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

NCT02670681 | Unknown

• 1 other identifier: 0602/14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Resistant Hypertension

Keywords

Exercise; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vasodilator Response

  Pre and post-intervention (8 weeks)

• Autonomic Modulation

  Pre and post-intervention (8 weeks)

• Baroreflex Sensitivity

  Pre and post-intervention (8 weeks)

Study Arms (3)

Aerobic Exercise Mild Intensity

ACTIVE COMPARATOR

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

Aerobic Exercise Moderate Intensity

ACTIVE COMPARATOR

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

Aerobic Exercise High Intensity

ACTIVE COMPARATOR

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

Interventions

Aerobic Exercise Training BEHAVIORAL

8 week of aerobic exercise training in different intensities.

Aerobic Exercise High Intensity; Aerobic Exercise Mild Intensity; Aerobic Exercise Moderate Intensity

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Physical Training Study Laboratory Applied to Health; Departament of Physical Education

João Pessoa, Paraíba, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28578691 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leone Severino do Nascimento, Universidade Federal da Paraíba

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 2, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)