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

Not Applicable

• Conditions: Type 2 Diabetes; Osteoporosis; Diabetic Neuropathies; Fall Prevention; Cardiovascular Diseases

• Registration Number: NCT06745544
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach.

Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated.

Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation.

This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.

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 Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 440

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Fall Rates	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)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Mechanisms associated with Fall Reduction	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
Improvement in Quality of Life	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.
Reduction in Fracture Risk	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.
Improvement in Cardiovascular Function	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.
Improvement in Cognitive Function	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.
Membran properties	year 2 and year 5	To evaluate changes in nerve membrane properties including shifts in ion-channel composition or activity.

Trial Locations

Locations (1)

Steno Diabetes Center North; 🇩🇰 Aalborg, Norh, Denmark