<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/NCT03825497</url>
  </required_header>
  <id_info>
    <org_study_id>H-18027877</org_study_id>
    <nct_id>NCT03825497</nct_id>
  </id_info>
  <brief_title>The WALK-Copenhagen Trial (WALK-Cph): a Mixed Methods Study</brief_title>
  <official_title>WALK-Copenhagen (WALK-Cph): Promoting Physical Activity in Older Adults During Hospitalization and After Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Velux Fonden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danske Fysioterapeuter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</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>
      The WALK-Copenhagen project aims at enhancing physical activity during and after&#xD;
      hospitalization in older medical patients by an intervention developed in co-operation with&#xD;
      key stakeholders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In four phases we will develop (Phase 1), fidelity- and feasibility test (Phase 2), efficacy&#xD;
      test (Phase 3) and adoption test the intervention (Phase 4). The project will use a&#xD;
      combination of qualitative (Phase 1-4) and quantitative methods (Phase 2-3) and consists of&#xD;
      two parallel tracks - WALK-Intervention and WALK-Implementation. Phase 1 of the study has&#xD;
      been completed. Through workshops with patients, relatives, health professionals and&#xD;
      researchers we have developped an intervention to enhance physical activity. Phase 2 will be&#xD;
      carried out in October 2018 and January 2019 at Copenhagen University Hospital Hvidovre and&#xD;
      in February 2019 at Copenhagen University Hospital, Frederiksberg. The developed intervention&#xD;
      will be fidelity tested through daily observations at the wards. Also, the intervention will&#xD;
      be feasibility tested in a prospective cohort study aiming at qualifying the intervention,&#xD;
      testing recruitment strategies, testing patient willingness towards the intervention, testing&#xD;
      randomization and blinding procedures and estimating an inclusion rate for Phase 3&#xD;
      (randomized controlled trial) to be conducted in 2019.&#xD;
&#xD;
      Update March 2019:&#xD;
&#xD;
      Due to a political decision to close down the medical ward at Copenhagen University Hospital,&#xD;
      Frederiksberg in the spring of 2019, it was decided to change Phase 3 to a cohort study at&#xD;
      Copenhagen University Hospital, Hvidovre. This decision was based on the fact that the&#xD;
      methodological setup of the study (cluster RCT) was unintentionally changed due to the close&#xD;
      down of one of the intervention wards.&#xD;
&#xD;
      Update November 2019:&#xD;
&#xD;
      Due to changes in characteristics of patients admitted to the intervention ward and thus a&#xD;
      very slow inclusion rate in Phase 3 (Cohort Study), it was decided to terminate inclusion of&#xD;
      patients. Qualitative data will still be collected as anticipated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">September 25, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 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>
    <intervention_model_description>A feasibility study at Medical Wards (intervention wards) in Oct 2018, January 2019 and February 2019 prior to a cluster randomized trial. Medical wards at 4 different hospitals representing clusters - 2 intervention clusters and 2 control clusters.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>All patients at the intervention wards will receive the intervention why neither investigators nor outcome assessors will be blinded to the intervention. Patients at intervention and control wards will get equal information regarding the study and will be asked to participate in equal assessments</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor</measure>
    <time_frame>Mean number of hours per day spent upright during hospitalization (up to 7 days)</time_frame>
    <description>Between group difference in time spent standing or walking per day (Upright time)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor</measure>
    <time_frame>Mean number of steps per day during hospitalization (up to 7 days)</time_frame>
    <description>Between group difference in number of steps per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor</measure>
    <time_frame>Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days)</time_frame>
    <description>Between group difference time spent lying/sitting per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor</measure>
    <time_frame>Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge</time_frame>
    <description>Between group difference in change in time spent standing or walking per day (Upright time)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor</measure>
    <time_frame>Change in mean number of steps per day between hospitalization and 4 weeks after discharge</time_frame>
    <description>between group difference in change in number of steps per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor</measure>
    <time_frame>Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge</time_frame>
    <description>Between group difference in change in time spent lying/sitting per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Life-Space mobility using The University of Alabama at Birmingham (UAB) Life Space Assessment (a 0-120 point scale with 0 representing low mobility and 120 high mobility)</measure>
    <time_frame>Change in Life Space between admission and 4 weeks after discharge</time_frame>
    <description>Between group difference in change in Life Space</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 4-meter gait speed test</measure>
    <time_frame>Change in habitual gait speed between admission and 4 weeks after discharge</time_frame>
    <description>Between group in change in Habitual gait speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mobility using The de Morton Mobility Index (DEMMI) (0-100 point scale with 0 representing low mobility and 100 representing high mobility)</measure>
    <time_frame>Change in DEMMI score between admission and 4 weeks after discharge</time_frame>
    <description>Between group difference in change in mobility</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Hospitalization</condition>
  <condition>Activity</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1) On admission, patients will receive a welcome folder focusing on physical activity; 2) daily during hospitalization, patients will be encouraged to walk along a walk path in the hallway; 3) during hospitalization, patients will be encouraged to consult and use posters with exercises (sit to stand, heel raise, balance); 4) on admission, patients will receive a prescribed walk plan with 3 daily walking sessions to perform during hospitalization (3 times 1 minute, 5 minutes or 10 minutes); 5) during hospitalization patients will be motivated to pick up of clothes and beverages themselves; 6) patients will be discharged with a walk plan to use at home; 7) after discharge the municipality will follow up on patients receiving home care and patients with a rehabilitation plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All patients admitted to the control wards will receive usual care during and after hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Promotion of activity during and after hospitalization</intervention_name>
    <description>1) a welcome folder encouraging physical activity; 2) encouragement to use a walk path established in the ward; 3) encouragement to use posters containing exercise suggestions;4) prescription of a walk-plan for in-hospital use; 5) encouragement to pick up clothes and beverages by oneself; 6) prescription of a walk-plan at discharge for at home use 7) follow-up on walk plan after discharge by municipality</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  +65 years&#xD;
&#xD;
          -  acutely admitted to intervention wards&#xD;
&#xD;
          -  able to walk independently with or without walking aid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  in isolation&#xD;
&#xD;
          -  inability to cooperate&#xD;
&#xD;
          -  not able to speak or understand Danish&#xD;
&#xD;
          -  in treatment for cancer&#xD;
&#xD;
          -  terminally ill&#xD;
&#xD;
          -  transferred to intensive care unit or another ward within 24 hours after admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette M Pedersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Copenhagen University Hospital, Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://bmjopen.bmj.com/content/8/3/e020272</url>
    <description>A tailored strategy for designing the Walk-Copenhagen (WALK-Cph) intervention to increase mobility in hospitalised older medical patients: a protocol for the qualitative part of the WALK-Cph project</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Mette Merete Pedersen</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>older medical patient</keyword>
  <keyword>mobility</keyword>
  <keyword>hospitalization</keyword>
  <keyword>activity monitoring</keyword>
  <keyword>cross sectoral</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/NCT03825497
org study id: H-18027877
nct id: NCT03825497
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The WALK-Copenhagen project aims at enhancing physical activity during and after
      hospitalization in older medical patients by an intervention developed in co-operation with
      key stakeholders
In four phases we will develop (Phase 1), fidelity- and feasibility test (Phase 2), efficacy
      test (Phase 3) and adoption test the intervention (Phase 4). The project will use a
      combination of qualitative (Phase 1-4) and quantitative methods (Phase 2-3) and consists of
      two parallel tracks - WALK-Intervention and WALK-Implementation. Phase 1 of the study has
      been completed. Through workshops with patients, relatives, health professionals and
      researchers we have developped an intervention to enhance physical activity. Phase 2 will be
      carried out in October 2018 and January 2019 at Copenhagen University Hospital Hvidovre and
      in February 2019 at Copenhagen University Hospital, Frederiksberg. The developed intervention
      will be fidelity tested through daily observations at the wards. Also, the intervention will
      be feasibility tested in a prospective cohort study aiming at qualifying the intervention,
      testing recruitment strategies, testing patient willingness towards the intervention, testing
      randomization and blinding procedures and estimating an inclusion rate for Phase 3
      (randomized controlled trial) to be conducted in 2019.

      Update March 2019:

      Due to a political decision to close down the medical ward at Copenhagen University Hospital,
      Frederiksberg in the spring of 2019, it was decided to change Phase 3 to a cohort study at
      Copenhagen University Hospital, Hvidovre. This decision was based on the fact that the
      methodological setup of the study (cluster RCT) was unintentionally changed due to the close
      down of one of the intervention wards.

      Update November 2019:

      Due to changes in characteristics of patients admitted to the intervention ward and thus a
      very slow inclusion rate in Phase 3 (Cohort Study), it was decided to terminate inclusion of
      patients. Qualitative data will still be collected as anticipated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A feasibility study at Medical Wards (intervention wards) in Oct 2018, January 2019 and February 2019 prior to a cluster randomized trial. Medical wards at 4 different hospitals representing clusters - 2 intervention clusters and 2 control clusters.
primary purpose: Treatment
masking: None (Open Label)
masking description: All patients at the intervention wards will receive the intervention why neither investigators nor outcome assessors will be blinded to the intervention. Patients at intervention and control wards will get equal information regarding the study and will be asked to participate in equal assessments
measure: Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
time frame: Mean number of hours per day spent upright during hospitalization (up to 7 days)
description: Between group difference in time spent standing or walking per day (Upright time)
measure: Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor
time frame: Mean number of steps per day during hospitalization (up to 7 days)
description: Between group difference in number of steps per day
measure: Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor
time frame: Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days)
description: Between group difference time spent lying/sitting per day
measure: Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
time frame: Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge
description: Between group difference in change in time spent standing or walking per day (Upright time)
measure: Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor
time frame: Change in mean number of steps per day between hospitalization and 4 weeks after discharge
description: between group difference in change in number of steps per day
measure: Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor
time frame: Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge
description: Between group difference in change in time spent lying/sitting per day
measure: Change in Life-Space mobility using The University of Alabama at Birmingham (UAB) Life Space Assessment (a 0-120 point scale with 0 representing low mobility and 120 high mobility)
time frame: Change in Life Space between admission and 4 weeks after discharge
description: Between group difference in change in Life Space
measure: Change in 4-meter gait speed test
time frame: Change in habitual gait speed between admission and 4 weeks after discharge
description: Between group in change in Habitual gait speed
measure: Change in mobility using The de Morton Mobility Index (DEMMI) (0-100 point scale with 0 representing low mobility and 100 representing high mobility)
time frame: Change in DEMMI score between admission and 4 weeks after discharge
description: Between group difference in change in mobility
arm group label: Intervention
arm group type: Experimental
description: 1) On admission, patients will receive a welcome folder focusing on physical activity; 2) daily during hospitalization, patients will be encouraged to walk along a walk path in the hallway; 3) during hospitalization, patients will be encouraged to consult and use posters with exercises (sit to stand, heel raise, balance); 4) on admission, patients will receive a prescribed walk plan with 3 daily walking sessions to perform during hospitalization (3 times 1 minute, 5 minutes or 10 minutes); 5) during hospitalization patients will be motivated to pick up of clothes and beverages themselves; 6) patients will be discharged with a walk plan to use at home; 7) after discharge the municipality will follow up on patients receiving home care and patients with a rehabilitation plan
arm group label: Usual care
arm group type: No Intervention
description: All patients admitted to the control wards will receive usual care during and after hospitalization.
intervention type: Other
intervention name: Promotion of activity during and after hospitalization
description: 1) a welcome folder encouraging physical activity; 2) encouragement to use a walk path established in the ward; 3) encouragement to use posters containing exercise suggestions;4) prescription of a walk-plan for in-hospital use; 5) encouragement to pick up clothes and beverages by oneself; 6) prescription of a walk-plan at discharge for at home use 7) follow-up on walk plan after discharge by municipality
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Mette M Pedersen, PhD
role: Principal Investigator
affiliation: Postdoc, Clinical Research Centre, Hvidovre Hospital, Denmark
facility: 
country: Denmark
url: https://bmjopen.bmj.com/content/8/3/e020272
description: A tailored strategy for designing the Walk-Copenhagen (WALK-Cph) intervention to increase mobility in hospitalised older medical patients: a protocol for the qualitative part of the WALK-Cph project
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Mette Merete Pedersen
investigator title: Postdoctoral Fellow