Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Inter… (NCT07048509) | Clinical Trial Compass
RecruitingNot Applicable
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Slovenia45 participantsStarted 2025-06-24
Plain-language summary
In this study, the investigators will evaluate acute changes in vascular function measures after moderate-intensity continuous and high-intensity interval exercise in healthy and prehypertensive individuals. Participants will be subjected to three separate visits: control condition (30 min rest), moderate-intensity continuous exercise, and high-intensity interval exercise. The investigators will measure aerobic capacity using a cardiopulmonary exercise test (CPET) using indirect gas-exchange to derive subsequent exercise intensity and maximal oxygen uptake. The investigators will evaluate different measures of vascular function (Pulse-wave velocity, Flow-mediated slowing, microvascular function) before and after each condition.
The study will involve two groups of participants: healthy individuals and prehypertensive individuals. The investigators aim to establish the reliability and validity of less-established methods of vascular function assessment (flow-mediated slowing and microvascular function) against established measures (pulse-wave velocity). The acute response of vascular function to different exercise intensities has not yet been thoroughly researched using the aforementioned measures in individuals with similar characteristics to the proposed study cohort.
Who can participate
Age range
18 Years – 50 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:
Normotensive participants inclusion criteria:
* 18 - 50 years of age, BMI \< 30, blood pressure (BP) within the optimal range according to the latest ESH guidelines (\< 120 mmHg systolic and/or \< 80 mmHg diastolic BP)
* Sedentary or low active according to the Global Physical Activity Questionnaire (GPAQ) (Armstrong \& Bull, 2006; Lim et al., 2012)
* No prescribed medication and absence of chronic diseases
Inclusion criteria for prehypertensive individuals:
* 18 - 50 years of age, BMI \< 30
* Diagnosed prehypertension by a clinican from the Hypertension clinic, University clinical centre of Ljubljana using established criteria
* Sedentary or low or moderately active according to the Global Physical Activity Questionnaire (GPAQ)
* No prescribed medication and absence of chronic diseases
Exclusion Criteria:
* Blood pressure out of the optimal range (normotensives)
* High level of phyisical activity (moderate or high active according to GPAQ)
* Hypotension
* Chronic diseases
* Prescribed medication
* Lower extremity injury in the last six months
* Menopause
* Absence of normal menstrual cycle
* Pregnancy
* Smoking
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
1
Arterial stiffness
Timeframe: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)
2
Microvascular function
Timeframe: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)
3
Flow-mediated slowing
Timeframe: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)