<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/NCT03041610</url>
  </required_header>
  <id_info>
    <org_study_id>Walking in HFrEF</org_study_id>
    <nct_id>NCT03041610</nct_id>
  </id_info>
  <brief_title>Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction</brief_title>
  <official_title>Effect of Pedometer-Based Walking Intervention on Functional Capacity and Neurohumoral Modulation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Hradec Kralove</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Olomouc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tomas Bata Hospital, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charles University, Czech Republic</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>
      A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically&#xD;
      inactive participants with chronic heart failure with reduced ejection fraction will be&#xD;
      randomly assigned to intervention or control arms.&#xD;
&#xD;
      The six-month intervention will consist of an individualized pedometer-based walking program&#xD;
      with weekly step goals, monthly face-to-face sessions with the physician, and monthly&#xD;
      telephone calls with the research nurse. The intervention will be based on effective&#xD;
      behavioral principles (goal setting, self-monitoring, personalized feedback).&#xD;
&#xD;
      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes&#xD;
      include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,&#xD;
      average daily step count measured by accelerometry, anthropometric measures, symptoms of&#xD;
      depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional capacity</measure>
    <time_frame>6 months</time_frame>
    <description>functional capacity change measured with 6-minute walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional capacity</measure>
    <time_frame>12 months</time_frame>
    <description>functional capacity change measured with 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-proBNP</measure>
    <time_frame>6 months</time_frame>
    <description>N-terminal pro-B-type natriuretic peptide levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hsCRP</measure>
    <time_frame>6 months</time_frame>
    <description>high-sensitivity C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary congestion</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>assessed by ultrasound detection of B-lines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>average daily step count measured over 7 days by ActiGraph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>assessed with the Beck Depression Inventory-II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>assessed with the 36-Item Short Form Health Survey (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-efficacy</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>assessed with the Czech version of the General Self-Efficacy scale (DOVE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>calculated by dividing the body weight (kg) by the square of the height (m2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>recorded with a measurement tape to the nearest 0.1 cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hip circumference</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>recorded with a measurement tape to the nearest 0.1 cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>method to predict survival in heart failure patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Systolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Walking intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking intervention</intervention_name>
    <description>The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.</description>
    <arm_group_label>Walking intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of heart failure with reduced ejection fraction (left ventricular ejection&#xD;
             fraction &lt;40%) with New York Heart Association (NYHA) class II or III symptoms.&#xD;
&#xD;
          2. Physically inactive, as determined by a question &quot;As a rule, do you do at least half&#xD;
             an hour of moderate or vigorous exercise (such as walking or a sport) on five or more&#xD;
             days of the week?&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort&#xD;
             angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks&#xD;
             delivered by the automated implantable cardioverter defibrillator.&#xD;
&#xD;
          2. Co-morbid conditions that would affect adherence to trial procedures (e.g.&#xD;
             inflammatory arthritis, active malignancy, renal disease requiring dialysis,&#xD;
             uncontrolled diabetes, major depression or other significant psychiatric disorders,&#xD;
             cognitive impairment, significant hearing or visual impairment).&#xD;
&#xD;
          3. Major surgery planned within the next 12 months.&#xD;
&#xD;
          4. Life expectancy shorter than 12 months.&#xD;
&#xD;
          5. Inability to walk from any reason.&#xD;
&#xD;
          6. Baseline six-minute walking distance &gt;450 meters. Patients covering more than 450&#xD;
             meters in the baseline six-minute walk test (6MWT) are excluded due to a possible&#xD;
             ceiling effect.&#xD;
&#xD;
          7. Pregnancy.&#xD;
&#xD;
          8. Failure to perform the 6MWT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Belohlavek, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles University, Czech Republic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Belohlavek, Ass. Prof.</last_name>
    <phone>+420724371594</phone>
    <email>Jan.Belohlavek@vfn.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>General University Hospital in Prague</name>
      <address>
        <city>Prague</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Belohlavek</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 14, 2018</last_update_submitted>
  <last_update_submitted_qc>May 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Jan Belohlavek</investigator_full_name>
    <investigator_title>Ass. Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</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/NCT03041610
org study id: Walking in HFrEF
nct id: NCT03041610
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically
      inactive participants with chronic heart failure with reduced ejection fraction will be
      randomly assigned to intervention or control arms.

      The six-month intervention will consist of an individualized pedometer-based walking program
      with weekly step goals, monthly face-to-face sessions with the physician, and monthly
      telephone calls with the research nurse. The intervention will be based on effective
      behavioral principles (goal setting, self-monitoring, personalized feedback).

      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes
      include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,
      average daily step count measured by accelerometry, anthropometric measures, symptoms of
      depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: functional capacity
time frame: 6 months
description: functional capacity change measured with 6-minute walk test
measure: functional capacity
time frame: 12 months
description: functional capacity change measured with 6-minute walk test
measure: NT-proBNP
time frame: 6 months
description: N-terminal pro-B-type natriuretic peptide levels
measure: hsCRP
time frame: 6 months
description: high-sensitivity C-reactive protein
measure: pulmonary congestion
time frame: 6 and 12 months
description: assessed by ultrasound detection of B-lines
measure: physical activity
time frame: 6 and 12 months
description: average daily step count measured over 7 days by ActiGraph
measure: depression
time frame: 6 and 12 months
description: assessed with the Beck Depression Inventory-II
measure: health-related quality of life
time frame: 6 and 12 months
description: assessed with the 36-Item Short Form Health Survey (SF-36)
measure: self-efficacy
time frame: 6 and 12 months
description: assessed with the Czech version of the General Self-Efficacy scale (DOVE)
measure: body mass index
time frame: 6 and 12 months
description: calculated by dividing the body weight (kg) by the square of the height (m2).
measure: waist circumference
time frame: 6 and 12 months
description: recorded with a measurement tape to the nearest 0.1 cm
measure: hip circumference
time frame: 6 and 12 months
description: recorded with a measurement tape to the nearest 0.1 cm
measure: Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
time frame: 6 and 12 months
description: method to predict survival in heart failure patients
arm group label: Walking intervention
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Walking intervention
description: The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.
arm group label: Walking intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Belohlavek, Ass. Prof.
role: Principal Investigator
affiliation: Charles University, Czech Republic
last name: Jan Belohlavek, Ass. Prof.
phone: +420724371594
email: Jan.Belohlavek@vfn.cz
facility: 
status: Recruiting
contact: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Jan Belohlavek
investigator title: Ass. Prof.
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
sharing ipd: No