Influence of Cognitive Training on Fall Prevention in At Risk Older Adults
Phase: NA
Conditions: Falls (Accidents) in Old Age
Sponsor: University of Washington

Study Protocol/Statistical Analysis Plan 
Evaluating Technology-Based Fall Prevention Interventions 
NCT03190460 
9/27/2016 

Objectives 
The primary study objective is to explore the effectiveness of a 16-week cognitive 
training (CT) intervention to reduce risk and incidence of fall in community-dwelling older adults 
at risk for fall. Additional objectives of the study are to explore the effectiveness of a CT 
intervention on cognition and functional outcomes and to examine the feasibility and 
acceptability of the study protocol and intervention in this population. 
 
Outcomes 
 
Primary Outcome. At time of allocation, participants will be provided with a Monthly Fall 
Calendar and instructed in its use. At the end of each day participants are asked to place one of 
3 letters in the box for the day: “N” for no fall; “F” for fall; and “I” for fall resulting in an injury), 
considered the “gold-standard” for falls assessment (See Table 1). For purposes of this study, a 
fall was defined as an “unintentional For individuals who experience multiple falls in a single 
day, they are asked to denote the number (ex. “F-2”). Fall calendars will be collected monthly 
(See Table 2), and a new calendar provided to the participant during the study period. The time 
period for primary outcome assessment is falls over the period of 4 months. For any fall 
resulting in injury, we will request permission from the participant to obtain medical records for 
any treatment sought at time of injury.  
 
Secondary Outcomes. Of interest as a secondary outcome in this study is reduction in risk of fall 
at the end of the 16-week intervention (See Tables 1 and 2). This is defined by 1) an increase in 
the 10M walking speed from baselineor 2) an increase in the Balance test score from baseline.40 
As secondary endpoints, we will measure cognitive outcomes (using the Cambridge 
Neurological Assessment Battery [CANTAB]), additional gait and postural sway measures 
(using body-worn inertial sensor system, the APDM Mobility Lab, Portland, OR; See Tables 1 
and 2), and disability (Gill Disability Scale). We will explore if there is retention of benefit of the 
intervention on fall risk, gait, balance and cognitive outcomes one month following end of the 
intervention. Feasibility and acceptability of the study protocol and CT intervention will also be 
evaluated.   
 
Table 1. Summary of Outcome Measures and Source of Measurement 
Measure 
Source (Instrument/Test[s]) 
PRIMARY OUTCOME 
Falls and Injurious Falls 
Self-Report (Prospective Fall Calendar) 
SECONDARY OUTCOMES 
Fall Risk 
10M Walk Test 
90 Second Balance Test 
Cognition  
Speed of Processing & Response Time  
Attention 
Working Memory  
Task Shifting  
Planning and Decision Making  
CANTAB  
Simple Response Time 
Rapid Visual Information Processing 
Verbal Recognition Memory 
Spatial Working Memory 
Intra-Extra Dimensional Set Shift 

Cambridge Gambling Task 
One Touch Stockings of Cambridge 
Stop Signal Test    
Quantitative Gait and Turning Measures 
Gait speed (m/s) 
cadence (steps/min)  
stride length (m)  
turn duration (s) 
turn peak velocity (m/s) 
APDM Inertial Sensors  
Walking trials under testing conditions of: 
Usual Pace 4-Meter walking laps x 4 
Usual Pace 7-Meter walking laps x 2 (if space allows) 
Fast Pace 4 or 7-Meter walking laps x 2 (space dependent) 
 
Postural Balance Measures: 
(medial heel-to-medial heel distance = 10 cm) 
ISway JERK (m2/s5) 
ISway PATH  (m2/s2) 
ISway Mean velocity (MV; m/s) 
   ISway Root mean squared (RMS; m/s2) 
APDM Inertial Sensors (ISway):  
(Inertial sensor at 5th lumbar level) 
Static Standing 30-second trials under six conditions:  
normal base-firm, eye open and eyes closed;  narrow base-
firm, eye open and eyes closed; normal base, foam surface, 
eye open and eyes closed 
Disability 
Gill Disability Scale 
 
Study Design 
 
 
The design is a two-group randomized controlled trial following a 1-week run-in procedure 
comparing 16-weeks of a web-based CT intervention to attention control (See Table 2). 
 
Baseline Visit (-T1) 
 
If eligible for inclusion after the in-person screening, the research staff member discusses 
the project in detail with the individual to ascertain interest in further participation and to allow for 
provision of informed consent.  Following informed consent, the baseline visit commences. At this 
visit, participants are asked about a) demographics (age, gender, race/ethnicity, formal education, 
income level, insurance status); b) pre-existing conditions (Charlson method); c) current 
medications (brown bag method). Questionnaires are administered to participants at baseline to 
assess: 1) social support (MOS Social Support Survey) and 2) functional status (Gill Disability 
Scale). Participants undergo an assessment of cognitive abilities using the Cambridge 
 
Table 2. Study Protocol (*denotes data are collected, but is secondary outcome) 
 
Study period 
 
 
Enrollment 
Allocation 
Post-
allocation 
 
 
 
Exit 
Time point 
-T2 
 
-T1 
T0 
T1 (4 wks) 
T2 (8 wks) 
T3 (12 
wks) 
T4 (16 
wks) 
T5 (20 
wks) 

Eligibility 
screening 
Phone screening 
 
In-person 
screening 
  10M walk 
  90 sec balance 
 
Informed consent 
 
 
X 
 
 
 
   
 
 
 
X 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Run-In Period 
  Vision screen 
 Medication      
review 
 Home safety 
check 
 
 
X 
    X  
 
         X 
 
 
 
 
 
 
Allocation 
 
 
X 
 
 
 
 
 
Intervention 
   Active     
Control 
 
Web-based  
Cognitive 
Training 
 
 
 
 
XXXXXXX 
 
 
XXXXXXX 
 
XXXXXXX 
 
 
XXXXXXX 
 
XXXXXXX 
 
 
XXXXXXX 
 
XXXXXXX 
 
 
XXXXXXX 
 
Assessments 
 
Baseline  
Demographics  
    Pre-existing    
conditions  
Medications  
Social Support 
 
Outcome 
Variables 
Primary  
Falls/Injurious 
Falls  
 
Secondary  
Fall Risk 
 10M walk 
  90 sec balance 
Cognition  
  CANTAB 
Gait/Turning 
  APDM 
Postural Sway 
 APDM  
Disability 
 Gill Disability 
 
Other Variables 
Short Physical 
Performance 
Battery 
 
Timed Up and Go 
 
Exit Interview 
 
 
 
 
X 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
   
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
* 
 
 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
 
X 
 
 
 
X 
X 
 
Neuropsychological Test Automated Battery (CANTAB) to provide an external method of 
assessment to that provided by the CT intervention (See Table 1 for specific tests).  Lastly, in-
home gait and mobility measures are assessed.  Gait, mobility and postural sway data are 

collected using a body-worn inertial sensor system, the APDM Mobility Lab system (APDM 
Wearable Technologies, Portland, OR). Use of the APDM system involves "instrumenting" the 
participant with 6 body worn inertial sensors (2 ankle, 2 wrist, 1 waist belt, 1 upper torso) that 
contain tri-axial accelerometers, gyroscopes, and magnetometers. Participants are asked to 
wear walking shoes during the assessments. A gait belt and guarding technique61 is used by a 
trained investigator during all testing for safety. Data are recorded via wireless transmission 
from the inertial sensors to a laptop computer and processed with Mobility Lab software.  For 
the instrumented walking assessment, participants are first asked to walk continuous laps with 
approximately 180-degree turns, at their comfortable (or usual) pace. They complete four 4-
meter laps and two 7-meter laps (if space allows) at usual pace.  Lastly, participants are asked 
to walk as quickly as possible, but not so quickly that they lose their balance (2 x 4 or 7-meters; 
see Table 1 for measures). Participants are able to take rest breaks between activities as 
needed. 
 
For the postural sway assessment, data are collected with APDM ISway during 6 static 
standing trials: (1) eyes open/normal base/firm surface (medial heel-to-medial heel distance = 
10 cm), (2) eyes open/narrow base/firm surface (feet together) (3) eyes closed/normal base/firm 
surface, and (4) eyes closed/narrow base/firm surface, (5) eyes open/usual base/foam surface, 
(6) eyes closed/usual base/foam surface. Participants wear walking shoes and are asked to 
stand still and keep their arms at their sides during testing. During the eyes open standing 
conditions, participants are instructed to focus on an “x” placed at eye-level on the wall in front 
of them. Participants do not use an assistive device, but wear a gait belt and are closely 
guarded and assisted as needed into the starting position. Measures utilized to assess postural 
sway are detailed in Table 1. In addition to the gait and balance measures, we collected data to 
obtain instrumented assessment of mobility: a) the Short Physical Performance Battery (SPPB) 
and b) the Timed Up and Go (TUG). The SPPB includes tests of static balance, gait speed, and 
sit to stand. For the sit to stand trial, participants are instructed to move from a seated position 
to a standing position five times as quickly, but as safely as possible. Participants undertake two 
trials, with the fastest of the two trials used as the measure. 
 
Run-in and Allocation (T0) 
During the 1-week run-in period, a trained member of the research team meets with the 
study subject three times over the course of a week (approximately 20 minutes per visit) to 
perform: 1) vision screen; 2) medication review and 3) home fall safety check. This run-in period 
allows the study staff to provide hazard reduction interventions per CDC recommendations prior 
to randomization to reduce the risk of these issues introducing bias across groups.  
 
Following successful completion of the run-in period, participants are randomly allocated 
(1:2) to either a group that is the attention control (n=20) or to the group that receives cognitive 
training (CT) intervention for a total of 16 weeks (n=40). Participants are not to be informed that 
they were assigned to "attention control" or "cognitive training" conditions; rather, individuals in 
both groups are told that the aim of the study is to determine whether participation in "computer 
learning activities" reduces the risk of falls and improves functional ability. Sealed envelopes, 
prepared in advance, assign the participants to one of the two groups. The randomization 
schedule is prepared by the consulting statistician using block randomization (blocks of 6) prior 
to the research team’s initial visit to interested parties. This approach ensures that consent is 
obtained prior to disclosure of group assignment and persons consent to participate in the 
study, regardless of the group they are assigned to. The envelope is not opened until 
completion of the run-in procedure. The principal investigator, co-investigators and outcome 
assessors are blinded to allocation until the end of the trial.  
 

Intervention 
Cognitive training, also known as "brain training", involves scheduled completion of 
specific tests of executive function, visuospatial orientation and perceptual speed.  The CT is 
completed using a web-based computer interface (Cognifit, Inc.), with task difficulty tailored to 
the participant's abilities.  We will use the Cognifit research interface as it allows tailoring of the 
intervention to specific tasks selected by the research team.  
The individual completes a 14-task baseline testing session, after which the program 
identifies individualized, tailored training goals for the intervention tasks. Individualized feedback 
is provided to the user regarding progress towards goals during each session. Our intervention 
includes 48 training sessions over 16 weeks (recommended 3 sessions per week; each session 
lasts approximately 20 minutes and covers 3 different cognitive tasks tailored to individual 
baseline ability and progress to date).  Training sessions can be completed on either PC or Mac 
platform and use a user identified login/password allowing secure access at the individual's 
home or a community setting per user accessibility and preference. The training allows the user 
to pick up from the last session to promote completion of the intervention. Because of their 
linkage to fall and injury prevention, we selected the following specific cognitive tasks to target in 
the intervention:  
 Reaction Time (the ability to perceive and process a stimulus and respond) 
 Processing Speed (the ability to fluently perform easy/over-learned tasks) 
 Awareness (the ability to evaluate one’s own cognitive functioning, realization, perception 
or knowledge) 
 Divided Attention (the ability to execute more than one task at a time) 
 Inhibition (the ability to ignore irrelevant information while performing a task) 
 Planning (the ability to anticipate and develop the best way to execute a task) 
 Shifting (the ability to redirect attention from one channel of information to another) 
 Updating (the ability to respond in a flexible and adaptive manner to keep up with 
environmental changes) 
We track sessions completed on a weekly basis and provide reminders as needed. 
Discontinuation of intervention is made on participant request.  
Attention Control 
 
 
Participants assigned to the attention control condition are provided with programmatic 
activities that are designed to control for nonspecific treatment effects (computer use, interaction 
with study staff). Participants will engage in an equal number of sessions (3 sessions/week for 
16 weeks) watching preselected healthy aging-related video content on the computer (e.g. 
NIHSenior Health videos on talking with your provider, taking medications safely, and making 
the most of a medical visit, how to exercise safely).Participants will be asked to briefly note any 
information gained from each video on a personal discussion board provided to them within the 
content module. We track sessions completed on a weekly basis and provide reminders as 
needed. Discontinuation of intervention is made on participant request.  
8-, 16- and 20-week Assessments 
 
 
A member of the research team blinded to intervention/control group assignment 
conducts participant outcome assessments at the 8-, 16- and 20-week time periods (see Table 
2). These assessments occur in same setting and under similar conditions to baseline testing 
(e.g., same shoes are to be worn). Following the 20-week assessment, an exit interview is 

completed in order to gain insight into the protocol’s acceptability including participant 
perceptions of the CT intervention. Participant interviews use a semi-structured interview 
protocol as a guide to explore their experiences, overall perceived benefits, challenges and 
attitudes towards the study protocol. All interview sessions are digitally recorded.  
 
ANALYSIS 
 
All planned statistical analyses will be performed using intention-to-treat. The primary 
time point of interest in this analysis is the 16-week post-randomization outcome assessment; 
however, means, standard deviations and distributions will be used to describe the outcomes of 
interest at baseline, midpoint of active intervention phase and 4 weeks post completion of 
intervention (week 20 post-randomization). A value of p<0.05 will be considered statistically 
significant. Should there be significant differences between groups on baseline demographic 
variables despite randomization, we will examine the relationship between the variable and the 
outcome using sensitivity analyses. 
The primary outcome of interest in the proposed RCT is reduction number of falls and 
injurious falls (See Table 1) at the end of the intervention (16 weeks). We are also interested in 
the retention of effect 1-month post-intervention. Number of falls and injurious falls will be 
determined from fall calendar data. Between group differences will be assessed using Mann 
Whitney U test. Of secondary interest as outcome in this study is reduction in risk of fall which is 
determined by an increase in the 10M walking speed from baseline and an increase in the 
Balance test score from baseline. Between group differences will be assessed using Student’s t-
test. In exploratory analyses, we will examine the change in risk of fall over time using linear 
mixed models for longitudinal data. As secondary endpoints, we will measure cognitive 
outcomes (CANTAB), functional outcomes (walking Gill Disability, inertial sensor gait and turn 
measures, and ISway measures; See Table 1). Outcomes will be compared between groups 
using either t-tests or Mann-Whitney U tests as appropriate. In exploratory analyses, we will 
examine the change in outcome measures over time using linear mixed models for longitudinal 
data. 
To better understand feasibility of the study, we will estimate the proportion of older 
adults found eligible for inclusion who actually agree to participate in such a study. Further, we 
will compare the characteristics of those who are willing to participate with those who are not. 
We will also evaluate numbers of study who complete the study protocol and note any 
differences in participant characteristics in those who drop out. We will also note the numbers of 
older adults who express interest in the study but are not eligible. To evaluate acceptability of 
the study procedures and intervention, transcripts of interview sessions will be digitally recorded 
and transcribed verbatim for descriptive content analysis.