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/NCT05991076</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0945</org_study_id>
      <secondary_id>EDUC/KINESIOLOGY</secondary_id>
      <nct_id>NCT05991076</nct_id>
    </id_info>
    <brief_title>Feasibility of a Community-based Dance Program for Latino Older Adults</brief_title>
    <official_title>Feasibility of Activate Bailando, a Community-based Dance Program, on Balance and Social Connectedness for Latino Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Wisconsin Institute For Healthy Aging</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Wisconsin, Madison</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to evaluate the feasibility and preliminary effectiveness of&#xD;
        Activate Bailando, a 6-week community-based dance class offered in Spanish to older adults.&#xD;
        20 older adults in the Madison, Wisconsin area who are enrolled in Activate Bailando will&#xD;
        complete a pre-and post-program test within 10 days for program start and completion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim is to evaluate the feasibility of the Activate Bailando program based on&#xD;
        measures of recruitment, retention, attendance, and acceptability.&#xD;
  &#xD;
        The secondary aim is to evaluate the preliminary effectiveness of the program on metrics of&#xD;
        balance, mobility, social connectedness, and fear of falling.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">September 12, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 12, 2023</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>Recruitment rate of participants who enroll in the study</measure>
      <time_frame>Baseline</time_frame>
      <description>A proportion of participants enrolled in the class and those who participate in the data collection will be reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rate of participants who enroll and complete the study</measure>
      <time_frame>Baseline, posttest (up to 7 weeks)</time_frame>
      <description>A proportion of participants who complete the pre data collection, attend at least half of the classes, and complete the post data collection.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attendance of Class Participation</measure>
      <time_frame>Posttest (up to 7 weeks)</time_frame>
      <description>Participants will be asked how many classes they attended at the end of the program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of participation in the class</measure>
      <time_frame>Posttest (up to 7 weeks)</time_frame>
      <description>Participants will be asked what they enjoyed and what they thought could be improved from the class.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in University of California Los Angeles (UCLA) Loneliness Scale</measure>
      <time_frame>Baseline, Posttest (up to 7 weeks)</time_frame>
      <description>A 3-item survey that measures three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. The scale has three response categories: hardly ever, some of the time, often. The scores of each question are added to give a range of scores from 3 (least lonely) to 9 (most lonely).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Timed Up and Go Results</measure>
      <time_frame>Baseline, Posttest (up to 7 weeks)</time_frame>
      <description>A mobility test records the time in seconds that it takes the participant to stand up, walk 10 feet (3 meters), walk back, and sit down again. An older adult who takes greater than or equal to 12 seconds to complete the task is at risk of falling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the 4-stage balance test</measure>
      <time_frame>Baseline, Posttest (up to 7 weeks)</time_frame>
      <description>A static balance test for 10 seconds in 4 different positions (stand feed side-by-side, place the instep of the foot so it is touching the big toes of the other foot, tandem stand, stand on one foot). The time the participant is able to balance in each position will be recorded in seconds. An older adult who cannot hold the tandem stand for at least 10 seconds is at increased risk of falling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Falls Efficacy Scale (Short Version)</measure>
      <time_frame>Baseline, Posttest (up to 7 weeks)</time_frame>
      <description>A 7-item survey that measures confidence in one's own ability to complete daily activities without falling on a scale of 1-7 where lower scores indicate more extreme confidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Lubben Social Network Scale (LSNS-6)</measure>
      <time_frame>Baseline, Posttest (up to 7 weeks)</time_frame>
      <description>A 6-item scale that measures social engagement including family and friends. The total score is calculated by finding the sum of all items. For the LSNS-R, the score ranges between 0 and 60, with a higher score indicating more social engagement. For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Mobility Limitation</condition>
    <arm_group>
      <arm_group_label>Activate Bailando Dance Program</arm_group_label>
      <description>The Activate Bailando program is a 6-week dance-focused exercise program that focuses on balance and social connectedness for community-dwelling Spanish-speaking older adults.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Latin Dance</intervention_name>
      <description>The Activate Bailando class is a dance-focused exercise class that is offered once per week for one hour. The program has been developed by dance educators in the Madison area.</description>
      <arm_group_label>Activate Bailando Dance Program</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Community-dwelling older adults including Spanish-speaking older adults are enrolled in&#xD;
          Activate Bailando, a community-based dance class.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being over the age of 55&#xD;
  &#xD;
            -  Willing and able to participate in the Activate Bailando class&#xD;
  &#xD;
            -  Willing and able to complete data collection before and after the program&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not Being over the age of 55&#xD;
  &#xD;
            -  Not willing and able to participate in the Activate Bailando class&#xD;
  &#xD;
            -  Not willing and able to complete data collection before and after the program&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Luis Columna, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UW Madison</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Catholic Multicultural Center</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53713</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hispanic/Latinos</keyword>
    <keyword>Older Adults</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/NCT05991076
  org study id: 2023-0945
  secondary id: EDUC/KINESIOLOGY
  nct id: NCT05991076
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the feasibility and preliminary effectiveness of
        Activate Bailando, a 6-week community-based dance class offered in Spanish to older adults.
        20 older adults in the Madison, Wisconsin area who are enrolled in Activate Bailando will
        complete a pre-and post-program test within 10 days for program start and completion.
  The primary aim is to evaluate the feasibility of the Activate Bailando program based on
        measures of recruitment, retention, attendance, and acceptability.
  
        The secondary aim is to evaluate the preliminary effectiveness of the program on metrics of
        balance, mobility, social connectedness, and fear of falling.
  observational model: Cohort
  time perspective: Prospective
  measure: Recruitment rate of participants who enroll in the study
  time frame: Baseline
  description: A proportion of participants enrolled in the class and those who participate in the data collection will be reported.
  measure: Retention rate of participants who enroll and complete the study
  time frame: Baseline, posttest (up to 7 weeks)
  description: A proportion of participants who complete the pre data collection, attend at least half of the classes, and complete the post data collection.
  measure: Attendance of Class Participation
  time frame: Posttest (up to 7 weeks)
  description: Participants will be asked how many classes they attended at the end of the program.
  measure: Acceptability of participation in the class
  time frame: Posttest (up to 7 weeks)
  description: Participants will be asked what they enjoyed and what they thought could be improved from the class.
  measure: Change in University of California Los Angeles (UCLA) Loneliness Scale
  time frame: Baseline, Posttest (up to 7 weeks)
  description: A 3-item survey that measures three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. The scale has three response categories: hardly ever, some of the time, often. The scores of each question are added to give a range of scores from 3 (least lonely) to 9 (most lonely).
  measure: Change in Timed Up and Go Results
  time frame: Baseline, Posttest (up to 7 weeks)
  description: A mobility test records the time in seconds that it takes the participant to stand up, walk 10 feet (3 meters), walk back, and sit down again. An older adult who takes greater than or equal to 12 seconds to complete the task is at risk of falling.
  measure: Change in the 4-stage balance test
  time frame: Baseline, Posttest (up to 7 weeks)
  description: A static balance test for 10 seconds in 4 different positions (stand feed side-by-side, place the instep of the foot so it is touching the big toes of the other foot, tandem stand, stand on one foot). The time the participant is able to balance in each position will be recorded in seconds. An older adult who cannot hold the tandem stand for at least 10 seconds is at increased risk of falling.
  measure: Changes in Falls Efficacy Scale (Short Version)
  time frame: Baseline, Posttest (up to 7 weeks)
  description: A 7-item survey that measures confidence in one's own ability to complete daily activities without falling on a scale of 1-7 where lower scores indicate more extreme confidence.
  measure: Changes in Lubben Social Network Scale (LSNS-6)
  time frame: Baseline, Posttest (up to 7 weeks)
  description: A 6-item scale that measures social engagement including family and friends. The total score is calculated by finding the sum of all items. For the LSNS-R, the score ranges between 0 and 60, with a higher score indicating more social engagement. For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.
  arm group label: Activate Bailando Dance Program
  description: The Activate Bailando program is a 6-week dance-focused exercise program that focuses on balance and social connectedness for community-dwelling Spanish-speaking older adults.
  intervention type: Other
  intervention name: Latin Dance
  description: The Activate Bailando class is a dance-focused exercise class that is offered once per week for one hour. The program has been developed by dance educators in the Madison area.
  arm group label: Activate Bailando Dance Program
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  last name: Luis Columna, PhD
  role: Principal Investigator
  affiliation: UW Madison
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Mobility Limitation
  sharing ipd: No