<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/NCT02987452</url>
  </required_header>
  <id_info>
    <org_study_id>55942216.4.0000.5404</org_study_id>
    <nct_id>NCT02987452</nct_id>
  </id_info>
  <brief_title>Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects</brief_title>
  <official_title>Hemodynamic, Autonomic and Inflammatory Answers to Different Types of Exercises in Resistant Hypertensive Patients: an Metabolomic Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heitor Moreno Junior</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure&#xD;
      (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic&#xD;
      parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive&#xD;
      (RHTN) patients, have not been investigated yet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and&#xD;
      combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters,&#xD;
      as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive&#xD;
      (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized,&#xD;
      single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10)&#xD;
      regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All&#xD;
      the subjects will be submitted to a previous adaptation of physical activity, especially to&#xD;
      determine the load to be implemented in each patient. Then, the modalities of physical&#xD;
      exercises (aerobic, resistance and combined) will be randomly performed in three isolated&#xD;
      sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45&#xD;
      minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b)&#xD;
      resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate&#xD;
      intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25&#xD;
      minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45&#xD;
      minutes. Body composition (plethysmography) and cardiorespiratory functional capacity&#xD;
      (ergometry) will be determined before the physical training. In addition, the investigators&#xD;
      will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by&#xD;
      pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6,&#xD;
      -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the&#xD;
      physical exercise in its different modalities provides chronic effects on BP in HTN patients,&#xD;
      the investigators hypothesized that the isolated (aerobic and resistance) and combined&#xD;
      exercise can acutely promote changes in BP levels in RHTN patients when compared to the&#xD;
      participants counterparts. Secondarily, some biological mechanisms related to BP control&#xD;
      (vascular function and cytokines production) may also be involved in these possible&#xD;
      alterations. Conclusion: The investigators expect to define whether a physical exercise&#xD;
      program applied to RHTN patients has medical relevance in a realistic clinical setting. These&#xD;
      findings may guide the prescription of physical activity as an additional therapeutic&#xD;
      approach, in order to decrease the cardiovascular risk associated to these subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>systolic blood pressure in mmHg</measure>
    <time_frame>15 minutes</time_frame>
    <description>systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>arterial stiffness</measure>
    <time_frame>baseline and 60 minutes post each intervention</time_frame>
    <description>by pulse wave velocity, Sphygmocor CPV system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ambulatory blood pressure monitoring</measure>
    <time_frame>baseline and post each intervention</time_frame>
    <description>ambulatory blood pressure will be assessed in baseline and post each intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin 6</measure>
    <time_frame>baseline, 60 minutes and 24 hours post each intervention</time_frame>
    <description>interleukin 6 will be assessed by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin 10</measure>
    <time_frame>baseline, 60 minutes and 24 hours post each intervention</time_frame>
    <description>interleukin 10 will be assessed by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor necrosis factor alpha</measure>
    <time_frame>baseline, 60 minutes and 24 hours post each intervention</time_frame>
    <description>tumor necrosis factor alpha will be assessed by ELISA</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>resistance exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combined exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test</description>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_label>combined exercise</arm_group_label>
    <arm_group_label>resistance exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>resistance exercise</intervention_name>
    <description>resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes</description>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_label>combined exercise</arm_group_label>
    <arm_group_label>resistance exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>combined exercise</intervention_name>
    <description>combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes</description>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_label>combined exercise</arm_group_label>
    <arm_group_label>resistance exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)&#xD;
&#xD;
          -  a 6-month period clinic follow-up&#xD;
&#xD;
          -  give written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary Hypertension&#xD;
&#xD;
          -  pseudoresistance hypertension (poor medication adherence and white coat hypertension)&#xD;
&#xD;
          -  patients with symptomatic ischemic heart disease, impaired renal function, liver&#xD;
             disease and history of stroke, myocardial infarction and peripheral vascular diseases,&#xD;
             heart failure&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  regular physical activity&#xD;
&#xD;
          -  mental or physical limitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nayara F. Pires, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campinas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nayara F. Pires, PhD student</last_name>
    <phone>+551935219538</phone>
    <email>nayarafraccari@yahoo.com.br</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Heitor Moreno Junior</investigator_full_name>
    <investigator_title>Full professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>resistant hypertension</keyword>
  <keyword>blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02987452
org study id: 55942216.4.0000.5404
nct id: NCT02987452
lead sponsor: 
has dmc: No
Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure
      (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic
      parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive
      (RHTN) patients, have not been investigated yet.
Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and
      combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters,
      as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive
      (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized,
      single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10)
      regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All
      the subjects will be submitted to a previous adaptation of physical activity, especially to
      determine the load to be implemented in each patient. Then, the modalities of physical
      exercises (aerobic, resistance and combined) will be randomly performed in three isolated
      sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45
      minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b)
      resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate
      intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25
      minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45
      minutes. Body composition (plethysmography) and cardiorespiratory functional capacity
      (ergometry) will be determined before the physical training. In addition, the investigators
      will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by
      pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6,
      -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the
      physical exercise in its different modalities provides chronic effects on BP in HTN patients,
      the investigators hypothesized that the isolated (aerobic and resistance) and combined
      exercise can acutely promote changes in BP levels in RHTN patients when compared to the
      participants counterparts. Secondarily, some biological mechanisms related to BP control
      (vascular function and cytokines production) may also be involved in these possible
      alterations. Conclusion: The investigators expect to define whether a physical exercise
      program applied to RHTN patients has medical relevance in a realistic clinical setting. These
      findings may guide the prescription of physical activity as an additional therapeutic
      approach, in order to decrease the cardiovascular risk associated to these subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: systolic blood pressure in mmHg
time frame: 15 minutes
description: systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.
measure: arterial stiffness
time frame: baseline and 60 minutes post each intervention
description: by pulse wave velocity, Sphygmocor CPV system
measure: ambulatory blood pressure monitoring
time frame: baseline and post each intervention
description: ambulatory blood pressure will be assessed in baseline and post each intervention
measure: interleukin 6
time frame: baseline, 60 minutes and 24 hours post each intervention
description: interleukin 6 will be assessed by ELISA
measure: interleukin 10
time frame: baseline, 60 minutes and 24 hours post each intervention
description: interleukin 10 will be assessed by ELISA
measure: tumor necrosis factor alpha
time frame: baseline, 60 minutes and 24 hours post each intervention
description: tumor necrosis factor alpha will be assessed by ELISA
arm group label: aerobic exercise
arm group type: Experimental
description: Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
arm group label: resistance exercise
arm group type: Active Comparator
description: resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
arm group label: combined exercise
arm group type: Active Comparator
description: combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
intervention type: Other
intervention name: aerobic exercise
description: Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
arm group label: aerobic exercise
arm group label: combined exercise
arm group label: resistance exercise
intervention type: Other
intervention name: resistance exercise
description: resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
arm group label: aerobic exercise
arm group label: combined exercise
arm group label: resistance exercise
intervention type: Other
intervention name: combined exercise
description: combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
arm group label: aerobic exercise
arm group label: combined exercise
arm group label: resistance exercise
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nayara F. Pires, PhD student
role: Principal Investigator
affiliation: University of Campinas
last name: Nayara F. Pires, PhD student
phone: +551935219538
email: nayarafraccari@yahoo.com.br
responsible party type: Sponsor-Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Heitor Moreno Junior
investigator title: Full professor
mesh term: Hypertension
sharing ipd: No