Introduction Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults. Methods and analysis A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website.
Background: Falls among older adults are a significant public health issue due to their high incidence, severe consequences, and substantial economic impact. Exercise programs incorporating balance and functional exercises have been shown to reduce fall rates, but adherence and scaling up the interventions remain challenges. Digital technology offers a promising avenue to deliver this type of exercise, potentially improving exercise adherence and enabling self-management of exercise in the aging population. Objective: This study aims to assess the effectiveness of the Safe Step app, a self-managed, unsupervised, home-based digital exercise program, in reducing fall rates or fall risk in community-dwelling older adults. Additional aims were to describe fall-related injuries in both the exercise and control groups, study attrition, and adherence to the Safe Step exercise program. Methods: Community-dwelling individuals, aged 70 years or older, who had experienced falls or a decline in balance in the past year were randomized to either an exercise group using the Safe Step app combined with educational videos, or a control group receiving educational videos alone. Both interventions lasted for 1 year. Information regarding fall events was self-reported monthly through questionnaires. Exercise adherence was monitored through questionnaires every third month. Negative binomial and logistic regression estimated the incidence rate ratio of fall rate and the risk ratio (RR) of experiencing falls, respectively. Fall-related injuries, study attrition, and exercise adherence were reported descriptively. Results: In total, 1628 people were enrolled in the study, 79% were women, and the mean age was 75.8 (SD 4.4) years (range 70-94 years). The intention-to-treat analysis showed no significant difference in fall rates between the exercise and control groups after 12 months (2.21 falls per person-year in the exercise group and 2.41 in the control group; incidence rate ratio 0.92, 95% CI 0.76-1.11; P=.37). The risk of experiencing at least 1 fall was significantly lower (11%) in the exercise group compared to the control group (53% vs 59.6%; RR 0.89, 95% CI 0.80-0.99; P=.03). No differences were observed regarding the risk of 2 or more falls (34.1% in the exercise group, 37.1% in the control group; RR 0.92, 95% CI 0.79-1.06; P=.23). Injurious fall rates were similar between the exercise and control group. During the trial, 161 (20%) participants from the exercise group and 63 (8%) from the control group formally withdrew. The proportion of exercise group participants meeting the 90-minute weekly exercise goal was 12.7%, 13.4%, 8.6%, and 9.1% at 3, 6, 9, and 12 months, respectively. Conclusions: Access to a self-managed unsupervised digital exercise program can be an effective component of a primary fall prevention strategy for community-dwelling older adults. Further research is needed to explore the mediating factors that influence the outcomes and develop strategies that enhance adherence for optimal impact in this population. Trial Registration: ClinicalTrials.gov NCT03963570; https://clinicaltrials.gov/study/NCT03963570