<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/NCT03253341</url>
  </required_header>
  <id_info>
    <org_study_id>Smart Aging Program</org_study_id>
    <nct_id>NCT03253341</nct_id>
  </id_info>
  <brief_title>Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions</brief_title>
  <official_title>Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to test the efficacy of delivering an exercise and healthy&#xD;
      lifestyle program, Smart Aging, to older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Smart Aging Program is designed to be scalable, implementable, and sustainable in the&#xD;
      real world. This program joins patients and their clinicians with community-based fitness&#xD;
      centers. The Smart Aging Program looks to use already existing resources to deliver an&#xD;
      innovative program to increase physical activity in older adults.&#xD;
&#xD;
      The program begins at the patient-physician level. The program is conducted in&#xD;
      community-based fitness centers, the participant's home (home exercise, monitoring) and also&#xD;
      sends physical activity data back to the clinician using mobile technology.&#xD;
&#xD;
      The Smart Aging Program consists of a personalized and structured exercise program combined&#xD;
      with lifestyle education and mobile-health monitoring. The exercise program includes a&#xD;
      12-week initiation phase, followed by a 40-week maintenance phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cardiorespiratory Fitness</measure>
    <time_frame>Change from Baseline to 12 Weeks</time_frame>
    <description>Measured by peak oxygen consumption (VO2 peak) during treadmill testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cardiorespiratory Fitness</measure>
    <time_frame>Change from Baseline to 52 Weeks</time_frame>
    <description>Measured by peak oxygen consumption (VO2 peak) during treadmill testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Insulin Resistance</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Measured using Homeostasis Model Assessment 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fat Mass</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Measured using a dual energy x-ray absorptiometry (DEXA) scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lean Mass</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Measured using a dual energy x-ray absorptiometry (DEXA) scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cholesterol</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Changes in total cholesterol, LDL, and HDL will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Aging</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Smart Aging Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be enrolled into the Smart Aging Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be enrolled into group that receives educational materials that reflect the current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smart Aging Program</intervention_name>
    <description>Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.</description>
    <arm_group_label>Smart Aging Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Materials</intervention_name>
    <description>Current standard of care. Includes education materials covering benefits of a healthy lifestyle.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinician referred&#xD;
&#xD;
          -  Ambulatory: walk unassisted and successfully complete the 6 minute walk test without&#xD;
             rest&#xD;
&#xD;
          -  Sufficiently fluent in English to participate in study procedures&#xD;
&#xD;
          -  Sedentary or underactive by the Telephone Assessment of Physical Activity61&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically-significant systemic or psychiatric illness that may affect safety or&#xD;
             completion&#xD;
&#xD;
          -  Diagnosis of dementia; use of dementia medications (cholinesterase inhibitors,&#xD;
             memantine)&#xD;
&#xD;
          -  Myocardial infarction or unstable coronary artery disease (e.g., angina, arrhythmia)&#xD;
             in last 6 months.&#xD;
&#xD;
          -  Cerebrovascular event (stroke or transient ischemic attack) in the last 6 months&#xD;
&#xD;
          -  Cancer diagnosis in the last 2 years (except non-metastatic basal or squamous cell&#xD;
             carcinoma or cancer in remission in the absence of treatment for at least 2 years)&#xD;
&#xD;
          -  Significant pain or musculoskeletal disorder limiting the ability to participate&#xD;
             safely&#xD;
&#xD;
          -  Another member of the household enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Burns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise program</keyword>
  <keyword>lifestyle changes</keyword>
  <keyword>fitness program</keyword>
  <keyword>lifestyle intervention</keyword>
  <!-- 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/NCT03253341
org study id: Smart Aging Program
nct id: NCT03253341
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the efficacy of delivering an exercise and healthy
      lifestyle program, Smart Aging, to older adults.
The Smart Aging Program is designed to be scalable, implementable, and sustainable in the
      real world. This program joins patients and their clinicians with community-based fitness
      centers. The Smart Aging Program looks to use already existing resources to deliver an
      innovative program to increase physical activity in older adults.

      The program begins at the patient-physician level. The program is conducted in
      community-based fitness centers, the participant's home (home exercise, monitoring) and also
      sends physical activity data back to the clinician using mobile technology.

      The Smart Aging Program consists of a personalized and structured exercise program combined
      with lifestyle education and mobile-health monitoring. The exercise program includes a
      12-week initiation phase, followed by a 40-week maintenance phase.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Cardiorespiratory Fitness
time frame: Change from Baseline to 12 Weeks
description: Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
measure: Change in Cardiorespiratory Fitness
time frame: Change from Baseline to 52 Weeks
description: Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
measure: Changes in Insulin Resistance
time frame: 52 Weeks
description: Measured using Homeostasis Model Assessment 2.
measure: Change in Fat Mass
time frame: 52 Weeks
description: Measured using a dual energy x-ray absorptiometry (DEXA) scan.
measure: Change in Lean Mass
time frame: 52 Weeks
description: Measured using a dual energy x-ray absorptiometry (DEXA) scan.
measure: Change in Cholesterol
time frame: 52 Weeks
description: Changes in total cholesterol, LDL, and HDL will be measured.
arm group label: Smart Aging Program
arm group type: Experimental
description: Participants will be enrolled into the Smart Aging Program.
arm group label: Control Group
arm group type: Active Comparator
description: Participants will be enrolled into group that receives educational materials that reflect the current standard of care.
intervention type: Behavioral
intervention name: Smart Aging Program
description: Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.
arm group label: Smart Aging Program
intervention type: Behavioral
intervention name: Educational Materials
description: Current standard of care. Includes education materials covering benefits of a healthy lifestyle.
arm group label: Control Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Burns, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor