Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 11, 2025
Open Peer Review Period: Jun 11, 2025 - Aug 6, 2025
Date Accepted: Nov 27, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effectiveness and cost-effectiveness of a digital falls' prevention programme versus usual care to improve balance, falls risk and function in older adults: protocol for the KOKU randomised controlled trial
ABSTRACT
Background:
Falls are the primary cause of fatal and non-fatal accidental injuries in older adults. The World Falls Prevention Guidelines recommend balance-challenging, functional exercise programmes as a key strategy for falls prevention but access, uptake and adherence to these programmes in community settings remain suboptimal. Keep-On-Keep-Up (KOKU), a digital, National Health Service (NHS) approved programme was co-developed with older adults and therapists, to provide progressive, evidence-based exercises and to raise awareness of fall prevention strategies.
Objective:
This trial aims to investigate the effectiveness and cost-effectiveness of the KOKU digital strength and balance programme for improving balance, enhancing physical function and reducing falls risk among community dwelling older adults.
Methods:
This is a two-arm, parallel group randomised controlled trial. A total of 196 community dwelling older adults aged 60 years and older will be randomised to either the intervention group comprising a digital strength and balance programme (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 three times per week following the tailored and progressive programme. Randomisation will take place after recruitment and baseline data collection. The trial’s primary outcome measure is balance function (Berg Balance Score) at twelve weeks post-randomisation. Secondary trial outcomes include: lower limb strength; healthcare utilisation and health-related quality of life; self-reported concerns about falling; self-reported physical activity; falls risk, pain, mood, fatigue, self-reported falls, acceptability and usability of the KOKU programme. 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 2024 recruiting a total of 202 participants (102 intervention and 100 control). 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 programme can improve balance and related outcomes in older adults compared to usual care. Clinical Trial: ClinicalTrials.gov: NCT06687135
Citation
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Copyright
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