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Arterial Function After Two Different Physical Exercise Intensities in Prehypertension (PREHTEXVAS)

Primary Purpose

Prehypertension, Masked Hypertension

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Moderate intensity continuous training - session
High intensity interval training - session
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Arterial function, Physical exercise, Arterial stiffness, Ambulatory Measurement of Blood Pressure

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moderate intensity continuous training - session

High intensity interval training - session

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in arterial stiffness by piezoelectric method (Complior)
Changes in arterial function behavior in response to two different physical exercise intensities.
Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric
Comparison of methods of evaluation of early markers of cardiovascular disease.

Secondary Outcome Measures

Changes in heart rate variability
Changes in heart rate variability
Ambulatory systolic blood pressure measurement
Ambulatory measurement of 24-hours ambulatory systolic blood pressure
Ambulatory diastolic blood pressure measurement
Ambulatory measurement of 24-hours ambulatory diastolic blood pressure
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.

Full Information

First Posted
October 31, 2019
Last Updated
January 30, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT04200716
Brief Title
Arterial Function After Two Different Physical Exercise Intensities in Prehypertension
Acronym
PREHTEXVAS
Official Title
Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Masked Hypertension
Keywords
Arterial function, Physical exercise, Arterial stiffness, Ambulatory Measurement of Blood Pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate intensity continuous training - session
Arm Type
Active Comparator
Arm Description
The volunteers perform a 30-minute moderate-intensity exercise session on the exercise bike.
Arm Title
High intensity interval training - session
Arm Type
Active Comparator
Arm Description
The volunteers perform a session of high intensity interval exercise on the exercise bike.
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity continuous training - session
Intervention Description
Moderate exercise continuous exercise 30 minuts session
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training - session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in arterial stiffness by piezoelectric method (Complior)
Description
Changes in arterial function behavior in response to two different physical exercise intensities.
Time Frame
Baseline, immediately after exercise and 24 hours after exercise
Title
Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric
Description
Comparison of methods of evaluation of early markers of cardiovascular disease.
Time Frame
Baseline.
Secondary Outcome Measure Information:
Title
Changes in heart rate variability
Description
Changes in heart rate variability
Time Frame
Baseline, immediately after exercise and 24 hours after exercise
Title
Ambulatory systolic blood pressure measurement
Description
Ambulatory measurement of 24-hours ambulatory systolic blood pressure
Time Frame
During 24 hours after each exercise session
Title
Ambulatory diastolic blood pressure measurement
Description
Ambulatory measurement of 24-hours ambulatory diastolic blood pressure
Time Frame
During 24 hours after each exercise session
Title
Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric
Description
Changes in arterial function behavior in response to two different physical exercise intensities by three methods.
Time Frame
Baseline, immediately after exercise and 24 hours after exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Bortolotto
Organizational Affiliation
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

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Arterial Function After Two Different Physical Exercise Intensities in Prehypertension

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