Arterial Function After Two Different Physical Exercise Intensities in Prehypertension

NCT ID: NCT04200716

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Prehypertension Masked Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate intensity continuous training - session

The volunteers perform a 30-minute moderate-intensity exercise session on the exercise bike.

Group Type ACTIVE_COMPARATOR

Moderate intensity continuous training - session

Intervention Type BEHAVIORAL

Moderate exercise continuous exercise 30 minuts session

High intensity interval training - session

Intervention Type BEHAVIORAL

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.

High intensity interval training - session

The volunteers perform a session of high intensity interval exercise on the exercise bike.

Group Type ACTIVE_COMPARATOR

Moderate intensity continuous training - session

Intervention Type BEHAVIORAL

Moderate exercise continuous exercise 30 minuts session

High intensity interval training - session

Intervention Type BEHAVIORAL

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.

Interventions

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Moderate intensity continuous training - session

Moderate exercise continuous exercise 30 minuts session

Intervention Type BEHAVIORAL

High intensity interval training - 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luiz Aparecido Bortolotto

Director of Hypertension Unity Professor of Cardiology Department of Medical School São Paulo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luiz Bortolotto

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

Locations

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Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 40175098 (View on PubMed)

Other Identifiers

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165778/2017-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

72503117.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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