PrehypertensionPREHTEXVASNCT04200716
Arterial Function After Two Different Physical Exercise Intensities in Prehypertension
A study testing Moderate intensity continuous training - session and High intensity interval training - session in people with Prehypertension and Masked Hypertension, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Masked Hypertension
- What is being tested?
- Moderate intensity continuous training - session and High intensity interval training - session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jul 2018to Jul 2023
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
São Paulo
About this study
Official title: Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial
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.
Read the detailed description
The measurement of central pressure and pulse wave velocity are achieved by three follow devices: Complior® , Sphygmocor® and Arteriograph®. The heart rate variability is achieved by Polar® device.
- Conditions
- Prehypertension, Masked Hypertension
- Being tested
- Moderate intensity continuous training - session, High intensity interval training - session
- Keywords
- Arterial function, Physical exercise, Arterial stiffness, Ambulatory Measurement of Blood Pressure
- Medical subject headings
- Prehypertension, Masked Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity continuous training - sessionBehavioural
Moderate exercise continuous exercise 30 minuts session
High intensity interval training - sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity continuous training - session | Active comparator | The volunteers perform a 30-minute moderate-intensity exercise session on the exercise bike. Receives: Behavioral: Moderate intensity continuous training - session; Behavioral: High intensity interval training - session |
| High intensity interval training - session | Active comparator | The volunteers perform a session of high intensity interval exercise on the exercise bike. Receives: Behavioral: Moderate intensity continuous training - session; Behavioral: High intensity interval training - session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in arterial stiffness by piezoelectric method (Complior)
Changes in arterial function behavior in response to two different physical exercise intensities.
Measured: 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.
Measured: Baseline.
Secondary outcomes (4)
Changes in heart rate variability
Changes in heart rate variability
Measured: Baseline, immediately after exercise and 24 hours after exercise
Ambulatory systolic blood pressure measurement
Ambulatory measurement of 24-hours ambulatory systolic blood pressure
Measured: During 24 hours after each exercise session
Ambulatory diastolic blood pressure measurement
Ambulatory measurement of 24-hours ambulatory diastolic blood pressure
Measured: During 24 hours after each exercise session
Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric
Changes in arterial function behavior in response to two different physical exercise intensities by three methods.
Measured: Baseline, immediately after exercise and 24 hours after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start3 Jul 2018
- Primary completion31 Oct 2021
- Study completionJul 2023 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Luiz Aparecido Bortolotto, University of Sao Paulo General Hospital
- Investigators
- Luiz Bortolotto, Principal investigator, Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200716
- Sponsor's protocol ID
- 72503117.0.0000.0068
- Other IDs
- 165778/2017-2
- Acronym
- PREHTEXVAS
- Status last verified
- Jan 2023
- First submitted
- 31 Oct 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40175098
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04200716
- Acronym / sponsor ID
- PREHTEXVAS / 72503117.0.0000.0068
- Conditions
- Prehypertension, Masked Hypertension
- Keywords
- Arterial function, Physical exercise, Arterial stiffness, Ambulatory Measurement of Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 Dec 2019 (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.
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.
Detailed description
The measurement of central pressure and pulse wave velocity are achieved by three follow devices: Complior® , Sphygmocor® and Arteriograph®. The heart rate variability is achieved by Polar® device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity continuous training - session | Active comparator | Behavioral: Moderate intensity continuous training - session, Behavioral: High intensity interval training - sessionThe volunteers perform a 30-minute moderate-intensity exercise session on the exercise bike. |
| High intensity interval training - session | Active comparator | Behavioral: Moderate intensity continuous training - session, Behavioral: High intensity interval training - sessionThe volunteers perform a session of high intensity interval exercise on the exercise bike. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Moderate intensity continuous training - sessionModerate exercise continuous exercise 30 minuts session | Behavioural | High intensity interval training - session, Moderate intensity continuous training - session |
| High intensity interval training - sessionThe 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. | Behavioural | High intensity interval training - session, Moderate intensity continuous training - session |
Primary outcome
Changes in arterial stiffness by piezoelectric method (Complior)
Time frame: Baseline, immediately after exercise and 24 hours after exercise
Changes in arterial function behavior in response to two different physical exercise intensities.
Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric
Time frame: Baseline.
Comparison of methods of evaluation of early markers of cardiovascular disease.
4 secondary outcomes
Changes in heart rate variability
Time frame: Baseline, immediately after exercise and 24 hours after exercise
Ambulatory systolic blood pressure measurement
Time frame: During 24 hours after each exercise session
Ambulatory diastolic blood pressure measurement
Time frame: During 24 hours after each exercise session
Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric
Time frame: Baseline, immediately after exercise and 24 hours after exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 40175098Rodrigues 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.
Related trials for Prehypertension
Not yet recruiting
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event
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.
Luiz Bortolotto principal investigator
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity continuous training - session and High intensity interval training - session in people with Prehypertension and Masked Hypertension, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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 Brazil. 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?
Results are not available in the source record.
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?
Changes in arterial stiffness by piezoelectric method (Complior) (time frame: Baseline, immediately after exercise and 24 hours after exercise). The study lists 2 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 NCT04200716, 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 31 Jan 2023.