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

NCT ID: NCT06714565

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-04

Study Completion Date

2026-12-05

Brief Summary

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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

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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.

Conditions

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Falls Orthostatic Hypotension Older Adults (65 Years and Older)

Keywords

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falls orthostatic hypotension blood pressure NIRS Older adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Older adults who have experienced a fall.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Nathalie van der Velde

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam University Medical Center, location Meibergdreef

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Anouschka C. Pronk, MD, PhD student

Role: CONTACT

Phone: +31205669111

Email: [email protected]

Facility Contacts

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Anouschka C. Pronk, MD, PhD student

Role: primary

Anouschka C. Pronk, MD, PhD student

Role: backup

Nathalie van der Velde, Prof.Dr.

Role: backup

Other Identifiers

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NL85457.018.24

Identifier Type: -

Identifier Source: org_study_id