Primary Objective: To investigate which measures/definitions from continuous BP measurements (using Finapres) and from cerebral oxygenation measurements (using NIRS) are associated with associated with future fall incidents in older adults at riskā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Valincidenten bij oudere volwassenen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the time to first fall
Secondary outcome
Secondary outcome measures are: number of falls during follow-up, injurious
falls, number of injurious falls, falls history and patient recorded outcomes.
Background summary
Falls, with or without injury, is a common problem among older adults.
Orthostatic hypotension (OH) (low blood pressure when standing), which is
common in the older adults, is an important risk factor for falls.
OH is often overlooked with the most commonly used method of measuring OH
(intermittent blood pressure measurements using a blood pressure monitor on the
upper arm). Previous research has shown that measuring blood pressure via
non-invasive continuous blood pressure measurements (Finometer) has added value
for finding OH in older fallers. This technique is currently mainly used in
specialized clinics (such as the AMC). Another technique that may be of added
value in detecting OH-related fall risk is the use of near-infrared
spectroscopy (NIRS). This is a sensor that is worn on the forehead and provides
a reflection of the cerebral blood flow. This technique is currently only used
for research purposes.
At our fall clinic, the two blood pressure measurements methods during postural
change is part of usual care. Measuring cerebral blood flow using NIRS will be
an addition to this. In addition, we ask participants to keep a fall calendar
for 1 year.
Our aim is to investigate which outcomes of continuous blood pressure
measurements with Finapres and measurements of cerebral oxygenation with NIRS
are associated with (future) fall risk in older adults at risk of an OH-related
fall. We will study various cut-off values, definitions, time points and
OH-related symptoms to quantitatively estimate the future fall risk and thus
take a first step in finding the optimal OH-related variables for fall
prediction.
Study objective
Primary Objective:
To investigate which measures/definitions from continuous BP measurements
(using Finapres) and from cerebral oxygenation measurements (using NIRS) are
associated with associated with future fall incidents in older adults at risk
of falls.
Secondary Objective(s):
To investigate which measures/definitions from continuous BP measurements
(using Finapres) and from cerebral oxygenation measurements (using NIRS) are
associated with secondary fall outcomes, including: number of falls, injurious
falls, number of innjurious falls, history of (recurrent) falls.
Study design
Prospective cohort study
Study burden and risks
The risks of participating in this study are negligible. The postural changes
that subjects are asked to perform (from lying down to standing) resemble
activities from everyday life. Participants may experience dizziness or other
symptoms related to standing up. However, the requested postural is part of the
usual care of the outpatient fall clinic.
The burden of wearing the NIRS (2 sensors on the forehead) is negligible.
Maintaining the fall calendar will take a few minutes per week.
meibergdreef 9
Amsterdam 1105AZ
NL
meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1.65 years or older
2.History of a fall (in the past year)
3.Ability to perform supine-to-stand manoeuvres.
4.Ability to sign informed consent.
5.a Mini-Mental State Examination score of 21 points or higher or a Montreal
Cognitive Assessment - Dutch score of 16 points or higher
6.Sufficient command of the Dutch language
Exclusion criteria
1. Physically not able to perform sit-to-stand and supine-to-stand manoeuvres.
2. Estimated life expectancy of less than one year.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85457.018.24 |