The Value of Near-infrared Spectroscopy and Blood Pressure Measurements in Estimating Future Fall Risk in Older Adults

Recruiting

• Conditions: Falls; Orthostatic Hypotension; Older Adults (65 Years and Older)

• Registration Number: NCT06714565
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-03
• Study Start: 2024-12-04
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-12-04
• Study Completion: 2026-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 141

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Falls during follow-up	From enrollment to 12 months follow-up	Falls data prospectively collected using fall calenders.

Trial Locations

Locations (1)

Amsterdam University Medical Center, location Meibergdreef; 🇳🇱 Amsterdam, Netherlands