Impact of exercise and screening on fall rates and cardiovascular health in older adults with diabetes
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE
This study is testing if a special exercise program and health screenings can help older adults with diabetes reduce their risk of falls and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg, Norh) |
| Trial ID | NCT06745544 on ClinicalTrials.gov |
What this trial studies
The DIACTIVE study is a randomized controlled trial designed to evaluate the effectiveness of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function, and cardiovascular outcomes in individuals aged 65 and older with diabetes. Participants undergo extensive baseline assessments, including fall risk stratification and cardiovascular profiling, followed by allocation to risk-based intervention arms. The centerpiece of the intervention is the RYMA exercise program, which integrates strength, balance, and cognitive training to address the multifaceted health challenges faced by this population. The study aims to provide new insights into diabetes management and improve health outcomes for older adults.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 65 and older with a diagnosis of Type 1 or Type 2 diabetes living independently.
Not a fit: Patients with significant neurological diseases, severe cognitive impairment, or those fully dependent on walking aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce fall rates and improve cardiovascular health in older adults with diabetes.
How similar studies have performed: Other studies have shown success with similar multidimensional approaches to managing diabetes-related complications, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aalborg, Norh
- Steno Diabetes Center North — Aalborg, Norh, Denmark (Recruiting)
Study contacts
- Study coordinator: Nicklas HH Rasmussen, Associate Professor, MD, Ph.D.
- Email: nicklas.rasmussen@rn.dk
- Phone: +45 61306306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.