| Registry | NCT06714565, acronym NIRS-Fall |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 141 (Estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other) |
| Conditions | Falls, Orthostatic Hypotension, Older Adults (65 Years and Older) |
| Dates | start 2024-12-04, primary completion 2026-12-04 (estimated), completion 2026-12-05 (estimated), first posted 2024-12-03, last updated 2024-12-19 |
| Locations | 1 site in Netherlands |
Related Papers Related Patents Related Grants Related Experts
All trials for Falls All trials for Orthostatic Hypotension
The investigators aim to study which measurements/definitions from continuous blood pressures measurements (using a Finometer) and from cerebral oxygenation measurements (using near-infrared spectroscopy (NIRS)) are associated with future fall incidents in older adults at risk of falls.
Patients aged 65 years and over with a fall in the last 12 months are eligible for inclusion. After being informed about the study, all participants giving written informed consent will perform the active stand procedure (5min lying, 5 min standing). The hemodynamic measurements that will be performed during this procedure simultaneously consist of:
1. Volume-clamp photoplethysmography on the finger in the digital artery (Finapres medical systems, Enschede, The Netherlands) for continuous blood pressure measurements.
2. PortaLite MKII (Artinis medical systems, Elst, The Netherlands) for continuous cerebral oximetry (NIRS).
After completing the measurements, participants will receive a falls calendar and will be instructed to record falls, fall-related injuries, and fall-related healthcare use on a weekly basis for 12 months.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Older adults who have experienced a fall. |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * 65 years or older * History of a fall (in the past year) * Ability to perform supine-to-stand manoeuvres. * Ability to sign informed consent. * a Mini-Mental State Examination (MMSE) score of 21 points or higher or a Montreal Cognitive Assessment (MOCA) - Dutch score of 16 points or higher. * Sufficient command of the Dutch language Exclusion Criteria: * Physically not able to perform sit-to-stand and supine-to-stand manoeuvres. * Estimated life expectancy of less than one year.
| Facility | City | Country | Status |
|---|---|---|---|
| Amsterdam University Medical Center, location Meibergdreef | Amsterdam | Netherlands | Recruiting |