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

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ClinicalTrials.gov Identifier: NCT02670681
Recruitment Status : Unknown
Verified July 2018 by Leone Severino do Nascimento, Federal University of Paraíba.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Leone Severino do Nascimento, 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.

Condition or disease Intervention/treatment Phase
Hypertension Resistant Hypertension Behavioral: Aerobic Exercise Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Different Intensities of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects
Study Start Date : November 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Systolic, diastolic and media blood pressure [ Time Frame: 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 :
  1. Vasodilator Response [ Time Frame: 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.


  2. Autonomic Modulation [ Time Frame: 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.

  3. Baroreflex Sensitivity [ Time Frame: 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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670681


Locations
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Brazil
Physical Training Study Laboratory Applied to Health; Departament of Physical Education
Joao Pessoa, Paraíba, Brazil
Sponsors and Collaborators
Federal University of Paraíba
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leone Severino do Nascimento, Leone Severino do Nascimento, Universidade Federal da Paraíba, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02670681    
Other Study ID Numbers: 0602/14
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).
Keywords provided by Leone Severino do Nascimento, Federal University of Paraíba:
Exercise
Aerobic Exercise
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases