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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Resistant Hypertension

Intervention / Treatment
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* Behavioral: Aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic Exercise Mild Intensity<br>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<br>* 8 week of aerobic exercise training in different intensities.<br>|
| Active Comparator: Aerobic Exercise Moderate Intensity<br>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<br>* 8 week of aerobic exercise training in different intensities.<br>|
| Active Comparator: Aerobic Exercise High Intensity<br>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<br>* 8 week of aerobic exercise training in different intensities.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Aerobic Exercise