NCT03001778

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 20, 2018

Completed
Last Updated

September 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

December 13, 2016

Results QC Date

July 25, 2018

Last Update Submit

August 22, 2018

Conditions

AgingPhysical Activity

Keywords

Physical ActivityOlder AdultsIndependent Living FacilitiesMultimedia technology

Outcome Measures

Primary Outcomes (1)

  • System Usability Scale (SUS)

    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.

    After 1 hour usability session

Study Arms (1)

Usability Testing

EXPERIMENTAL

Prototype testing

Other: Usability Testing

Interventions

Usability TestingOTHER

Usability testing of "ready made" workouts in a group format.

Usability Testing

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • live in an ILF
  • able tor read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)

You may not qualify if:

  • under 55 years of age
  • not live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)
  • years of age or older
  • not live in an ILF
  • able to read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)
  • under 55 years of age
  • live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Related Publications (26)

  • 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: 23009149BACKGROUND

  • 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: 22935515BACKGROUND

  • 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: 22929394BACKGROUND

  • 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: 22469534BACKGROUND

  • 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: 23189083BACKGROUND

  • 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: 23174546BACKGROUND

  • 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: 23115329BACKGROUND

  • 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: 19436015BACKGROUND

  • 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: 16813773BACKGROUND

  • 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: 15814861BACKGROUND

  • 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: 11427784BACKGROUND

  • 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: 12661673BACKGROUND

  • 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: 11983637BACKGROUND

  • 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: 18586135BACKGROUND

  • 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.

    BACKGROUND

  • 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: 24124940BACKGROUND

  • 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: 24106864BACKGROUND

  • 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: 24144579BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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: 20445177BACKGROUND

  • 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: 17762378BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Mather Lifeways Institute on Aging. Trend survey reveals future of senior living communities. http://matherlifeways.com/archives/1373. May 19, 2009.

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

User-Centered Design

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Equipment DesignInvestigative TechniquesUniversal DesignEngineeringTechnology, Industry, and Agriculture

Results Point of Contact

Title
Valerie Myers, PhD
Organization
Klein Buendel
vmyers@kleinbuendel.com
3035654343

Study Officials

  • Valerie Myers, PhD'

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 23, 2016

Study Start

August 15, 2014

Primary Completion

January 30, 2017

Study Completion

June 30, 2017

Last Updated

September 20, 2018

Results First Posted

September 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)