Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Conditions: Fall, Physical Inactivity, Sedentary Behavior
Sponsor: University of Central Florida

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PROTOCOL TITLE: 
Technology-based fall risk assessments for older adults in low-income settings  
PRINCIPAL INVESTIGATOR: 
Name: Ladda Thiamwong PhD, RN 
Department: Nursing Systems, College of Nursing 
Telephone Number: 407-823-0470 
Email Address: ladda.thiamwong@ucf.edu 
VERSION NUMBER/DATE: 
Version 1 8/26/2020 
Version 2 9/3/2020 
Version 3 9/10/2020 
Version 4 2/01/2021 
Version 5 11/03/2021 
 
REVISION HISTORY 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
1 
9/3/2020 
1. Revise aim 1 
2. Add the literature review related to the impact 
of COVID-19 on falls, physical activity, and fear 
of falling (Please see Background 3.1) 
3. Revise to include details on when and where 
the consent process will take place.   
4. Revise to include details on the screening 
process.   
5. Add inclusion of living in the Kinneret 
community and update the general summary of 
inclusion/exclusion criteria in the protocol, flyer, 
and consent. Include participants who speak 
English or Spanish.  
6. Increase the amount of Walmart gift card 
from $10 to $20. Participants will receive 
$20 gift card at the end of the second day 
(or second visit) of the study. 
7. Update the data retention, all research data, 
including identifiers and linking sheets, needs to 
be retained for at least 5 years after the study 
closure.   
Yes 
 
 
 
 
 
2 
9/10/2020 
Include the Spanish version of the consent, flyer 
and surveys with a translation verification letter 
Yes 

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by a 3rd party. Include an assessment of day-to-
day experiences with anxiety in Appendix D. 
3  
02/01/ 
2021 
-Add two research assistants (Oscar Garcia and 
Maxine Furtado) and remove Lorraine Vicente  
-Add the recruitment methods (using social 
media and word of mouth to recruit low-income 
older adults in Central Florida  
-Indicate where the screening, consent, and 
experimental procedures will take place for each 
group (Kinneret apartments and general 
population) 
-Update the body composition measure from 
Inbody 770 to Inbody S10 and include a 
handgrip strength test  
-Discuss how to return the activity monitoring 
device via mail (with pre-paid mailers) or pick up 
-Discuss the attachment of the electrodes in 
detail (such as who places them, where) 
-Include the additional time (2-3 mins) for the 
handgrip strength test in the protocol, consent, 
and flyer 
- Increase the amount of Walmart gift cards from 
$20 to $30 in the protocol, consent, and flyer 
-Update the flyer (research locations, the total 
amount of time). 
-Update the exclusion criteria (include having a 
metal implant) 
Yes 
5 
11/3/2021 
-As of modification request 10/18/2021, add 
timepoint 2 for 60 participants out of the 120 
participants that participated in timepoint 1. 
-Include additional questions related to 
behavioral changes in the fear of falling domain 
including ageing perceptions, regulatory focus 
and behavioral avoidance/inhibition (Appendix 
E).  
-Include additional questions in the Acceptability 
of fall risk assessments using technology 
interview form (Appendix J). 
-Add research team 
 
 

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Table of Contents 
1.0 
Study Summary........................................................................................... 4 
2.0 
Objectives* ................................................................................................. .4 
3.0 
Background* ............................................................................................... 5 
4.0 
Study Endpoints*......................................................................................... 7 
5.0 
Study Intervention/Investigational Agent ..................................................... 7 
6.0 
Procedures Involved* .................................................................................. 7 
7.0 
Data and Specimen Banking* ................................................................... 16 
8.0 
Sharing of Results with Subjects* ............................................................. 17 
9.0 
Study Timelines* ....................................................................................... 17 
10.0 Inclusion and Exclusion Criteria* ............................................................... 17 
11.0 Vulnerable Populations* ......................................................................... .. 14 
12.0 Local Number of Subjects ......................................................................... 18 
13.0 Recruitment Methods ................................................................................ 18 
14.0 Withdrawal of Subjects* ............................................................................ 19 
15.0 Risks to Subjects* ..................................................................................... 19 
16.0 Potential Benefits to Subjects* .................................................................. 20 
17.0 Data Management* and Confidentiality ..................................................... 20 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ............. 22 
19.0 Provisions to Protect the Privacy Interests of Subjects ............................. 22 
20.0 Compensation for Research-Related Injury .............................................. 23 
21.0 Economic Burden to Subjects ................................................................... 23 
22.0 Consent Process ....................................................................................... 23 
23.0 Process to Document Consent in Writing .................................................. 24 
24.0 Setting ....................................................................................................... 24 
25.0 Resources Available ................................................................................. 25 
26.0 Multi-Site Research* ................................................................................. 25 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Technology-based fall risk assessments for older 
adults in low-income settings  
Study Design 
We will use a cross-sectional design to address our 
aims and test hypotheses.  
 
Primary Objective 
Examine the associations among fall risk appraisal, 
body composition, and physical activity.   
       
Secondary 
Objective(s) 
-Examine the feasibility of recruitment (e.g., how many 
older adults (OAs) need to be screened to recruit the 
sample?), especially during the COVID-19 pandemic, 
and acceptability of technologies and procedures for 
use among OAs in low-income settings. 
-Determine the dynamic relationships between fall risk 
appraisal, body composition, physical activity, and 
behavioral changes related to fear of falling  
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
NA 
IND/IDE #  
NA 
Study Population 
Adults aged 60 years and older 
Sample Size 
120 participants for timepoint 1 
60 participants for timepoint 2 
Study Duration for 
individual 
participants 
Total 9 days with two visits (105-158 mins, total)  
 
Study Specific 
Abbreviations/ 
Definitions  
Older Adults (OAs) 
Physical Activity (PA) 
Fall Risk appraisal (FRA) 
Fear of Falling (FOF)  
Assistive Health Technology (AHT) 
BTrackS Balance Plate (BBP) 
BTrackS Balance System (BBS) 
Body Mass Index (BMI) 
Bioelectrical Impedance Analysis (BIA)  
Fall-Efficacy Scale International (FES-I)  
Patient Health Questionnaire-9 (PHQ-9) 
 
2.0 
Objectives* 
Aim 1. Examine the feasibility of recruitment (e.g., how many OAs need to be 
screened to recruit the sample?), especially during the COVID-19 pandemic, and 

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acceptability of technologies and procedures for use among OAs in low-income 
settings.  
 
Aim 2. Examine the associations among fall risk appraisal, body composition, 
and physical activity.         
 
H2.1: Rational FRA is associated with higher levels of PA and skeletal muscle 
mass, and lower levels of percent of body fat and BMI.  
 
H2.2: Incongruent FRA is associated with higher levels of PA and skeletal 
muscle mass, and lower levels of percent of body fat and BMI.  
 
H2.3: Irrational and congruent FRAs are associated with lower levels of PA and 
skeletal muscle mass, and higher levels of percent of body fat and BMI.  
Aim 3. Determine the dynamic relationships between fall risk appraisal, body 
composition, physical activity and behavioral changes related to fear of falling.  
 
 
3.0 
Background* 
3.1 
More than 15 million (30%) OAs in the US have incomes below the 200% of 
poverty line.1, 2 Poverty rate increases with age, and is higher among women, 
Blacks and Hispanics, and individuals with poor health.1 OAs who live in low-
income communities are less likely to engage in PA,3-5 defined as any bodily 
movement produced by skeletal muscle that results in energy expenditure.6 Lack 
of PA is related to chronic conditions and reduced quality of life among low-
income OAs.7, 8 Limited data suggest that OAs who overestimate their fall risk 
and report fear of falling (FOF) are less likely to participate in PA, and the 
association between FOF and PA intensity differs by fear severity.9 Changes in 
body composition also have a significant impact on functional capacity and 
quality of life.10 However; these studies have not included OAs from low-income 
settings, who are more likely to report falls in the prior year.11 Recent systematic 
reviews found that most studies have not used objective measures of fall risk and 
PA.5, 12 We will use objective measures of body composition, balance 
performance, and PA among OAs from low-income settings.   
Additionally, up to 50% of OAs who have FOF limit their daily physical activity 
(PA) because of the fear.13 The COVID-19 pandemic is causing increased fear 
and related to perceived risks for loved ones and health anxiety.14 Physical 
distancing and fear of the virus have led to reductions in OAs’ use of routine 
healthcare and performing daily PA.15 With the high levels fear; individuals may 
not think rationally when reacting to COVID-19 and taking care of themselves.16 
 

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3.2 
One-third of OAs have maladaptive fall risk 
appraisal (FRA), a condition in which there is a 
discrepancy between perceived fall risk (levels of 
FOF) and physiological fall risk (balance 
performance).17, 18 Measuring FRA in OAs can be 
challenging due to self-report bias and cognitive 
deficit.19, 20 Using both subjective and objective measures provides better fall risk 
assessment among OAs.20, 21 Thus, we developed a fall risk appraisal matrix, a 
graphical grid categorizing levels of FOF and balance performance into four 
quadrants (Fig 1):  1) rational FRA (low FOF and normal balance), 2) incongruent 
FRA (low FOF despite poor balance), 3) irrational FRA (high FOF despite normal 
balance), and 4) congruent FRA (high FOF and poor balance).17 In our pilot study 
(N=102), we measured FOF by a questionnaire and balance performance using 
a portable and novel force balance plate (BTrackS Balance System; BBS). We 
found that 40% of OAs had maladaptive FRA. Of this group, 19% with 
incongruent FRA and 30% with irrational FRA reported falling in the past year.17 
OAs with congruent FRA were 3.29 times more likely to fall than those with 
rational FRA.22 However; our sample included only 11% of low-income OAs.  
3.3 
Maladaptive FRA may impede low-income OAs participation in PA and can result 
in social isolation.20, 23 Irrational FRA serves as a barrier, creating an irrational 
fear that inhibits OAs from staying active. Conversely, incongruent FRA can act 
as an impediment to OAs’ safety by fabricating a sense of wellbeing when more 
caution is warranted. Rational FRA is a crucial component of regular 
engagement in PA.24 However, research has not examined the association 
between FRA and PA among low-income OAs. We will examine the association 
between FRA and PA among low-income OAs.  
Body composition (e.g., obesity, low relative skeletal muscle mass) has been 
associated with FOF, functional impairment, and disability in American OAs.25-27 
Higher BMI and percent body fat were associated with poor physical function 
while percent appendicular lean mass was associated with better physical 
function (e.g., walking, balance test).26 OAs who have higher daily PA have 
better physical function than those who engage in less PA.28 Although Body 
Mass Index (BMI) is the most widely used measurement to classify 
overweight/obesity status.  It is prone to measurement error and does not 
consider body fat distribution and skeletal muscle mass.29 We will use the 
Bioelectrical Impedance Analysis (BIA) device, which measures body 
composition and has established normative data among OAs.30  
Research has not examined the associations among body composition, FRA, 
and PA using Assistive Health Technology (AHT), which is the application of 
organization knowledge, skills, procedures, and systems in order to improve 
functioning.31 Majority of studies have used self-reported measures of fall risk 
and PA among OAs.32-36 OAs who overestimate their fall risk are less likely to 
participate in PA.24, 37 AHT eliminates recall bias associated with subjective 
Fig. 1 FRA matrix 

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measures.38, 39 Systematic reviews also indicate the importance of technology-
based assessments for PA and prevent falls.40, 41 We will examine the 
associations among body composition, FRA, and PA using AHT, including the 
Bioelectrical Impedance Analysis42, BTrackS Balance System,43, 44, and 
accelerometer-based physical activity devices. These devices are portable, non-
invasive, safe, valid, reliable, and allow for home testing.26, 30, 45, 46  
 
4.0 
Study Endpoints*  
4.1 
 
We expect to complete data collection within two years. The study will conclude 
after the study results are published (~10 years, October 30, 2031). 
 
 
5.0 
Study Intervention/Investigational Agent 
NA 
 
6.0 
Procedures Involved* 
6.1 Describe and explain the study design. 
We will use a cross-sectional design to address our aims and test 
hypotheses. Using novel technologies to advance fall risk assessments is 
one of the essential recommendations for promoting PA.47, 48 17, 37, 41, 49 To 
accomplish this goal, we employ the behavioral epidemiology framework50 
to understand 
the associations 
among body 
composition, 
FRA, and PA. 
This framework 
consists of 5 
phases: (1) 
establish links between behaviors and health, 
(2) develop measures of the behaviors, (3) identify influences on the 
behaviors, (4) evaluate interventions to change the behavior, and (5) 
translate research into practice.50 We focus on Phase 1 and in our model, 
body composition is an antecedent of FRA and the accelerometer-based 
PA is a consequence of FRA. We consider OAs’ characteristics (e.g., sex) 
as covariates and control for them in the analysis (Fig 2).  
 
6.2 Provide a description of all research procedures  
We will administer the study instruments which consist of objective and 
subjective measures (see Table 1) for total 120 participants.  Participants 
will complete questionnaires about OA’s characteristics, socio-
demographic, medical history, cognition, depressive symptoms, anxiety, 
Fig. 2 Conceptual Framework 

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and FOF.  We will also assess static balance performance using the 
BTrackS Balance System43, 44, assess dynamic balance using a sit to 
stand test, assess body composition using the Bioelectrical Impedance 
Analysis device42, and assess handgrip strength test using a hand-grip 
dynamometer (JAMAR 5030J1). They will wear an accelerometer-based 
physical activity device for 7 consecutive days. 
 
Table 1. Description of study variables and instruments  
Variable 
Instrument 
Description 
OA’s 
Characteristics 
- Socio-
demographics and 
medical history 
 
-Cognition 
 
 
 
 
 
 
 
 
 
 
 
 
 
- Depressive 
symptoms  
 
 
 
 
 
 
 
-Anxiety and day-to-
day experiences 
 
Self-report 
questionnaire  
 
 
 
 
- Memory Impairment 
Screen (MIS)51-53 
 
 
 
 
 
 
 
 
 
 
 
 
-Patient Health 
Questionnaire-9 
(PHQ-9) 54, 55 
 
 
 
 
 
 
-Geriatric Anxiety 
Inventory-Short form 
(GAI-SF).56-58 
 
 
 
 
 
e.g., age, gender, living status, 
education level, socioeconomic 
status, perceived general health, 
comorbidities, FOF, frailty, fall 
risk, and social network. 
 
 
- The Memory Impairment 
Screen (MIS) is a widely used 
test of cognitive function and 
screening Alzheimer's disease 
among OAs. It is a 4‐minute, 
four‐item delayed free and cued 
recall memory test with 
controlled learning and high 
discriminative validity. The 
maximum score for the MIS is 8 
and if score 5-8=no cognitive 
impairment and score ≤4 
=possible cognitive impairment.  
 
-10 items (e.g., feeling tired) on 
a 4-point scale; measures 
symptoms of depression within 
the prior 2 weeks; Total scores 
range 0-27, scores ≥10 
moderate depression.54 
Cronbach’s alpha=0.89 among 
OAs.54, 55  
 
 
- The GAI-SF is an 
abbreviated version of GAI 
comprising only five of the 
original items. The GAI-SF has 
good internal consistency, 
convergent and divergent 
validity, and was highly 

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- Trait Mindful 
Attention Awareness 
Scale (MAAS).59 
correlated with the original 
GAI.57, 60 A score of three or 
greater was optimal for the 
detection of DSM-IV 
Generalized Anxiety Disorder 
(GAD) in community-dwelling 
OAs (sensitivity 75%, specificity 
87%). Internal consistency was 
high (Cronbach's α = 0.81) and 
concurrent validity against the 
State-Trait Anxiety Inventory 
was good (rs = 0.48, p < 
0.001).57 
 
Day-to-day experiences will be 
assessed by the trait Mindful 
Attention Awareness Scale 
(MAAS). The MASS is a 15-item 
scale with English and Spanish 
versions. The MMAS has been 
validated for use with community 
adults and has demonstrated 
high reliability and validity.59 
Fear of falling 
(FOF),  
ageing perceptions, 
behavioral 
avoidance/inhibition, 
and regulatory 
focus. 
(Please see 
Appendix E) 
Short Fall Efficacy 
Scale International 
(Short FES-I)61 
 
 
 
 
 
 
 
 
 
 
 
 
 
-Brief Ageing 
Perceptions 
Questionnaire 
 
 
 
 
7-items (e.g., going in or out of a 
chair) on a 4-point scale; 
measures concerns about the 
possibility of falling when 
performing seven activities (e.g., 
getting dressed).62 Total scores 
range 7-28.61 Higher total 
scores=higher FOF.63 Scores 7-
10=low concern about falling; 
scores 11-28=high concern 
about falling.62, 64 The short FES-
I has been validated in 
community-dwelling OAs.62 
Cronbach’s alpha =0.97 and 
ICC=0.979 among OAs.65 
 
- Brief Ageing Perceptions 
Questionnaire (B-APQ) is a 
multi-dimensional measure of 
aging perception which consists 
of 17 items (5 response 
choices). 

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-Behavioral 
avoidance/inhibition 
scales 
 
 
 
-Regulatory focus 
Questionnaire (RFQ) 
 
 
 
 
 
 
 
-A single fear of 
falling scale 
 
It has good construct validity and 
internal consistency. Cronbach’s 
alpha =0.75-0.84.66 
 
-Behavioral avoidance/inhibition 
scales consist of 24 items with 4 
domains and 4 response 
choices. Cronbach’s alpha 
=0.66-0.76. 67 
 
-Regulatory focus Questionnaire 
(RFQ) includes two domains 
including promotion on hopes 
and accomplishments and 
prevention on safety and 
responsibilities. The RFQ 
consists of 11 items with scores 
ranging from 1 to 5. 68 
 
-Are you afraid of falling (Y/N) 
-If yes, did your fear of falling 
lead you to restrict some of your 
activities (Y/N). 
 
Static balance 
performance  
BTrackS Balance 
System (BBS)43, 44 
See description in 6.3 
Hand-grip strength 
test 
A hand-grip 
dynamometer 
(JAMAR 5030J1) 
Hand-grip strength will be 
measured in kilograms (kg) as 
maximal isometric force 
achieved on a hand-grip 
dynamometer (ICC3,1 = 0.959, 
SEM = 3.1 kg).  
 
Dynamic balance 
Sit to stand test 69, 70 
A sit to stand test has been 
widely used to assess balance 
and predict falls, and was 
reliable and validated in 
community-dwelling OAs.69, 70  
Body composition 
Bioelectrical 
impedance analysis 
(BIA): InBody S10. 
See description in 6.3 
Physical activity 
ActiGraph GT9X Link 
wireless activity 
monitors (ActiGraph 
LLC.) 71 
See description in 6.3 

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Physical activity 
Rapid 
Assessment of 
Physical 
Activity 
(RAPA) 
9-items related to how physically 
active in aerobic activity level 
and anaerobic activity level in 
the last f weeks (Y/N). 
Acceptability of 
technology  
-Evaluation form  
 
-Short Version of 
Senior Technology 
Acceptance 
-OAs evaluation of the devices 
and procedures. 
-14-items of 4 components, 
including attitudinal beliefs, 
control beliefs, gerotechnology 
anxiety and health conditions 
(rating from 1-10). 
Balance performance will be assessed by the BTrackS 
Balance System (BBS).43, 44 BBS includes the portable 
BTrackS Balance Plate (BBP), and BTrackS Assess 
Balance Software running on a computer device (Fig 3). 
The BBP dimensions are 15.5" x 23.5" x 2.5", weight 
14.5 lbs., and operated on Windows 7 or higher via a 
USB port. The BBS is manufactured (by the Balance Tracking Systems, Inc.) in 
California in an FDA Qualified Facility that has achieved ISO 13485 Compliance. 
The FDA Registration is under Part 890 – Physical Medical Devices and is 
further categorized within 890.1575 as a Force-Measuring Platform. The FDA 
Registration number is 3010668481, and the CFDB License Number is 73881.  
During the test, a piece of sturdy furniture or a standard walker will be placed 
within the participant’s reach to reduce the risk that FOF will contaminate 
performance and enable even frail people to participate.72 In comparison to the 
age group, the software utilizes the BBS Normative Database to compare the 
individual to others in their age group. BBS score is dependent on age and sex 
but not body size so that the percentile rankings can be determined across 
various age groups, and for men and women separately.73 A scale from 0 to 100 
represents the percentile ranking of the BBS.  Score 0-30 indicates low fall risk 
(normal balance) and ≥ 31 moderate-high fall risk (poor balance).73 BBS has 
excellent validity using Pearson correlations (r>.90) and high test-retest reliability 
[intraclass correlation coefficients (ICC)=0.83].45   
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 (Please see 
Appendix F for static balance performance test (BTracks Balance System).  
Fig. 3 BTrackS Balance 

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Body composition will be assessed using a bioelectrical impedance 
analysis (BIA): InBody S10. The BIA is a widely used commercial 
device that is FDA approved.  The BIA is manufactured by 
the Biospace Corporation Limited, Naple, FL. The BIA InBody S10 
uses 30 impedance measurements, 6 frequencies at each of the 5 
segments (Right Arm, Left Arm, Trunk, Right Leg, Left Leg). The BIA 
InBody S10 specification: Frequencies: 1, 5, 50, 250, 500, 1000 kHz, 
Weight Range 22-551 lbs, Age Range 3-99 years, Height Range 3 ft 
1.4 in-7 ft 2.6 inch, Equipment Weight 4.4 lbs, and 
Dimensions 12.7 x 8 x 46.5 (L x W x H ) inches with stand 
and Dimensions 8 x 2.1 x 12.7 ( L x W x H ) inches without stand. 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.  Reliability of the 
test-retest of the BIA was high with an ICC of 0.89.74  
 
 
Physical Activity (PA) will be measured by activity 
monitoring devices. All OAs will wear the ActiGraph GT9X 
Link wireless activity monitor (ActiGraph LLC.), a tri-axial 
accelerometer, on the non-dominant wrist for 7 consecutive 
days. The GT9X Link has a sample rate of 30-100 Hz, a 
dynamic range of ±8G, 14 days battery life (rechargeable), 
180 days/4 GB data storage, and is water-resistant. Data are 
collected in 1-minute intervals. A sensor determines whether 
the device is on or off the wrist. The GT9X Link provides 
objective 24-hour physical activity measures, including steps, energy 
expenditure, intensity, and participant’s position. Accelerometry is a reliable 
method of assessing free-living physical activity (ICC=0.98)75 and has been 
validated against direct observation, energy expenditure, and sedentary 
behavior.76, 77 ActiGraph accelerometers have been used for data collection in 
the National Health and Nutrition Examination (NHANE) surveys and are the 
most commonly used device in research studies.71 The device display screen 
can be disabled, so the device does not display the participant’s activity (it will 
show date and time only).  
 
6.3 
We will follow the UCF COVID-19 Human Subject Research (HSR) Standard 
Safety Plan below: 
 
 
6.4 Screening, consent, and experimental procedures 
 
Screening, consent for participants in Kinneret Sr Apartments 
Fig. 4 BIA InBody S10 
Fig. 5  ActiGraph GT9X 

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Staff from this site will introduce the researchers to older adults in Kinneret 
Sr Apartments for performing recruitment. Our team will meet with 
participants at a meeting room in Kinneret Sr Apartments. We will screen 
participants by asking their age and language (English or Spanish). We 
will also ask if they have a medical condition precluding balance test 
and/or physical activity (e.g., shortness of breath, unable to stand on the 
balance plate) or currently receiving treatment from a rehabilitation facility 
or have a metal implant. Finally, we will assess their cognition using the 
Memory Impairment Screen (MIS) test. It will take about 3-5 mins (total) 
per person.  
We will complete the informed consent in a private and quiet place in 
Kinneret Sr. apartments for participants who meet the inclusion criteria. If 
the participant needs time to discuss taking part in this research study with 
family members, friends, and other care providers, we will reschedule a 
visit for completing surveys and tests.   
If he/she indicates that she/he is ready and wants to participate in this research 
study, she/he will be asked to complete the questionnaires such as socio-
demographics and fear of falling.  
Procedure for contacting participants for timepoint 2:  
Screening, consent for the general population (outside Kinneret)  
 
Our team will meet with each participant (by appointment) in a private and quiet 
place at the UCF College of Nursing. Participants will complete a simple COVID-
19 self-checker questionnaire before coming to the UCF campus. We will screen 
participants by asking their age and language (English or Spanish). We will also 
ask if they have a medical condition precluding balance test and/or physical 
activity (e.g., shortness of breath, unable to stand on the balance plate) or 
currently receiving treatment from a rehabilitation facility, or having a metal 
implant. Finally, we will assess their cognition using the Memory Impairment 
Screen (MIS) test. It will take about 3-5 mins (total) per person.  
 
We will complete the informed consent in the participants who meet the inclusion 
criteria. If the participant needs time to discuss taking part in this research study 
with family members, friends, and other care providers, we will reschedule a visit 
for completing surveys and tests.   
If he/she indicates that she/he is ready and wants to participate in this research 
study, she/he will be asked to complete the questionnaires such as socio-
demographics and fear of falling.  
Procedure for contacting participants for timepoint 2:  
Experimental procedures for both groups 
We will assess the static balance performance using the BBS. Participants will 
take off their shoes and stand as still as possible on the balance plate with hands 
on their hips and eyes closed for 2-3 minutes. Participants will then complete the 

Page 14 of 31 
 
 
 
 
dynamic balance performance test using the sit to stand by full standing up from 
a chair as many as possible within 30 seconds.  
Participants will be stratified by the FRA matrix.17 We will continually 
evaluate across four groups (rational/ incongruent/ irrational/ congruent) to 
maintain equal cell distribution (30 OAs/group)*. 
 
1) rational FRA: low FOF [Short Fall Efficacy Scale International (short FES-I) 
score ≤10] and aligned with normal balance (BBS score =0-30). 
2) incongruent FRA: low FOF (short FES-1 score ≤10) despite poor balance 
(BBS score= 31-100). 
3) irrational FRA: high FOF (short FES-I score >10) whereas normal balance 
(BBS score= 0-30). 
4) congruent FRA: high FOF(short FES-I score >10) and poor balance (BBS 
score= 31-100).17  
 
*Please note: This is not an intervention study and subjects will not be assigned 
to the study group. 
 
They will perform the hand-grip strength and sit to stand tests. Hand-grip strength 
will be measured in kilograms (kg) as maximal isometric force achieved on a 
hand-grip dynamometer. This test will be administered with participants sitting in 
a chair with feet flat on the floor and the elbow bent at 90°. The dynamometer will 
be placed in the hand and adjusted so the palm side of the grip will be at the 
palm, and the front end will be lined up between the joints of the medial and 
distal phalanges. The grip size will be adjusted so that the second metacarpals 
were flat with a 90° bend at the knuckles. Participants will be asked to squeeze 
the strength gauge as hard as possible for 3–5 seconds. Three trials on each 
hand will be performed with 30-s of rest given between trials. Participants will 
complete the sit to stand by full standing up from a chair as many as possible 
within 30 seconds.78 
Body composition will be tested, and all participants will be asked to empty their 
bladder, remove socks, shoes, and metal objects (e.g., watches, jewelry) before 
testing. The participants will be instructed to avoid exercise 6-12 hrs, eating 3-4 
hrs, and drinking alcohol/coffee 24 hrs before the body composition test. We will 
obtain weight from a scale. Participants will be asked to stand for 10-15 mins 
before testing in a standing position or sit for 10-15 min for a seated position or 
lie down for 15 mins before testing in a supine position. The RA will present a 
photo of wipe hands and feet using an InBody tissue (optional).   

Page 15 of 31 
 
 
 
 
 
The RA will also present photos of how to place the touch-type electrodes                   
(labeled LT or RT) at the left and right ankles, middle fingers, and thumbs. 
 
 
The participants will then place the touch-type electrodes to their left and right 
ankles, middle fingers, and thumbs. They will hold this position for one minute as 
the Bioelectrical Impedance Analysis (BIA) device; a minute electrical current will 
be conducted through the body to determine body composition.  The participants 
will then remove the touch-type electrodes from their left and right ankles, middle 
fingers, and thumbs. The BIA machine is a widely used commercial device that 
is FDA approved. There are no risks or discomforts associated with the use of 
bioelectrical impedance analysis.  
 
Participants will then be instructed to wear the ActiGraph GT9X Link wireless 
activity monitor on the non-dominant wrist for 7 consecutive days. Participants 
can remove the monitor only for imaging studies. Each participant will be asked 
to continue their normal activities while wearing the device. Written instructions 
will be provided to participants for the use of ActiGraph. The questionnaires and 
instructions will be provided in English or Spanish by bilingual research 
assistants (RAs) who will be trained and randomly monitored to ensure quality 
and consistency in administering questionnaires and tests. Participants will be 

Page 16 of 31 
 
 
 
 
provided a phone number for the study team if they have questions about using 
the activity monitoring device. 
 
Lastly, participants will be asked (using our evaluation form) about their reactions 
to the questions and technology (i.e., what they thought about the questionnaires 
and technology) and let them describe any concerns or problems in wearing the 
device (e.g., uncomfortable to wear during walking). We will provide feedback on 
the BBS and BIA test results, and participants will receive $30 Walmart gift card 
upon completion of the study. 
After 7 days of wearing ActiGraph, the participants will return the monitoring 
device via mail (we will provide pre-paid mailers) or schedule a date/time for 
picking it up. Participants will leave the device in front of their place.  
• Please see Appendix A for a demographic survey 
• Please see Appendix B for the Memory Impairment 
Screen (MIS)  
• Please see Appendix C for Patient Health 
Questionnaire-9 (PHQ-9 
• Please see Appendix D for the Geriatric Anxiety 
Inventory-Short form (GAI-SF) and Day-to-Day 
Experiences with the trait Mindful Attention 
Awareness Scale (MAAS). 
• Please see Appendix E for Short Fall Efficacy Scale 
International (short FES-I) and behavioral changes 
related to fear of falling  
• Please see Appendix F for hand-grip strength test and 
static balance performance test  
• Please see Appendix G for dynamic balance 
performance test (Sit to stand) and  
• Please see Appendix H for Bioelectrical Impedance 
Analysis (BIA)  
• Please see Appendix I for ActiGraph GT9X Link 
wireless activity monitors and the Rapid Assessment 
of Physical Activity (RAPA) 
• Please see Appendix J for Evaluation form of 
acceptability of technology and procedures and the 
short version of Senior Technology Acceptance 
6.5 
NA, No plan for long-term follow-up in this study. 
 
6.6 NA  
 
7.0 
Data and Specimen Banking* 

Page 17 of 31 
 
 
 
 
NA 
 
8.0 
Sharing of Results with Subjects* 
8.1 
 
There are no plans to share the results for this study directly with 
the participants because the results have no direct benefits to the 
participants. The results of this study will be published in journals 
and provided to participants upon their request. 
9.0 
Study Timelines* 
 
Participants will need about 105-158 minutes (total) to obtain consent and 
complete the questionnaires (e.g., socio-demographic, FOF, PHQ-9, fall risk, 
frailty, social network), the static and dynamic balance performance tests, body 
composition testing, learn how to wear the ActiGraph GT9X Link wireless activity 
monitor, and to complete the evaluation form of acceptability of technology and 
procedures. 
 
 
Table 2. Timeline of activities and tasks to be accomplished during the proposed 
2-year grant period  
 
 
10.0 Inclusion and Exclusion Criteria* 
10.1 
We will screen individuals who will be eligible to participate based on the  
inclusion and exclusion criteria listed 
 
10.2  
Participants will be enrolled if they meet all of the following inclusion criteria: 1) ≥ 
60 years of age; 2) no marked cognitive impairment [Memory Impairment Screen 
(MIS) score ≥5], 3) speak English or Spanish, and 4) live in Kinneret Sr. 
Apartments.  

Page 18 of 31 
 
 
 
 
 
Exclusion criteria:1) 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); or 2) currently receiving treatment from a rehabilitation 
facility, or 3) have a metal implant. 
 
10.3 
We will exclude all the special populations:  
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, 
teenagers) 
• 
Pregnant women  
• 
Prisoners 
 
11.0 Vulnerable Populations* 
NA (This study will not include any vulnerable populations such as 
cognitively impaired adults, children, pregnant woman or prisoners) 
 
12.0 Local Number of Subjects 
12.1 
 
About 120 participants for timepoint 1, 60 participants for timepoint 
2. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how  
Approximately 150-200 older adults in Central Florida and Kinneret Sr 
Apartments will be screened to enroll 120 older adults in this study.  
For the Kinneret Sr Apartments, staff from this site will introduce the 
researchers to older adults for performing recruitment. Our team 
will meet with participants in a common room or a meeting room in 
Kinneret Sr Apartments for screening participants. 
In the general population, we will recruit them via social media, flyers, and 
word of mouth. 
The research team will follow the UCF COVID-19 Human Subject 
Research Standard Safety Plan and maintain a log that tracks 
screening, eligibility, contact, and recruitment. 
Approximately 60 adults of the 120 adults who participated at 
timepoint 1 will be contacted for enrollment for timepoint 2. We will 
contact participants who elected to be contacted for future studies 
in their original consent form.  
13.2 Source to subjects 

Page 19 of 31 
 
 
 
 
-Kinneret Sr Apartments, Orlando, FL (Please see Table in Section 
24 for the source of subjects). 
-General population who are living in Central Florida 
 
13.3 Methods that will be used to identify potential subjects 
In recruitment at the Kinneret Sr Apartments, authorized representatives 
will coordinate and support us as we participate and recruit within this site. 
They will introduce our team to their staff and older adults for performing 
the initial screening and determining study eligibility. Dr. Thiamwong (PI) 
has created continuing relationships with staff in this site in our previous 
study.  
In the general population, we will recruit them via social media, flyers, and 
word of mouth. Potential subjects who want to participate in this study will 
contact us via email or phone.  
13.4 Describe materials that will be used to recruit subjects 
We will post an advertisement for participants screening in the form 
of a flyer on the public boards (in dining rooms, entrances, 
elevators) and social media. See the printed advertisement.  
 
13.5 
All 120 participants are estimated to complete the study, and they will be 
enrolled in this study for 9 days with two visits. The participants will 
receive $30 Walmart gift card after they are done with the second visit. If 
participants withdraw from the study, they will not receive them. All 60 
participants are estimated to complete the second timepoint assessment, 
and they will be enrolled in this study for 9 days with two visits. The 
participants will receive $30 Walmart gift card after they are done with the 
second visit. If participants withdraw from the study, they will not receive 
them.  
 
 
14.0 Withdrawal of Subjects* 
Participation is entirely voluntary. The participants can withdraw from the 
study at any time without consequences of any kind. However, responses 
of participants that were submitted, and the data recorded will not be 
excluded from the analysis. The primary investigator also reserves the 
right to withdraw participants at any time without their approval. 
 
15.0 Risks to Subjects*  
15.1 
 

Page 20 of 31 
 
 
 
 
The risks to participants are minimal and do not exceed the risks 
associated with activities found in daily life. Minimal risk of fatigue 
may occur related to the balance performance test, sit to stand test, 
bioelectrical impedance analysis test, and wearing an activity 
monitoring device. They will be encouraged to stop the test and rest 
in the area, which will be provided in the test area. In addition, the 
participant needs to answer the Patient Health Questionnaire-9 
(PHQ-9), a 9-item survey, which includes questions about 
depressive symptoms. If they have a higher score (A score ≥ 10 
points), which is suggestive of depression, the researcher will 
advise and recommend them to seek a comprehensive assessment 
with their doctor. The cost for any treatment will be billed to the 
participant or their medical or hospital insurance. 
15.2 NA 
15.3 NA 
15.4 NA 
16.0 Potential Benefits to Subjects* 
16.1 
 
There is no direct benefit to the participants in this study  
16.2 
NA 
 
17.0 Data Management* and Confidentiality 
17.1  
Data Analysis. All analyses will be performed in SPSS version 25 or SAS 
version 9.4 with sufficient annotation for reproducibility. Descriptive and 
exploratory analyses will be performed first to investigate distributional 
assumptions. Although no differences are hypothesized, descriptive subgroup 
analyses by sex will be conducted. 
Aim 1. Examine the feasibility of recruitment, especially during the COVID-
19 pandemic and acceptability of technologies and procedures for use 
among OAs in low-income settings. We will assess the ability to recruit the 
sample by calculating the proportions of low-income OAs: (a) recruited out of the 
total screened, and (b) who completed all study procedures. We will track the 
number of days and time spent to recruit the sample. The results will inform 
planning for future larger studies. The acceptability of the technologies and 
procedures will be examined based on an evaluation form (e.g., what they 
thought about the questionnaires and technology) and their recommendations. 
We will identify code, categorize participants’ responses, and determine the 
frequency for each category. Demographic data, including essential 
characteristics of OAs will be obtained for study participants. We anticipate no 

Page 21 of 31 
 
 
 
 
more than 3% missing values on any one item, as data will be collected in person 
on-site.  
Aim 2. Examine the associations among fall risk appraisal, body 
composition, and physical activity.  
Aim 2 hypotheses are: 1) Rational FRA is associated with higher levels of PA 
and skeletal muscle mass, and lower levels of percent of body fat and BMI, 2) 
Incongruent FRA is associated with higher levels of PA and skeletal muscle 
mass, and lower levels of percent of body fat and BMI, 3) Irrational and 
congruent FRAs are associated with lower levels of PA and skeletal muscle 
mass, and higher levels of percent of body fat and BMI. General summary 
statistics will be presented for continuous data, and percentages will be 
presented for categorical data. Participant demographic data will be summarized. 
Analyses will be performed without adjusting for any covariates, followed by the 
analyses adjusted for age, comorbidities, depressive symptoms, and fall history. 
Age, the number of comorbidities and the number of falls in the past year will be 
selected as covariates in the selected model because of their association with 
FRA, body composition, and PA. Data from InBodys770 (e.g., BMI) and 
ActiGraph (e.g., steps/day) could be modeled as continuous. 
Regression models or one-way ANOVA will be used to examine differences in 
continuous variables (e.g., BMI, steps/day) across the four groups (rational, 
incongruent, irrational, and congruent FRAs), and categorical variables (e.g., 
comorbidities) will be tested using Chi-Squared tests. Rational FRA group will set 
as a base group, and the other three groups (incongruent, irrational, and 
congruent FRAs) will be compared with this base group. Whenever feasible, 
models will be adjusted for age, sex, day order, wear time (minutes/day), and the 
number of fall history. These following variables will add one by one to evaluate 
the role of each: mobility problems (Y/N), depression (score or category), fall risk 
(high/low), perceived general health (score of category), medication use (Y/N), 
and comorbidities (Y/N). A final model will include all significant potential 
variables to evaluate whether associations between FRA, body composition and 
PA, whenever feasible.  
Specific Aim 2 Sample Size and Power Analysis. There is no historical precedent 
and limited information to inform the sample size for this study; therefore, the 
sample size estimate was based on the variable of the BBS score in our pilot 
study. The standard deviations of the mean BBS scores in our pilot study were 
7.91 in the high PA group and 7.78 in the low PA group (PA by self-report), 
assuming a two-tail alpha 0.05 and a power 0.8, the estimated total sample size 
N=120 would allow to sufficiently detect a mean difference about 5 between the 
two groups. Furthermore, to be able to compare the effect sizes of the different 
body composition and PA measures, we will perform post-hoc analyses to 
compare the mean values between the two groups of PA, adjusted for the age 
group.  
Aim 3. Determine the dynamic relationships between fall risk appraisal, 
body composition, physical activity and behavioral changes related to fear 
of falling  

Page 22 of 31 
 
 
 
 
 
We hypothesize that higher percentage body fat, and lower frequency and 
duration of physical activity are associated with fall risk appraisal and the 
associations vary between four groups. We will collect data at the 2nd timepoint 
and then a dynamic prediction model will be used to investigate their temporal, 
dynamic associations.  
17.2 
We will maintain a master list that will contain identifiable data and links 
the subject ID codes with the participant’s information. The electronic 
version of this master list will be encrypted, password protected, and 
stored on a computer and is located in a restricted access room at the 
College of Nursing. The master list is the only document with identifiable 
data.  
All research data, including identifiers and linking sheets, will be retained 
for at least 5 years after the study closure.   
The de-identified data (such as balance performance test data will be 
password protected, encrypted, and stored on computers and external 
hard drives in the restricted access laboratory). The de-identified data will 
be kept indefinitely. The reason for keeping the de-identified data 
indefinitely is for scientific reproducibility and transparency. 
17.3 NA 
17.4 
Efforts will be made to limit the use and disclosure of participants’ 
personal information, including research study to people who have a need 
to review this information. We cannot promise complete secrecy.  
Organizations that may inspect and copy our information include the IRB 
and other representatives of this organization. Research records will be 
kept in a locked file in the PI’s locked office; only the researchers will have 
access to the records. The researchers will maintain a computer 
encrypted, a password-protected master list that will contain identifiable 
data that links the subject ID codes with their information.   
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Subjects*  
 
This research involves minimal risk to the participants. 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 
 
Only the participant and researcher will be present during the 
interview and the tests. 
19.2 
 

Page 23 of 31 
 
 
 
 
To help participants feel comfortable, the researcher will provide small talk 
before beginning the surveys and tests.  
19.3  
The research team is only permitted to access the collected data on 
a needed basis. 
20.0 Compensation for Research-Related Injury 
20.1 
NA. This research involves minimal risk to the 
participants. If needed, the researchers can help facilitate 
seeking medical care, such as calling for medical help or 
transporting them to the nearest medical facility. The cost for 
any treatments will be billed to the participant or his/her 
medical or hospital insurance. 
20.2    NA 
 
21.0 Economic Burden to Subjects 
21.1 
There is no cost to the participants.   
22.0 Consent Process 
22.1 
We will obtain IRB approval at the University of Central Florida. The PI or trained 
research assistants (RAs) will obtain consent from the subjects within the 
designed enrollment period.  
Potential subjects will be contacted via phone to schedule the first visit for 
obtaining consent and completing surveys and tests.   
 
For the residents in Kinneret Sr. apartments, the consent process will take place 
at a private or quiet room in Kinneret Sr. apartments. For the general population, 
the consent process will take place at a private room at the UCF, College of 
Nursing. If participants have a primary language is Spanish and cannot speak 
English, our research assistant, who fluent in both Spanish and English, will 
perform the consent using the Spanish language. The bilingual research 
assistant will explain the details in such a way that the participant understands 
what it would be like to take part in the research study and answer all questions.  
 
The PI or RA will explain all aspects of the approved IRB consent form, including 
all required information (purpose, number of subjects, procedures, time 
requirements, potential risks, and benefits, measures to protect confidentiality) 
with subjects before obtaining consent. The subjects will be informed that 
participation in this study is voluntary. They are free to decline to be in the study 
or to withdraw from this study at any point without any negative consequence.  

Page 24 of 31 
 
 
 
 
At the time potential subjects provide consent, they will be asked, for follow-up 
purposes, to provide their name, address, phone number, and email address 
along with the phone number and email addresses of their significant person or 
family member. Contact information will be kept separate from study records and 
will not be a permanent part of the study records.  
Potential subjects will be told that they will participate in this study for 
approximately 9 days. They will participate in a screening, balance test, body 
composition test, and then wear activity-monitoring devices for 7 days.  
Study subjects will be informed that study records will be kept as confidential as 
possible. No individual identifies will be used on any reports or publications 
resulting from this study. Study information will be coded and kept in locked files 
at all times. Only study personnel will have access to the files.  
The subject will read the informed consent form and will be able to hear a 
detailed description of the study and then will be given the informed consent 
document.  
We will give subjects time to discuss taking part in this research study with family 
members, friends, and other care providers or take the written information home 
if they want, and we will reschedule a new visit for completing surveys and tests.  
If the subject indicates that he/she ready and wants to take part in this research 
study, we will perform the surveys and test as described above in the first visit. 
However, if the subject indicates that he/she does not want to take part in the 
research study, the consent process will stop.  
 
23.0 Process to Document Consent in Writing 
23.1 
 
Because this is a minimal risk study using non-significant risk 
devices, we believe that this meets the requirements for a waiver of 
written consent documentation. Our devices (BTracks balance test, 
bioelectrical impedance analysis, and activity monitor devices) are 
not represented to be for use in supporting or sustaining human life 
and not present a potential for serious risk to the health, safety, or 
welfare of our participants.  
 
24.0 Settings 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
Name of site 
Contact name Contact 
phone 
Has the site 
granted 
permission 
for your to 
Does 
the site 
have an 
IRB? 
If the site 
has an IRB, 
select one 

Page 25 of 31 
 
 
 
 
conduct the 
research? 
Kinneret Sr 
Apartments: 515 
Delaney Ave. 
Orlando, FL 32801 
My Dung Do  
407-843-
1695 
 
Yes 
No 
The 
organization 
will rely on 
our IRB. 
25.0 Resources Available 
25.1 
Dr. Ladda Thiamwong (PI) have successfully led 
interdisciplinary teams to develop research studies that 
demonstrate the effectiveness of strategies in different 
contexts related to falls, fear of falling, measurements and 
interventions, and established the feasibility of recruitment, 
retention, and adherence of community-dwelling older adults. 
 
25.2 NA 
 
26.0 Multi-Site Research* 
NA 
 
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