<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/NCT01716832</url>
  </required_header>
  <id_info>
    <org_study_id>Walking_Stress_Reduction</org_study_id>
    <nct_id>NCT01716832</nct_id>
  </id_info>
  <brief_title>Walking for Stress Reduction</brief_title>
  <official_title>Effectiveness of Mindfulness Walking on Stress Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <brief_summary>
    <textblock>
      The effectiveness of a mindfulness walking program is tested in subjects with a high level of&#xD;
      subjectively perceived stress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>Cohens Perceived Stress Scale 14 Items</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (SF 36)</measure>
    <time_frame>Baseline, 4 weeks, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Stress Level (Visual Analogue Scale)</measure>
    <time_frame>Baseline, 4 weeks, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of effect on a Likert - Scale</measure>
    <time_frame>4 weeks, 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Mindfulness walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention (waiting list)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Walking</intervention_name>
    <description>Mindful walking in a small group twice a week for 60 minutes within 4 weeks.</description>
    <arm_group_label>Mindfulness walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women between 18 and 65 years&#xD;
&#xD;
          -  Increased level of stress (visual analog scale &gt;40 mm (0-100))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular walking training in the last 6 weeks&#xD;
&#xD;
          -  Medical therapy with psychopharmacological drugs&#xD;
&#xD;
          -  Regular mindfulness based meditations/exercises in the last 6 weeks&#xD;
&#xD;
          -  CAM therapies against stress in the last 6 weeks&#xD;
&#xD;
          -  medium or severe chronic diseases&#xD;
&#xD;
          -  Stress due to chronic diseases&#xD;
&#xD;
          -  Acute disease at inclusion&#xD;
&#xD;
          -  Not being able to walk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charité University Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Benno Brinkhaus</investigator_full_name>
    <investigator_title>Prof. MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01716832
org study id: Walking_Stress_Reduction
nct id: NCT01716832
lead sponsor: 
The effectiveness of a mindfulness walking program is tested in subjects with a high level of
      subjectively perceived stress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cohens Perceived Stress Scale 14 Items
time frame: 4 weeks
measure: Quality of Life (SF 36)
time frame: Baseline, 4 weeks, 12 weeks
measure: Subjective Stress Level (Visual Analogue Scale)
time frame: Baseline, 4 weeks, 12 weeks
measure: Assessment of effect on a Likert - Scale
time frame: 4 weeks, 12 weeks
arm group label: Mindfulness walking
arm group type: Experimental
arm group label: No intervention (waiting list)
arm group type: No Intervention
intervention type: Behavioral
intervention name: Mindfulness Walking
description: Mindful walking in a small group twice a week for 60 minutes within 4 weeks.
arm group label: Mindfulness walking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Benno Brinkhaus
investigator title: Prof. MD