<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/NCT04424186</url>
  </required_header>
  <id_info>
    <org_study_id>SLB-Phys-06-2020</org_study_id>
    <nct_id>NCT04424186</nct_id>
  </id_info>
  <brief_title>'Rehabilitation for Life'</brief_title>
  <official_title>Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kolding Sygehus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kolding Sygehus</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>
      Despite implementing hospital quality programs after hip fracture surgery older adults often&#xD;
      experience a decline in the level of physical function, reduced quality of life; and the&#xD;
      mortality and readmission rates are high.&#xD;
&#xD;
      Early mobilization is important in order to prevent loss of muscle mass; however to prevent&#xD;
      morbidity an early start of strength training is also necessary. Furthermore, the risk of&#xD;
      complications, morbidity, and mortality are associated with insufficient management of pain.&#xD;
&#xD;
      The project aims to examine the effect of measuring vital signs and consistent rehabilitation&#xD;
      in the primary and secondary sectors in older adults after hip fracture surgery.&#xD;
&#xD;
      Method/ design:&#xD;
&#xD;
      The study is a cluster-randomized stepped wedge study. Participants will be recruited among&#xD;
      patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in&#xD;
      one of three municipalities. Participants are also the health professionals in the&#xD;
      orthogeriatric ward and the three municipalities.&#xD;
&#xD;
      The three municipalities form five clusters, which are randomized, and every three-month one&#xD;
      cluster cross from control to intervention.&#xD;
&#xD;
      The study compares usual practice (control) to an intervention named 'Rehabilitation of&#xD;
      Life'. An intervention best described as an empowerment-oriented cross-sectorial program&#xD;
      including vital sign measurement and systematic progressive rehabilitation and combined with&#xD;
      convenient access for collaboration among professionals.&#xD;
&#xD;
      Primary outcome: Timed Up and Go (TUG) measured 2 months after the time of operation.&#xD;
&#xD;
      The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip&#xD;
      fracture will result in a significant reduced TUG-score in comparison to a practice not&#xD;
      offering 'Rehabilitation of Life'&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 22, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2022</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>Crossover Assignment</intervention_model>
    <intervention_model_description>A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed up and go</measure>
    <time_frame>Two months after the time of operation</time_frame>
    <description>Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulated Ambulation Score (CAS)</measure>
    <time_frame>One months after the time of operation</time_frame>
    <description>Measures basic mobility. The score 0-6. Higher scores mean a better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>'Rehabilitation for Life'</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vital sign measurement and rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care and rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care and rehabilitation provided in primary and secondary sectors</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>'Rehabilitation for Life'</intervention_name>
    <description>An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.</description>
    <arm_group_label>'Rehabilitation for Life'</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care and rehabilitation</intervention_name>
    <description>The care and rehabilitation usual provided to patients after hip fracture surgery</description>
    <arm_group_label>Usual care and rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a hip fracture&#xD;
&#xD;
          -  Patients of 65 years of age or older&#xD;
&#xD;
          -  Patients admitted to an orthogeriatric ward&#xD;
&#xD;
          -  Patient who are citizens in one og three municipalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients discharged for permanent residence in nursing homes&#xD;
&#xD;
          -  Patients who cannot participate in a conversation&#xD;
&#xD;
          -  Terminal registered patients.&#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>Inge Bruun, post doc</last_name>
    <role>Study Chair</role>
    <affiliation>The Region of Southern Denmark and University of Southern Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Inge Bruun, post doc</last_name>
    <phone>+45 7636 2886</phone>
    <email>Inge.Hansen.Bruun@rsyd.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Inge Bruun</name>
      <address>
        <city>Kolding</city>
        <state>Southern Denmark</state>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inge Bruun</last_name>
      <phone>76362886</phone>
      <email>Inge.Hansen.Bruun@rsyd.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>cross-sectorial cooperation</keyword>
  <keyword>older</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04424186
org study id: SLB-Phys-06-2020
nct id: NCT04424186
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite implementing hospital quality programs after hip fracture surgery older adults often
      experience a decline in the level of physical function, reduced quality of life; and the
      mortality and readmission rates are high.

      Early mobilization is important in order to prevent loss of muscle mass; however to prevent
      morbidity an early start of strength training is also necessary. Furthermore, the risk of
      complications, morbidity, and mortality are associated with insufficient management of pain.

      The project aims to examine the effect of measuring vital signs and consistent rehabilitation
      in the primary and secondary sectors in older adults after hip fracture surgery.

      Method/ design:

      The study is a cluster-randomized stepped wedge study. Participants will be recruited among
      patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in
      one of three municipalities. Participants are also the health professionals in the
      orthogeriatric ward and the three municipalities.

      The three municipalities form five clusters, which are randomized, and every three-month one
      cluster cross from control to intervention.

      The study compares usual practice (control) to an intervention named 'Rehabilitation of
      Life'. An intervention best described as an empowerment-oriented cross-sectorial program
      including vital sign measurement and systematic progressive rehabilitation and combined with
      convenient access for collaboration among professionals.

      Primary outcome: Timed Up and Go (TUG) measured 2 months after the time of operation.

      The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip
      fracture will result in a significant reduced TUG-score in comparison to a practice not
      offering 'Rehabilitation of Life'
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Timed up and go
time frame: Two months after the time of operation
description: Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
measure: Cumulated Ambulation Score (CAS)
time frame: One months after the time of operation
description: Measures basic mobility. The score 0-6. Higher scores mean a better outcome
arm group label: 'Rehabilitation for Life'
arm group type: Experimental
description: Vital sign measurement and rehabilitation
arm group label: Usual care and rehabilitation
arm group type: Active Comparator
description: Usual care and rehabilitation provided in primary and secondary sectors
intervention type: Other
intervention name: 'Rehabilitation for Life'
description: An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.
arm group label: 'Rehabilitation for Life'
intervention type: Other
intervention name: Usual care and rehabilitation
description: The care and rehabilitation usual provided to patients after hip fracture surgery
arm group label: Usual care and rehabilitation
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Inge Bruun, post doc
role: Study Chair
affiliation: The Region of Southern Denmark and University of Southern Denmark
last name: Inge Bruun, post doc
phone: +45 7636 2886
email: Inge.Hansen.Bruun@rsyd.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Hip Fractures
sharing ipd: No