<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/NCT01667913</url>
  </required_header>
  <id_info>
    <org_study_id>Hip Fracture study 7/7-12</org_study_id>
    <nct_id>NCT01667913</nct_id>
  </id_info>
  <brief_title>Reliability of 6-Minutes Walking Test in Hip Fracture Patients</brief_title>
  <official_title>The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lolland Community, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lolland Community, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the relative (ICC) and absolute intertester&#xD;
      reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient&#xD;
      facility. The data collection is conducted by two physiotherapists, who are blinded to each&#xD;
      other. The physiotherapists are randomized so they each are doing an equal number of baseline&#xD;
      tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The 6-Minutes Walking Test</measure>
    <time_frame>3 to 5 weeks post surgery</time_frame>
    <description>The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hip Fracture</condition>
  <arm_group>
    <arm_group_label>6 minutes walking test</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>6 minutes walking test</intervention_name>
    <arm_group_label>6 minutes walking test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years or above&#xD;
&#xD;
          -  Hip fracture patients with a Intra - or Extra Capsular hip fracture&#xD;
&#xD;
          -  Testing within 3 - 5 weeks postsurgery in an outpatient facility&#xD;
&#xD;
          -  No weightbearing restrictions on the fractured limb&#xD;
&#xD;
          -  Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points)&#xD;
&#xD;
          -  Participants should not experiencing hip related pain more or less than moderate&#xD;
             according to Verbal Ranking Scale when resting&#xD;
&#xD;
          -  To have the ability to write and understand danish language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - MMSE score ≤19 points&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan A Overgaard, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morten T Kristensen, Ph.d</last_name>
    <role>Study Director</role>
    <affiliation>Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Center Maribo</name>
      <address>
        <city>Maribo</city>
        <zip>4930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.thoracic.org/statements/resources/pfet/sixminute.pdf</url>
    <description>Protocol for the 6-Minutes Walking Test</description>
  </link>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>November 13, 2013</last_update_submitted>
  <last_update_submitted_qc>November 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lolland Community, Denmark</investigator_affiliation>
    <investigator_full_name>Mr. Jan Overgaard</investigator_full_name>
    <investigator_title>Bachelor in Physiotherapy</investigator_title>
  </responsible_party>
  <keyword>Hip Fracture</keyword>
  <keyword>6-minutes walking test</keyword>
  <keyword>Reliability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</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/NCT01667913
org study id: Hip Fracture study 7/7-12
nct id: NCT01667913
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to examine the relative (ICC) and absolute intertester
      reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient
      facility. The data collection is conducted by two physiotherapists, who are blinded to each
      other. The physiotherapists are randomized so they each are doing an equal number of baseline
      tests.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The 6-Minutes Walking Test
time frame: 3 to 5 weeks post surgery
description: The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions.
arm group label: 6 minutes walking test
arm group type: No Intervention
intervention type: Other
intervention name: 6 minutes walking test
arm group label: 6 minutes walking test
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Jan A Overgaard, Bachelor
role: Principal Investigator
affiliation: Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark
last name: Morten T Kristensen, Ph.d
role: Study Director
affiliation: Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
facility: 
country: Denmark
url: http://www.thoracic.org/statements/resources/pfet/sixminute.pdf
description: Protocol for the 6-Minutes Walking Test
responsible party type: Principal Investigator
investigator affiliation: Lolland Community, Denmark
investigator full name: Mr. Jan Overgaard
investigator title: Bachelor in Physiotherapy
mesh term: Fractures, Bone
mesh term: Hip Fractures