Effects of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects

Effects of Different Intensities of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects

The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. After, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. In both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Resistant Hypertension
• Intervention / Treatment: Behavioral: Aerobic Exercise Training

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraíba
    • Joao Pessoa, Paraíba, Brazil
      • Physical Training Study Laboratory Applied to Health; Departament of Physical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 40 and 70 years
• Men or women
• Body mass index under 40 kg / m²
• Able to participate in exercise
• No regular physically active in the last 4 months

Exclusion Criteria:

- Smoking; with history of ischemic stroke or hemorrhagic; or coronary heart disease; or obstructive pulmonary disease or chronic restrictive; or diabetes mellitus; or chronic atrial fibrillation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic Exercise Mild Intensity; The subjects engage in aerobic exercise training (8 weeks) of mild intensity (continuous). The intensity is controlled by a corresponding heart rate at anaerobic threshold.	Behavioral: Aerobic Exercise Training; 8 week of aerobic exercise training in different intensities.
Active Comparator: Aerobic Exercise Moderate Intensity; The subjects engage in aerobic exercise training (8 weeks) of moderate intensity (continuous). The intensity is controlled by a corresponding heart rate between anaerobic threshold and respiratory compensation point.	Behavioral: Aerobic Exercise Training; 8 week of aerobic exercise training in different intensities.
Active Comparator: Aerobic Exercise High Intensity; The subjects engage in aerobic exercise (8 weeks) of high intensity interval training. The intensity is controlled by a corresponding heart rate above respiratory compensation point.	Behavioral: Aerobic Exercise Training; 8 week of aerobic exercise training in different intensities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic, diastolic and media blood pressure	Control in blood pressure levels, assess by the method of Ambulatory Blood Pressure Monitoring (ABPM), from decrease of blood pressure in measurements pre and post-intervention with physical exercise.	Pre and post-intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasodilator Response	Improve in vasodilator response, assess by the method of venous occlusion plethysmography, verified by increased of 10% in blood flow in measurements pre and post-intervention with physical exercise. Improve in vasodilator response, assess by the method of venous occlusion plethysmography, verified by incresead of 10% in blood flow in measurements pre and post-intervention with physical exercise.	Pre and post-intervention (8 weeks)
Autonomic Modulation	Improve in autonomic modulation, assess by spectral analysis, verified by increased of 10% parasympathetic modulation and/or by decrease of 10% of sympathetic modulation in measurements pre and post-intervention with physical exercise.	Pre and post-intervention (8 weeks)
Baroreflex Sensitivity	Improve in baroreflex sensitivity, assess by alpha index, verified by increased of 10% in sensitivity in measurements pre and post-intervention with physical exercise.	Pre and post-intervention (8 weeks)

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Publications and helpful links

General Publications

• Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Aerobic Exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 0602/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data are not the most important points of this study, but the results for the overall sample (external validity of the results found).