<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/NCT02995681</url>
  </required_header>
  <id_info>
    <org_study_id>16-018-WP</org_study_id>
    <nct_id>NCT02995681</nct_id>
  </id_info>
  <brief_title>Balance Training for Fall Reduction in COPD</brief_title>
  <official_title>Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>La Trobe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aveiro University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West Park Healthcare Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their&#xD;
      balance and a high incidence of falls compared to those of a similar age. Pulmonary&#xD;
      rehabilitation is recommended for people with COPD, however, these training programs do not&#xD;
      typically include balance training or fall prevention strategies. In this study, patients&#xD;
      with COPD who report problems with their balance or have had a fall in the last two years&#xD;
      will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or&#xD;
      control group (standard pulmonary rehabilitation). We will record the number of falls using&#xD;
      monthly diaries and evaluate patient's balance, strength, confidence and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in&#xD;
      Canada. In addition to lung impairment, secondary effects of the disease are well established&#xD;
      including impairments in muscle function and exercise capacity. However, individuals with&#xD;
      COPD also have marked deficits in balance and an increased risk of falls with a 3-5 times&#xD;
      higher annual fall rate than those of similar age. The underlying mechanisms remain unclear,&#xD;
      but several factors have been implicated including decreased physical activity, muscle&#xD;
      weakness, altered trunk mechanics, comorbidities, hypoxemia and proprioceptive deficits.&#xD;
      Given this unique impairment profile, tailored approaches to balance training and fall&#xD;
      prevention are needed in COPD.&#xD;
&#xD;
      Pulmonary rehabilitation (PR) is an integral therapeutic intervention for individuals with&#xD;
      COPD. The program typically consists of supervised exercise, disease-specific education, and&#xD;
      psychological and social support. Balance training and fall prevention strategies are not&#xD;
      currently included in international guidelines for PR and few programs include any balance&#xD;
      assessment. We have previously shown that the exercise component of traditional PR has&#xD;
      minimal effect on measures of balance and fall risk. We then conducted an RCT to examine the&#xD;
      effects of balance training alongside PR, which specifically addressed the profile of balance&#xD;
      deficits we had identified in COPD. Tailored balance training alongside PR results in&#xD;
      clinically important improvements in balance performance compared to PR alone. Given these&#xD;
      results, we now have the opportunity to build on our existing experience to test the effect&#xD;
      of the intervention on falls.&#xD;
&#xD;
      The purpose of this study is to establish the efficacy of a tailored balance exercise program&#xD;
      for reducing falls in individuals with COPD enrolled in PR. If participation in tailored&#xD;
      balance training decreases falls compared to usual PR, this approach will represent an&#xD;
      innovative and potential cost-saving strategy to prevent falls and reduce associated&#xD;
      healthcare utilization in COPD. Our results will be relevant for guiding clinical and&#xD;
      policy-based decision making, given the large population of individuals with COPD and the&#xD;
      potential for severe consequences of falls in this population.&#xD;
&#xD;
      The primary objective of this study is to evaluate the long-term effects of tailored balance&#xD;
      exercise on the rate of falls in individuals with COPD enrolled in PR. Secondary objectives&#xD;
      are to determine 1) the long-term effects of the program on measures of balance, balance&#xD;
      confidence and muscle strength; and 2) the cost-utility of the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 pandemic restrictions&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2022</completion_date>
  <primary_completion_date type="Actual">March 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of falls</measure>
    <time_frame>12 months</time_frame>
    <description>Number of falls will be measured using monthly falls diaries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Clinical measure of balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance Evaluation Systems Test (BESTest)</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Clinical measure of balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities Specific Balance Confidence Scale</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Balance confidence questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Second Repeated Chair Stand Test</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Functional lower body strength test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months</time_frame>
    <description>Health status questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Baseline Dyspnea Index</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Descriptive measure of shortness of breath</description>
  </other_outcome>
  <other_outcome>
    <measure>Falls Risk for Older People - Community Setting (FROP-Com)</measure>
    <time_frame>Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months</time_frame>
    <description>Descriptive measure of falls risk in community dwelling older people</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Copd</condition>
  <condition>Fall Patients</condition>
  <arm_group>
    <arm_group_label>Pulmonary rehab and balance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive standard pulmonary rehab plus additional balance training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary rehab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive pulmonary rehab only and a pulmonary rehab home program (walking and lower extremity resistance exercises) upon discharge from pulmonary. They will also receive the same monthly phone calls and three home visits at three, six and nine months to ensure proper technique and progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance training</intervention_name>
    <description>Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.</description>
    <arm_group_label>Pulmonary rehab and balance training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary rehab</intervention_name>
    <description>Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.</description>
    <arm_group_label>Pulmonary rehab</arm_group_label>
    <arm_group_label>Pulmonary rehab and balance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a physician diagnosis of COPD based on GOLD criteria; a self-reported decline in&#xD;
             balance, a fall within the last two years or a recent near fall; and an ability to&#xD;
             provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive impairment (dementia, neurological condition) an inability to&#xD;
             communicate because of language skills (aphasia, non-English speaking), or evidence of&#xD;
             a neurological or musculoskeletal condition that severely limits mobility and postural&#xD;
             control (e.g. cerebrovascular accident, Parkinson's Disease, amputation) and may&#xD;
             jeopardize their safety or influence their balance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Brooks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Park Healthcare Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roger Goldstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Park Healthcare Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marla Beauchamp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Park Healthcare Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Health</name>
      <address>
        <city>Saint Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G.F. Macdonald Centre for Lung Health</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5K 0L4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Pulmonary Rehab Program</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colchester East Hants Health Authority</name>
      <address>
        <city>Truro</city>
        <state>Nova Scotia</state>
        <zip>B2N 4Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Rehabilitation Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Park Healthcare Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>School of Health Sciences, University of Aveiro</name>
      <address>
        <city>Aveiro</city>
        <zip>3810-193</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <state>North Yorkshire</state>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Portugal</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Park Healthcare Centre</investigator_affiliation>
    <investigator_full_name>Roger Goldstein</investigator_full_name>
    <investigator_title>Respirologist</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Falls</keyword>
  <keyword>Balance training</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995681
org study id: 16-018-WP
nct id: NCT02995681
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their
      balance and a high incidence of falls compared to those of a similar age. Pulmonary
      rehabilitation is recommended for people with COPD, however, these training programs do not
      typically include balance training or fall prevention strategies. In this study, patients
      with COPD who report problems with their balance or have had a fall in the last two years
      will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or
      control group (standard pulmonary rehabilitation). We will record the number of falls using
      monthly diaries and evaluate patient's balance, strength, confidence and quality of life.
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in
      Canada. In addition to lung impairment, secondary effects of the disease are well established
      including impairments in muscle function and exercise capacity. However, individuals with
      COPD also have marked deficits in balance and an increased risk of falls with a 3-5 times
      higher annual fall rate than those of similar age. The underlying mechanisms remain unclear,
      but several factors have been implicated including decreased physical activity, muscle
      weakness, altered trunk mechanics, comorbidities, hypoxemia and proprioceptive deficits.
      Given this unique impairment profile, tailored approaches to balance training and fall
      prevention are needed in COPD.

      Pulmonary rehabilitation (PR) is an integral therapeutic intervention for individuals with
      COPD. The program typically consists of supervised exercise, disease-specific education, and
      psychological and social support. Balance training and fall prevention strategies are not
      currently included in international guidelines for PR and few programs include any balance
      assessment. We have previously shown that the exercise component of traditional PR has
      minimal effect on measures of balance and fall risk. We then conducted an RCT to examine the
      effects of balance training alongside PR, which specifically addressed the profile of balance
      deficits we had identified in COPD. Tailored balance training alongside PR results in
      clinically important improvements in balance performance compared to PR alone. Given these
      results, we now have the opportunity to build on our existing experience to test the effect
      of the intervention on falls.

      The purpose of this study is to establish the efficacy of a tailored balance exercise program
      for reducing falls in individuals with COPD enrolled in PR. If participation in tailored
      balance training decreases falls compared to usual PR, this approach will represent an
      innovative and potential cost-saving strategy to prevent falls and reduce associated
      healthcare utilization in COPD. Our results will be relevant for guiding clinical and
      policy-based decision making, given the large population of individuals with COPD and the
      potential for severe consequences of falls in this population.

      The primary objective of this study is to evaluate the long-term effects of tailored balance
      exercise on the rate of falls in individuals with COPD enrolled in PR. Secondary objectives
      are to determine 1) the long-term effects of the program on measures of balance, balance
      confidence and muscle strength; and 2) the cost-utility of the program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of falls
time frame: 12 months
description: Number of falls will be measured using monthly falls diaries
measure: Berg Balance Scale
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Clinical measure of balance
measure: Balance Evaluation Systems Test (BESTest)
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Clinical measure of balance
measure: Activities Specific Balance Confidence Scale
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Balance confidence questionnaire
measure: 30 Second Repeated Chair Stand Test
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Functional lower body strength test
measure: European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L)
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months
description: Health status questionnaire
measure: Baseline Dyspnea Index
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Descriptive measure of shortness of breath
measure: Falls Risk for Older People - Community Setting (FROP-Com)
time frame: Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
description: Descriptive measure of falls risk in community dwelling older people
arm group label: Pulmonary rehab and balance training
arm group type: Experimental
description: The intervention group will receive standard pulmonary rehab plus additional balance training.
arm group label: Pulmonary rehab
arm group type: Active Comparator
description: The control group will receive pulmonary rehab only and a pulmonary rehab home program (walking and lower extremity resistance exercises) upon discharge from pulmonary. They will also receive the same monthly phone calls and three home visits at three, six and nine months to ensure proper technique and progression.
intervention type: Other
intervention name: Balance training
description: Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.
arm group label: Pulmonary rehab and balance training
intervention type: Other
intervention name: Pulmonary rehab
description: Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.
arm group label: Pulmonary rehab
arm group label: Pulmonary rehab and balance training
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Dina Brooks, PhD
role: Principal Investigator
affiliation: West Park Healthcare Centre
last name: Roger Goldstein, MD
role: Principal Investigator
affiliation: West Park Healthcare Centre
last name: Marla Beauchamp, PhD
role: Principal Investigator
affiliation: West Park Healthcare Centre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Portugal
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: West Park Healthcare Centre
investigator full name: Roger Goldstein
investigator title: Respirologist
sharing ipd: No