CompletedNot Applicable

Diet and Exercise on Ambulatory Blood Pressure

South Korea70 participantsStarted 2022-05-15

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in 24-hour ambulatory systolic blood pressure

Timeframe: from baseline to 12 weeks

Change in 24-hour ambulatory diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in daytime ambulatory systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in nighttime ambulatory systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in office systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks

Trial details

NCT IDNCT05274971

SponsorKorea University Anam Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Prehypertension trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in 24-hour ambulatory systolic blood pressure

Timeframe: from baseline to 12 weeks

Change in 24-hour ambulatory diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in daytime ambulatory systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in nighttime ambulatory systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks

Change in office systolic and diastolic blood pressure

Timeframe: from baseline to 12 weeks