<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/NCT02249507</url>
  </required_header>
  <id_info>
    <org_study_id>13-0309</org_study_id>
    <secondary_id>13-0309</secondary_id>
    <nct_id>NCT02249507</nct_id>
  </id_info>
  <brief_title>Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Trial</brief_title>
  <official_title>Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aerobic exercise has the potential to diminish blood pressure values. The aim of this study&#xD;
      is to determine whether this potential is also applicable for those with resistant&#xD;
      hypertension and whether exercise intensity plays a role in this context. We hypothesize that&#xD;
      performing an aerobic exercise session reduces blood pressure values in resistant&#xD;
      hypertensive patients in a dose-response relation with exercise intensity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise prescription is gathering great importance in preventive health. Several&#xD;
      organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk&#xD;
      of higher intensities in order to achieve better health parameters in different contexts.&#xD;
      Aerobic exercise is known to be an effective way to diminish BP levels post-session. These&#xD;
      responses are widely applicable in hypertensive subjects, acting in aid of BP management&#xD;
      treatment. Although these benefits of aerobic exercise are well known, few studies explore&#xD;
      the potential of this intervention in resistant-to-treatment patients. Moreover, the effects&#xD;
      different intensities of aerobic exercise in this population is scarce. Thus, the aim of this&#xD;
      study is to determine the magnitude of BP responses, if there is any, of resistant&#xD;
      hypertensive subjects to two different intensities of aerobic exercise, compared with a&#xD;
      control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary&#xD;
      exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax.&#xD;
      Prior and immediately after all intervention sessions (during 1h), forearm blood flow and&#xD;
      reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions,&#xD;
      24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ambulatory Blood Pressure Monitoring</measure>
    <time_frame>22h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forearm blood flow</measure>
    <time_frame>1h</time_frame>
    <description>Accessed by venous occlusion plethysmography. Compared with pre-intervention values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive hyperemia</measure>
    <time_frame>pre and 30min post</time_frame>
    <description>Accessed by venous occlusion plethysmography.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>sited rest for 45 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>higher intensity aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45 minutes of aerobic exercise at 75%HRmax</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lower intensity aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45 minutes of aerobic exercise at 50%HRmax</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)</description>
    <arm_group_label>higher intensity aerobic exercise</arm_group_label>
    <arm_group_label>lower intensity aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        resistant-to-treatment hypertensive subjects (24h ambulatory BP above 130/80, or daytime&#xD;
        ambulatory BP above 135/85, or night-time ambulatory BP above 120/70 in spite use of 3&#xD;
        anti-hypertensive medications of different classes, being one diuretic; or use of 4 or more&#xD;
        anti-hypertensive medications).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Muscle or skeletal abnormalities that preclude effort, abnormal exercise stress test, major&#xD;
        illnesses that would preclude exercise effort or could influence in the outcome variables&#xD;
        (pulmonary disease, valve disease, renal insufficiency, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Umpierre, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Science of Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>August 19, 2015</last_update_submitted>
  <last_update_submitted_qc>August 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Resistant Hypertension</keyword>
  <keyword>Aerobic Exercise</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/NCT02249507
org study id: 13-0309
secondary id: 13-0309
nct id: NCT02249507
lead sponsor: 
has dmc: Yes
Aerobic exercise has the potential to diminish blood pressure values. The aim of this study
      is to determine whether this potential is also applicable for those with resistant
      hypertension and whether exercise intensity plays a role in this context. We hypothesize that
      performing an aerobic exercise session reduces blood pressure values in resistant
      hypertensive patients in a dose-response relation with exercise intensity.
Exercise prescription is gathering great importance in preventive health. Several
      organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk
      of higher intensities in order to achieve better health parameters in different contexts.
      Aerobic exercise is known to be an effective way to diminish BP levels post-session. These
      responses are widely applicable in hypertensive subjects, acting in aid of BP management
      treatment. Although these benefits of aerobic exercise are well known, few studies explore
      the potential of this intervention in resistant-to-treatment patients. Moreover, the effects
      different intensities of aerobic exercise in this population is scarce. Thus, the aim of this
      study is to determine the magnitude of BP responses, if there is any, of resistant
      hypertensive subjects to two different intensities of aerobic exercise, compared with a
      control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary
      exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax.
      Prior and immediately after all intervention sessions (during 1h), forearm blood flow and
      reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions,
      24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Ambulatory Blood Pressure Monitoring
time frame: 22h
measure: Forearm blood flow
time frame: 1h
description: Accessed by venous occlusion plethysmography. Compared with pre-intervention values
measure: Reactive hyperemia
time frame: pre and 30min post
description: Accessed by venous occlusion plethysmography.
arm group label: Control
arm group type: No Intervention
description: sited rest for 45 minutes
arm group label: higher intensity aerobic exercise
arm group type: Experimental
description: 45 minutes of aerobic exercise at 75%HRmax
arm group label: lower intensity aerobic exercise
arm group type: Experimental
description: 45 minutes of aerobic exercise at 50%HRmax
intervention type: Other
intervention name: aerobic exercise
description: aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
arm group label: higher intensity aerobic exercise
arm group label: lower intensity aerobic exercise
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Daniel Umpierre, PhD
role: Principal Investigator
affiliation: Federal University of Health Science of Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hypertension