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

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06063187
• Other study ID #: STUDY00002473
• Secondary ID: R03AG069799
• Status: Completed
• Start date: September 30, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall
• Physical Inactivity
• Sedentary Behavior

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Balance Performance	Balance performance will be assessed using the BTrackS Balance test.	Once at baseline, an average of 4 minutes
Primary	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	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."	Once at baseline, an average of 10 minutes