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DiaActive protocol: A randomized controlled trial of cognitive-motor multicomponent exercise to reduce fall rate in
Aksayan Arunanthy Mahalingasivam1,2, Asger Ahlmann Bech1,2, Peter Vestergaard1,2
1Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
Introduction:
Older adults with diabetes have an increased risk of falls due to neuropathy, impaired bone health and cardiovascular disease, resulting in significant morbidity and mortality. Conventional fall-prevention programmes primarily target strength and balance, while cognitive-motor integration, essential for safe mobility in complex environments, is often overlooked. Multicomponent exercise combining physical and cognitive training may therefore provide additional benefits in this population.
Methods:
The DiaActive trial is a single-centre, stratified, parallel-group randomized controlled trial including adults aged ≥65 years with type 1 or type 2 diabetes. After comprehensive baseline assessments, 440 participants (220 with type 1 diabetes and 220 with type 2 diabetes) with low-to-moderate fall risk are randomized 1:1 within diabetes type to a 26-week cognitive-motor multicomponent exercise intervention (RYMA) or usual care. The intervention includes two weekly supervised sessions combining rhythm-based motor training with activities-of-daily-living-focused strength and balance exercises.
Results:
The primary outcome is fall rate during the intervention, assessed using weekly fall calendars. Secondary outcomes include balance performance, fall-related outcomes, bone mineral density, fractures, neuropathy progression, cardiovascular risk markers, muscle strength and cognitive function. Follow-up continues to 104 weeks, with registry-based outcomes assessed at 5 years.
Conclusion:
The trial is approved by the North Denmark Region Ethics Committee (N-20240025). Written informed consent will be obtained. Results will be disseminated through peer-reviewed publications, conferences and stakeholder engagement.
