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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02670681
Other study ID # 0602/14
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date March 2019

Study information

Verified date July 2018
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date March 2019
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic Exercise Training
8 week of aerobic exercise training in different intensities.

Locations

Country Name City State
Brazil Physical Training Study Laboratory Applied to Health; Departament of Physical Education Joao Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
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