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Clinical Trials/NCT04200716
NCT04200716Active, not recruitingNot Applicable

Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial

University of Sao Paulo General Hospital1 site in 1 country22 target enrollmentStarted: July 3, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
22
Locations
1
Primary Endpoint
Changes in arterial stiffness by piezoelectric method (Complior)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
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

  • •Engaged in other studies or programs of physical activity or training
  • •In drug treatment (for hypertension or other metabolic disease)
  • •Unable to perform exercise on exercise bike
  • •Presence of cardiovascular or metabolic disease (eg diabetes, hypercholesterolemia)

Arms & Interventions

Moderate intensity continuous training - session

Active Comparator

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

Intervention: Moderate intensity continuous training - session (Behavioral)

Moderate intensity continuous training - session

Active Comparator

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

Intervention: High intensity interval training - session (Behavioral)

High intensity interval training - session

Active Comparator

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

Intervention: Moderate intensity continuous training - session (Behavioral)

High intensity interval training - session

Active Comparator

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

Intervention: High intensity interval training - session (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luiz Aparecido Bortolotto

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

University of Sao Paulo General Hospital

Study Sites (1)

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