Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Denmark
Steno Diabetes Center North
RECRUITING
Aalborg
Contact Information
Primary
Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.
nicklas.rasmussen@rn.dk
+45 61306306
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 490
Treatments
Experimental: RYMA group
Participants in this arm will engage in the Rhythm- and Multitask-Based Activity (RYMA) exercise program, a multicomponent intervention that combines strength, balance, coordination, and cognitive-motor training. The intervention also incorporates Activities of Daily Living (ADL)-based exercises to address real-world functional needs. The program is delivered over 26 weeks and includes music-based exercises designed to improve fall prevention, bone health, and cardiovascular outcomes.
No_intervention: Usual Care/No Structured Exercise Intervention
Participants in this arm will continue their usual daily routines without any structured exercise intervention during the first 26 weeks.
No_intervention: Control Group without diabetes
Healthy controls without diabetes equally divided between men and women without diabetes for baseline comparisons.
Related Therapeutic Areas
Sponsors
Collaborators: Aalborg University, Maastricht University Medical Center
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov