New horizons in falls prevention.
Stephen R Lord, Jacqueline C T Close
https://pubmed.ncbi.nlm.nih.gov/29697780/Actively Recruiting
Led by Aalborg University Hospital · Updated on 2026-04-17
490
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to evaluate the effects of comprehensive screening and multicomponent interventions on preventing falls, improving bone health, nerve function, and cardiovascular outcomes in people with diabetes aged 65 and older. Diabetes increases the risk of falls, fractures, and cardiovascular disease, yet these risks are not well studied together. The trial uses a novel, multidimensional approach to address these challenges through integrated care and long-term follow-up. Participants undergo detailed baseline assessments including fall risk evaluation, bone density scans using DXA, neuropathy tests, and cardiovascular profiling with imaging like MRI and seismocardiography. Based on these results, participants are randomized to different groups, including one that receives the RYMA exercise programa 26-week regimen combining rhythm-based cognitive-motor training, strength, balance, coordination, and daily activity exercises set to music. Pharmacological treatments for osteoporosis and cardiovascular risk management with medications such as SGLT2 inhibitors and GLP-1 receptor agonists are also tailored to participant needs. Throughout the study, participants are assessed at 26 weeks, 52 weeks, 2 years, and 5 years. Evaluations include fall rates, bone mineral density, nerve function, cardiovascular events, gait and balance analysis, cognitive and physical tests, and quality of life measures. Continuous monitoring and follow-up ensure understanding of both short- and long-term effects. The study also tracks participants adherence to interventions and explores mechanisms behind fall reduction and health improvements.
CONDITIONS
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
N
Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.
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Aalborg University Hospital
Lead Sponsor
Aalborg University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are recruited and screened from outpatient diabetes clinics to confirm eligibility, including assessments of diabetes diagnosis, cognitive function, and mobility.
Duration - Up to 1 week
Participants undergo comprehensive baseline assessments including fall risk evaluation, bone mineral density scans, nerve function tests, cardiovascular profiling, and cognitive and physical performance evaluations before starting the intervention.
1 screening and enrollment visit (in-person) with multiple assessments
Duration - 26 weeks
Participants in the intervention group engage in a 26-week cognitive-motor exercise program combining rhythm-based multitasking exercises with activities of daily living to improve balance, strength, coordination, executive function, and cardiovascular health.
Regular sessions over 26 weeks; visit frequency depends on program schedule
Duration - Up to 5 years
Participants are followed with repeated assessments of fall rates, bone mineral density, cardiovascular health, nerve function, cognitive function, and quality of life at multiple timepoints to evaluate short- and long-term effects of the intervention.
Visits at 26 weeks, 52 weeks, 2 years, and 5 years post-intervention
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/32636957/Aalborg University Hospital
Lead Sponsor
Aalborg University
Collaborating Sponsor