Clinical trial NCT06063187: Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Official title: Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Physical Inactivity
Sedentary Behavior
Keywords: accidental falls
body composition
falls
fear
risk assessment
technology
wearable devices
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-02
Enrollment: 124
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The goal of this observational study is to examine the associations among fall risk appraisal, body composition, and physical activity in older adults in low-income settings.

The main questions it aims to answer are:

* What is the feasibility of recruitment (e.g., how many older adults need to be screened to recruit the sample?), especially during the COVID-19 pandemic, and acceptability of technologies and procedures for use among older adults in low-income settings?
* What are the the dynamic relationships between fall risk appraisal, body composition, physical activity, and behavioral changes related to fear of falling?

Participants will:

* complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.
* participate in static and dynamic balance tests, body composition measurement and handgrip strength test.
* wear an accelerometer for physical activity assessment for 7 consecutive days.

Detailed description: The investigators will use a cross-sectional design to address aims. The investigators will administer the study instruments which consist of objective and subjective measures. Participants will complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.

Balance performance will be assessed by the BTrackS Balance System (BBS). This test consists of four, 20 seconds trials. For each trial, the participants will stand as still as possible on the BBP with hands on their hips, and eye closed. This test consists of four trials. This test will take about 5-10 minutes.

Body composition will be assessed using a bioelectrical impedance analysis (BIA): InBody S10. The BIA InBody S10 measures fat mass, muscle mass and body water levels. There are no risks, no dunking, no pinching, no discomfort associated with the use of bioelectrical impedance analysis. Test duration is 1-2 minutes.

Physical Activity (PA) will be measured by activity monitoring devices. All participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.

Eligibility criteria: Inclusion Criteria:

* ≥ 60 years of age
* no marked cognitive impairment \[Memory Impairment Screen (MIS) score ≥5\]
* speak English or Spanish
* live in Kinneret Sr. Apartments or in Orlando FL.

Exclusion Criteria:

* a medical condition precluding balance test (e.g., unable to stand on the balance plate) and/or PA (e.g., shortness of breath; feeling pressure when performing PA)
* currently receiving treatment from a rehabilitation facility
* have a metal implant.

Primary outcomes:
measure: Feasibility of recruitment of low-income older adults
timeFrame: Through study completion, an average of 2 years
measure: Acceptability of using technologies in low-income older adults
timeFrame: Through study completion, an average of 2 years
measure: Maladaptive fall risk appraisal
timeFrame: Once at baseline, an average of 5 minutes
measure: Time spent in each physical activity intensity domain
timeFrame: 7 days
measure: Body Composition
timeFrame: Once at baseline, an average of 2 minutes
measure: Balance Performance
timeFrame: Once at baseline, an average of 4 minutes
measure: Fear of Falling
timeFrame: Once at baseline, an average of 10 minutes
Secondary outcomes:
measure: Depression
timeFrame: Once at baseline, an average of 10 minutes
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Ladda Thiamwong, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiamwong L, Stout JR, Park JH, Yan X. Technology-Based Fall Risk Assessments for Older Adults in Low-Income Settings: Protocol for a Cross-sectional Study. JMIR Res Protoc. 2021 Apr 7;10(4):e27381. doi: 10.2196/27381.
citation: Choudhury R, Park JH, Thiamwong L, Xie R, Stout JR. Objectively Measured Physical Activity Levels and Associated Factors in Older US Women During the COVID-19 Pandemic: Cross-sectional Study. JMIR Aging. 2022 Aug 22;5(3):e38172. doi: 10.2196/38172.