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

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT04733222.

Keywords: geriatric medicine; preventive medicine; sports medicine.

Figure 1

Illustration of the study flow. Blue squares indicate the study flow of the treadmill-perturbation-based balance training group, while the orange squares illustrate the study flow of the treadmill walking group.

Figure 2

The sequential arrangement of perturbation intensity levels in the training protocol. The protocol is arranged in three phases: (1) an ascending phase in which the intensity of the perturbations progressively increases, (2) a mixed phase where the perturbation intensity varies between level 4 and 5 and (3) a cool-down phase at which the perturbation intensity decreases.