Arterial Function After Two Different Physical Exercise Intensities in Prehypertension
PREHTEXVAS
Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial
2 other identifiers
interventional
22
1 country
1
Brief Summary
Individuals with prehypertension, diagnosed according to the 7th Brazilian Guidelines on Hypertension with the presence of systolic blood pressure (SBP) between 121 and 139 and / or diastolic (DBP) between 81 and 89 mmHg, are more likely to become hypertensive and to develop cardiovascular complications. Moreover, they already have alterations in the function of large arteries that may play a role in the development of the disease in the future. An option in the prevention / treatment of hypertension is the moderate intensity physical training, but high intensity interval training offers the possibility of greater exercise adherence, since it can be performed with less volume and less time spent, with the same benefits than moderate exercise, or even higher, being preferred by the population. Among these benefits, the investigators can mention the post-exercise hypotension (PEH) which occurs in normotensive, prehypertensive, and hypertensive individuals, due the decreased in sympathetic nerve activity and improved in vascular function. Also, selected participants with prehypertension can present a profile of masked hypertension, identified only by 24 hours ambulatory BP monitoring (ABPM). Given the possible differences between vascular responses to exercise intensities, the investigators intend to compare, in prehypertensive patients, the vascular responses of large arteries by noninvasive methods and PEH to a session of high intensity exercise and a session of moderate intensity continuous exercise. In addition, to study some of the possible physiological variables involved in this response by measuring heart rate variability. It is expected to find differences in vascular responses according to the presence of masked hypertension. Twenty two prehypertensive individuals aged between 30 and 60 years of both sexes will be studied. Subjects will perform cardiopulmonary testing and baseline vascular measurements (central pressure and pulse wave velocity measurements by three different methods), as well as 24 -hour ABPM. The vascular measurements will be repeated immediately after, and 24 hours after each session. Each participant will perform the session of one type of exercise in one day, and after three days will perform the other, with random distribution to the sequence of exercise type. Participants will perform 24-hour ABPM prior to exercise and for 24 hours after each exercise session. Data will be compared by appropriate statistical analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2018
CompletedFirst Submitted
Initial submission to the registry
October 31, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJanuary 31, 2023
January 1, 2023
3.3 years
October 31, 2019
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in arterial stiffness by piezoelectric method (Complior)
Changes in arterial function behavior in response to two different physical exercise intensities.
Baseline, immediately after exercise and 24 hours after exercise
Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric
Comparison of methods of evaluation of early markers of cardiovascular disease.
Baseline.
Secondary Outcomes (4)
Changes in heart rate variability
Baseline, immediately after exercise and 24 hours after exercise
Ambulatory systolic blood pressure measurement
During 24 hours after each exercise session
Ambulatory diastolic blood pressure measurement
During 24 hours after each exercise session
Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric
Baseline, immediately after exercise and 24 hours after exercise.
Study Arms (2)
Moderate intensity continuous training - session
ACTIVE COMPARATORThe volunteers perform a 30-minute moderate-intensity exercise session on the exercise bike.
High intensity interval training - session
ACTIVE COMPARATORThe volunteers perform a session of high intensity interval exercise on the exercise bike.
Interventions
Moderate exercise continuous exercise 30 minuts session
The high intensity interval exercise sessions are isocaloric to the moderate intensity continuous exercise, therefore, the necessary exercise time equivalent to 30 minutes of the moderate exercise continuous exercise session was calculated.
Eligibility Criteria
You may qualify if:
- Age ≥30 and ≤60 years old
- Prehypertension, according to the 7 th Brazilian Arterial Hypertension Guideline values
- Both sexes
- Those who agree to sign the free and informed consent form
You may not qualify if:
- Engaged in other studies or programs of physical activity or training
- In drug treatment (for hypertension or other metabolic disease)
- Smokers
- Unable to perform exercise on exercise bike
- Presence of cardiovascular or metabolic disease (eg diabetes, hypercholesterolemia)
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
São Paulo, Brazil
Related Publications (1)
Rodrigues S, Verardino RGS, Costa-Hong V, Jordao CP, Jose Andrade da Costa M, Bortolotto L. Evaluation of vascular responses to moderate-intensity continuous and high-intensity interval physical exercise in subjects with elevated blood pressure: a randomised, cross-over clinical trial. Open Heart. 2025 Apr 2;12(1):e003121. doi: 10.1136/openhrt-2024-003121.
PMID: 40175098DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiz Bortolotto
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Hypertension Unity Professor of Cardiology Department of Medical School São Paulo University
Study Record Dates
First Submitted
October 31, 2019
First Posted
December 16, 2019
Study Start
July 3, 2018
Primary Completion
October 31, 2021
Study Completion
July 1, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01