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Citation
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Hassett L, van den Berg M, Lindley RI, Crotty M, McCluskey A, van der Ploeg HP, Smith ST, Schurr K, Killington M, Bongers B, Howard K, Heritier S, Togher L, Hackett ML, Treacy D, Dorsch S, Wong S, Scrivener K, Chagpar S, Weber H, Pearson R, Sherrington C. BMJ Open 2016; 6(6): e012074. |
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Affiliation
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The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia. |
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Abstract
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INTRODUCTION: People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone.
METHODS AND ANALYSIS: A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. ETHICS AND DISSEMINATION: The protocol has been approved by the relevant Human Research Ethics Committees and the results will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12614000936628. Pre-results.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Language: en |