Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAalborg University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
Other interventionThe Rhythm- and Multitask-Based Activity (RYMA) program is a unique cognitive-motor exercise intervention designed for older adults with diabetes. It incorporates rhythm-based multitasking exercises, performed to improvised piano music, combined with Activities of Daily Living (ADL)-focused exercises. The intervention targets physical (strength, balance, and coordination) and cognitive (executive function, reaction time) components to reduce fall risk, improve bone health, and optimize cardiovascular outcomes. Delivered over 26 weeks, the program emphasizes social interaction to enhance adherence and long-term engagement.
Treatment groups
490 Participants
are divided into 3 treatment groupsGroup A: RYMA groupExperimental treatment 1 intervention
Group B: Usual Care/No Structured Exercise InterventionNo intervention 0 interventions
Group C: Control Group without diabetesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Reduction in Fall Rates
To estimate changes in fall rates in people with T1D and T2D diabetes aged \>65 after RYMA intervention. Fall rates will be compared to participants' baseline measures (self-controls) and to a usual care group (no RYMA).
Time frame
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.2
Improvement in Bone Mineral Density (BMD)
The primary outcome is to measure change in bone mineral density (BMD) after 26 weeks of intervention compared to baseline and the control group. BMD will be assessed using dual-energy X-ray absorptiometry (DXA) scans at key anatomical sites, including the lumbar spine and femoral neck. Fracture incidence will also be tracked during the follow-up period
Time frame
Measurements will assess changes at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate sustained benefits.3
Reduction in Cardiovascular Risk and Events
To estimate the change of cardiovascular risk factors on microvascular and cardiac function in people at high risk for CVD when intervented with RYMA intervention. This will be assessed using high-frequency echocardiography for detailed imaging of the heart and aorta, and magnetic resonance imaging (MRI) to evaluate cardiac structure and function.
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.4
Improvement in Nerve Function
To estimate the change of nerve fiber function by determining the degree of small, large and autonomic neuropathy after RYMA and cardiovascular optimization.
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.Secondary outcomes
1
Mechanisms associated with Fall Reduction
Secondary outcomes include investigating the mechanisms underlying fall reduction. These will be assessed through gait analysis, postural stability tests, and muscle strength evaluations (e.g., handgrip strength and knee extension). Changes in cognitive function, particularly executive functions like decision-making and reaction time, will also be measured. The outcomes aim to provide insights into how the intervention impacts fall risk factors
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention2
Improvement in Quality of Life
Secondary outcomes include changes in quality of life as measured by validated instruments such as the EQ-5D and Falls Efficacy Scale. These assessments will evaluate physical, emotional, and social well-being, including reduced fear of falling and increased confidence in performing daily activities. Changes will be tracked longitudinally.
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention3
Reduction in Fracture Risk
Secondary outcomes include a changes in fracture incidences over the study period. Fractures will be recorded through participant reports and verified via medical records. Risk reduction will be analyzed in relation to improvements in bone mineral density and fall rates.
Time frame
52 weeks, 104 weeks, and 5 years post-intervention.4
Improvement in Cardiovascular Function
Secondary outcomes include changes in cardiovascular function, assessed through imaging techniques such as cardiac MRI and seismocardiography, as well as biochemical markers like NT-proBNP and hs-CRP. Functional capacity will also be evaluated through tests like the 6-minute walk test.
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.Other outcomes
1
Sustainability of Intervention Effects
Exploratory outcomes include the sustainability of changes in fall rates, bone health, cardiovascular markers, and neuropathy beyond the primary study follow-up period. This will assess whether the intervention's effects persist after the active program ends, particularly focusing on fall prevention and quality-of-life metrics.
Time frame
2 years and 5 years post-intervention.2
Changes in Muscle Mass and Composition
Exploratory outcomes include changes in muscle mass and body composition as measured by DXA scans. These outcomes will evaluate whether the intervention influences muscle quality, fat distribution, and sarcopenia risk over time, with comparisons between intervention and control groups
Time frame
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.3
Changes in Inflammatory Biomarkers
Exploratory outcomes include changes in systemic inflammation, assessed through biomarkers. These outcomes aim to evaluate potential mechanisms linking reduced inflammation to improved cardiovascular and bone hea
Time frame
26 weeks, 52 weeks, and 104 weeks post-intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Aalborg University
Collaborator
Maastricht University Medical Center
Collaborator
Source ClinicalTrials.gov