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

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes, Osteoporosis, Diabetic Neuropathies, Fall Prevention, Cardiovascular Diseases

In brief

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.

Key facts

Study ID: NCT06745544
Run by: Aalborg University Hospital
People needed: 490
Starts: 2025-10-01
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men and women with either T1D or T2D with a minimum of 65 years of age with no upper limit.
Living in their own home
A diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.
Signed the informed consent.

You may not qualify if…

No previous experience with rhythm-based multitask exercise.
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.
Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment "the short orientation-memory-concentration test."
Being fully dependent on walking aids.
Pregnancy or breast feeding
Active malignancy or terminally ill.
Not being able to understand Danish written and/or verbally.
Participating in other interventional clinical studies within the last six months
People with a weekly exercise activity above 5 hours a week

Where it is running

Steno Diabetes Center North — Aalborg, Norh, Denmark (enrolling)

Full record on ClinicalTrials.gov

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