<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/NCT01705912</url>
  </required_header>
  <id_info>
    <org_study_id>OLLGF01</org_study_id>
    <secondary_id>OLLGF0112</secondary_id>
    <nct_id>NCT01705912</nct_id>
  </id_info>
  <brief_title>Fall Prevention Among Community Living Elderly</brief_title>
  <official_title>Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gunilla Fahlstrom</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Örebro County Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Örebro County Council</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess effects of a home exercise program, supervised by&#xD;
      assistant nurses with the aim of preventing falls.&#xD;
&#xD;
      Community living persons 65 years of age or older having a risk of falling were invited to&#xD;
      participate. Participants were randomized to either training or control.&#xD;
&#xD;
      The training program was individually designed by a physiotherapist and the 5-month program&#xD;
      performance was supervised in the partcipants home by eight home visits from an assistant&#xD;
      nurse.&#xD;
&#xD;
      All participants received a visit from an occupational therapist who assessed the home and,&#xD;
      if necessary, gave advice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Falls among elderly are a major public health problem, but preventive interventions&#xD;
      containing physical exercise and home improvement are available.&#xD;
&#xD;
      In this study the crucial question was to test whether unlicensed staff, assistant nurses,&#xD;
      could be used for preventive work.&#xD;
&#xD;
      Estimation of study power gave that 170 participants in each group would be needed to detect&#xD;
      a difference in days with falls, the main outcome measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with fall</measure>
    <time_frame>12 months</time_frame>
    <description>Self reported calendar data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise</measure>
    <time_frame>12 months</time_frame>
    <description>Self reported calendar data</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Strength</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
    <description>Chair stand test</description>
  </other_outcome>
  <other_outcome>
    <measure>Balance</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
    <description>Falls efficacy scale (FES)</description>
  </other_outcome>
  <other_outcome>
    <measure>Balance</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
    <description>Bergs balance scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Walking 3 metres test</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
    <description>Self reported interview data, SF-36</description>
  </other_outcome>
  <other_outcome>
    <measure>Activities of daily living</measure>
    <time_frame>Pre and post intervention, 5 months</time_frame>
    <description>ADL</description>
  </other_outcome>
  <other_outcome>
    <measure>Walking</measure>
    <time_frame>12 months</time_frame>
    <description>Minutes of walking per day, self reported calendar data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital days</measure>
    <time_frame>12 months</time_frame>
    <description>Hospital register data</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital visits</measure>
    <time_frame>12 months</time_frame>
    <description>Hospital register data</description>
  </other_outcome>
  <other_outcome>
    <measure>Fractures or other harms</measure>
    <time_frame>12 months</time_frame>
    <description>Hospital register data</description>
  </other_outcome>
  <other_outcome>
    <measure>Strength</measure>
    <time_frame>Pre and post assessment, 5 months</time_frame>
    <description>Timed Up and Go, TUG</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Accidental Falls/Prevention and Control</condition>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Complete intervention i.e. basic intervention + individual training program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basic intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complete intervention</intervention_name>
    <description>The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.</description>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basic intervention</intervention_name>
    <description>The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  community living persons at least 65 years old&#xD;
&#xD;
          -  independent walking ability with or without walking aid&#xD;
&#xD;
          -  experienced at least one fall during the last 12 months&#xD;
&#xD;
          -  ability to communicate and cooperate with study staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing physiotherapy treatment&#xD;
&#xD;
          -  ongoing participation in exercise/acitivity containing balance and strength enhancing&#xD;
             components&#xD;
&#xD;
          -  a dementia diagnose&#xD;
&#xD;
          -  mental disorder that affects possibility to communicate and cooperate&#xD;
&#xD;
          -  other medical reason making participation inte the study inappropriate.&#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>Gunilla Fahlstrom, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Örebro County Council</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Family medicine research center</name>
      <address>
        <city>Orebro</city>
        <zip>701 16</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Örebro County Council</investigator_affiliation>
    <investigator_full_name>Gunilla Fahlstrom</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>fall</keyword>
  <keyword>prevention</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/NCT01705912
org study id: OLLGF01
secondary id: OLLGF0112
nct id: NCT01705912
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess effects of a home exercise program, supervised by
      assistant nurses with the aim of preventing falls.

      Community living persons 65 years of age or older having a risk of falling were invited to
      participate. Participants were randomized to either training or control.

      The training program was individually designed by a physiotherapist and the 5-month program
      performance was supervised in the partcipants home by eight home visits from an assistant
      nurse.

      All participants received a visit from an occupational therapist who assessed the home and,
      if necessary, gave advice.
Falls among elderly are a major public health problem, but preventive interventions
      containing physical exercise and home improvement are available.

      In this study the crucial question was to test whether unlicensed staff, assistant nurses,
      could be used for preventive work.

      Estimation of study power gave that 170 participants in each group would be needed to detect
      a difference in days with falls, the main outcome measure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of days with fall
time frame: 12 months
description: Self reported calendar data
measure: Exercise
time frame: 12 months
description: Self reported calendar data
measure: Strength
time frame: Pre and post intervention, 5 months
description: Chair stand test
measure: Balance
time frame: Pre and post intervention, 5 months
description: Falls efficacy scale (FES)
measure: Balance
time frame: Pre and post intervention, 5 months
description: Bergs balance scale
measure: Walking 3 metres test
time frame: Pre and post intervention, 5 months
measure: Health related quality of life
time frame: Pre and post intervention, 5 months
description: Self reported interview data, SF-36
measure: Activities of daily living
time frame: Pre and post intervention, 5 months
description: ADL
measure: Walking
time frame: 12 months
description: Minutes of walking per day, self reported calendar data.
measure: Hospital days
time frame: 12 months
description: Hospital register data
measure: Hospital visits
time frame: 12 months
description: Hospital register data
measure: Fractures or other harms
time frame: 12 months
description: Hospital register data
measure: Strength
time frame: Pre and post assessment, 5 months
description: Timed Up and Go, TUG
arm group label: Training
arm group type: Experimental
description: Complete intervention i.e. basic intervention + individual training program.
arm group label: Control
arm group type: Active Comparator
description: Basic intervention.
intervention type: Other
intervention name: Complete intervention
description: The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.
arm group label: Training
intervention type: Other
intervention name: Basic intervention
description: The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.
arm group label: Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Gunilla Fahlstrom, PhD
role: Principal Investigator
affiliation: Örebro County Council
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Örebro County Council
investigator full name: Gunilla Fahlstrom
investigator title: PhD