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Technology-based Fall Risk Assessments for Older Adults in Low-income Settings

Technology-based Fall Risk Assessments for Older Adults in Low-income Settings

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06063187
Enrollment
124
Registered
2023-10-02
Start date
2020-09-30
Completion date
2023-07-01
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Physical Inactivity, Sedentary Behavior

Keywords

accidental falls, body composition, falls, fear, risk assessment, technology, wearable devices

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.

Interventions

None listed

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Central Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fear of FallingOnce at baseline, an average of 10 minutesFear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items.The minimum score possible is 7 and the maximum possible score is 28. Scores of 7-8 indicate low concern, scores of 9-13 indicate moderate concern, and scores of 14-28 indicate high concern.
Feasibility of recruitment of low-income older adultsThrough study completion, an average of 2 yearsThe investigators will assess the ability to recruit the participants by tracking the number of days and time spent to recruit the sample.
Acceptability of using technologies in low-income older adultsThrough study completion, an average of 2 yearsThe acceptability of the technologies and procedures will be examined based on an evaluation form (e.g., what the participants thought about the questionnaires and technology) and participants' recommendations.
Maladaptive fall risk appraisalOnce at baseline, an average of 5 minutesA condition in which there is a discrepancy between perceived fall risk (levels of fear of falling) and physiological fall risk (balance performance). Fear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items and balance performance will be assessed using the BTrackS Balance test. Maladaptive fall risk will be plotted on a electronic graph as the interaction between balance performance on the X-axis and fear of falling on the Y-axis.
Time spent in each physical activity intensity domain7 daysParticipants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.This device will assess the time (minutes) spent in light, moderate, and vigorous physical activity domains throughout the 7-day assessment period.
Body CompositionOnce at baseline, an average of 2 minutesBody composition will be assessed using a direct segmental multi-frequency bioelectrical impedance analysis (BIA): InBody s10 device.
Balance PerformanceOnce at baseline, an average of 4 minutesBalance performance will be assessed using the BTrackS Balance test.

Secondary

MeasureTime frameDescription
DepressionOnce at baseline, an average of 10 minutesDepression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The minimum possible score is 0 and the maximum possible score is 27. Scores of 0-4 indicate minimal depression, scores of 5-9 indicate mild depression, scores of 10-14 indicate moderate depression, scores of 15-19 indicate moderately severe depression, and scores of 20-27 indicate severe depression.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026