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NCT Number: NCT06714565

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Center, location Meibergdreef

Amsterdam, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Anouschka C. Pronk, MD, PhD student

CONTACT

+31205669111

Anouschka C. Pronk, MD, PhD student

CONTACT

Nathalie van der Velde, Prof.Dr.

CONTACT

About this study

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:

  • Volume-clamp photoplethysmography on the finger in the digital artery (Finapres medical systems, Enschede, The Netherlands) for continuous blood pressure measurements.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Falls during follow-up

    Time frame: From enrollment to 12 months follow-up

    Falls data prospectively collected using fall calenders.

Study contacts

Contact information is provided by the study sponsor or research team.

Anouschka C. Pronk, MD, PhD student

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: NIRS-Fall

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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