The effectiveness and cost effectiveness of strength and balance Exergames to reduce falls risk for people aged 55 years and older in UK assisted living facilities : A multi centre , cluster randomised controlled

Background: Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. The use of Exergames (active, gamified video-based exercises) is a possible innovative, community-based approach. This study aimed to determine the effectiveness of a tailored OTAGO/FaME-based strength and balance Exergame programme for improving balance, maintaining function and reducing falls risk in older people. Methods: A two-arm cluster randomised controlled trial recruiting adults aged 55 years and older living in 18 assisted living (sheltered housing) facilities (clusters) in the UK. Standard care (physiotherapy advice and leaflet) was compared to a tailored 12-week strength and balance Exergame programme, supported by physiotherapists or trained assistants. Complete case analysis (intention-to-treat) was used to compare the Berg Balance Scale (BBS) at baseline and at 12 weeks. Secondary outcomes included fear of falling, mobility, fall risk, pain, mood, fatigue, cognition, healthcare utilisation and health-related quality of life, and self-reported physical activity and falls. Results: Eighteen clusters were randomised (9 to each arm) with 56 participants allocated to the intervention and 50 to the control (78% female, mean age 78 years). Fourteen participants withdrew over the 12weeks (both arms), mainly for ill health. There was an adjusted mean improvement in balance (BBS) of 6.2 (95% CI 2.4 to 10.0) and reduced fear of falling (p = 0.007) and pain (p = 0.02) in the Exergame group. Mean attendance at sessions was 69% (mean exercising time of 33min/week). Twenty-four percent of the control group and 20% of the Exergame group fell over the trial period. The change in fall rates significantly favoured the intervention (incident rate ratio 0.31 (95% CI 0.16 to 0.62, p= 0.001)). The point estimate of the incremental cost-effectiveness ratio (ICER) was £15,209.80 per quality-adjusted life year (QALY). Using 10,000 bootstrap replications, at the lower bound of the NICE threshold of £20,000 per QALY, there was a 61% probability of Exergames being cost-effective, rising to 73% at the upper bound of £30,000 per QALY. Conclusions: Exergames, as delivered in this trial, improve balance, pain and fear of falling and are a cost-effective fall prevention strategy in assisted living facilities for people aged 55 years or older. Trial registration: The trial was registered at ClinicalTrials.gov on 18 Dec 2015 with reference number NCT02634736. * Correspondence: emma.k.stanmore@manchester.ac.uk Division of Nursing, Midwifery and Social Work, School of Health Sciences, Jean McFarlane Building, University of Manchester, Oxford Road, Manchester M13 9PL, UK Manchester Academic Health Science Centre, Core Technology Facility, The University of Manchester, 46 Grafton Street, Manchester M13 9NT, UK Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Stanmore et al. BMC Medicine (2019) 17:49 https://doi.org/10.1186/s12916-019-1278-9

[1]  E. Stanmore,et al.  Motivational Determinants of Exergame Participation for Older People in Assisted Living Facilities: Mixed-Methods Study , 2017, Journal of medical Internet research.

[2]  John R. Hodges,et al.  Validation of the Addenbrooke's Cognitive Examination III in Frontotemporal Dementia and Alzheimer's Disease , 2013, Dementia and Geriatric Cognitive Disorders.

[3]  R. Lima,et al.  Do virtual reality games improve mobility skills and balance measurements in community-dwelling older adults? Systematic review and meta-analysis , 2017, Clinical rehabilitation.

[4]  P J Holliday,et al.  Clinical and laboratory measures of postural balance in an elderly population. , 1992, Archives of physical medicine and rehabilitation.

[5]  Roberto Gatti,et al.  Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. , 2015, Journal of physiotherapy.

[6]  A. Campbell,et al.  Preventing Injuries in Older People by Preventing Falls: A Meta‐Analysis of Individual‐Level Data , 2002, Journal of the American Geriatrics Society.

[7]  K. Rothman,et al.  Epidemiologic Analysis with a Programmable Calculator , 1982 .

[8]  S. Lord,et al.  Implementing falls prevention research into policy and practice in Australia: past, present and future. , 2011, Journal of safety research.

[9]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance. , 2013, International journal of nursing studies.

[10]  L. Yardley,et al.  Older people's views of advice about falls prevention: a qualitative study. , 2005, Health education research.

[11]  C. Victor,et al.  Older people's participation in and engagement with falls prevention interventions in community settings: an augment to the Cochrane systematic review. , 2012, Age and ageing.

[12]  Philip T. Kortum,et al.  Determining what individual SUS scores mean: adding an adjective rating scale , 2009 .

[13]  J. E. Lee,et al.  A systematic review of active video games on rehabilitative outcomes among older patients , 2016, Journal of sport and health science.

[14]  S. Iliffe,et al.  Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial , 2010, Trials.

[15]  A. Campbell,et al.  Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women , 1997, BMJ.

[16]  J. Millán-Calenti,et al.  Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials , 2015, BMC Geriatrics.

[17]  R. Cumming,et al.  Effective Exercise for the Prevention of Falls: A Systematic Review and Meta‐Analysis , 2008, Journal of the American Geriatrics Society.

[18]  T. Kohlmann,et al.  Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[19]  Beatrix Vereijken,et al.  Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy , 2016, Int. J. Medical Informatics.

[20]  Sarah E Lamb,et al.  Interventions for preventing falls in older people living in the community. , 2012, The Cochrane database of systematic reviews.

[21]  C. Friedenreich,et al.  Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials: A Systematic Review , 2015, PloS one.

[22]  A. O’Cathain,et al.  Process evaluation of complex interventions: Medical Research Council guidance , 2015, BMJ : British Medical Journal.

[23]  Stephen R Lord,et al.  The Effect of Group Exercise on Physical Functioning and Falls in Frail Older People Living in Retirement Villages: A Randomized, Controlled Trial , 2003, Journal of the American Geriatrics Society.

[24]  Kim Delbaere,et al.  Adherence to Technology-Based Exercise Programs in Older Adults: A Systematic Review , 2018, Journal of geriatric physical therapy.

[25]  M. Tinetti,et al.  Falls and Injuries in Frail and Vigorous Community Elderly Persons , 1991, Journal of the American Geriatrics Society.

[26]  S. Hui,et al.  Level of Participation and Knowledge of Physical Activity in Hong Kong Chinese Adults and Their Association with Age , 2001 .

[27]  David Armstrong,et al.  DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial , 2018, British Medical Journal.

[28]  C. Todd,et al.  Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review , 2012, BMC Medical Research Methodology.

[29]  S. Iliffe,et al.  Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study. , 2015, Age and ageing.

[30]  J. B. Brooke,et al.  SUS: A 'Quick and Dirty' Usability Scale , 1996 .

[31]  Stephanie Taylor,et al.  Development and preliminary examination of the predictive validity of the Falls Risk Assessment Tool (FRAT) for use in primary care. , 2004, Journal of public health.

[32]  Henry Brodaty,et al.  Determinants of disparities between perceived and physiological risk of falling among elderly people: cohort study , 2010, BMJ : British Medical Journal.

[33]  C. Becker,et al.  Development of a Common Outcome Data Set for Fall Injury Prevention Trials: The Prevention of Falls Network Europe Consensus , 2005, Journal of the American Geriatrics Society.

[34]  Catherine Sherrington,et al.  Adherence to exercise programs for older people is influenced by program characteristics and personal factors: a systematic review. , 2014, Journal of physiotherapy.

[35]  R. Cumming,et al.  Exercise to prevent falls in older adults: an updated systematic review and meta-analysis , 2016, British Journal of Sports Medicine.

[36]  D. French,et al.  What are the most effective techniques for self-efficacy and physical activity behaviour – and are they the same? , 2010 .

[37]  Jan Stegenga,et al.  Exergaming for balance training of elderly: state of the art and future developments , 2013, Journal of NeuroEngineering and Rehabilitation.

[38]  Kamiar Aminian,et al.  Mobile Health Applications to Promote Active and Healthy Ageing , 2017, Sensors.

[39]  L. Rubenstein,et al.  Development and Testing of a Five‐Item Version of the Geriatric Depression Scale , 1999, Journal of the American Geriatrics Society.

[40]  Mohammad Chuttur,et al.  Overview of the Technology Acceptance Model: Origins, Developments and Future Directions , 2009 .

[41]  Nancy Devlin,et al.  Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial , 2001, BMJ : British Medical Journal.

[42]  Anna Maria Turcato,et al.  Comparison of Reliability, Validity, and Responsiveness of the Mini-BESTest and Berg Balance Scale in Patients With Balance Disorders , 2012, Physical Therapy.

[43]  Robert D. Herbert,et al.  A Post-Hospital Home Exercise Program Improved Mobility but Increased Falls in Older People: A Randomised Controlled Trial , 2014, PloS one.

[44]  David P French,et al.  Which Behaviour Change Techniques Are Most Effective at Increasing Older Adults’ Self-Efficacy and Physical Activity Behaviour? A Systematic Review , 2014, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[45]  E. Vieira,et al.  Prevention of falls in older people living in the community , 2016, British Medical Journal.

[46]  Lynne Baillie,et al.  Identifying Barriers to Effective User Interaction with Rehabilitation Tools in the Home , 2011, INTERACT.

[47]  Manuel Gomes,et al.  A Guide to Handling Missing Data in Cost-Effectiveness Analysis Conducted Within Randomised Controlled Trials , 2014, PharmacoEconomics.

[48]  D. Skelton,et al.  EXERGAMES TO REDUCE FALLS RISK IN OLDER PEOPLE IN UK ASSISTED LIVING FACILITIES: A MULTI-CENTRE, CLUSTER RCT , 2018, Innovation in Aging.

[49]  C. Cooper,et al.  Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review , 2017, Osteoporosis International.

[50]  Lillemor Lundin-Olsson,et al.  Berg Balance Scale: Intrarater Test-Retest Reliability Among Older People Dependent in Activities of Daily Living and Living in Residential Care Facilities , 2007, Physical Therapy.

[51]  E. Stokes,et al.  How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. , 2009, Journal of rehabilitation medicine.

[52]  Paul Dewick,et al.  Applying Game Thinking to Slips, Trips and Falls Prevention , 2017, AAATE Conf..

[53]  R. Moe-Nilssen,et al.  Responsiveness of the Berg Balance Scale in patients early after stroke , 2016, Physiotherapy theory and practice.

[54]  Malcolm Campbell,et al.  Tailored group exercise (Falls Management Exercise -- FaME) reduces falls in community-dwelling older frequent fallers (an RCT). , 2005, Age and ageing.

[55]  A. King,et al.  Telephone versus mail interventions for maintenance of physical activity in older adults. , 2001, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[56]  Klaus Hauer,et al.  The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. , 2007, Age and ageing.

[57]  Catherine Sherrington,et al.  Older people's perspectives on participation in physical activity: a systematic review and thematic synthesis of qualitative literature , 2015, British Journal of Sports Medicine.

[58]  Stoyan R. Stoyanov,et al.  Gamification for health and wellbeing: A systematic review of the literature , 2016, Internet interventions.

[59]  M. Sculpher,et al.  Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. , 2005, Health economics.

[60]  D. French,et al.  How acceptable do older adults find the concept of being physically active? A systematic review and meta-synthesis , 2017 .

[61]  N. Freemantle,et al.  An Educational Review of the Statistical Issues in Analysing Utility Data for Cost-Utility Analysis , 2015, PharmacoEconomics.

[62]  Roger A. Sugden,et al.  Multiple Imputation for Nonresponse in Surveys , 1988 .

[63]  J. Stevens,et al.  A CDC compendium of effective fall interventions : what works for community-dwelling older adults. 2nd edition , 2010 .

[64]  Diane Podsiadlo,et al.  The Timed “Up & Go”: A Test of Basic Functional Mobility for Frail Elderly Persons , 1991, Journal of the American Geriatrics Society.

[65]  G. Bonsel,et al.  Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) , 2011, Quality of Life Research.

[66]  Dawn A. Skelton,et al.  ACCEPTABILITY AND USABILITY OF EVIDENCE BASED EXERGAMES DESIGNED TO IMPROVE FUNCTION IN OLDER PEOPLE , 2015 .

[67]  C. Todd,et al.  Review of how we should define (and measure) adherence in studies examining older adults' participation in exercise classes , 2016, BMJ Open.

[68]  M C Ashe,et al.  Does a home-based strength and balance programme in people aged ≥80 years provide the best value for money to prevent falls? A systematic review of economic evaluations of falls prevention interventions , 2009, British Journal of Sports Medicine.

[69]  R A Boileau,et al.  The physical activity scale for the elderly (PASE): evidence for validity. , 1999, Journal of clinical epidemiology.

[70]  Patrick Royston,et al.  Multiple imputation using chained equations: Issues and guidance for practice , 2011, Statistics in medicine.

[71]  A. Rizzo,et al.  Game-based telerehabilitation. , 2009, European journal of physical and rehabilitation medicine.

[72]  J. Helbostad,et al.  The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. , 2014, Physiotherapy research international : the journal for researchers and clinicians in physical therapy.