<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/NCT03229473</url>
  </required_header>
  <id_info>
    <org_study_id>3331</org_study_id>
    <nct_id>NCT03229473</nct_id>
  </id_info>
  <brief_title>Fall Risk Assessment in COPD</brief_title>
  <official_title>Validity and Reliability of Balance Screening Tests for Fall Risk Assessment in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</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>
      People with chronic obstructive pulmonary disease (COPD) have balance problems and are at&#xD;
      risk of falling. New guidelines recommend balance assessment be included in pulmonary&#xD;
      rehabilitation (PR) however no specific tests are recommended. Our goal is to determine the&#xD;
      best balance test for identifying COPD patients who are at risk of falling. In this study,&#xD;
      COPD patients who report balance problems or falling in the last year will participate in a&#xD;
      testing session. Balance, balance confidence, lower body strength, exercise tolerance and&#xD;
      perceived physical limitations will be assessed. The number of falls over the following year&#xD;
      will be recorded using monthly calendars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD is a leading cause of death, disability and hospitalization in Canada. In addition to&#xD;
      the primary lung impairment, secondary effects of the disease are well established including&#xD;
      impairments in muscle function, mobility and exercise capacity. Individuals with COPD also&#xD;
      have marked deficits in balance and an increased risk of falls.&#xD;
&#xD;
      The updated American Thoracic Society/European Respiratory Society Statement on PR&#xD;
      recommended expanding the scope of outcome assessment in COPD to include balance however no&#xD;
      specific tests are suggested. An examination of brief balance measures feasible for fall risk&#xD;
      screening has not been conducted. Such information will inform clinicians as to those most&#xD;
      likely to benefit from targeted intervention. This study aims to determine the optimal&#xD;
      balance measure for identifying patients with COPD who are high risk for falling.&#xD;
&#xD;
      The specific objectives of the study are to: 1) Investigate the construct validity&#xD;
      (convergent and known-groups) and reliability (inter-rater and test-retest) of three short&#xD;
      balance screening measures in people with COPD; 2) Investigate the predictive validity of the&#xD;
      balance screening tests for falls; and 3) Identify cut-off scores for identifying fallers&#xD;
      with COPD on the balance screening tool with the strongest psychometric properties.&#xD;
&#xD;
      One hundred and twenty individuals with COPD will be recruited from two sites. Upon&#xD;
      enrolment, participants will undergo a physical assessment session measuring balance,&#xD;
      functional lower body strength and exercise tolerance. Participants will also complete&#xD;
      questionnaires of balance confidence, perceived physical function limitations, fall risk,&#xD;
      dyspnea, global cognitive impairment and executive function. Participants will then be&#xD;
      followed for 12 months to measure incidence of falls.&#xD;
&#xD;
      To assess inter-rater reliability of the primary measures, two raters will simultaneously&#xD;
      administer the balance tests with a subset of the first 32 subjects to agree to participate&#xD;
      in this study. This subset will also be asked to return for repeat testing two-three days&#xD;
      after the baseline assessment to assess test-retest reliability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brief-Balance Evaluation Systems Test (Brief-BESTest)</measure>
    <time_frame>Upon enrolment, sub-group will repeat 2-3 days later.</time_frame>
    <description>Measure of balance. The Brief-BESTest is a shortened 6-item version of the 36-item full BESTest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go (TUG)</measure>
    <time_frame>Upon enrolment, sub-group will repeat 2-3 days later.</time_frame>
    <description>Measure of balance and functional mobility in older adults. Includes a dual-task condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single-leg Stance Test (SLS)</measure>
    <time_frame>Upon enrolment, sub-group will repeat 2-3 days later.</time_frame>
    <description>Measure of balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Falls</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>Falls during the previous year will be measured at baseline and then prospectively for 12 months using monthly fall diary calendars.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence Scale (ABC Scale)</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of balance confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-second Repeated Chair Stand Test</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of functional lower body strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of exercise tolerance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported function (PF-10)</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fried's Frailty Phenotype</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of frailty including the following criteria: weight loss, exhaustion, physical activity, walk speed and grip strength in community-dwelling older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Exam</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test</measure>
    <time_frame>Upon enrolment</time_frame>
    <description>Measure of cognitive executive function.</description>
  </secondary_outcome>
  <enrollment type="Actual">94</enrollment>
  <condition>Pulmonary Disease</condition>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals greater than 60 years of age diagnosed with COPD who have had one or more falls&#xD;
        in the last year or who self-report problems with their balance or fear of falling.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of COPD according to GOLD guidelines&#xD;
&#xD;
          -  history of one or more falls in the previous year or a self-reported problem with&#xD;
             balance/fear of falling&#xD;
&#xD;
          -  ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to communicate because of language skills (e.g. aphasia, non-English&#xD;
             speaking)&#xD;
&#xD;
          -  inability to follow instructions due to dementia or severe cognitive impairment&#xD;
&#xD;
          -  evidence of a condition that severely limits mobility (e.g Parkinson's disease,&#xD;
             cerebrovascular accident)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marla Beauchamp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Hamilton Community Health Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 4N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Firestone Institute for Respiratory Health</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Park Healthcare Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Balance</keyword>
  <keyword>Falls</keyword>
  <keyword>Screening</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229473
org study id: 3331
nct id: NCT03229473
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with chronic obstructive pulmonary disease (COPD) have balance problems and are at
      risk of falling. New guidelines recommend balance assessment be included in pulmonary
      rehabilitation (PR) however no specific tests are recommended. Our goal is to determine the
      best balance test for identifying COPD patients who are at risk of falling. In this study,
      COPD patients who report balance problems or falling in the last year will participate in a
      testing session. Balance, balance confidence, lower body strength, exercise tolerance and
      perceived physical limitations will be assessed. The number of falls over the following year
      will be recorded using monthly calendars.
COPD is a leading cause of death, disability and hospitalization in Canada. In addition to
      the primary lung impairment, secondary effects of the disease are well established including
      impairments in muscle function, mobility and exercise capacity. Individuals with COPD also
      have marked deficits in balance and an increased risk of falls.

      The updated American Thoracic Society/European Respiratory Society Statement on PR
      recommended expanding the scope of outcome assessment in COPD to include balance however no
      specific tests are suggested. An examination of brief balance measures feasible for fall risk
      screening has not been conducted. Such information will inform clinicians as to those most
      likely to benefit from targeted intervention. This study aims to determine the optimal
      balance measure for identifying patients with COPD who are high risk for falling.

      The specific objectives of the study are to: 1) Investigate the construct validity
      (convergent and known-groups) and reliability (inter-rater and test-retest) of three short
      balance screening measures in people with COPD; 2) Investigate the predictive validity of the
      balance screening tests for falls; and 3) Identify cut-off scores for identifying fallers
      with COPD on the balance screening tool with the strongest psychometric properties.

      One hundred and twenty individuals with COPD will be recruited from two sites. Upon
      enrolment, participants will undergo a physical assessment session measuring balance,
      functional lower body strength and exercise tolerance. Participants will also complete
      questionnaires of balance confidence, perceived physical function limitations, fall risk,
      dyspnea, global cognitive impairment and executive function. Participants will then be
      followed for 12 months to measure incidence of falls.

      To assess inter-rater reliability of the primary measures, two raters will simultaneously
      administer the balance tests with a subset of the first 32 subjects to agree to participate
      in this study. This subset will also be asked to return for repeat testing two-three days
      after the baseline assessment to assess test-retest reliability.
observational model: Cohort
time perspective: Prospective
measure: Brief-Balance Evaluation Systems Test (Brief-BESTest)
time frame: Upon enrolment, sub-group will repeat 2-3 days later.
description: Measure of balance. The Brief-BESTest is a shortened 6-item version of the 36-item full BESTest
measure: Timed Up and Go (TUG)
time frame: Upon enrolment, sub-group will repeat 2-3 days later.
description: Measure of balance and functional mobility in older adults. Includes a dual-task condition.
measure: Single-leg Stance Test (SLS)
time frame: Upon enrolment, sub-group will repeat 2-3 days later.
description: Measure of balance.
measure: Incidence of Falls
time frame: baseline, 12 months
description: Falls during the previous year will be measured at baseline and then prospectively for 12 months using monthly fall diary calendars.
measure: Berg Balance Scale (BBS)
time frame: Upon enrolment
description: Measure of balance.
measure: Activities-specific Balance Confidence Scale (ABC Scale)
time frame: Upon enrolment
description: Measure of balance confidence.
measure: 30-second Repeated Chair Stand Test
time frame: Upon enrolment
description: Measure of functional lower body strength.
measure: Six-Minute Walk Test (6MWT)
time frame: Upon enrolment
description: Measure of exercise tolerance.
measure: Self-reported function (PF-10)
time frame: Upon enrolment
description: Physical function sub-scale of the Medical Outcomes Study 36-item Short-form Health Survey
measure: Fried's Frailty Phenotype
time frame: Upon enrolment
description: Measure of frailty including the following criteria: weight loss, exhaustion, physical activity, walk speed and grip strength in community-dwelling older adults.
measure: Mini-Mental State Exam
time frame: Upon enrolment
description: Measure of five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
measure: Trail Making Test
time frame: Upon enrolment
description: Measure of cognitive executive function.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Marla Beauchamp, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Diseases