Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals

NCT07048509 | Recruiting

• 3 other identifiers: 0120-63/2025-2711-3802-15/2023-5005-1/2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prehypertension (Elevated Blood Pressure) or Hypertension; Healthy

Keywords

aerobic exercise; vascular function; prehypertension

Outcome Measures

Primary Outcomes (3)

• Arterial stiffness

  Arterial stiffness will be measured by pulse wave velocity

  At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

• Microvascular function

  Microvascular function will be mesured using near-infrared spectroscopy during and after a 5-minute occlusion of the brachial artery.

  At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

• Flow-mediated slowing

  Flow-mediated slowing will be measured by pulse wave velocity deceleration after occlusion of the brachial artery.

  At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

Secondary Outcomes (3)

• Aerobic capacity

  Baseline

• Blood pressure

  Baseline

• Blood markers

  At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

Study Arms (2)

Normotensive

PLACEBO COMPARATOR

Normotensives with ambulatory blood pressure measurements within the optimal range according to the 2023 ESH guidelines

Other: Control-no treatment; Other: Exercise

Prehypertensive

ACTIVE COMPARATOR

Prehypertensives with blood pressure within 120-139 mmHg systolic and/or 80-89 diastolic.

Other: Control-no treatment; Other: Exercise

Interventions

Control-no treatment OTHER

30 minutes of rest

Normotensive; Prehypertensive

Exercise OTHER

30 minutes of Moderate-Intensity Continuous Exercise

Normotensive; Prehypertensive

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University of Ljubljana, Faculty of sport

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Armin H Paravlic, PhD

CONTACT

+386015207840; armin.paravlic@fsp.uni-lj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective double-blind crossover randomized study design

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 2, 2025
• Study Start: June 24, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

SL (1)