The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach. Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated. Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation. This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.
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Reduction in Fall Rates
Timeframe: Measurements will take place at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate both short- and long-term effects of the intervention.
Improvement in Bone Mineral Density (BMD)
Timeframe: Measurements will assess changes at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate sustained benefits.
Reduction in Cardiovascular Risk and Events
Timeframe: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Improvement in Nerve Function
Timeframe: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Blood glucose changes
Timeframe: HbA1c measurements will take place at baseline and after 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate both short- and long-term effects of the intervention. CGM will be measures blinded during the 26 weeks RYMA intervention.
Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.