<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/NCT03001778</url>
  </required_header>
  <id_info>
    <org_study_id>R21AG046670</org_study_id>
    <secondary_id>5R21AG046670</secondary_id>
    <secondary_id>0283</secondary_id>
    <nct_id>NCT03001778</nct_id>
  </id_info>
  <brief_title>Smart Television and Exercise Promotion for Independent Living Facilities</brief_title>
  <acronym>STEP4Life</acronym>
  <official_title>Smart Television and Exercise Promotion for Independent Living Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g.,&#xD;
      increased strength and balance, reduced frailty, fewer falls, improved brain function, lower&#xD;
      mortality risk), yet many seniors have limited access to exercise options due to numerous&#xD;
      barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This&#xD;
      project will overcome common exercise barriers by creating an interactive web-enabled TV&#xD;
      program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an&#xD;
      Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF&#xD;
      residents and administrators will be able to create, use, and evaluate a customizable&#xD;
      exercise program tailored to the individual's preferred type of exercise, intensity, and&#xD;
      duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S.&#xD;
      population. As life expectancy increases, maintaining physical independence has become a&#xD;
      public health priority. It is well recognized that regular physical activity (PA) can be done&#xD;
      safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they&#xD;
      remain the least physically active of any age group. This suggests that the translational&#xD;
      reach of efficacious PA protocols to the real-world remains limited, and a need for research&#xD;
      which is scalable to the individual in more naturalistic settings exists. An emerging trend&#xD;
      for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a&#xD;
      variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g.,&#xD;
      wireless Internet), web-based education, and wellness programs are a priority for ILF&#xD;
      residents, thus opportunities for using technology for health promotion with OAs exists. ILFs&#xD;
      provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for&#xD;
      aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase&#xD;
      their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into&#xD;
      wellness offerings. Research is needed to translate efficacious PA protocols for seniors into&#xD;
      formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge&#xD;
      gained from efficacy research to improve the utilization and sustainability of evidence-based&#xD;
      methods by producing programs that are agreeable, user-friendly, and optimal at both the&#xD;
      individual and organizational level. Smart Television and Exercise Promotion for Independent&#xD;
      Living Facilities (STEP for LIFE) will establish the feasibility for translating an&#xD;
      evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e.,&#xD;
      Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective&#xD;
      medium to reach seniors, 2) the ability to select and sequence together a session that is&#xD;
      personalized to fitness level, type of exercise, and duration, and 3) organizations the&#xD;
      ability to provide desired wellness options which meet both resident and organizational&#xD;
      needs. The purpose of this study is to provide the initial research for translating&#xD;
      efficacious research-based PA protocols for seniors into a scalable format usable in a&#xD;
      real-world ILF setting, and to gain knowledge at individual and organizational levels to&#xD;
      improve implementation and sustainability of this evidence-based approach. Specific Aims&#xD;
      include extensive formative research on the use, interest, and effectiveness of interactive&#xD;
      multimedia approaches for promoting PA, and its integration into senior living settings. A&#xD;
      working prototype will be developed and tested for usability with ILF residents and&#xD;
      administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of&#xD;
      producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can&#xD;
      inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted&#xD;
      living, memory care, rural settings), and 2) sustainable implementation strategies for other&#xD;
      evidence-based health promotion protocols for seniors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2014</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Scale (SUS)</measure>
    <time_frame>After 1 hour usability session</time_frame>
    <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Aging</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Usability Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prototype testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usability Testing</intervention_name>
    <description>Usability testing of &quot;ready made&quot; workouts in a group format.</description>
    <arm_group_label>Usability Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Independent Living Facility (ILF) Resident Inclusion Criteria:&#xD;
&#xD;
          -  55 years of age or older&#xD;
&#xD;
          -  live in an ILF&#xD;
&#xD;
          -  able tor read and speak English&#xD;
&#xD;
          -  able to consent to participate&#xD;
&#xD;
          -  exercise 60 min or more a week (self-reported)&#xD;
&#xD;
        ILF Resident Exclusion Criteria:&#xD;
&#xD;
          -  under 55 years of age&#xD;
&#xD;
          -  not live in an ILF&#xD;
&#xD;
          -  unable to read and speak English&#xD;
&#xD;
          -  unable to consent to participate&#xD;
&#xD;
          -  exercise less than 60 minutes (self-reported)&#xD;
&#xD;
        Non-ILF Resident Inclusion Criteria:&#xD;
&#xD;
          -  55 years of age or older&#xD;
&#xD;
          -  not live in an ILF&#xD;
&#xD;
          -  able to read and speak English&#xD;
&#xD;
          -  able to consent to participate&#xD;
&#xD;
          -  exercise 60 min or more a week (self-reported)&#xD;
&#xD;
        Non-ILF Resident Exclusion Criteria:&#xD;
&#xD;
          -  under 55 years of age&#xD;
&#xD;
          -  live in an ILF&#xD;
&#xD;
          -  unable to read and speak English&#xD;
&#xD;
          -  unable to consent to participate&#xD;
&#xD;
          -  exercise less than 60 minutes (self-reported)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Myers, PhD'</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.</citation>
    <PMID>23009149</PMID>
  </reference>
  <reference>
    <citation>Xue QL, Bandeen-Roche K, Mielenz TJ, Seplaki CL, Szanton SL, Thorpe RJ, Kalyani RR, Chaves PH, Dam TT, Ornstein K, RoyChoudhury A, Varadhan R, Yao W, Fried LP. Patterns of 12-year change in physical activity levels in community-dwelling older women: can modest levels of physical activity help older women live longer? Am J Epidemiol. 2012 Sep 15;176(6):534-43. doi: 10.1093/aje/kws125. Epub 2012 Aug 30.</citation>
    <PMID>22935515</PMID>
  </reference>
  <reference>
    <citation>Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.</citation>
    <PMID>22929394</PMID>
  </reference>
  <reference>
    <citation>Kamegaya T; Long-Term-Care Prevention Team of Maebashi City; Maki Y, Yamagami T, Yamaguchi T, Murai T, Yamaguchi H. Pleasant physical exercise program for prevention of cognitive decline in community-dwelling elderly with subjective memory complaints. Geriatr Gerontol Int. 2012 Oct;12(4):673-9. doi: 10.1111/j.1447-0594.2012.00840.x. Epub 2012 Apr 2.</citation>
    <PMID>22469534</PMID>
  </reference>
  <reference>
    <citation>Uemura K, Doi T, Shimada H, Makizako H, Yoshida D, Tsutsumimoto K, Anan Y, Suzuki T. Effects of exercise intervention on vascular risk factors in older adults with mild cognitive impairment: a randomized controlled trial. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):445-55. doi: 10.1159/000343486. Epub 2012 Oct 25.</citation>
    <PMID>23189083</PMID>
  </reference>
  <reference>
    <citation>Concannon LG, Grierson MJ, Harrast MA. Exercise in the older adult: from the sedentary elderly to the masters athlete. PM R. 2012 Nov;4(11):833-9. doi: 10.1016/j.pmrj.2012.08.007.</citation>
    <PMID>23174546</PMID>
  </reference>
  <reference>
    <citation>Rydwik E, Welmer AK, Kareholt I, Angleman S, Fratiglioni L, Wang HX. Adherence to physical exercise recommendations in people over 65--the SNAC-Kungsholmen study. Eur J Public Health. 2013 Oct;23(5):799-804. doi: 10.1093/eurpub/cks150. Epub 2012 Oct 31.</citation>
    <PMID>23115329</PMID>
  </reference>
  <reference>
    <citation>Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.</citation>
    <PMID>19436015</PMID>
  </reference>
  <reference>
    <citation>Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. doi: 10.1016/j.apmr.2006.04.005.</citation>
    <PMID>16813773</PMID>
  </reference>
  <reference>
    <citation>Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.</citation>
    <PMID>15814861</PMID>
  </reference>
  <reference>
    <citation>Spirduso WW, Cronin DL. Exercise dose-response effects on quality of life and independent living in older adults. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S598-608; discussion S609-10. doi: 10.1097/00005768-200106001-00028.</citation>
    <PMID>11427784</PMID>
  </reference>
  <reference>
    <citation>Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.</citation>
    <PMID>12661673</PMID>
  </reference>
  <reference>
    <citation>Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.</citation>
    <PMID>11983637</PMID>
  </reference>
  <reference>
    <citation>Sze PC, Cheung WH, Lam PS, Lo HS, Leung KS, Chan T. The efficacy of a multidisciplinary falls prevention clinic with an extended step-down community program. Arch Phys Med Rehabil. 2008 Jul;89(7):1329-34. doi: 10.1016/j.apmr.2007.11.044.</citation>
    <PMID>18586135</PMID>
  </reference>
  <reference>
    <citation>Stevens JA, Sogolow ED. Preventing Falls: What Works: A CDC Compendium of Effective Community-Based Interventions From Around the World. National Center for Injury Prevention and Control; 2008.</citation>
  </reference>
  <reference>
    <citation>Najafi B, Armstrong DG, Mohler J. Novel wearable technology for assessing spontaneous daily physical activity and risk of falling in older adults with diabetes. J Diabetes Sci Technol. 2013 Sep 1;7(5):1147-60. doi: 10.1177/193229681300700507.</citation>
    <PMID>24124940</PMID>
  </reference>
  <reference>
    <citation>Gschwind YJ, Kressig RW, Lacroix A, Muehlbauer T, Pfenninger B, Granacher U. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2013 Oct 9;13:105. doi: 10.1186/1471-2318-13-105.</citation>
    <PMID>24106864</PMID>
  </reference>
  <reference>
    <citation>Lee H, Lee JA, Brar JS, Rush EB, Jolley CJ. Physical activity and depressive symptoms in older adults. Geriatr Nurs. 2014 Jan-Feb;35(1):37-41. doi: 10.1016/j.gerinurse.2013.09.005. Epub 2013 Oct 18.</citation>
    <PMID>24144579</PMID>
  </reference>
  <reference>
    <citation>National Prevention Council, Health Promotion Council, Public Health Council. Active Living. The National Prevention Strategy. http://www.surgeongeneral.gov/initiatives/prevention/strategy/report.html. June 16, 2011.</citation>
  </reference>
  <reference>
    <citation>Schillinger D. An introduction to effectiveness, dissemination and implementation research. In: Fleisher P, Goldstein E, editors. San Francisco: Clinical Translational Science Institute Community Engagement Program, University of California San Francisco; 2010.</citation>
  </reference>
  <reference>
    <citation>Koh HK. A 2020 vision for healthy people. N Engl J Med. 2010 May 6;362(18):1653-6. doi: 10.1056/NEJMp1001601. No abstract available.</citation>
    <PMID>20445177</PMID>
  </reference>
  <reference>
    <citation>Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.</citation>
    <PMID>17762378</PMID>
  </reference>
  <reference>
    <citation>U.S.Department of Health and Human Services. 2008 physical activity guidelines for Americans. Be active, healthy, and happy. Publication No.U0036 http://www.health.gov/paguidelines/. 2008.</citation>
  </reference>
  <reference>
    <citation>The Society of Certified Senior Advisors. State of the senior housing industry. The Society of Certified Senior Advisors Web site. http://www.csa.us/docs/StateoftheSeniorHousingIndustryReport.pdf. 2011.</citation>
  </reference>
  <reference>
    <citation>Brecht S, Fein S, Hollinger-Smith L. Preparing for the future: trends in continuing care retirement communities. Seniors Housing &amp; Care Journal. 2009;17(1):75-90.</citation>
  </reference>
  <reference>
    <citation>Mather Lifeways Institute on Aging. Trend survey reveals future of senior living communities. http://matherlifeways.com/archives/1373. May 19, 2009.</citation>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>August 22, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2018</results_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Older Adults</keyword>
  <keyword>Independent Living Facilities</keyword>
  <keyword>Multimedia technology</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03001778/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03001778/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Community Residents</title>
          <description>Community prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts.</description>
        </group>
        <group group_id="P2">
          <title>ILF Resident Usability Testing</title>
          <description>ILF Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Community Usability Testing</title>
          <description>Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts in a group format.</description>
        </group>
        <group group_id="B2">
          <title>ILF Usability Testing</title>
          <description>Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts in as an individual.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="67"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="NA" spread="NA">Data not collected</measurement>
                    <measurement group_id="B2" value="NA" spread="NA">Data not collected</measurement>
                    <measurement group_id="B3" value="NA" spread="NA">Data not collected</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>System Usability Scale (SUS)</title>
        <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
        <time_frame>After 1 hour usability session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Community Residents</title>
            <description>Community prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts.</description>
          </group>
          <group group_id="O2">
            <title>ILF Resident Usability Testing</title>
            <description>ILF Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready made&quot; workouts.</description>
          </group>
        </group_list>
        <measure>
          <title>System Usability Scale (SUS)</title>
          <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.57" spread="22.12"/>
                    <measurement group_id="O2" value="74.70" spread="13.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Community Usability Testing</title>
          <description>Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready-made&quot; workouts in a group format.</description>
        </group>
        <group group_id="E2">
          <title>ILF Usability Testing</title>
          <description>Prototype testing&#xD;
Usability Testing: Usability testing of &quot;ready-made&quot; workouts in a group format.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Valerie Myers, PhD</name_or_title>
      <organization>Klein Buendel</organization>
      <phone>3035654343</phone>
      <email>vmyers@kleinbuendel.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03001778
org study id: R21AG046670
secondary id: 5R21AG046670
secondary id: 0283
nct id: NCT03001778
lead sponsor: 
collaborator: 
has dmc: No
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g.,
      increased strength and balance, reduced frailty, fewer falls, improved brain function, lower
      mortality risk), yet many seniors have limited access to exercise options due to numerous
      barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This
      project will overcome common exercise barriers by creating an interactive web-enabled TV
      program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an
      Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF
      residents and administrators will be able to create, use, and evaluate a customizable
      exercise program tailored to the individual's preferred type of exercise, intensity, and
      duration.
Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S.
      population. As life expectancy increases, maintaining physical independence has become a
      public health priority. It is well recognized that regular physical activity (PA) can be done
      safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they
      remain the least physically active of any age group. This suggests that the translational
      reach of efficacious PA protocols to the real-world remains limited, and a need for research
      which is scalable to the individual in more naturalistic settings exists. An emerging trend
      for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a
      variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g.,
      wireless Internet), web-based education, and wellness programs are a priority for ILF
      residents, thus opportunities for using technology for health promotion with OAs exists. ILFs
      provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for
      aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase
      their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into
      wellness offerings. Research is needed to translate efficacious PA protocols for seniors into
      formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge
      gained from efficacy research to improve the utilization and sustainability of evidence-based
      methods by producing programs that are agreeable, user-friendly, and optimal at both the
      individual and organizational level. Smart Television and Exercise Promotion for Independent
      Living Facilities (STEP for LIFE) will establish the feasibility for translating an
      evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e.,
      Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective
      medium to reach seniors, 2) the ability to select and sequence together a session that is
      personalized to fitness level, type of exercise, and duration, and 3) organizations the
      ability to provide desired wellness options which meet both resident and organizational
      needs. The purpose of this study is to provide the initial research for translating
      efficacious research-based PA protocols for seniors into a scalable format usable in a
      real-world ILF setting, and to gain knowledge at individual and organizational levels to
      improve implementation and sustainability of this evidence-based approach. Specific Aims
      include extensive formative research on the use, interest, and effectiveness of interactive
      multimedia approaches for promoting PA, and its integration into senior living settings. A
      working prototype will be developed and tested for usability with ILF residents and
      administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of
      producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can
      inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted
      living, memory care, rural settings), and 2) sustainable implementation strategies for other
      evidence-based health promotion protocols for seniors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: System Usability Scale (SUS)
time frame: After 1 hour usability session
description: Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
arm group label: Usability Testing
arm group type: Experimental
description: Prototype testing
intervention type: Other
intervention name: Usability Testing
description: Usability testing of "ready made" workouts in a group format.
arm group label: Usability Testing
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie Myers, PhD'
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
country: United States
citation: Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
PMID: 23009149
citation: Xue QL, Bandeen-Roche K, Mielenz TJ, Seplaki CL, Szanton SL, Thorpe RJ, Kalyani RR, Chaves PH, Dam TT, Ornstein K, RoyChoudhury A, Varadhan R, Yao W, Fried LP. Patterns of 12-year change in physical activity levels in community-dwelling older women: can modest levels of physical activity help older women live longer? Am J Epidemiol. 2012 Sep 15;176(6):534-43. doi: 10.1093/aje/kws125. Epub 2012 Aug 30.
PMID: 22935515
citation: Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
PMID: 22929394
citation: Kamegaya T; Long-Term-Care Prevention Team of Maebashi City; Maki Y, Yamagami T, Yamaguchi T, Murai T, Yamaguchi H. Pleasant physical exercise program for prevention of cognitive decline in community-dwelling elderly with subjective memory complaints. Geriatr Gerontol Int. 2012 Oct;12(4):673-9. doi: 10.1111/j.1447-0594.2012.00840.x. Epub 2012 Apr 2.
PMID: 22469534
citation: Uemura K, Doi T, Shimada H, Makizako H, Yoshida D, Tsutsumimoto K, Anan Y, Suzuki T. Effects of exercise intervention on vascular risk factors in older adults with mild cognitive impairment: a randomized controlled trial. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):445-55. doi: 10.1159/000343486. Epub 2012 Oct 25.
PMID: 23189083
citation: Concannon LG, Grierson MJ, Harrast MA. Exercise in the older adult: from the sedentary elderly to the masters athlete. PM R. 2012 Nov;4(11):833-9. doi: 10.1016/j.pmrj.2012.08.007.
PMID: 23174546
citation: Rydwik E, Welmer AK, Kareholt I, Angleman S, Fratiglioni L, Wang HX. Adherence to physical exercise recommendations in people over 65--the SNAC-Kungsholmen study. Eur J Public Health. 2013 Oct;23(5):799-804. doi: 10.1093/eurpub/cks150. Epub 2012 Oct 31.
PMID: 23115329
citation: Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
PMID: 19436015
citation: Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. doi: 10.1016/j.apmr.2006.04.005.
PMID: 16813773
citation: Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.
PMID: 15814861
citation: Spirduso WW, Cronin DL. Exercise dose-response effects on quality of life and independent living in older adults. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S598-608; discussion S609-10. doi: 10.1097/00005768-200106001-00028.
PMID: 11427784
citation: Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
PMID: 12661673
citation: Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.
PMID: 11983637
citation: Sze PC, Cheung WH, Lam PS, Lo HS, Leung KS, Chan T. The efficacy of a multidisciplinary falls prevention clinic with an extended step-down community program. Arch Phys Med Rehabil. 2008 Jul;89(7):1329-34. doi: 10.1016/j.apmr.2007.11.044.
PMID: 18586135
citation: Stevens JA, Sogolow ED. Preventing Falls: What Works: A CDC Compendium of Effective Community-Based Interventions From Around the World. National Center for Injury Prevention and Control; 2008.
citation: Najafi B, Armstrong DG, Mohler J. Novel wearable technology for assessing spontaneous daily physical activity and risk of falling in older adults with diabetes. J Diabetes Sci Technol. 2013 Sep 1;7(5):1147-60. doi: 10.1177/193229681300700507.
PMID: 24124940
citation: Gschwind YJ, Kressig RW, Lacroix A, Muehlbauer T, Pfenninger B, Granacher U. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2013 Oct 9;13:105. doi: 10.1186/1471-2318-13-105.
PMID: 24106864
citation: Lee H, Lee JA, Brar JS, Rush EB, Jolley CJ. Physical activity and depressive symptoms in older adults. Geriatr Nurs. 2014 Jan-Feb;35(1):37-41. doi: 10.1016/j.gerinurse.2013.09.005. Epub 2013 Oct 18.
PMID: 24144579
citation: National Prevention Council, Health Promotion Council, Public Health Council. Active Living. The National Prevention Strategy. http://www.surgeongeneral.gov/initiatives/prevention/strategy/report.html. June 16, 2011.
citation: Schillinger D. An introduction to effectiveness, dissemination and implementation research. In: Fleisher P, Goldstein E, editors. San Francisco: Clinical Translational Science Institute Community Engagement Program, University of California San Francisco; 2010.
citation: Koh HK. A 2020 vision for healthy people. N Engl J Med. 2010 May 6;362(18):1653-6. doi: 10.1056/NEJMp1001601. No abstract available.
PMID: 20445177
citation: Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
PMID: 17762378
citation: U.S.Department of Health and Human Services. 2008 physical activity guidelines for Americans. Be active, healthy, and happy. Publication No.U0036 http://www.health.gov/paguidelines/. 2008.
citation: The Society of Certified Senior Advisors. State of the senior housing industry. The Society of Certified Senior Advisors Web site. http://www.csa.us/docs/StateoftheSeniorHousingIndustryReport.pdf. 2011.
citation: Brecht S, Fein S, Hollinger-Smith L. Preparing for the future: trends in continuing care retirement communities. Seniors Housing & Care Journal. 2009;17(1):75-90.
citation: Mather Lifeways Institute on Aging. Trend survey reveals future of senior living communities. http://matherlifeways.com/archives/1373. May 19, 2009.
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 