NCT06063187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

February 7, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

accidental fallsbody compositionfallsfearrisk assessmenttechnologywearable devices

Outcome Measures

Primary Outcomes (7)

  • 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.

    Through study completion, an average of 2 years

  • 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.

    Through study completion, an average of 2 years

  • 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.

    Once at baseline, an average of 5 minutes

  • 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.

    7 days

  • Body Composition

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

    Once at baseline, an average of 2 minutes

  • Balance Performance

    Balance performance will be assessed using the BTrackS Balance test.

    Once at baseline, an average of 4 minutes

  • 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."

    Once at baseline, an average of 10 minutes

Secondary Outcomes (1)

  • Depression

    Once at baseline, an average of 10 minutes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

Related Publications (2)

  • 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.

    PMID: 33825688BACKGROUND
  • 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.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ladda Thiamwong, PhD, RN

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

October 2, 2023

Study Start

September 30, 2020

Primary Completion

June 30, 2022

Study Completion

July 1, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

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.

Locations