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/NCT05986058</url>
    </required_header>
    <id_info>
      <org_study_id>21916</org_study_id>
      <nct_id>NCT05986058</nct_id>
    </id_info>
    <brief_title>Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic</brief_title>
    <official_title>Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Illinois at Urbana-Champaign</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Illinois at Urbana-Champaign</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>
        This study tested preliminary efficacy of a hybrid (web-based and center-based) PA&#xD;
        intervention combining use of a smartwatch and mobile application. The 12-week hybrid PA&#xD;
        intervention included 120 older Korean adults and was concurrently implemented in-person at&#xD;
        the local senior center and at-home through a web-based modality. Overall, increases were&#xD;
        evident in systolic/diastolic blood pressure, total cholesterol, and high-density-lipoprotein&#xD;
        at posttest, with decreases seen for triglyceride levels. Participants showed improvements in&#xD;
        muscular function and cardiopulmonary endurance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2020</start_date>
    <completion_date type="Actual">June 30, 2021</completion_date>
    <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiovascular health</measure>
      <time_frame>Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)</time_frame>
      <description>systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, and triglycerides</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical function</measure>
      <time_frame>Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)</time_frame>
      <description>muscular function and cardiopulmonary endurance</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">120</enrollment>
    <condition>Cardiovascular Health</condition>
    <condition>Physical Function</condition>
    <arm_group>
      <arm_group_label>Hybrid PA intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The PA intervention implemented 1-hour sessions for 12 weeks focusing on improving (1) body muscle, (2) body flexibility, (3) muscle endurance, and (4) body balance. The 12-week hybrid PA intervention was concurrently deployed in-person at a senior center and at-home through a web-based modality.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Golden Circle</intervention_name>
      <description>The original Golden Circle project was deployed in response to the COVID-19 pandemic and the need to implement remote social services in South Korea. Golden Circle had the aim of building a case management model using a healthcare-oriented automation system based on wearable devices (smartwatches and mobile applications). Through innovative system expansions, the goals were to promote healthful CVH and physical function and cultivate self-care management skills in older Korean adults.</description>
      <arm_group_label>Hybrid PA intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged 60 and over&#xD;
  &#xD;
            -  enrolled member at the participating senior center for at least three years&#xD;
  &#xD;
            -  fluent in Korean&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  younger than 60 years old&#xD;
  &#xD;
            -  less than three years enrollment at the senior center&#xD;
  &#xD;
            -  cannot read and speak Korean&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mokdong Senior Welfare Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>December 14, 2022</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Illinois at Urbana-Champaign</investigator_affiliation>
      <investigator_full_name>Soonhyung Kwon</investigator_full_name>
      <investigator_title>Doctoral Student</investigator_title>
    </responsible_party>
    <keyword>Physical activity intervention</keyword>
    <keyword>Older adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>It requires the data agreement from the director (Noh-Suk Park).</ipd_description>
    </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/NCT05986058
  org study id: 21916
  nct id: NCT05986058
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study tested preliminary efficacy of a hybrid (web-based and center-based) PA
        intervention combining use of a smartwatch and mobile application. The 12-week hybrid PA
        intervention included 120 older Korean adults and was concurrently implemented in-person at
        the local senior center and at-home through a web-based modality. Overall, increases were
        evident in systolic/diastolic blood pressure, total cholesterol, and high-density-lipoprotein
        at posttest, with decreases seen for triglyceride levels. Participants showed improvements in
        muscular function and cardiopulmonary endurance.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Cardiovascular health
  time frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
  description: systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, and triglycerides
  measure: Physical function
  time frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
  description: muscular function and cardiopulmonary endurance
  arm group label: Hybrid PA intervention
  arm group type: Experimental
  description: The PA intervention implemented 1-hour sessions for 12 weeks focusing on improving (1) body muscle, (2) body flexibility, (3) muscle endurance, and (4) body balance. The 12-week hybrid PA intervention was concurrently deployed in-person at a senior center and at-home through a web-based modality.
  intervention type: Behavioral
  intervention name: Golden Circle
  description: The original Golden Circle project was deployed in response to the COVID-19 pandemic and the need to implement remote social services in South Korea. Golden Circle had the aim of building a case management model using a healthcare-oriented automation system based on wearable devices (smartwatches and mobile applications). Through innovative system expansions, the goals were to promote healthful CVH and physical function and cultivate self-care management skills in older Korean adults.
  arm group label: Hybrid PA intervention
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: University of Illinois at Urbana-Champaign
  investigator full name: Soonhyung Kwon
  investigator title: Doctoral Student
  mesh term: COVID-19
  sharing ipd: Undecided
  ipd description: It requires the data agreement from the director (Noh-Suk Park).