<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/NCT03254225</url>
  </required_header>
  <id_info>
    <org_study_id>CEP1844640</org_study_id>
    <nct_id>NCT03254225</nct_id>
  </id_info>
  <brief_title>Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability</brief_title>
  <official_title>Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluates the inffluence of 16 weeks of resistance training on heart rate&#xD;
      variability of hypertensive elderlies patients. All volunteers will be divided in two groups,&#xD;
      one will participate in a protocol of sixteen weeks of resistance training, an the other will&#xD;
      remain sedentary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study evaluates the inffluence of 16 weeks of resistance training on heart rate&#xD;
      variability using time and frequency-domains by ECG tracks. Will be assessed the blood&#xD;
      pressure using the ambulatory blood pressure monitoring method of hypertensive elderly&#xD;
      patients. All volunteers will be divided in two groups, one will participate in a protocol of&#xD;
      sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal&#xD;
      repetition, an the ontrol group will remain sedentary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2018</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure change due to resistance training</measure>
    <time_frame>16 weeks</time_frame>
    <description>Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - Time domain - change due to resistance training</measure>
    <time_frame>16 weeks</time_frame>
    <description>Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - Frequency domain - change due to resistance training</measure>
    <time_frame>16 weeks</time_frame>
    <description>Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability - Non-linear methods - change due to resistance training</measure>
    <time_frame>16 weeks</time_frame>
    <description>Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Resistance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).</description>
    <arm_group_label>Resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertensives&#xD;
&#xD;
          -  Age 60 to 80 years&#xD;
&#xD;
          -  Nonactive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopedic problems or other problem that prevented the exercises&#xD;
&#xD;
          -  Change in drug treatment during protocol&#xD;
&#xD;
          -  Absence in more than 25% of the exercise sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabio T Montrezol</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fabio Tanil Montrezol</name>
      <address>
        <city>Santos</city>
        <state>Sao Paulo</state>
        <zip>11070061</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Alessandra Medeiros</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Elderly</keyword>
  <keyword>Resistance training</keyword>
  <keyword>Heart rate variability</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/NCT03254225
org study id: CEP1844640
nct id: NCT03254225
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the inffluence of 16 weeks of resistance training on heart rate
      variability of hypertensive elderlies patients. All volunteers will be divided in two groups,
      one will participate in a protocol of sixteen weeks of resistance training, an the other will
      remain sedentary.
This study evaluates the inffluence of 16 weeks of resistance training on heart rate
      variability using time and frequency-domains by ECG tracks. Will be assessed the blood
      pressure using the ambulatory blood pressure monitoring method of hypertensive elderly
      patients. All volunteers will be divided in two groups, one will participate in a protocol of
      sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal
      repetition, an the ontrol group will remain sedentary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood pressure change due to resistance training
time frame: 16 weeks
description: Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
measure: Heart rate variability - Time domain - change due to resistance training
time frame: 16 weeks
description: Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
measure: Heart rate variability - Frequency domain - change due to resistance training
time frame: 16 weeks
description: Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
measure: Heart rate variability - Non-linear methods - change due to resistance training
time frame: 16 weeks
description: Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
arm group label: Resistance training
arm group type: Experimental
description: Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
arm group label: Control
arm group type: No Intervention
description: in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period
intervention type: Behavioral
intervention name: Resistance training
description: Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
arm group label: Resistance training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fabio T Montrezol
role: Principal Investigator
affiliation: Federal University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Alessandra Medeiros
investigator title: Principal Investigator
mesh term: Hypertension
sharing ipd: No