An observational study in Fall, Physical Inactivity and Sedentary Behavior, sponsored by University of Central Florida. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of Central Florida · Observational
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:
Participants will:
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.
368 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.
This study's enrollment of 124 is below the median of 150 across 51 observational studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Central Florida is the lead sponsor of 104 studies on the registry; 43 are open to participants now.
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Community sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Body Composition
Body composition will be assessed using a direct segmental multi-frequency bioelectrical impedance analysis (BIA): InBody s10 device.
Time frame: Once at baseline, an average of 2 minutes
Balance Performance
Balance performance will be assessed using the BTrackS Balance test.
Time frame: 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."
Time frame: Once at baseline, an average of 10 minutes
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."
Time frame: Once at baseline, an average of 10 minutes
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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