Effect of Exercise on Endothelial Injury in Hypertensive Patients

April 27, 2020 updated by: Gustavo Waclawovsky, Instituto de Cardiologia do Rio Grande do Sul

Effect of Aerobic Exercise, Resistance or Combined in Endothelial Injury in Hypertensive Patients

Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients with hypertension. Increasing physical activity levels and/or physical exercise are part of the recommendations of antihypertensive therapy. However, the effects of oscillations and/or increase the systemic blood pressure induced by exercise session on endothelial function has not been studied.

Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension.

Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry. Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention. Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10 minutes before, 10, 30 and 60 minutes after the intervention.

Statistics: generalized estimating equation (GEE) for repeated measurements and Person correlation, being significant p < 0.05.

It is expected to show results to ensure cardiovascular protection in patients with hypertension caused by different types of exercise and consequent endothelial injury and release induced regenerative factors. Knowledge of the magnitude of injury and endothelial recovery provided by different types of exercise can contribute scientifically to health professionals aimed at prescribing exercise with a vascular protective vision in patients with hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with hypertension;
  • 30 to 59 years old.

Exclusion Criteria:

  • Diabetes;
  • Heart disease;
  • Participating in any regular exercise program over the last six months;
  • Orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise;
  • Body Mass Index in class II obesity or more (BMI ≥ 35 kg / m2);
  • Smoking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AEROBIC
The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.
Other: AEROBIC
The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.
Other Names:
  • Aerobic exercise
Active Comparator: RESISTANCE
The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60% of a maximum repetition (1-RM) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).
Other: RESISTANCE
The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).
Other Names:
  • Resistance exercise
Active Comparator: COMBINED
The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.
Other: COMBINED
The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.
Other Names:
  • Combined exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of exercise on the percentage of circulating endothelial progenitor cells analyzed by flow cytometry in patients with hypertension
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of exercise on the number of circulating endothelial microparticles analyzed by flow cytometry in patients with hypertension
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endothelial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be presented to participants from lectures.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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