<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03282942</url>
  </required_header>
  <id_info>
    <org_study_id>69373217.3.0000.5347</org_study_id>
    <nct_id>NCT03282942</nct_id>
  </id_info>
  <brief_title>Cardiovascular Effects of Aerobic and Strength Training in Hypertensive Middle-aged Individuals</brief_title>
  <official_title>Effects of Aerobic or Strength Training on Cardiovascular, Endothelial Response, and Blood Flow in Hypertensive Middle Ages Individuals: a Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood&#xD;
      pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors&#xD;
      associated with cardiovascular disease is critical, as such factors are related alteration of&#xD;
      endothelial vasodilator response leading to progressive loss of its protective function.&#xD;
      However, endothelial dysfunction related to hypertension is not only related to the decrease&#xD;
      in the bioavailability of endothelium relaxants, but also to the time of presence of&#xD;
      hypertension, increased production of vessel contraction factors and oxidative stress related&#xD;
      to the disease. In this way, physical training presents as a non-drug strategy capable of&#xD;
      directly and indirectly influencing the pathophysiology of hypertension. In this way the&#xD;
      objective of the present work will be to evaluate the acute and chronic effect of aerobic&#xD;
      exercise and strength on blood pressure, blood markers of vasodilation and vascular&#xD;
      endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and&#xD;
      oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks&#xD;
      of training. Study hypothesis: The expected results of the research are that the endothelial&#xD;
      response of biochemical markers of vasodilation and vasoconstriction will change positively&#xD;
      after aerobic and strength training and the responses will be similar when compared between&#xD;
      groups. There will be an improvement in the antioxidant capacity in both groups and the&#xD;
      magnitude of the hypotensive effect will be greater in the aerobic group when compared to&#xD;
      control and strength.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>End of 12-week exercise period</time_frame>
    <description>24-h Ambulatory blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endothelial Function</measure>
    <time_frame>End of 12-week exercise period</time_frame>
    <description>Flow mediated dilation to reactive hyperemia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endothelium derived factors</measure>
    <time_frame>End of 12-week exercise period</time_frame>
    <description>The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory Profile</measure>
    <time_frame>End of 12-week exercise period</time_frame>
    <description>The inflammatory profile was accessed trough the cytokines and chemokines levels</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>Exercise training protocols</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomized in one of TWO groups: aerobic training group (AT) or strength training group (ST). Each training protocol will last 12 weeks, being the initial two weeks designed to participants' gradual adaptations to respective training protocol, with sessions performed three times per week in non-consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The individuals who will be part of the control group will be instructed to follow their daily activities, avoiding any systematic exercise program and return to the end of the 12 weeks for reevaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength training group</intervention_name>
    <description>Individuals in the strength training group will perform exercises based on exercises with free weights and equipment, for upper and lower limbs with a weekly frequency of three times for twelve weeks. The periodization will start with 2 sets, 15 - 20 repetitions, passive rest of 120 seconds, exercises performed alternating by segments and the intensity of 50% of maximum repetition. After twelve weeks the periodization will be finished with 3 sets, 8-12 repetitions, passive rest of 120 seconds, exercises performed alternated by segments and the intensity of 70% of maximum repetition.&#xD;
The following exercises will compose the strength training protocol:&#xD;
Squatting&#xD;
Leg press&#xD;
Knee Extension&#xD;
Knee Flexion&#xD;
Supine Challenge&#xD;
High Pull&#xD;
Elbow flexion&#xD;
Extension of elbows&#xD;
Development&#xD;
Abdominal</description>
    <arm_group_label>Exercise training protocols</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training Group</intervention_name>
    <description>Individuals in the aerobic training group will perform aerobic treadmill exercise three times a week for twelve weeks. The training prescription will be performed through the percentage of maximum oxygen consumption with intensity in 60% to 80% with an average duration of 50 minutes of continuous exercise.</description>
    <arm_group_label>Exercise training protocols</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Study inclusion criteria consisted of the following: 1) Individuals should use&#xD;
        antihypertensive medication; 2) 30-59 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The following aspects were regarded as exclusion criteria: 1) body mass index (BMI) up to&#xD;
        40 kg/m2; 2) regular engagement in any type of physical exercise training in the past 6&#xD;
        months prior to inclusion in the study; 3) symptomatic peripheral arterial occlusive&#xD;
        disease; 4) aortic insufficiency or stenosis more than stage I; 5) hypertrophic obstructive&#xD;
        cardiomyopathy; 6) congestive heart failure (&gt;NYHA II); 7) uncontrolled cardiac arrhythmia&#xD;
        with hemodynamic relevance; 7) change of antihypertensive medication in the past 4 weeks&#xD;
        prior to inclusion in the study; 8) indication of unstable coronary artery disease. 9) use&#xD;
        of tobacco products.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alvaro Reischak-Oliveira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Alvaro Reischak-Oliveira</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>Aerobic training</keyword>
  <keyword>Strength training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03282942
org study id: 69373217.3.0000.5347
nct id: NCT03282942
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood
      pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors
      associated with cardiovascular disease is critical, as such factors are related alteration of
      endothelial vasodilator response leading to progressive loss of its protective function.
      However, endothelial dysfunction related to hypertension is not only related to the decrease
      in the bioavailability of endothelium relaxants, but also to the time of presence of
      hypertension, increased production of vessel contraction factors and oxidative stress related
      to the disease. In this way, physical training presents as a non-drug strategy capable of
      directly and indirectly influencing the pathophysiology of hypertension. In this way the
      objective of the present work will be to evaluate the acute and chronic effect of aerobic
      exercise and strength on blood pressure, blood markers of vasodilation and vascular
      endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and
      oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks
      of training. Study hypothesis: The expected results of the research are that the endothelial
      response of biochemical markers of vasodilation and vasoconstriction will change positively
      after aerobic and strength training and the responses will be similar when compared between
      groups. There will be an improvement in the antioxidant capacity in both groups and the
      magnitude of the hypotensive effect will be greater in the aerobic group when compared to
      control and strength.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Blood pressure
time frame: End of 12-week exercise period
description: 24-h Ambulatory blood pressure
measure: Endothelial Function
time frame: End of 12-week exercise period
description: Flow mediated dilation to reactive hyperemia
measure: Endothelium derived factors
time frame: End of 12-week exercise period
description: The plasma levels of NOx and ET-1 will be determined by enzyme-linked immunosorbent assay
measure: Inflammatory Profile
time frame: End of 12-week exercise period
description: The inflammatory profile was accessed trough the cytokines and chemokines levels
arm group label: Exercise training protocols
arm group type: Experimental
description: Participants will be randomized in one of TWO groups: aerobic training group (AT) or strength training group (ST). Each training protocol will last 12 weeks, being the initial two weeks designed to participants' gradual adaptations to respective training protocol, with sessions performed three times per week in non-consecutive days.
arm group label: Control Group
arm group type: No Intervention
description: The individuals who will be part of the control group will be instructed to follow their daily activities, avoiding any systematic exercise program and return to the end of the 12 weeks for reevaluation.
intervention type: Other
intervention name: Strength training group
description: Individuals in the strength training group will perform exercises based on exercises with free weights and equipment, for upper and lower limbs with a weekly frequency of three times for twelve weeks. The periodization will start with 2 sets, 15 - 20 repetitions, passive rest of 120 seconds, exercises performed alternating by segments and the intensity of 50% of maximum repetition. After twelve weeks the periodization will be finished with 3 sets, 8-12 repetitions, passive rest of 120 seconds, exercises performed alternated by segments and the intensity of 70% of maximum repetition.
The following exercises will compose the strength training protocol:
Squatting
Leg press
Knee Extension
Knee Flexion
Supine Challenge
High Pull
Elbow flexion
Extension of elbows
Development
Abdominal
arm group label: Exercise training protocols
intervention type: Other
intervention name: Aerobic Training Group
description: Individuals in the aerobic training group will perform aerobic treadmill exercise three times a week for twelve weeks. The training prescription will be performed through the percentage of maximum oxygen consumption with intensity in 60% to 80% with an average duration of 50 minutes of continuous exercise.
arm group label: Exercise training protocols
criteria: 
gender: All
minimum age: 30 Years
maximum age: 59 Years
healthy volunteers: No
last name: Alvaro Reischak-Oliveira, PhD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Alvaro Reischak-Oliveira
investigator title: Principal Investigator
mesh term: Hypertension