
interleukin-18
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Tumour Necrosis Factor alpha
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
high sensitivity-C-reactive protein
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Soluble intercellular adhesion molecule-1 (sICAM-1)
Measured: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Plasminogen activator inhibitor-1
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start15 May 2022
- Primary completion1 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group versus Control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Vascular Research Working Group
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
- Investigators
- Ki-Chul Sung, Study chair, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274971
- Sponsor's protocol ID
- Daphne
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lim S, Hong SJ, Kim JH, Cha JJ, Joo HJ, Park JH, Yu CW, Lim DS, Shin JH, Lee JY, Lim YH, Kim SH, Sung KC. Dietary management and aerobic exercise counselling on blood pressure control in subjects with prehypertension and drug-naive stage 1 hypertension: a randomized clinical trial. Sci Rep. 2025 Dec 29;15(1):45683. doi: 10.1038/s41598-025-20828-7.
PubMed 41462029
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05274971
- Acronym / sponsor ID
- Daphne
- Conditions
- Prehypertension
- Keywords
- Prehypertension, aerobic exercise, Dietary management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- The Korean Vascular Research Working Group
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group versus Control group
| Arm | Type | Receives |
|---|---|---|
| Active management group | Experimental | Other: Active dietary management and aerobic exercise training.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. |
| Control group | No intervention | –Subjects will not receive education and recommendation of dietary management and aerobic exercise training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active dietary management and aerobic exercise training.Active dietary management and aerobic exercise training. | Other | Active management group |
Primary outcome
Change in 24-hour ambulatory systolic blood pressure
Time frame: from baseline to 12 weeks
Change in 24-hour ambulatory systolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
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
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
Change in office systolic and diastolic blood pressure
Time frame: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
11 secondary outcomes
Change in arterial stiffness
Time frame: from baseline to 12 weeks
Change in arterial stiffness
Time frame: from baseline to 12 weeks
Change in serum renin level
Time frame: from baseline to 12 weeks
Change in serum angiotensin converting enzyme (ACE) level
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Change in circulating endothelial and inflammatory biomarkers
Time frame: from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 41462029Lim S, Hong SJ, Kim JH, Cha JJ, Joo HJ, Park JH, Yu CW, Lim DS, Shin JH, Lee JY, Lim YH, Kim SH, Sung KC. Dietary management and aerobic exercise counselling on blood pressure control in subjects with prehypertension and drug-naive stage 1 hypertension: a randomized clinical trial. Sci Rep. 2025 Dec 29;15(1):45683. doi: 10.1038/s41598-025-20828-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Chul Sung study chair
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active dietary management and aerobic exercise training. in people with Prehypertension, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour ambulatory systolic blood pressure (time frame: from baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.