<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/NCT03796039</url>
  </required_header>
  <id_info>
    <org_study_id>CAT2018-15</org_study_id>
    <nct_id>NCT03796039</nct_id>
  </id_info>
  <brief_title>Stand if You Can: A Standing Intervention in Long Term Care</brief_title>
  <official_title>Stand if You Can- A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Brunswick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Horizon Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Thomas University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universite de Moncton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Frailty Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Brunswick</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>
      It is currently unknown if reducing sitting time, an activity that is highly prevalent in&#xD;
      frail older adults living in long term care (LTC) facilities, is associated with an&#xD;
      improvement in physical capacity such as walking speed. Simple tasks such as walking speed is&#xD;
      associated with important outcomes for residents in LTC such as autonomy and hospitalization.&#xD;
      The investigators hypothesize that standing an additional 100 minutes per week for 5 months&#xD;
      will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC&#xD;
      residents compared to residents receiving a sitting social activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC&#xD;
      facilities randomized as the intervention and half as the control group. The investigators&#xD;
      are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88&#xD;
      residents (44 in the control group, 44 in the intervention group) will be enrolled in the&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 23, 2020</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>Long term care (LTC) facilities will be recruited, with half of the LTC facilities randomized as the intervention (n=2) and half as the control group (n=2).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator was masked at pre-testing. It was unknown which participants would be receiving the intervention. However, due to resources this was not repeated at post testing</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Walking Speed</measure>
    <time_frame>Pre and post intervention testing</time_frame>
    <description>Measured by the 10m walking speed test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Balance</measure>
    <time_frame>Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.</time_frame>
    <description>Measured by a portable device (Wii Balance board), which has sensors that detects sway .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leg Strength</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>Using hand-held dynamometer to quantify leg strength through knee extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Lower Limb Power</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>Using the 30second sit-stand test following senior fitness test protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Symptoms</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall Efficacy</measure>
    <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
    <description>Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Falls</measure>
    <time_frame>The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.</time_frame>
    <description>Falls, injuries due to falls and hospitalization will be collected at 3 timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Profile - Triglycerides</measure>
    <time_frame>Pre-Post Testing (before and following the 5 month intervention).</time_frame>
    <description>Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Behaviours</measure>
    <time_frame>Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed</time_frame>
    <description>Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Profile - High Density Lipoprotein Cholesterol</measure>
    <time_frame>Pre and post testing (before and after the 5-month intervention)</time_frame>
    <description>High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Profile - Low Density Lipoprotein Cholesterol</measure>
    <time_frame>Pre-Post intervention (before and after 5-month intervention)</time_frame>
    <description>Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Profile - Blood Glucose</measure>
    <time_frame>Pre-Post Intervention (before and after 5-month intervention)</time_frame>
    <description>Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Frailty</condition>
  <condition>Sedentary Behavior</condition>
  <condition>Physical Disability</condition>
  <arm_group>
    <arm_group_label>Standing and Social Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will receive social visits, but no exposure to standing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standing</intervention_name>
    <description>Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
    <arm_group_label>Standing and Social Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident at one of the selected LTC facilities;&#xD;
&#xD;
          -  Able to provide consent or have a power of attorney agree on behalf of a resident to&#xD;
             participate in the study;&#xD;
&#xD;
          -  Able to walk for ten meters, with or without a walking aid; The main outcome is&#xD;
             walking speed performed for a distance of 10 meters. Therefore, we want everyone who&#xD;
             participates in the study to be able to complete the test at baseline. This way we can&#xD;
             answer the main research question, while adhering to our sample size calculation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If Identified by staff at the facility as too high risk for falling by participating&#xD;
             in the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pine Grove Nursing Home</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>May 12, 2021</results_first_submitted>
  <results_first_submitted_qc>June 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 6, 2021</results_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Brunswick</investigator_affiliation>
    <investigator_full_name>Danielle Bouchard</investigator_full_name>
    <investigator_title>Associate Investigator</investigator_title>
  </responsible_party>
  <keyword>Long Term Care</keyword>
  <keyword>Physical Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03796039/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standing and Social Intervention</title>
          <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Control group will receive social visits, but no exposure to standing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standing and Social Intervention</title>
          <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Control group will receive social visits, but no exposure to standing</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="97"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.14" spread="8.46"/>
                    <measurement group_id="B2" value="85.11" spread="7.63"/>
                    <measurement group_id="B3" value="86" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.93" spread="6.53"/>
                    <measurement group_id="B2" value="25.56" spread="9.01"/>
                    <measurement group_id="B3" value="26.2" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frailty</title>
          <description>Frailty was measured using the Clinical Frailty Scale (1-9). 1 indicates very fit, 9 indicates terminally ill. LTC staff were asked to rate participants at pre and post intervention</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" spread="1.5"/>
                    <measurement group_id="B2" value="6.13" spread="0.8"/>
                    <measurement group_id="B3" value="6.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Transfer Status (Independent Transfer)</title>
          <description>Transfer status was assessed by LTC staff following jurisdiction regulations (Work Safe New Brunswick). It is assessed upon admission, quarterly (90 days) and when a significant change in health status occurs (e.g., fall, stroke). For our study, we used the most recent Transfer status update. Residents were categorized as requiring no assistance to transfer from sit to stand (independent), requiring staff assistance to stand (assisted transfer), or requiring staff and mechanical assistance to stand (dependent).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of stay in LTC</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.6" spread="5.4"/>
                    <measurement group_id="B2" value="3.9" spread="3.5"/>
                    <measurement group_id="B3" value="4.2" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cognition (MMSE)</title>
          <description>The mini-mental state examination was administered by research assistants at baseline to assess cognition. Scored out of 30, the questionnaire categorized a person as having none, mild or severe cognitive impairment. A score of 0-17 indicates severe cognitive impairment, 18-23 as mild, and 24-30 as no cognitive impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="47"/>
                    <count group_id="B3" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.76" spread="9.2"/>
                    <measurement group_id="B2" value="17.7" spread="8.8"/>
                    <measurement group_id="B3" value="16.7" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Walking Speed</title>
        <description>Measured by the 10m walking speed test</description>
        <time_frame>Pre and post intervention testing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Walking Speed</title>
          <description>Measured by the 10m walking speed test</description>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.17"/>
                    <measurement group_id="O2" value="0.43" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.20"/>
                    <measurement group_id="O2" value="0.40" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Balance</title>
        <description>Measured by a portable device (Wii Balance board), which has sensors that detects sway .</description>
        <time_frame>Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Leg Strength</title>
        <description>Using hand-held dynamometer to quantify leg strength through knee extension</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Leg Strength</title>
          <description>Using hand-held dynamometer to quantify leg strength through knee extension</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.48" spread="5.95"/>
                    <measurement group_id="O2" value="7.87" spread="5.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.15" spread="5.25"/>
                    <measurement group_id="O2" value="7.28" spread="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Lower Limb Power</title>
        <description>Using the 30second sit-stand test following senior fitness test protocol</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Change Lower Limb Power</title>
          <description>Using the 30second sit-stand test following senior fitness test protocol</description>
          <units>Number of repetitions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="1.84"/>
                    <measurement group_id="O2" value="0.89" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="1.81"/>
                    <measurement group_id="O2" value="1.1" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Anxiety Symptoms</title>
        <description>The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <population>Only participants with MMSE score greater than or equal to 18 were included (to ensure participants had the cognitive abilities to respond to the questionnaires)</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Anxiety Symptoms</title>
          <description>The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.</description>
          <population>Only participants with MMSE score greater than or equal to 18 were included (to ensure participants had the cognitive abilities to respond to the questionnaires)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="7.2"/>
                    <measurement group_id="O2" value="6.6" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="7.1"/>
                    <measurement group_id="O2" value="6.6" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <population>Only participants with a MMSE score of 18 or higher were included</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.</description>
          <population>Only participants with a MMSE score of 18 or higher were included</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="3.2"/>
                    <measurement group_id="O2" value="4.9" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="4.0"/>
                    <measurement group_id="O2" value="4.5" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Loneliness</title>
        <description>Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <population>Participants only included if MMSE score is equal to or greater than 18.</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Loneliness</title>
          <description>Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome</description>
          <population>Participants only included if MMSE score is equal to or greater than 18.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="12.0"/>
                    <measurement group_id="O2" value="39.7" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="12.4"/>
                    <measurement group_id="O2" value="33.8" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fall Efficacy</title>
        <description>Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score</description>
        <time_frame>Pre-Post Testing (following the 5 month intervention)</time_frame>
        <population>This was only measured among participants who had a MMSE score of 18 or higher (to ensure they had the cognitive capacity to properly answer the questionnaire)</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Fall Efficacy</title>
          <description>Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score</description>
          <population>This was only measured among participants who had a MMSE score of 18 or higher (to ensure they had the cognitive capacity to properly answer the questionnaire)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7" spread="13.2"/>
                    <measurement group_id="O2" value="31.0" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="17.4"/>
                    <measurement group_id="O2" value="39.0" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Falls</title>
        <description>Falls, injuries due to falls and hospitalization will be collected at 3 timepoints</description>
        <time_frame>The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Profile - Triglycerides</title>
        <description>Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device.</description>
        <time_frame>Pre-Post Testing (before and following the 5 month intervention).</time_frame>
        <population>Blood draws were difficult among this population due to participant agitation, therefore we were not able to collect blood for all participants</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Profile - Triglycerides</title>
          <description>Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device.</description>
          <population>Blood draws were difficult among this population due to participant agitation, therefore we were not able to collect blood for all participants</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="1.30"/>
                    <measurement group_id="O2" value="1.21" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="0.74"/>
                    <measurement group_id="O2" value="1.47" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Behaviours</title>
        <description>Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study</description>
        <time_frame>Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Profile - High Density Lipoprotein Cholesterol</title>
        <description>High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test.</description>
        <time_frame>Pre and post testing (before and after the 5-month intervention)</time_frame>
        <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Profile - High Density Lipoprotein Cholesterol</title>
          <description>High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test.</description>
          <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="1.52"/>
                    <measurement group_id="O2" value="1.33" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="0.44"/>
                    <measurement group_id="O2" value="1.17" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Profile - Low Density Lipoprotein Cholesterol</title>
        <description>Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
        <time_frame>Pre-Post intervention (before and after 5-month intervention)</time_frame>
        <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Profile - Low Density Lipoprotein Cholesterol</title>
          <description>Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
          <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="1.63"/>
                    <measurement group_id="O2" value="2.91" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="1.21"/>
                    <measurement group_id="O2" value="2.72" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Metabolic Profile - Blood Glucose</title>
        <description>Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
        <time_frame>Pre-Post Intervention (before and after 5-month intervention)</time_frame>
        <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
        <group_list>
          <group group_id="O1">
            <title>Standing and Social Intervention</title>
            <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control group will receive social visits, but no exposure to standing</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolic Profile - Blood Glucose</title>
          <description>Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).</description>
          <population>Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="2.38"/>
                    <measurement group_id="O2" value="5.43" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="2.29"/>
                    <measurement group_id="O2" value="5.47" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During trial (5 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standing and Social Intervention</title>
          <description>Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.&#xD;
Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Control group will receive social visits, but no exposure to standing</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Danielle Bouchard</name_or_title>
      <organization>University of New Brunswick</organization>
      <phone>(506) 443-3908</phone>
      <email>dboucha1@unb.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03796039
org study id: CAT2018-15
nct id: NCT03796039
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is currently unknown if reducing sitting time, an activity that is highly prevalent in
      frail older adults living in long term care (LTC) facilities, is associated with an
      improvement in physical capacity such as walking speed. Simple tasks such as walking speed is
      associated with important outcomes for residents in LTC such as autonomy and hospitalization.
      The investigators hypothesize that standing an additional 100 minutes per week for 5 months
      will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC
      residents compared to residents receiving a sitting social activity.
LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC
      facilities randomized as the intervention and half as the control group. The investigators
      are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88
      residents (44 in the control group, 44 in the intervention group) will be enrolled in the
      program.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Long term care (LTC) facilities will be recruited, with half of the LTC facilities randomized as the intervention (n=2) and half as the control group (n=2).
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: Investigator was masked at pre-testing. It was unknown which participants would be receiving the intervention. However, due to resources this was not repeated at post testing
measure: Changes in Walking Speed
time frame: Pre and post intervention testing
description: Measured by the 10m walking speed test
measure: Change in Balance
time frame: Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.
description: Measured by a portable device (Wii Balance board), which has sensors that detects sway .
measure: Change in Leg Strength
time frame: Pre-Post Testing (following the 5 month intervention)
description: Using hand-held dynamometer to quantify leg strength through knee extension
measure: Change Lower Limb Power
time frame: Pre-Post Testing (following the 5 month intervention)
description: Using the 30second sit-stand test following senior fitness test protocol
measure: Change in Anxiety Symptoms
time frame: Pre-Post Testing (following the 5 month intervention)
description: The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.
measure: Depression
time frame: Pre-Post Testing (following the 5 month intervention)
description: Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.
measure: Loneliness
time frame: Pre-Post Testing (following the 5 month intervention)
description: Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome
measure: Fall Efficacy
time frame: Pre-Post Testing (following the 5 month intervention)
description: Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score
measure: Rate of Falls
time frame: The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.
description: Falls, injuries due to falls and hospitalization will be collected at 3 timepoints
measure: Metabolic Profile - Triglycerides
time frame: Pre-Post Testing (before and following the 5 month intervention).
description: Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device.
measure: Social Behaviours
time frame: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed
description: Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study
measure: Metabolic Profile - High Density Lipoprotein Cholesterol
time frame: Pre and post testing (before and after the 5-month intervention)
description: High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test.
measure: Metabolic Profile - Low Density Lipoprotein Cholesterol
time frame: Pre-Post intervention (before and after 5-month intervention)
description: Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
measure: Metabolic Profile - Blood Glucose
time frame: Pre-Post Intervention (before and after 5-month intervention)
description: Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
arm group label: Standing and Social Intervention
arm group type: Experimental
description: Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.
arm group label: Control Group
arm group type: No Intervention
description: Control group will receive social visits, but no exposure to standing
intervention type: Behavioral
intervention name: Standing
description: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday
arm group label: Standing and Social Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of New Brunswick
investigator full name: Danielle Bouchard
investigator title: Associate Investigator
mesh term: Frailty
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 