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

April 14, 2026 updated by: Nicklas Højgaard-hessellund Rasmussen, Aalborg University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.
  • Phone Number: +45 61306306
  • Email: nicklas.rasmussen@rn.dk

Study Locations

  • Denmark
    • Norh
      • Aalborg, Norh, Denmark, 9000
        • Recruiting
        • Steno Diabetes Center North
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. No previous experience with rhythm-based multitask exercise.
  2. 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.
  3. Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment "the short orientation-memory-concentration test."
  4. Being fully dependent on walking aids.
  5. Pregnancy or breast feeding
  6. Active malignancy or terminally ill.
  7. Not being able to understand Danish written and/or verbally.
  8. Participating in other interventional clinical studies within the last six months
  9. People with a weekly exercise activity above 5 hours a week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL)
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.
Other Names:
  • Exercise
  • training
  • balance training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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
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
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.
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
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.
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanisms associated with Fall Reduction
Time Frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention
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
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
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.
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.
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.
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.
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.
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.
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.
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Membran properties
Time Frame: year 2 and year 5
To evaluate changes in nerve membrane properties including shifts in ion-channel composition or activity.
year 2 and year 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustainability of Intervention Effects
Time Frame: 2 years and 5 years post-intervention.
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.
2 years and 5 years post-intervention.
Changes in Muscle Mass and Composition
Time Frame: 26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
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
26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.
Changes in Inflammatory Biomarkers
Time Frame: 26 weeks, 52 weeks, and 104 weeks post-intervention.
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
26 weeks, 52 weeks, and 104 weeks post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Maastricht University Medical Center
Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20240025
  • NNF22SA0079901 (Other Grant/Funding Number: the Danish Diabetes and Endocrine Academy, which is funded by the Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

It will be made available one year after the study period ends including the following year.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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