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Clinical Trials/NCT06063187
NCT06063187
Completed
Not Applicable

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

University of Central Florida1 site in 1 country124 target enrollmentSeptember 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall
Sponsor
University of Central Florida
Enrollment
124
Locations
1
Primary Endpoint
Acceptability of using technologies in low-income older adults
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2020
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ladda Thiamwong

Associate Professor

University of Central Florida

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.

Outcomes

Primary Outcomes

Acceptability of using technologies in low-income older adults

Time Frame: Through study completion, an average of 2 years

The 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.

Balance Performance

Time Frame: Once at baseline, an average of 4 minutes

Balance performance will be assessed using the BTrackS Balance test.

Fear of Falling

Time Frame: Once at baseline, an average of 10 minutes

Fear 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 adults

Time Frame: Through study completion, an average of 2 years

The investigators will assess the ability to recruit the participants by tracking the number of days and time spent to recruit the sample.

Maladaptive fall risk appraisal

Time Frame: Once at baseline, an average of 5 minutes

A 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.

Body Composition

Time Frame: Once at baseline, an average of 2 minutes

Body composition will be assessed using a direct segmental multi-frequency bioelectrical impedance analysis (BIA): InBody s10 device.

Time spent in each physical activity intensity domain

Time Frame: 7 days

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.This device will assess the time (minutes) spent in light, moderate, and vigorous physical activity domains throughout the 7-day assessment period.

Secondary Outcomes

  • Depression(Once at baseline, an average of 10 minutes)

Study Sites (1)

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