Accidental Falls
Conditions
Brief summary
The goal of this observational study is to identify clinical, laboratory, and biological markers associated with past (and future falls) in healthy older adults aged 65 years and over. The main question it aims to answer is: Which clinical, functional, laboratory, and blood-based markers distinguish older adults who have fallen at least once during the previous 12 months from those who have not? Researchers will compare older adults with a history of falls with similar older adults without a history of falls. One hundred healthy older adults aged 65 and over, including both fallers and non-fallers, will be recruited for the study. Participants will complete questionnaires and undergo cognitive and physical tests, physical activity and sleep monitoring, gait, balance, muscle, sensory and vestibular assessments, brain and muscle imaging, and blood sampling. Blood samples will be used to study proteins and genetic variants that may be associated with falls. Participants will then be followed for one year using a smartphone-based application to report falls. The study is based on the hypothesis that a history of falling in an otherwise healthy older adult may be associated with subtle clinical, functional, and biological differences compared with a similar older adult without a history of falls. The findings may support the future development of more accurate and scalable tools for early fall-risk detection and targeted fall-prevention strategies. No direct therapeutic benefit is expected from participation.
Interventions
None listed
Sponsors
Slb Pharma
Université de Caen Normandie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* being aged ≥65 years, * having independent ambulation, * having an Mini Mental State Examination (MMSE) score ≥24, * being fluent in French, * being affiliated with the national social security system, * providing written informed consent.
Exclusion criteria
* neurological or psychiatric disorders affecting motor or cognitive function (e.g., Parkinson's disease, stroke sequelae, major depression) or other severe comorbidities that could affect participant safety and study outcomes, * recent lower-limb surgery (\<12 months), * polypharmacy (use of more than four medications) or fall-risk increasing drugs, * significant sensory impairments limiting assessment, * immune-related conditions or recent infections, * contraindications to MRI, * hospitalization within the past 30 days, * participation in another clinical study, * unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stable Candidate Multimodal Biomarkers Discriminating Participants With and Without Prior Falls | Baseline assessment | The outcome will be the number and identity of stable candidate biomarkers that discriminate participants who experienced at least one fall during the previous 12 months from participants who experienced no falls during that period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Performance of Baseline Biomarkers for Incident Falls | From completion of baseline assessments through 12 months of prospective follow-up | The ability of baseline biomarkers retained by the stability-selection procedure to predict at least one incident fall during prospective follow-up will be evaluated. Predictive performance will be reported using the area under the receiver operating characteristic curve, sensitivity, and specificity, each with 95% confidence intervals. |
Contacts
CONTACTAntoine Langeard, PhD
Outcome results
None listed