NCT06714565

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

November 28, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

November 28, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

fallsorthostatic hypotensionblood pressureNIRSOlder adults

Outcome Measures

Primary Outcomes (1)

  • Falls during follow-up

    Falls data prospectively collected using fall calenders.

    From enrollment to 12 months follow-up

Study Arms (1)

Older adults who have experienced a fall.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 65 years and over referred to the outpatient (fall) clinic who have experienced a fall in the past 12 months.

You may qualify if:

  • 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

You may not qualify if:

  • Physically not able to perform sit-to-stand and supine-to-stand manoeuvres.
  • Estimated life expectancy of less than one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center, location Meibergdreef

Amsterdam, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Anouschka C. Pronk, MD, PhD student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 3, 2024

Study Start

December 4, 2024

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

December 5, 2026

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations