- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001778
Smart Television and Exercise Promotion for Independent Living Facilities (STEP4Life)
August 22, 2018 updated by: Klein Buendel, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Independent Living Facility (ILF) Resident Inclusion Criteria:
- 55 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)
ILF Resident Exclusion Criteria:
- 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)
Non-ILF Resident Inclusion Criteria:
- 55 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)
Non-ILF Resident Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Usability Testing
Prototype testing
|
Usability testing of "ready made" workouts in a group format.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale (SUS)
Time Frame: After 1 hour usability session
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerie Myers, PhD', Klein Buendel, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Mather Lifeways Institute on Aging. Trend survey reveals future of senior living communities. http://matherlifeways.com/archives/1373. May 19, 2009.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 15, 2014
Primary Completion (ACTUAL)
January 30, 2017
Study Completion (ACTUAL)
June 30, 2017
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
December 20, 2016
First Posted (ESTIMATE)
December 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2018
Last Update Submitted That Met QC Criteria
August 22, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- R21AG046670 (NIH)
- 5R21AG046670 (NIH)
- 0283 (OTHER: Klein Buendel, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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