An interventional study of Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in Type 2 Diabetes, Osteoporosis and Diabetic Neuropathies, sponsored by Aalborg University Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Prevention
Among 475 studies in Diabetes Mellitus, Type 2 with a site in Denmark — 44 open to participants now, 60 under way, 7 of them phase 3. Diabetes Mellitus, Type 2 · Denmark.
Among the 475 studies in Diabetes Mellitus, Type 2 with a site in Denmark, this one is the 90th largest by planned enrollment of the 377 interventional ones that give a count, is one of 10 that started in 2025, is one of 179 with no phase, reaches primary completion later than 38 of the 59 other live ones, and was the 441st registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →44 of the 475 studies in Diabetes Mellitus, Type 2 with a site in Denmark are open now. Recruiting first, the newest first:
Odense University Hospital · Sites in Denmark
AstraZeneca · Sites in Denmark, United States, Argentina and 8 more countries
AstraZeneca · Sites in Denmark, United States, Argentina and 10 more countries
AstraZeneca · Sites in Denmark, United States, Argentina and 21 more countries
AstraZeneca · Sites in Denmark, United States, Bulgaria and 13 more countries
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
475 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 51 · Phase 3 88 · Phase 4 49
First in 1992; this study’s year is marked. 10 started in 2025.
This study's planned enrollment of 490 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 64 across the 377 interventional studies, 150 across the 97 observational. Of the 370 that completed or were terminated, 82 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
157 of 475 have an industry lead sponsor. The 10 most frequent:
Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Aalborg University Hospital has 4 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
15 of the studies in Diabetes Mellitus, Type 2 with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07482072Rigshospitalet, DenmarkBrain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study | 2026-12 |
| NCT07421024Morten Hostrup, PhDGRK-Biased Activation Via β2-Adrenergic Receptors in Human Skeletal Muscle | 2026-12-31 |
| NCT03620266Ole Frobert, MD, PhDEffects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI | 2026-12-31 |
| NCT05915260Slagelse HospitalCMR in T2DM: The NSR Cohort | 2026-12-31 |
| NCT07026539University of AarhusEffect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes. | 2026-12-31 |
Among the 475 studies in Diabetes Mellitus, Type 2 with a site in Denmark, from their registry updates:
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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 guidelines. Outcomes are assessed at 26 weeks, 52 weeks, 2 years, and 5 years, covering fall rates, BMD, nerve function, cardiovascular health, and quality of life.
The RYMA exercise program is the core intervention and focuses on cognitive-motor training through rhythm-based exercises. It targets key risk factors for falls by improving balance, strength, executive function, and coordination while integrating social elements to enhance adherence and sustainability. Bone health interventions involve stratification based on DXA results, with pharmacological treatments for osteoporosis provided according to ADA guidelines. Cardiovascular optimization includes medications such as SGLT2 inhibitors, GLP-1 receptor agonists, and statins, tailored to the participants' risk profiles. The study's primary endpoints include reducing fall rates, improving BMD, reducing fracture risk, optimizing cardiovascular outcomes, and enhancing nerve function. Secondary endpoints focus on understanding the mechanisms underlying these improvements, quality-of-life metrics, and participant adherence to the interventions.
Assessments include validated fall risk algorithms, DXA scans, neuropathy tests (e.g., NC-Stat DPNCheck, vibration perception thresholds, and sensory testing), cardiovascular imaging (e.g., MRI, seismocardiography), and cognitive and physical performance evaluations. Gait analysis, postural stability, muscle strength, and executive function tests provide insights into the intervention's mechanistic effects. The trial aims to recruit 440 participants (220 T1D and 220 T2D). Inclusion criteria are: age ≥65 years, confirmed diagnosis of diabetes for at least one year, and the ability to live independently and participate in the exercise program. Exclusion criteria include severe cognitive impairment, neurological or orthopedic conditions affecting mobility, and participation in other interventional studies within six months.
This study represents a paradigm shift in diabetes management by addressing interconnected health risks through a holistic approach. Its multidisciplinary interventions combine physical, cognitive, and pharmacological elements to improve outcomes in older people with diabetes. By targeting fall prevention, bone health, and cardiovascular risk factors simultaneously, DIACTIVE has the potential to significantly enhance the quality of life and inform future healthcare strategies. Findings from the study will contribute to clinical guidelines, emphasizing integrated care models and tailored interventions for high-risk populations. Long-term follow-ups will provide critical data on the sustainability and scalability of such programs, paving the way for broader implementation in healthcare systems
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
Participants in this arm will continue their usual daily routines without any structured exercise intervention during the first 26 weeks.
Healthy controls without diabetes equally divided between men and women without diabetes for baseline comparisons.
The 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.
Also known as: Exercise, training, balance training
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.
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.
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.
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.
Blood glucose changes
To estimate changes in blood glucose levels in people with T1D and T2D diabetes aged \>65 after RYMA intervention. Measures includes HbA1c and blinded continuous Glucose monitoring (CGM). Glucose levels will be compared to participants' baseline measures (self-controls) and to a usual care group (no RYMA). CGM measures will take place during the RYMA intervention
Time frame: 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.
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-intervention
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-intervention
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.
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.
Improvement in Cognitive Function
Secondary outcomes include changes in cognitive function, particularly in executive functions such as attention, memory, and problem-solving. These will be assessed using validated neuropsychological tests and reaction time measures.
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Membran properties
To evaluate changes in nerve membrane properties including shifts in ion-channel composition or activity.
Time frame: year 2 and year 5
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.
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.
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.
Plan to share: Yes — De-identified individual participant data related to primary and secondary outcomes will be shared. This includes data on fall rates, bone mineral density, neuropathy, cardiovascular markers, and quality of life assessments. The data will exclude any personally identifiable information and will be shared in compliance with ethical guidelines and data privacy regulations and upon reasonable request from qualified researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: It will be made available one year after the study period ends including the following year.
Access criteria: Access to the IPD and supporting information will be granted to qualified researchers who submit a formal request and provide a detailed research proposal outlining the intended use of the data. Requests will be reviewed by the study team or a designated oversight committee to ensure appropriate use. Approved researchers will receive de-identified data and supporting documentation, such as the study protocol, statistical analysis plan, and informed consent forms, through a secure online repository.
Data sharing details ↗ · stenodiabetescenter.rn.dk
Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 26 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Dec 2026 → Dec 2027 and completion Dec 2027 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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