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FallNCT06063187

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

An observational study of Fall and Physical Inactivity, run by University of Central Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Fall, Physical Inactivity, Sedentary Behavior
How many people
124 participants
Where
1 siteUnited States
Study dates
30 Sep 2020to 1 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community sample

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Central Florida

    Orlando, Florida, 32816

Other trials in United States

About this study

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:

Read more
  • 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.
Read the 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.

Keywords
accidental falls, body composition, falls, fear, risk assessment, technology, wearable devices
Medical subject headings
Sedentary Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment of low-income older adults

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

    Measured: Through study completion, an average of 2 years

  2. Acceptability of using technologies in low-income older adults

    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.

    Measured: Through study completion, an average of 2 years

  3. Maladaptive fall risk appraisal

    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.

    Measured: Once at baseline, an average of 5 minutes

  4. Time spent in each physical activity intensity domain

    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.

    Measured: 7 days

  5. Body Composition

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

    Measured: Once at baseline, an average of 2 minutes

  6. Balance Performance

    Balance performance will be assessed using the BTrackS Balance test.

    Measured: Once at baseline, an average of 4 minutes

  7. Fear of Falling

    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."

    Measured: Once at baseline, an average of 10 minutes

Secondary outcomes (1)

  1. Depression

    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."

    Measured: Once at baseline, an average of 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start30 Sep 2020
  3. Primary completion30 Jun 2022
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063187
Sponsor's protocol ID
STUDY00002473
Other IDs
R03AG069799
Status last verified
Sep 2023
First submitted
7 Feb 2023
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be made available at the end of the funding period (anticipated Fall 2023). We plan to share the de-identified datasets in both proprietary (SPSS files containing variables descriptions) and non-proprietary (.csv with accompanying .txt file containing variable descriptions) formats.

Publications

  • 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.

    PubMed 33825688

  • 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.

    PubMed 35994346

  • Sterner DA, Stout JR, Lafontant K, Park JH, Fukuda DH, Thiamwong L. Phase Angle and Impedance Ratio as Indicators of Physical Function and Fear of Falling in Older Adult Women: Cross-Sectional Analysis. JMIR Aging. 2024 Mar 5;7:e53975. doi: 10.2196/53975.

    PubMed 38488531

Questions about this trial

What is this clinical trial studying?

An observational study of Fall and Physical Inactivity, run by University of Central Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment of low-income older adults (time frame: Through study completion, an average of 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063187, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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