xml: <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/NCT05978336</url>
    </required_header>
    <id_info>
      <org_study_id>H21-00858</org_study_id>
      <nct_id>NCT05978336</nct_id>
    </id_info>
    <brief_title>SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults</brief_title>
    <official_title>SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of British Columbia</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>
        The goal of this randomized controlled trial is to investigate the effectiveness of a&#xD;
        health-coaching intervention to improve physical activity in older adults with limited&#xD;
        mobility when compared to a control, health education group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 290 older adults with limited mobility will be randomized to either a 26-week&#xD;
        health coaching program or health education program. Outcomes will be assessed at baseline,&#xD;
        13-weeks, 26-weeks (end of intervention), and 52 week (6-month follow-up period).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2027</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 (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mobility</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 52-weeks</time_frame>
      <description>Measured by the Short Physical Performance Battery (SPPB)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time in moderate to vigorous physical activity</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 52-weeks</time_frame>
      <description>Time spent in moderate to vigorous physical activity (MVPA) measured by accelerometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sedentary Time</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 52-weeks</time_frame>
      <description>Time spent sedentary measured by accelerometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gait speed</measure>
      <time_frame>Baseline, 13- weeks, 26-weeks, 52-weeks</time_frame>
      <description>Measured during the 400-m walk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Capacity to complete the 400-m walk in ≤ 15 minutes</measure>
      <time_frame>Baseline, 13- weeks, 26-weeks, 52-weeks</time_frame>
      <description>measured as yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>Baseline, 26-weeks, 52-weeks</time_frame>
      <description>Measured with the NIH Toolbox and standard neuropsychological assessments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Community mobility</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured with the Life Space Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical mobility</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured as the time to complete the Timed Up-and-Go (TUG)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured by the 9-item Fatigue Severity Scale (FSS) scored from 9 to 63, with higher scores indicating more severe fatigue</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower extremity strength</measure>
      <time_frame>Baseline, 13- weeks, 26-weeks, 52-weeks</time_frame>
      <description>Measured with strain gauge (kilograms) on dominant quadriceps</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip strength</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 52-weeks</time_frame>
      <description>Measured with digital Jamar isometric dynamometer (Newtons)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported Quality of Life</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured with questionnaire EuroQol (EQ-5D-5L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Measured with 19-item Pittsburgh Sleep Quality Index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 52-weeks</time_frame>
      <description>Measured by accelerometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Falls</measure>
      <time_frame>Baseline, monthly</time_frame>
      <description>Assessed with monthly calendar and questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health resource utilization</measure>
      <time_frame>Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks</time_frame>
      <description>Assessed with a questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">290</enrollment>
    <condition>Limitation, Mobility</condition>
    <condition>Older Adults</condition>
    <arm_group>
      <arm_group_label>Health Coaching (HC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The health coaching program will be delivered by trained and certified kinesiologists utilizing Brief Action Planning (BAP) principals. The BAP behavior change approach utilizes the following 4 techniques: 1) goal-setting; 2 )action planning; 3) self-monitoring; and 4) feedback. Participants will utilize daily physical activity diaries to enable self-monitoring, and BAP coaches will provide feedback on progress toward individualized physical activity goals.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health Education Program (ED)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This program is an attention control group, which consists of general health education. Education sessions will be delivered either by zoom or in person. The education sessions will cover the following topics: 1) falls prevention; 2) sleep; 3) healthy eating; 4) cognitive health; and 5) mental and emotional health.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Coaching Program</intervention_name>
      <description>The HC program will be delivered over 26-weeks. Participants will have an initial hour-long HC session where the BAP coach will conduct a brief physical assessment and work with the participant to establish their physical activity goals and develop a plan. After the initial consult, coaches will conduct 8 x 20-minute phone calls with participants over the 26-week trial decreasing from bi-weekly phone calls in weeks 1-12 to monthly phone calls in weeks 13-26.&#xD;
  Participants in the HC group will have an overall goal of increasing their weekly participation in moderate to vigorous physical activity by 50 minutes, via 5-, 7-, or 10-minute bouts of progressive exercises, at a rate of perceived exertion range of 13-14 (&quot;somewhat hard&quot;) by week 16. Participants will have access to specific exercise sessions made available by YouTube and/or hardcopy manuals created by the research team.</description>
      <arm_group_label>Health Coaching (HC)</arm_group_label>
      <other_name>HC</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education Program</intervention_name>
      <description>Participants will begin with a one-hour, group-based, interactive education session on falls prevention delivered either in-person or by Zoom. Following the initial education session, ED participants will receive additional group education sessions (in-person or by Zoom) with the same duration and schedule as the HC program covering a variety of healthy aging topics.</description>
      <arm_group_label>Health Education Program (ED)</arm_group_label>
      <other_name>ED</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  scored ≤ 9/12 on the SPPB&#xD;
  &#xD;
            -  are able to complete the 400-m walk in ≤ 15 minutes without sitting or physical&#xD;
               assistance from another person or walker (use of cane is acceptable)&#xD;
  &#xD;
            -  scored 22/30 on the Mini-Mental State Examination (MMSE)&#xD;
  &#xD;
            -  have no significant functional impairment and no dementia&#xD;
  &#xD;
            -  are able to safely engage in MVPA as indicated by the PAR-Q+ and by the family or&#xD;
               study physician as necessary&#xD;
  &#xD;
            -  are community-dwelling&#xD;
  &#xD;
            -  are able to provide written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  are diagnosed with dementia or stroke&#xD;
  &#xD;
            -  self-report engaging in MVPA ≥ 10 minutes per week in the prior 3 months&#xD;
  &#xD;
            -  are unable to understand, speak, and read English proficiently&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Teresa Liu-Ambrose, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of British Columbia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nathan Wei, B.Sc.</last_name>
      <phone>604-875-4111</phone>
      <phone_ext>69056</phone_ext>
      <email>nathan.wei@ubc.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vancouver Coastal Health Research Institute Research Pavilion</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V5Z 1L8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nathan Wei, B.SC</last_name>
        <phone>604-875-4111</phone>
        <phone_ext>69056</phone_ext>
        <email>cogmob.research@hiphealth.ca</email>
      </contact>
      <investigator>
        <last_name>Teresa Liu-Ambrose, Ph.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Teresa Liu-Ambrose</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>physical activity</keyword>
    <keyword>health coaching</keyword>
    <keyword>exercise</keyword>
    <keyword>limited mobility</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978336
  org study id: H21-00858
  nct id: NCT05978336
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to investigate the effectiveness of a
        health-coaching intervention to improve physical activity in older adults with limited
        mobility when compared to a control, health education group.
  A total of 290 older adults with limited mobility will be randomized to either a 26-week
        health coaching program or health education program. Outcomes will be assessed at baseline,
        13-weeks, 26-weeks (end of intervention), and 52 week (6-month follow-up period).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Mobility
  time frame: Baseline, 13-weeks, 26-weeks, 52-weeks
  description: Measured by the Short Physical Performance Battery (SPPB)
  measure: Time in moderate to vigorous physical activity
  time frame: Baseline, 13-weeks, 26-weeks, 52-weeks
  description: Time spent in moderate to vigorous physical activity (MVPA) measured by accelerometer
  measure: Sedentary Time
  time frame: Baseline, 13-weeks, 26-weeks, 52-weeks
  description: Time spent sedentary measured by accelerometer
  measure: Gait speed
  time frame: Baseline, 13- weeks, 26-weeks, 52-weeks
  description: Measured during the 400-m walk
  measure: Capacity to complete the 400-m walk in ≤ 15 minutes
  time frame: Baseline, 13- weeks, 26-weeks, 52-weeks
  description: measured as yes or no
  measure: Cognitive function
  time frame: Baseline, 26-weeks, 52-weeks
  description: Measured with the NIH Toolbox and standard neuropsychological assessments
  measure: Community mobility
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured with the Life Space Questionnaire
  measure: Physical mobility
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured as the time to complete the Timed Up-and-Go (TUG)
  measure: Fatigue
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured by the 9-item Fatigue Severity Scale (FSS) scored from 9 to 63, with higher scores indicating more severe fatigue
  measure: Lower extremity strength
  time frame: Baseline, 13- weeks, 26-weeks, 52-weeks
  description: Measured with strain gauge (kilograms) on dominant quadriceps
  measure: Grip strength
  time frame: Baseline, 13-weeks, 26-weeks, 52-weeks
  description: Measured with digital Jamar isometric dynamometer (Newtons)
  measure: Mood
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)
  measure: Self Reported Quality of Life
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured with questionnaire EuroQol (EQ-5D-5L)
  measure: Sleep
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Measured with 19-item Pittsburgh Sleep Quality Index
  measure: Sleep
  time frame: Baseline, 13-weeks, 26-weeks, 52-weeks
  description: Measured by accelerometer
  measure: Falls
  time frame: Baseline, monthly
  description: Assessed with monthly calendar and questionnaire
  measure: Health resource utilization
  time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
  description: Assessed with a questionnaire
  arm group label: Health Coaching (HC)
  arm group type: Experimental
  description: The health coaching program will be delivered by trained and certified kinesiologists utilizing Brief Action Planning (BAP) principals. The BAP behavior change approach utilizes the following 4 techniques: 1) goal-setting; 2 )action planning; 3) self-monitoring; and 4) feedback. Participants will utilize daily physical activity diaries to enable self-monitoring, and BAP coaches will provide feedback on progress toward individualized physical activity goals.
  arm group label: Health Education Program (ED)
  arm group type: Active Comparator
  description: This program is an attention control group, which consists of general health education. Education sessions will be delivered either by zoom or in person. The education sessions will cover the following topics: 1) falls prevention; 2) sleep; 3) healthy eating; 4) cognitive health; and 5) mental and emotional health.
  intervention type: Behavioral
  intervention name: Health Coaching Program
  description: The HC program will be delivered over 26-weeks. Participants will have an initial hour-long HC session where the BAP coach will conduct a brief physical assessment and work with the participant to establish their physical activity goals and develop a plan. After the initial consult, coaches will conduct 8 x 20-minute phone calls with participants over the 26-week trial decreasing from bi-weekly phone calls in weeks 1-12 to monthly phone calls in weeks 13-26.
  Participants in the HC group will have an overall goal of increasing their weekly participation in moderate to vigorous physical activity by 50 minutes, via 5-, 7-, or 10-minute bouts of progressive exercises, at a rate of perceived exertion range of 13-14 ("somewhat hard") by week 16. Participants will have access to specific exercise sessions made available by YouTube and/or hardcopy manuals created by the research team.
  arm group label: Health Coaching (HC)
  other name: HC
  intervention type: Behavioral
  intervention name: Health Education Program
  description: Participants will begin with a one-hour, group-based, interactive education session on falls prevention delivered either in-person or by Zoom. Following the initial education session, ED participants will receive additional group education sessions (in-person or by Zoom) with the same duration and schedule as the HC program covering a variety of healthy aging topics.
  arm group label: Health Education Program (ED)
  other name: ED
  criteria: 
  gender: All
  minimum age: 70 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Teresa Liu-Ambrose, PhD
  role: Principal Investigator
  affiliation: University of British Columbia
  last name: Nathan Wei, B.Sc.
  phone: 604-875-4111
  phone ext: 69056
  email: nathan.wei@ubc.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Teresa Liu-Ambrose
  investigator title: Professor
  mesh term: Mobility Limitation
  sharing ipd: No