<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/NCT02223962</url>
  </required_header>
  <id_info>
    <org_study_id>S55086</org_study_id>
    <secondary_id>ML8991</secondary_id>
    <nct_id>NCT02223962</nct_id>
  </id_info>
  <brief_title>Effects of Physical Activity Counseling After an Exacerbation in COPD</brief_title>
  <official_title>The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant&#xD;
      a hospitalization. During the hospitalization, patients are extremely physically inactive&#xD;
      with only a limited recovery one month after discharge. Physical inactivity is associated&#xD;
      with negative health benefits. Therefore intervening in the period after and exacerbation&#xD;
      seems useful to improve the levels of physical activity. Physical activity counseling and&#xD;
      real-time feedback have already been applied in stable patients with COPD, with beneficial&#xD;
      effects.The present study will investigate whether this specific intervention will help to&#xD;
      improve the activity level in patients after an acute exacerbation. Further we investigated&#xD;
      the effects of the intervention on improvements in functional exercise capacity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the informed consent, the patients will be randomized into a control group,&#xD;
      receiving usual care, or the intervention group receiving real-time feedback and physical&#xD;
      activity counseling.&#xD;
&#xD;
      Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts&#xD;
      based on the step count from the Fitbit Ultra. In agreement with the patient and based on the&#xD;
      step counts a patients provided, a new goal for the next week was set. The goal was to strive&#xD;
      for the highest possible level of physical activity during one month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in physical activity</measure>
    <time_frame>1 month</time_frame>
    <description>The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in functional exercise capacity</measure>
    <time_frame>1 month</time_frame>
    <description>Functional exercise capacity was measured by the six minutes walking distance test (6MWD; meter). This measurement was performed at baseline and after 1 month.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.</description>
    <arm_group_label>Physical activity</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  Chronic Obstructive Lung Disease (Tiff&lt;70%)&#xD;
&#xD;
          -  Hospitalized because of exacerbation&#xD;
&#xD;
          -  Capable of working with electronic devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopedic/Neurologic problems making it difficult to be active&#xD;
&#xD;
          -  Participation in a rehabilitation program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 4, 2013</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>April 30, 2015</last_update_submitted>
  <last_update_submitted_qc>April 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Marc Decramer</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>COPD</keyword>
  <keyword>activity monitors</keyword>
  <!-- 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/NCT02223962
org study id: S55086
secondary id: ML8991
nct id: NCT02223962
lead sponsor: 
has dmc: No
Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant
      a hospitalization. During the hospitalization, patients are extremely physically inactive
      with only a limited recovery one month after discharge. Physical inactivity is associated
      with negative health benefits. Therefore intervening in the period after and exacerbation
      seems useful to improve the levels of physical activity. Physical activity counseling and
      real-time feedback have already been applied in stable patients with COPD, with beneficial
      effects.The present study will investigate whether this specific intervention will help to
      improve the activity level in patients after an acute exacerbation. Further we investigated
      the effects of the intervention on improvements in functional exercise capacity.
After signing the informed consent, the patients will be randomized into a control group,
      receiving usual care, or the intervention group receiving real-time feedback and physical
      activity counseling.

      Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts
      based on the step count from the Fitbit Ultra. In agreement with the patient and based on the
      step counts a patients provided, a new goal for the next week was set. The goal was to strive
      for the highest possible level of physical activity during one month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Improvement in physical activity
time frame: 1 month
description: The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.
measure: Improvement in functional exercise capacity
time frame: 1 month
description: Functional exercise capacity was measured by the six minutes walking distance test (6MWD; meter). This measurement was performed at baseline and after 1 month.
arm group label: Physical activity
arm group type: Experimental
description: The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.
arm group label: Usual Care
arm group type: Placebo Comparator
description: During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.
intervention type: Behavioral
intervention name: Physical activity
description: Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
arm group label: Physical activity
arm group label: Usual Care
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Marc Decramer
investigator title: Prof. Dr.