Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes

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.

The DIACTIVE study is a randomized controlled trial with a 5-year follow-up designed to assess the effectiveness of a comprehensive intervention targeting fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older. This innovative research seeks to address critical health vulnerabilities associated with diabetes, particularly the elevated risks of falls, fractures, and cardiovascular diseases (CVD). The study's integrated approach involves advanced screening techniques, tailored interventions, and long-term follow-ups, providing new insights into diabetes management for older populations. Diabetes mellitus (DM) is a chronic condition with rising global prevalence, projected to affect over 783 million people by 2045. While much attention has been given to micro- and macrovascular complications, less focus has been placed on other significant diabetes-related concerns such as bone health, neuropathy, and fall risk. Diabetes exacerbates age-related declines in musculoskeletal strength, sensory function, and cardiovascular resilience, increasing risks of falls and fractures. The interplay between these factors remains underexplored, necessitating multidimensional approaches to care. The DIACTIVE trial addresses these gaps by integrating advanced fall screening, comprehensive bone health evaluations, and cardiovascular profiling with targeted interventions. Its cornerstone is the RYMA exercise program, a novel, music-based training regimen that combines physical and cognitive elements to enhance balance, strength, and executive function. The study has several primary objectives: reducing fall rates by 30% after 26 weeks of intervention, sustained at 52 weeks and beyond; improving bone mineral density (BMD) and mitigating fracture risks; lowering cardiovascular event rates and improving key cardiovascular markers; enhancing nerve function and reducing the progression of diabetic peripheral neuropathy (DPN); and improving psychological and social outcomes, including reduced fear of falling, enhanced mobility, and better mental well-being. This trial adopts a prospective, randomized controlled design and includes recruitment and screening of people aged ≥65 years with T1D or T2D from outpatient diabetes clinics. Participants undergo comprehensive baseline assessments, including DXA scans for BMD, fall risk stratification, neuropathy evaluations, and cardiovascular profiling using blood pressure, ECG, and advanced imaging techniques like MRI and seismocardiography. Based on their risk profiles, participants are randomized into intervention and control groups. The intervention group engages in the RYMA exercise program, which combines physical and cognitive training elements, including multitasking, reaction-based exercises, and coordination tasks, set to improvised piano music. Pharmacological treatments for osteoporosis and cardiovascular optimization are implemented as per ADA and local guid Покажи пълното описание...

Inclusion Criteria: 1. Men and women with either T1D or T2D with a minimum of 65 years of age with no upper limit. 2. Living in their own home 3. A diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes. 4. Signed the informed consent. Exclusion Criteria: 1. No previous experience with rhythm-based multitask exercise. 2. Having significant neurological diseases (e.g., Parkinson's and Multiple Sclerosis), vestibular diseases, or orthopedic surgeries (e.g., hip/knee replacement) affecting their ability to participate in the study. 3. Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment "the short orientation-memory-concentration test." 4. Being fully dependent on walking aids. 5. Pregnancy or breast feeding 6. Active malignancy or terminally ill. 7. Not being able to understand Danish written and/or verbally. 8. Participating in other interventional clinical studies within the last six months 9. People with a weekly exercise activity above 5 hours a week