<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/NCT02209207</url>
  </required_header>
  <id_info>
    <org_study_id>Walking trial 2014</org_study_id>
    <nct_id>NCT02209207</nct_id>
  </id_info>
  <brief_title>Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study</brief_title>
  <official_title>Continuous Versus Interval Walking Training in Patients With Severe Chronic Obstructive Pulmonary Disease - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the effects of interval walking training versus continuous&#xD;
      walking training in patients with chronic obstructive pulmonary disease. Patients will be&#xD;
      recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized&#xD;
      to one of the two intervention groups. All walking training sessions will be performed on the&#xD;
      same treadmill. Walking intensity in the continuous walking group will be 60 percent of the&#xD;
      average speed of the 6-minute walking test. Patients in the interval training group will&#xD;
      perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds&#xD;
      alternating with 60 seconds of rest. The total exercise duration will be progressively&#xD;
      increased from 10 to 32 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>perceived exertion for dyspnea during walking training</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>measured via modified Borg scale (0 to 10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate during walking training</measure>
    <time_frame>day 1 to 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived exertion for leg fatigue (Borg-scale)</measure>
    <time_frame>during three weeks of rehabilitation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation during walking training</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>measured via pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fat free mass in kilogram</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>measured via Bioimpedance Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>forced expiratory volume in 1 second (FEV1) in liter</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>measured by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sit-to-stand-test</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walking test</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>the best 6-minute walking test out of two tests on admission and at discharge will be taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 item short-form health Survey (SF-36)</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>questionnaire for disease unspecific quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic respiratory questionnaire (CRQ)</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>disease specific quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital anxiety and depression scale (HADS)</measure>
    <time_frame>day 1 to 21</time_frame>
    <description>questionnaire on symptoms of anxiety and depression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Obstructive Airway Disease</condition>
  <arm_group>
    <arm_group_label>Continuous walking training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interval walking training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>n=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treadmill</intervention_name>
    <arm_group_label>Continuous walking training</arm_group_label>
    <arm_group_label>Interval walking training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>walking training</intervention_name>
    <arm_group_label>Continuous walking training</arm_group_label>
    <arm_group_label>Interval walking training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD stage III or IV according to the Global Initiative for chronic obstructive lung&#xD;
             disease [GOLD]&#xD;
&#xD;
          -  stationary patient in the Schön Klinik Berchtesgadener Land&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute, severe exacerbation of COPD&#xD;
&#xD;
          -  failure to comply with study process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Schön Klinik Berchtesgadener Land</name>
      <address>
        <city>Schönau am Königssee</city>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Klaus Kenn</investigator_full_name>
    <investigator_title>Head physican (department of pneumology)</investigator_title>
  </responsible_party>
  <keyword>chronic obstructive pulmonary disease</keyword>
  <keyword>endurance training</keyword>
  <keyword>interval training</keyword>
  <keyword>continuous training</keyword>
  <keyword>walking training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02209207
org study id: Walking trial 2014
nct id: NCT02209207
lead sponsor: 
has dmc: No
This study will investigate the effects of interval walking training versus continuous
      walking training in patients with chronic obstructive pulmonary disease. Patients will be
      recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized
      to one of the two intervention groups. All walking training sessions will be performed on the
      same treadmill. Walking intensity in the continuous walking group will be 60 percent of the
      average speed of the 6-minute walking test. Patients in the interval training group will
      perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds
      alternating with 60 seconds of rest. The total exercise duration will be progressively
      increased from 10 to 32 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: perceived exertion for dyspnea during walking training
time frame: day 1 to 21
description: measured via modified Borg scale (0 to 10)
measure: heart rate during walking training
time frame: day 1 to 21
measure: perceived exertion for leg fatigue (Borg-scale)
time frame: during three weeks of rehabilitation
measure: Oxygen saturation during walking training
time frame: day 1 to 21
description: measured via pulse oximeter
measure: fat free mass in kilogram
time frame: day 1 to 21
description: measured via Bioimpedance Analysis
measure: forced expiratory volume in 1 second (FEV1) in liter
time frame: day 1 to 21
description: measured by spirometry
measure: Sit-to-stand-test
time frame: day 1 to 21
description: 5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible
measure: 6-minute walking test
time frame: day 1 to 21
description: the best 6-minute walking test out of two tests on admission and at discharge will be taken
measure: 36 item short-form health Survey (SF-36)
time frame: day 1 to 21
description: questionnaire for disease unspecific quality of life
measure: chronic respiratory questionnaire (CRQ)
time frame: day 1 to 21
description: disease specific quality of life questionnaire
measure: hospital anxiety and depression scale (HADS)
time frame: day 1 to 21
description: questionnaire on symptoms of anxiety and depression
arm group label: Continuous walking training
arm group type: Active Comparator
description: n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed
arm group label: Interval walking training
arm group type: Active Comparator
description: n=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest
intervention type: Device
intervention name: Treadmill
arm group label: Continuous walking training
arm group label: Interval walking training
intervention type: Other
intervention name: walking training
arm group label: Continuous walking training
arm group label: Interval walking training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Head physican (department of pneumology)
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive