Effectiveness and Cost-Effectiveness of a Digital Falls Prevention Program Versus Usual Care to Improve Balance, Falls Risk, and Function in Older Adults: Protocol for the Keep-On-Keep-Up Randomized Controlled Trial.

Background: Falls are the primary cause of fatal and nonfatal accidental injuries in older adults. The World Falls Prevention Guidelines recommend balance-challenging, functional exercise programs as a key strategy for falls prevention, but access, uptake, and adherence to these programs in community settings remain suboptimal. Keep-On-Keep-Up (KOKU), a digital, National Health Service-approved program, was codeveloped with older adults and therapists to provide progressive, evidence-based exercises and to raise awareness of falls prevention strategies. Objective: This trial aims to investigate the effectiveness and cost-effectiveness of the KOKU digital strength and balance program for improving balance, enhancing physical function, and reducing falls risk among community-dwelling older adults. Methods: This is a 2-arm, parallel-group randomized controlled trial. A total of 196 community-dwelling older adults 60 years and older will be randomized to either the intervention group, comprising a digital strength and balance program (KOKU) alongside standard care (strength and balance exercise advice and a falls prevention leaflet), or to a control group, receiving standard care only. Participants receiving the intervention will be asked to exercise 3 times per week following the tailored and progressive program. Randomization will take place after recruitment and baseline data collection. The trial's primary outcome measure is balance function (Berg Balance Score) at 12 weeks post randomization. Secondary trial outcomes include lower limb strength, health care utilization and health-related quality of life, self-reported concerns about falling, self-reported physical activity, falls risk, pain, mood, fatigue, self-reported falls, and acceptability and usability of the KOKU program. Intention-to-treat analysis and a cost-effectiveness analysis will be employed for trial data analysis. Qualitative interviews and focus groups will be undertaken with around 10 care providers and 13 participants to further understand views of the intervention and trial processes. Results: This study began recruitment in July 2024 and concluded in March 2025, recruiting a total of 202 participants (102 intervention group and 100 control group). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in 2027. Conclusions: This trial will provide important evidence on whether a digital strength and balance program can improve balance and related outcomes in older adults compared with usual care.