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

NCT06745544 | Recruiting

• 2 other identifiers: N-20240025NNF22SA0079901
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Osteoporosis; Diabetic Neuropathies; Fall Prevention; Cardiovascular Diseases

Keywords

Diabetes; T1D; T2D; RYMA; Falls; Neuropathy; CVD; Diabetic Complications; Bone health; Fractures

Outcome Measures

Primary Outcomes (5)

• 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).

  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

  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.

  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.

  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

  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

  26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention

• Improvement in Quality of Life

  26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention

• Reduction in Fracture Risk

  52 weeks, 104 weeks, and 5 years post-intervention.

• Improvement in Cardiovascular Function

  26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.

• Improvement in Cognitive Function

  26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.

Other Outcomes (3)

• Sustainability of Intervention Effects

  2 years and 5 years post-intervention.

• Changes in Muscle Mass and Composition

  26 weeks, 52 weeks, 104 weeks, and 5 years post-intervention.

• Changes in Inflammatory Biomarkers

  26 weeks, 52 weeks, and 104 weeks post-intervention.

Study Arms (3)

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.

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.

Interventions

Rhythm- and Multitask-Based Activity (RYMA) and Activities of Daily Living (ADL) OTHER

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

RYMA group

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Male and females
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Signed the informed consent.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

Steno Diabetes Center North

Aalborg, Norh, 9000, Denmark

RECRUITING

Related Publications (11)

• 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.

  PMID: 16291301 BACKGROUND

• Mahalingasivam 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.

  PMID: 37515636 BACKGROUND

• Jansen 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.

  PMID: 26455926 BACKGROUND

• Rajbhandari 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.

  PMID: 33889286 BACKGROUND

• Kressig 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.

  PMID: 15817027 BACKGROUND

• Lord SR, Close JCT. New horizons in falls prevention. Age Ageing. 2018 Jul 1;47(4):492-498. doi: 10.1093/ageing/afy059.

  PMID: 29697780 BACKGROUND

• Wollesen 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.

  PMID: 32636957 BACKGROUND

• Sherrington 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.

  PMID: 33239019 BACKGROUND

• Rasmussen 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.

  PMID: 32900349 BACKGROUND

• Langdahl 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.

  PMID: 33755157 BACKGROUND

• Rasmussen 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.

  PMID: 30915638 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoporosis; Diabetic Neuropathies; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Complications; Fractures, Bone

Interventions

Activities of Daily Living; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.

CONTACT

+45 61306306; nicklas.rasmussen@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 20, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

DK (1)