Quantitative sensory testing: a comprehensive protocol for clinical trials.
R Rolke, W Magerl, K Andrews Campbell...
https://pubmed.ncbi.nlm.nih.gov/16291301Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
ID06745544
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE
Led by Aalborg University Hospital · Updated on 2026-04-17
490
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
A
Aalborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 program—a 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
Brief Title
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Who Can Participate
Age: 65Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Men and women aged 65 years or older with type 1 or type 2 diabetes
- Living independently in their own home
- Diagnosed with diabetes at least one year before joining the study
- Signed informed consent to participate
You will not qualify if you...
- No previous experience with rhythm-based multitask exercise
- Significant neurological diseases such as Parkinson's or Multiple Sclerosis
- Vestibular diseases or orthopedic surgeries affecting mobility (e.g., hip/knee replacement)
- Severely impaired cognitive function (score below 8 on the short orientation-memory-concentration test)
- Fully dependent on walking aids
- Pregnancy or breastfeeding
- Active cancer or terminal illness
- Unable to understand Danish in writing or verbally
- Participation in other interventional clinical studies within the last six months
- Engaging in more than 5 hours of exercise per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
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.
Baseline Assessments and Enrollment
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
Intervention: Rhythm- and Multitask-Based Activity (RYMA) Program
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
Follow-up Assessments and Long-term Monitoring
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
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center North
Aalborg, Norh, Denmark, 9000
Actively Recruiting
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Research Team
N
Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.
How is the study designed?
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/32900349Cardiovascular Safety and Sclerostin Inhibition.
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