Effects of treadmill slip and trip perturbation-based balance training on falls in community-dwelling older adults (STABILITY): study protocol for a randomised controlled trial.

Abstract

Falls among older adults are most frequently caused by slips and trips and can have devastating consequences. Perturbation-based balance training (PBT) have recently shown promising fall preventive effects after even small training dosages. However, the fall preventive effects of PBT delivered on a treadmill are still unknown. Therefore, this parallel-group randomised controlled trial aims to quantify the effects of a four-session treadmill-PBT training intervention on falls compared with treadmill walking among community-dwelling older adults aged 65 years or more. 140 community-dwelling older adults will be recruited and randomised into either the treadmill-PBT or the treadmill walking group. Each group will undergo three initial training sessions within a week and an additional 'booster' session after 26 weeks. Participants in the treadmill-PBT group will receive 40 slip and/or trip perturbations induced by accurately timed treadmill belt accelerations at each training session. The primary outcome of interest is daily life fall rates collected using fall calendars for a follow-up period of 52 weeks. Secondary outcomes include physical, cognitive and social-psychological fall-related risk factors and will be collected at the pre-training and post-training test and the 26-week and 52-week follow-up tests. All outcomes will be analysed using the intention-to-treat approach by an external statistician. A Poisson's regressions with bootstrapping, to account for overdispersion, will be used to compare group differences in fall rates. The study protocol has been approved by the North Denmark Region Committee on Health Research Ethics (N-20200089). The results will be disseminated in peer-reviewed journals and at international conferences. NCT04733222.