Type 2 DiabetesDiaACTIVENCT06745544
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
A study testing Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in people with Type 2 Diabetes and Osteoporosis, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Osteoporosis, Diabetic Neuropathies
- What is being tested?
- Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center North
Aalborg, Norh, 9000
Nicklas HH Rasmussen, Associate Professor, MD Ph.D., 61306306, nicklas.rasmussen@rn.dk
About this study
Official title: Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE
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.
Read more
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.
Read the detailed description
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
- Conditions
- Type 2 Diabetes, Osteoporosis, Diabetic Neuropathies, Fall Prevention, Cardiovascular Diseases
- Being tested
- Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
- Keywords
- Diabetes, T1D, T2D, RYMA, Falls, Neuropathy, CVD, Diabetic Complications, Bone health, Fractures
- Medical subject headings
- Diabetes Mellitus, Type 2, Osteoporosis, Diabetic Neuropathies, Cardiovascular Diseases, Diabetes Mellitus, Diabetes Complications, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)Other
Also called Exercise, training, balance training
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.
| Study group | Role | What they receive |
|---|---|---|
| RYMA group | Experimental | 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. Receives: Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) |
| Usual Care/No Structured Exercise Intervention | No intervention | Participants in this arm will continue their usual daily routines without any structured exercise intervention during the first 26 weeks. |
| Control Group without diabetes | No intervention | Healthy controls without diabetes equally divided between men and women without diabetes for baseline comparisons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: year 2 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study follows a randomized controlled trial design. Participants are randomly allocated to either the 26 weeks RYMA/ADL exercise intervention group or the control group (usual care). Baseline measures are performed at day 0. Then, follow-up regardless of group is after 26, 52 and 104 weeks and a final visit after 5 years from baseline.
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Maastricht University Medical Center
- Responsible party
- Principal investigator, Nicklas Højgaard-hessellund Rasmussen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745544
- Sponsor's protocol ID
- N-20240025
- Other IDs
- NNF22SA0079901
- Acronym
- DiaACTIVE
- Status last verified
- Jul 2025
- First submitted
- 28 Nov 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. doi: 10.1016/j.ejpain.2005.02.003.
PubMed 16291301Mahalingasivam AA, Jespersen AK, Ejskjaer N, Hougaard DD, Vestergaard P, Rasmussen NH, Roikjer J. The co-existence of peripheral and vestibular neuropathy in diabetes: a cross-sectional study. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):663-672. doi: 10.1007/s00405-023-08130-6. Epub 2023 Jul 29.
PubMed 37515636Jansen S, Bhangu J, de Rooij S, Daams J, Kenny RA, van der Velde N. The Association of Cardiovascular Disorders and Falls: A Systematic Review. J Am Med Dir Assoc. 2016 Mar 1;17(3):193-9. doi: 10.1016/j.jamda.2015.08.022. Epub 2015 Oct 9.
PubMed 26455926Rajbhandari J, Fernandez CJ, Agarwal M, Yeap BXY, Pappachan JM. Diabetic heart disease: A clinical update. World J Diabetes. 2021 Apr 15;12(4):383-406. doi: 10.4239/wjd.v12.i4.383.
PubMed 33889286Kressig RW, Allali G, Beauchet O. Long-term practice of Jaques-Dalcroze eurhythmics prevents age-related increase of gait variability under a dual task. J Am Geriatr Soc. 2005 Apr;53(4):728-9. doi: 10.1111/j.1532-5415.2005.53228_2.x. No abstract available.
PubMed 15817027Lord SR, Close JCT. New horizons in falls prevention. Age Ageing. 2018 Jul 1;47(4):492-498. doi: 10.1093/ageing/afy059.
PubMed 29697780Wollesen B, Wildbredt A, van Schooten KS, Lim ML, Delbaere K. The effects of cognitive-motor training interventions on executive functions in older people: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Jul 2;17:9. doi: 10.1186/s11556-020-00240-y. eCollection 2020.
PubMed 32636957Sherrington C, Fairhall N, Kwok W, Wallbank G, Tiedemann A, Michaleff ZA, Ng CACM, Bauman A. Evidence on physical activity and falls prevention for people aged 65+ years: systematic review to inform the WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):144. doi: 10.1186/s12966-020-01041-3.
PubMed 33239019Rasmussen NH, Dal J, den Bergh JV, de Vries F, Jensen MH, Vestergaard P. Increased Risk of Falls, Fall-related Injuries and Fractures in People with Type 1 and Type 2 Diabetes - A Nationwide Cohort Study. Curr Drug Saf. 2021;16(1):52-61. doi: 10.2174/1574886315666200908110058.
PubMed 32900349Langdahl BL, Hofbauer LC, Forfar JC. Cardiovascular Safety and Sclerostin Inhibition. J Clin Endocrinol Metab. 2021 Jun 16;106(7):1845-1853. doi: 10.1210/clinem/dgab193.
PubMed 33755157Rasmussen NH, Dal J. Falls and Fractures in Diabetes-More than Bone Fragility. Curr Osteoporos Rep. 2019 Jun;17(3):147-156. doi: 10.1007/s11914-019-00513-1.
PubMed 30915638
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE
- ClinicalTrials.gov ID
- NCT06745544
- Acronym / sponsor ID
- DiaACTIVE / N-20240025
- Conditions
- Type 2 Diabetes, Osteoporosis, Diabetic Neuropathies, Fall Prevention, Cardiovascular Diseases
- Keywords
- Diabetes, T1D, T2D, RYMA, Falls, Neuropathy, CVD, Diabetic Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University, Maastricht University Medical Center
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study follows a randomized controlled trial design. Participants are randomly allocated to either the 26 weeks RYMA/ADL exercise intervention group or the control group (usual care). Baseline measures are performed at day 0. Then, follow-up regardless of group is after 26, 52 and 104 weeks and a final visit after 5 years from baseline.
| Arm | Type | Receives |
|---|---|---|
| RYMA group | Experimental | Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)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. |
| Usual Care/No Structured Exercise Intervention | No intervention | –Participants in this arm will continue their usual daily routines without any structured exercise intervention during the first 26 weeks. |
| Control Group without diabetes | No intervention | –Healthy controls without diabetes equally divided between men and women without diabetes for baseline comparisons. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)Also: Exercise, training, balance trainingThe 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. | Other | RYMA group |
Primary outcome
Reduction in Fall Rates
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.
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).
Improvement in Bone Mineral Density (BMD)
Time frame: Measurements will assess changes at 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention to evaluate sustained benefits.
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
Reduction in Cardiovascular Risk and Events
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
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.
Improvement in Nerve Function
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
To estimate the change of nerve fiber function by determining the degree of small, large and autonomic neuropathy after RYMA and cardiovascular optimization.
Blood glucose changes
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.
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
6 secondary outcomes
Mechanisms associated with Fall Reduction
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention
Improvement in Quality of Life
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention
Reduction in Fracture Risk
Time frame: 52 weeks, 104 weeks, and 5 years post-intervention.
Improvement in Cardiovascular Function
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Improvement in Cognitive Function
Time frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Membran properties
Time frame: year 2 and year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 16291301Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. doi: 10.1016/j.ejpain.2005.02.003.
- Background: PubMed 37515636Mahalingasivam AA, Jespersen AK, Ejskjaer N, Hougaard DD, Vestergaard P, Rasmussen NH, Roikjer J. The co-existence of peripheral and vestibular neuropathy in diabetes: a cross-sectional study. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):663-672. doi: 10.1007/s00405-023-08130-6. Epub 2023 Jul 29.
- Background: PubMed 26455926Jansen S, Bhangu J, de Rooij S, Daams J, Kenny RA, van der Velde N. The Association of Cardiovascular Disorders and Falls: A Systematic Review. J Am Med Dir Assoc. 2016 Mar 1;17(3):193-9. doi: 10.1016/j.jamda.2015.08.022. Epub 2015 Oct 9.
- Background: PubMed 33889286Rajbhandari J, Fernandez CJ, Agarwal M, Yeap BXY, Pappachan JM. Diabetic heart disease: A clinical update. World J Diabetes. 2021 Apr 15;12(4):383-406. doi: 10.4239/wjd.v12.i4.383.
- Background: PubMed 15817027Kressig RW, Allali G, Beauchet O. Long-term practice of Jaques-Dalcroze eurhythmics prevents age-related increase of gait variability under a dual task. J Am Geriatr Soc. 2005 Apr;53(4):728-9. doi: 10.1111/j.1532-5415.2005.53228_2.x. No abstract available.
- Background: PubMed 29697780Lord SR, Close JCT. New horizons in falls prevention. Age Ageing. 2018 Jul 1;47(4):492-498. doi: 10.1093/ageing/afy059.
- Background: PubMed 32636957Wollesen B, Wildbredt A, van Schooten KS, Lim ML, Delbaere K. The effects of cognitive-motor training interventions on executive functions in older people: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Jul 2;17:9. doi: 10.1186/s11556-020-00240-y. eCollection 2020.
- Background: PubMed 33239019Sherrington C, Fairhall N, Kwok W, Wallbank G, Tiedemann A, Michaleff ZA, Ng CACM, Bauman A. Evidence on physical activity and falls prevention for people aged 65+ years: systematic review to inform the WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):144. doi: 10.1186/s12966-020-01041-3.
- Background: PubMed 32900349Rasmussen NH, Dal J, den Bergh JV, de Vries F, Jensen MH, Vestergaard P. Increased Risk of Falls, Fall-related Injuries and Fractures in People with Type 1 and Type 2 Diabetes - A Nationwide Cohort Study. Curr Drug Saf. 2021;16(1):52-61. doi: 10.2174/1574886315666200908110058.
- Background: PubMed 33755157Langdahl BL, Hofbauer LC, Forfar JC. Cardiovascular Safety and Sclerostin Inhibition. J Clin Endocrinol Metab. 2021 Jun 16;106(7):1845-1853. doi: 10.1210/clinem/dgab193.
- Background: PubMed 30915638Rasmussen NH, Dal J. Falls and Fractures in Diabetes-More than Bone Fragility. Curr Osteoporos Rep. 2019 Jun;17(3):147-156. doi: 10.1007/s11914-019-00513-1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) in people with Type 2 Diabetes and Osteoporosis, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicklas HH Rasmussen, Associate Professor, MD, Ph.D. (+45 61306306, nicklas.rasmussen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Fall Rates (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06745544, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.