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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 trial
Stanmore EK, Mavroeidi A, de Jong LD, Skelton DA, Sutton CJ, Benedetto V, Munford LA, Meekes W, Bell V, Todd C
BMC Medicine 2019 Feb 28;17(49):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 12 weeks (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 33 min/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 GBP 15,209.80 per quality-adjusted life year (QALY). Using 10,000 bootstrap replications, at the lower bound of the NICE threshold of GBP 20,000 per QALY, there was a 61% probability of exergames being cost-effective, rising to 73% at the upper bound of GBP 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 on 18 Dec 2015 with reference number NCT02634736.

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