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Completed

NCT Number: NCT06063187

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

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.

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Key information

Conditions

Fall Behavior Physical Inactivity Sedentary Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Balance Performance

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

    Balance performance will be assessed using the BTrackS Balance test.

  7. 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."

Secondary outcomes

  1. Depression

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

    Depression 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."

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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