<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/NCT03306888</url>
  </required_header>
  <id_info>
    <org_study_id>546845</org_study_id>
    <nct_id>NCT03306888</nct_id>
  </id_info>
  <brief_title>Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage HD</brief_title>
  <official_title>Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teachers College, Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teachers College, Columbia 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>
      This study will evaluate the feasibility and acceptability of a clinic-based physical&#xD;
      activity coaching intervention in people with pre-manifest and early stage Huntington's&#xD;
      Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to&#xD;
      participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment&#xD;
      and retention rates, and acceptability will be assessed by participant interviews.&#xD;
      Participants will also be evaluate at baseline and following the coaching intervention to&#xD;
      explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific&#xD;
      motor and cognitive function, walking endurance and strength.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators have previously developed and evaluated a physical activity behavioral&#xD;
      change intervention in people with early-mid stage HD (Engage-HD). In a study conducted in&#xD;
      the United Kingdom, self-reported physical activity, self-efficacy for exercise, and&#xD;
      cognition were increased for those in the coaching intervention group compared to a social&#xD;
      contact control group. This intervention has not yet been applied to individuals with&#xD;
      pre-manifest (prior to onset of clinical symptoms) and early stage HD, where it may be most&#xD;
      critical to engage in exercise. To date, no study has prospectively evaluated a physical&#xD;
      activity intervention to facilitate exercise uptake in these earliest stages. This study will&#xD;
      explore the feasibility and acceptability of the Engage-HD intervention in 14 individuals&#xD;
      with pre-manifest and early stage HD. The intervention will entail one face-to-face coaching&#xD;
      session (approximately 1 hour), and three remote video sessions (via secure Webex connection&#xD;
      via computer or smart phone, or phone call if internet/smart phone is not available to&#xD;
      participant) lasting approximately 20 minutes. Participants will also be given FitBit&#xD;
      wearable activity monitors to allow for self- monitoring of physical activity for use during&#xD;
      the 4-month intervention. Participants will be evaluated at baseline and again 4 months later&#xD;
      on a range of exploratory outcomes including physical activity, self efficacy,&#xD;
      disease-specific motor and cognitive function, walking endurance and strength. Results from&#xD;
      this study will be used to make relevant adaptations to prepare for a multi-site randomized&#xD;
      controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single arm feasibility study with 14 participants</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity (daily step counts) at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Physical activity as measured by waist worn device (Actigraph)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire evaluating level of physical activity over past 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lorig self efficacy scale at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Self efficacy questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 minute walk distance at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in grip strength at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Hand strength as measured with hand held dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HD-PRO-TRIAD at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Huntington Disease rating scale Total Motor Score at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Disease-specific measure of motor function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>A 19 item questionnaire measuring stages of self determination continuum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months</measure>
    <time_frame>4 months</time_frame>
    <description>Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Huntington's Disease</condition>
  <arm_group>
    <arm_group_label>Physical Activity Coaching Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will entail one face-to-face coaching session (approximately 1 hour) to be held approximately 1 week following the baseline assessment, and three remote video sessions (via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant) lasting approximately 20 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Activity Coaching</intervention_name>
    <description>Physical activity coaching over 4 months</description>
    <arm_group_label>Physical Activity Coaching Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For premanifest - Confirmatory genetic testing for Huntington disease (HD) and&#xD;
             diagnostic confidence score of 0-3 on Unified Huntington Disease Rating Scale,&#xD;
             indicating pre-manifest disease state. For manifest HD - Confirmatory genetic testing&#xD;
             for HD or confirmed clinical diagnosis of HD by neurologist&#xD;
&#xD;
          -  Successful completion of Physical Activity Readiness Questionnaire (PAR-Q), or medical&#xD;
             clearance from General Practioner&#xD;
&#xD;
          -  For potential participants over age 60, a minimum score of 24 on the Mini-Mental State&#xD;
             Examination (MMSE) (completed within 3 months) will be required for capacity to&#xD;
             consent.&#xD;
&#xD;
          -  For potential participants age 60-65, successful pass of electrocardiogram screen will&#xD;
             be required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal injury that would interfere with participation in an exercise program&#xD;
&#xD;
          -  Currently participating in a structured exercise program 3 times per week or more&#xD;
&#xD;
          -  Uncontrolled psychiatric or behavioral problems that would interfere with&#xD;
             participation in an exercise program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington Disease</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/NCT03306888
org study id: 546845
nct id: NCT03306888
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the feasibility and acceptability of a clinic-based physical
      activity coaching intervention in people with pre-manifest and early stage Huntington's
      Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to
      participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment
      and retention rates, and acceptability will be assessed by participant interviews.
      Participants will also be evaluate at baseline and following the coaching intervention to
      explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific
      motor and cognitive function, walking endurance and strength.
The investigators have previously developed and evaluated a physical activity behavioral
      change intervention in people with early-mid stage HD (Engage-HD). In a study conducted in
      the United Kingdom, self-reported physical activity, self-efficacy for exercise, and
      cognition were increased for those in the coaching intervention group compared to a social
      contact control group. This intervention has not yet been applied to individuals with
      pre-manifest (prior to onset of clinical symptoms) and early stage HD, where it may be most
      critical to engage in exercise. To date, no study has prospectively evaluated a physical
      activity intervention to facilitate exercise uptake in these earliest stages. This study will
      explore the feasibility and acceptability of the Engage-HD intervention in 14 individuals
      with pre-manifest and early stage HD. The intervention will entail one face-to-face coaching
      session (approximately 1 hour), and three remote video sessions (via secure Webex connection
      via computer or smart phone, or phone call if internet/smart phone is not available to
      participant) lasting approximately 20 minutes. Participants will also be given FitBit
      wearable activity monitors to allow for self- monitoring of physical activity for use during
      the 4-month intervention. Participants will be evaluated at baseline and again 4 months later
      on a range of exploratory outcomes including physical activity, self efficacy,
      disease-specific motor and cognitive function, walking endurance and strength. Results from
      this study will be used to make relevant adaptations to prepare for a multi-site randomized
      controlled trial.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm feasibility study with 14 participants
primary purpose: Other
masking: None (Open Label)
measure: Change in physical activity (daily step counts) at 4 months
time frame: 4 months
description: Physical activity as measured by waist worn device (Actigraph)
measure: Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months
time frame: 4 months
description: Questionnaire evaluating level of physical activity over past 7 days
measure: Change in Lorig self efficacy scale at 4 months
time frame: 4 months
description: Self efficacy questionnaire
measure: Change in 6 minute walk distance at 4 months
time frame: 4 months
description: Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking
measure: Change in grip strength at 4 months
time frame: 4 months
description: Hand strength as measured with hand held dynamometer
measure: Change in HD-PRO-TRIAD at 4 months
time frame: 4 months
description: Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)
measure: Change in Unified Huntington Disease rating scale Total Motor Score at 4 months
time frame: 4 months
description: Disease-specific measure of motor function
measure: Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months
time frame: 4 months
description: A 19 item questionnaire measuring stages of self determination continuum
measure: Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months
time frame: 4 months
description: Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency)
arm group label: Physical Activity Coaching Intervention
arm group type: Experimental
description: The intervention will entail one face-to-face coaching session (approximately 1 hour) to be held approximately 1 week following the baseline assessment, and three remote video sessions (via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant) lasting approximately 20 minutes.
intervention type: Other
intervention name: Physical Activity Coaching
description: Physical activity coaching over 4 months
arm group label: Physical Activity Coaching Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Huntington Disease