Clinical trial NCT04200716: Arterial Function After Two Different Physical Exercise Intensities in Prehypertension
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
Overall status: UNKNOWN
Phase: NA
Conditions: Prehypertension
Masked Hypertension
Keywords: Arterial function
Physical exercise
Arterial stiffness
Ambulatory Measurement of Blood Pressure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in arterial stiffness by piezoelectric method (Complior)
timeFrame: Baseline, immediately after exercise and 24 hours after exercise
measure: Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric
timeFrame: Baseline.
Secondary outcomes:
measure: Changes in heart rate variability
timeFrame: Baseline, immediately after exercise and 24 hours after exercise
measure: Ambulatory systolic blood pressure measurement
timeFrame: During 24 hours after each exercise session
measure: Ambulatory diastolic blood pressure measurement
timeFrame: During 24 hours after each exercise session
measure: Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric
timeFrame: Baseline, immediately after exercise and 24 hours after exercise.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
Study officials:
affiliation: Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
name: Luiz Bortolotto
role: PRINCIPAL_INVESTIGATOR
References: