<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/NCT03264443</url>
  </required_header>
  <id_info>
    <org_study_id>17-0044</org_study_id>
    <secondary_id>17-0044</secondary_id>
    <nct_id>NCT03264443</nct_id>
  </id_info>
  <brief_title>Hypertension Approaches in the Elderly: a Lifestyle Study</brief_title>
  <acronym>HAEL</acronym>
  <official_title>Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Two-center randomized, parallel, controlled trial which will compare a pragmatic combined&#xD;
      training program with a health education program in 184 older adults with hypertension. This&#xD;
      study will last 12 weeks with assessments conducted at baseline, previously to the group&#xD;
      allocation, and after interventions. There is a set of secondary outcomes which show clinical&#xD;
      importance to the elderly population and are possibly influenced by the tested intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present protocol describes a randomized controlled trial that aims to evaluate blood&#xD;
      pressure effects of a pragmatic combined training program, with low equipment needs, in&#xD;
      comparison with a health education program. The sample is composed by 184 older adults,&#xD;
      divided in two implementation centers. Randomization ratio will be 1:1 and interventions will&#xD;
      last 12 weeks, with three weekly sessions for the exercise arm and one to the health&#xD;
      education arm. In order to analyze the effects of interventions in a comprehensive way, a&#xD;
      range of variables related to ambulatory blood pressure (primary outcome), physical fitness,&#xD;
      vascular and autonomous function, together with emotional and cognitive aspects will be&#xD;
      evaluated in a pre-post fashion. The study's hypothesis, as well as the sample size&#xD;
      calculation and analysis plan, is based on a superiority expectation for the exercise program&#xD;
      in comparison with the health education program, especially for the blood pressure control,&#xD;
      functional capacity and quality of life. The present study was designed and will be conducted&#xD;
      by a multidisciplinary staff and follows ethical and methodological recommendations for&#xD;
      clinical trials. It is expected that this multicenter randomized trial will provide&#xD;
      scientific evidences with a high applicability to the non-pharmacological management of&#xD;
      hypertension in the elderly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ambulatory Blood Pressure</measure>
    <time_frame>Change from baseline 24-hour systolic blood pressure at 12 weeks</time_frame>
    <description>24h ambulatory blood pressure measured through automatic oscillometric device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking distance</measure>
    <time_frame>Change from baseline walking distance at 12 weeks</time_frame>
    <description>Longest distance walked as assessed by the six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limbs functional capacity</measure>
    <time_frame>Change from baseline SPPB score at 12 weeks</time_frame>
    <description>By using the Short Physical Performance Battery (SPPB), lower-limb mobility will be assess in the following sequence: static standing balance, walking speed and indirect muscle strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Change from baseline VO2peak at 12 weeks</time_frame>
    <description>Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Symptoms</measure>
    <time_frame>Change from baseline GDS-15 score at 12 weeks</time_frame>
    <description>15-item depression symptoms scale (GDS-15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>Change from baseline QoL score at 12 weeks</time_frame>
    <description>World Health Organization Quality of Life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic function</measure>
    <time_frame>Change from baseline beat-to-beat blood pressure variability at 12 weeks</time_frame>
    <description>Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function, early adaptation</measure>
    <time_frame>Change from baseline FMD at 6 weeks</time_frame>
    <description>Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>Change from baseline FMD at 12 weeks</time_frame>
    <description>Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Health education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive weekly lectures on hypertension related topics during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will complete 12 weeks of combined training (aerobic + strength exercise, 3x/week) in a pragmatic setup. In order to make the interventions more similar, contents of the health education arm will also be discussed with patients receiving this intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health education</intervention_name>
    <description>Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.</description>
    <arm_group_label>Health education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combined training</intervention_name>
    <description>Combined training (aerobic and strength exercises), in moderate intensities (perceived exertion controlled) performed 3x/week (1h) duration with a education component (10') based on the contents of the health intervention.</description>
    <arm_group_label>Combined training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension diagnosis (through ambulatory blood pressure monitoring or medication&#xD;
             use)&#xD;
&#xD;
          -  Verified ability to exercise&#xD;
&#xD;
          -  Unaltered pharmacological plan within previous 4 weeks&#xD;
&#xD;
          -  Willingness to participate in any of interventions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or refusal to give written consent&#xD;
&#xD;
          -  Myocardial infarction, revascularization proceedings, deep vein thrombosis&#xD;
&#xD;
          -  Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia,&#xD;
             unstable angina, or use of implantable defibrillator&#xD;
&#xD;
          -  Chronic pulmonary disease which requires the use of oxygen or steroidal therapy&#xD;
&#xD;
          -  Incidence of cardiovascular event, hospitalization or other severe health-related&#xD;
             event during the experimental period&#xD;
&#xD;
          -  High alcohol consumption (over 14 doses per week)&#xD;
&#xD;
          -  Renal disease needing dialysis&#xD;
&#xD;
          -  Language, cognitive or hearing problems&#xD;
&#xD;
          -  Plans of moving to another city during the study&#xD;
&#xD;
          -  Living together with another person enrolled in the study&#xD;
&#xD;
          -  Osteoarticular or muscular injuries or another health conditions which generate&#xD;
             inability to carry on the interventions&#xD;
&#xD;
          -  Progressive neurological disorders (Parkinson, multiple sclerosis, etc.)&#xD;
&#xD;
          -  Cancer treatment in the past 2 years&#xD;
&#xD;
          -  A medical report indicating exercise counterindication based cardiopulmonary exercise&#xD;
             testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie S Pinto, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Umpierre, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Umpierre, PhD</last_name>
    <phone>+555133596332</phone>
    <email>daniel.umpierre@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucas P Santos, MSc</last_name>
    <phone>+555133596332</phone>
    <email>lucaspsantos87@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidade Federal de Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Umpierre, PhD</last_name>
      <phone>+555133596332</phone>
      <email>daniel.umpierre@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Lucas P Santos, PhD</last_name>
      <phone>+555133596332</phone>
      <phone_ext>Santos</phone_ext>
      <email>lucaspsantos87@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>exercise</keyword>
  <keyword>aging</keyword>
  <keyword>older</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>Yes</sharing_ipd>
    <ipd_description>Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. ABPM data and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available.Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration and acceptance of the study team's data sharing terms and policy.</ipd_description>
    <ipd_time_frame>The individual participant dataset will become available at a public repository up to six months after the first study publication.</ipd_time_frame>
    <ipd_access_criteria>A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.</ipd_access_criteria>
  </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/NCT03264443
org study id: 17-0044
secondary id: 17-0044
nct id: NCT03264443
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Two-center randomized, parallel, controlled trial which will compare a pragmatic combined
      training program with a health education program in 184 older adults with hypertension. This
      study will last 12 weeks with assessments conducted at baseline, previously to the group
      allocation, and after interventions. There is a set of secondary outcomes which show clinical
      importance to the elderly population and are possibly influenced by the tested intervention.
The present protocol describes a randomized controlled trial that aims to evaluate blood
      pressure effects of a pragmatic combined training program, with low equipment needs, in
      comparison with a health education program. The sample is composed by 184 older adults,
      divided in two implementation centers. Randomization ratio will be 1:1 and interventions will
      last 12 weeks, with three weekly sessions for the exercise arm and one to the health
      education arm. In order to analyze the effects of interventions in a comprehensive way, a
      range of variables related to ambulatory blood pressure (primary outcome), physical fitness,
      vascular and autonomous function, together with emotional and cognitive aspects will be
      evaluated in a pre-post fashion. The study's hypothesis, as well as the sample size
      calculation and analysis plan, is based on a superiority expectation for the exercise program
      in comparison with the health education program, especially for the blood pressure control,
      functional capacity and quality of life. The present study was designed and will be conducted
      by a multidisciplinary staff and follows ethical and methodological recommendations for
      clinical trials. It is expected that this multicenter randomized trial will provide
      scientific evidences with a high applicability to the non-pharmacological management of
      hypertension in the elderly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Ambulatory Blood Pressure
time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks
description: 24h ambulatory blood pressure measured through automatic oscillometric device
measure: Walking distance
time frame: Change from baseline walking distance at 12 weeks
description: Longest distance walked as assessed by the six-minute walk test
measure: Lower limbs functional capacity
time frame: Change from baseline SPPB score at 12 weeks
description: By using the Short Physical Performance Battery (SPPB), lower-limb mobility will be assess in the following sequence: static standing balance, walking speed and indirect muscle strength
measure: Cardiorespiratory fitness
time frame: Change from baseline VO2peak at 12 weeks
description: Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
measure: Geriatric Depression Symptoms
time frame: Change from baseline GDS-15 score at 12 weeks
description: 15-item depression symptoms scale (GDS-15)
measure: Quality of life (QoL)
time frame: Change from baseline QoL score at 12 weeks
description: World Health Organization Quality of Life questionnaire
measure: Autonomic function
time frame: Change from baseline beat-to-beat blood pressure variability at 12 weeks
description: Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability
measure: Endothelial function, early adaptation
time frame: Change from baseline FMD at 6 weeks
description: Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
measure: Endothelial function
time frame: Change from baseline FMD at 12 weeks
description: Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
arm group label: Health education
arm group type: Active Comparator
description: Patients will receive weekly lectures on hypertension related topics during 12 weeks.
arm group label: Combined training
arm group type: Experimental
description: Patients will complete 12 weeks of combined training (aerobic + strength exercise, 3x/week) in a pragmatic setup. In order to make the interventions more similar, contents of the health education arm will also be discussed with patients receiving this intervention.
intervention type: Behavioral
intervention name: Health education
description: Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
arm group label: Health education
intervention type: Behavioral
intervention name: Combined training
description: Combined training (aerobic and strength exercises), in moderate intensities (perceived exertion controlled) performed 3x/week (1h) duration with a education component (10') based on the contents of the health intervention.
arm group label: Combined training
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Stephanie S Pinto, PhD
role: Study Director
affiliation: Federal University of Pelotas
last name: Daniel Umpierre, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
last name: Daniel Umpierre, PhD
phone: +555133596332
email: daniel.umpierre@gmail.com
last name: Lucas P Santos, MSc
phone: +555133596332
email: lucaspsantos87@gmail.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. ABPM data and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available.Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration and acceptance of the study team's data sharing terms and policy.
ipd time frame: The individual participant dataset will become available at a public repository up to six months after the first study publication.
ipd access criteria: A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.