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Status unknownNCT04200716PREHTEXVASUpdated Jan 31, 2023

Arterial Function After Two Different Physical Exercise Intensities in Prehypertension

An interventional study of Moderate intensity continuous training - session and High intensity interval training - session in Prehypertension and Masked Hypertension, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Prehypertension
  • Masked Hypertension

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Keywords

  • Arterial function
  • Physical exercise
  • Arterial stiffness
  • Ambulatory Measurement of Blood Pressure
03

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Active comparator
    Moderate intensity continuous training - session

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

    Behavioral: Moderate intensity continuous training - session · Behavioral: High intensity interval training - session

  • Active comparator
    High intensity interval training - session

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

    Behavioral: Moderate intensity continuous training - session · Behavioral: High intensity interval training - session

Interventions

  • BehavioralModerate intensity continuous training - session

    Moderate exercise continuous exercise 30 minuts session

  • BehavioralHigh 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.

05

What researchers measure

Primary outcomes

  1. Changes in arterial stiffness by piezoelectric method (Complior)

    Changes in arterial function behavior in response to two different physical exercise intensities.

    Time frame: Baseline, immediately after exercise and 24 hours after exercise

  2. Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric

    Comparison of methods of evaluation of early markers of cardiovascular disease.

    Time frame: Baseline.

Secondary outcomes

  1. Changes in heart rate variability

    Changes in heart rate variability

    Time frame: Baseline, immediately after exercise and 24 hours after exercise

  2. Ambulatory systolic blood pressure measurement

    Ambulatory measurement of 24-hours ambulatory systolic blood pressure

    Time frame: During 24 hours after each exercise session

  3. Ambulatory diastolic blood pressure measurement

    Ambulatory measurement of 24-hours ambulatory diastolic blood pressure

    Time frame: During 24 hours after each exercise session

  4. 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.

    Time frame: Baseline, immediately after exercise and 24 hours after exercise.

06

Study locations

1 site
  • Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
    São Paulo, Brazil
07

Registry details

Key details

Study ID
NCT04200716
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Luiz Aparecido Bortolotto (Director of Hypertension Unity Professor of Cardiology Department of Medical School São Paulo University, University of Sao Paulo General Hospital) — Principal investigator
First posted
Dec 16, 2019
Start date
Jul 3, 2018
Primary completion
Oct 31, 2021
Completion
Jul 2023 (estimated)
Last update
Jan 31, 2023

Study contacts

Luiz Bortolotto
principal investigator · Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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