<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/NCT03003780</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000368</org_study_id>
    <nct_id>NCT03003780</nct_id>
  </id_info>
  <brief_title>Mindful Steps: Promoting Physical Activity</brief_title>
  <official_title>Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a developmental project with two phases. The first phase will adapt an existing&#xD;
      web-based intervention to incorporate mind-body exercises to develop a multi-modal&#xD;
      intervention to promote physical activity in patients with COPD and HF. The second phase will&#xD;
      pilot test this new intervention in a longitudinal study (subjects randomized to intervention&#xD;
      or usual care).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">July 6, 2021</completion_date>
  <primary_completion_date type="Actual">July 6, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>6 months</time_frame>
    <description>intervention acceptability (qualitative interview)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>baseline, months 3, 6, 9 and 12</time_frame>
    <description>change in self-efficacy between time points (exercise self-efficacy scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>baseline, months 3,6,9, and 12</time_frame>
    <description>change in physical activity between time points (physical activity questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Copd</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Mindful Steps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Web-based behavioral intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Steps</intervention_name>
    <description>Integrated website, activity tracker, and mind-body training</description>
    <arm_group_label>Mindful Steps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of COPD OR clinical diagnosis of HF syndrome (New York Heart&#xD;
             Association Class 1-3)&#xD;
&#xD;
          -  Able to participate in an exercise program&#xD;
&#xD;
          -  Have an active email account and access to a computer with internet connection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COPD or HF exacerbation in the previous month&#xD;
&#xD;
          -  Inability to ambulate&#xD;
&#xD;
          -  Clinical signs of unstable cardiovascular disease&#xD;
&#xD;
          -  Hypoxemia during 6MWT&#xD;
&#xD;
          -  Inability to collect at least 7 of 14 days of baseline step counts&#xD;
&#xD;
          -  Current participation in a cardiac or pulmonary rehabilitation program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BIDMC</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Gloria Y. Yeh</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03003780
org study id: 2016P000368
nct id: NCT03003780
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a developmental project with two phases. The first phase will adapt an existing
      web-based intervention to incorporate mind-body exercises to develop a multi-modal
      intervention to promote physical activity in patients with COPD and HF. The second phase will
      pilot test this new intervention in a longitudinal study (subjects randomized to intervention
      or usual care).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility
time frame: 6 months
description: intervention acceptability (qualitative interview)
measure: Self-efficacy
time frame: baseline, months 3, 6, 9 and 12
description: change in self-efficacy between time points (exercise self-efficacy scale)
measure: Physical activity
time frame: baseline, months 3,6,9, and 12
description: change in physical activity between time points (physical activity questionnaire)
arm group label: Mindful Steps
arm group type: Experimental
description: Web-based behavioral intervention
arm group label: Usual Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Mindful Steps
description: Integrated website, activity tracker, and mind-body training
arm group label: Mindful Steps
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Gloria Y. Yeh
investigator title: Associate Professor of Medicine
mesh term: Heart Failure