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

Not Applicable

• Conditions: Resistant Hypertension; Hypertension
• Interventions: Behavioral: Aerobic Exercise Training

• Registration Number: NCT02670681
• Lead Sponsor: Federal University of Paraíba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18
• Primary Completion: 2018-10
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Mild Intensity	Aerobic Exercise Training	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.
Aerobic Exercise Moderate Intensity	Aerobic Exercise Training	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.
Aerobic Exercise High Intensity	Aerobic Exercise Training	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.

Primary Outcome Measures

Name	Time	Method
Systolic, diastolic and media blood pressure	Pre and post-intervention (8 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Autonomic Modulation	Pre and post-intervention (8 weeks)	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.
Baroreflex Sensitivity	Pre and post-intervention (8 weeks)	Improve in baroreflex sensitivity, assess by alpha index, verified by increased of 10% in sensitivity in measurements pre and post-intervention with physical exercise.
Vasodilator Response	Pre and post-intervention (8 weeks)	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.

Trial Locations

Locations (1)

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