Adapted Lifestyle-integrated Functional Exercise Program for Older Adults in Under Resourced Communities: A Pilot Study
Phase: NA
Conditions: Accidental Fall
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
______________________________________________________________________________________ 
 
1 
 
 
 
 
 
Protocol: Adapted Lifestyle-integrated Functional Exercise Program for Medically 
Underserved Older Adults (LiFE) 
Stark, Susan*, Yi-Ling Hu, Marian Keglovits, Emily Sommerville  
 
*To whom correspondence should be addressed 
 
Washington University School of Medicine 
5232 Oakland Ave,  
St. Louis, MO 63110 
 
 
 
 
 
 
 
Version:  
Last updated, September 18, 2018 
 
 
 
 
Clinical Trial # NCT03704194 
 
Funding for the Gephardt Institute for Civic and Community Engagement at Washington 
University in St. Louis   
 
 
 
 
 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
2 
TABLE OF CONTENTS 
 
A 
INTRODUCTION .......................................................................................................................... 4 
A1 
STUDY ABSTRACT ..................................................................................................................... 4 
A2 
PURPOSE OF THE STUDY PROTOCOL ........................................................................................... 5 
B 
BACKGROUND ............................................................................................................................. 5 
B1 
PRIOR LITERATURE AND STUDIES .............................................................................................. 5 
B2 
RATIONALE FOR THIS STUDY ..................................................................................................... 5 
C 
STUDY OBJECTIVES ................................................................................................................... 6 
C1 
PRIMARY AIM ........................................................................................................................... 6 
C2 
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ......................................................... 6 
D 
INVESTIGATIONAL AGENT ...................................................................................................... 6 
D1 
PRECLINICAL DATA .................................................................................................................. 6 
D2 
DOSE RATIONALE AND RISK/BENEFITS ...................................................................................... 7 
E 
STUDY DESIGN ............................................................................................................................ 8 
E1 
OVERVIEW OF STUDY DESIGN ................................................................................................... 8 
E2 
SUBJECT SELECTION AND WITHDRAWAL ................................................................................... 8 
2.a 
Inclusion Criteria ................................................................................................................. 8 
2.a 
Exclusion Criteria ................................................................................................................ 9 
2.b 
Ethical Considerations ......................................................................................................... 9 
2.c 
Subject Recruitment Plans and Consent Process ................................................................... 9 
2.d 
Randomization Method and Blinding .................................................................................. 10 
2.e 
Risks and Benefits .............................................................................................................. 10 
2.f 
When and How to Withdraw Subjects...................................................................................... 10 
2.g 
Data Collection and Follow-up for Withdrawn Subjects ...................................................... 11 
E3 
STUDY INTERVENTION ............................................................................................................ 11 
3.a 
Treatment: Adapted LiFE ................................................................................................... 11 
3.b 
Control: Go4life ................................................................................................................. 12 
3.c 
Subject Compliance Monitoring ......................................................................................... 12 
3.d 
Blinding ............................................................................................................................. 12 
F 
STUDY PROCEDURES ............................................................................................................... 12 
1.a 
Screening for Eligibility ..................................................................................................... 12 
1.b 
Consent visit and Pre-test ................................................................................................... 13 
1.c 
Intervention Sessions .......................................................................................................... 13 
1.d 
Post-test ............................................................................................................................. 17 
1.e 
One-month phone follow-up ............................................................................................... 17 
1.f 
Safety and Adverse Events ...................................................................................................... 17 
1.g 
Safety and Compliance Monitoring ..................................................................................... 17 
1.h 
Definitions of Adverse Events ............................................................................................. 17 
1.i 
Data Collection Procedures for Adverse Events ...................................................................... 18 
1.j 
Reporting Procedures ............................................................................................................. 18 
1.k 
Adverse Event Reporting Period ......................................................................................... 18 
F2 
STUDY OUTCOME MEASUREMENTS ............................................................................................. 18 
G 
STATISTICAL PLAN .................................................................................................................. 20 
G1 
SAMPLE SIZE DETERMINATION AND POWER ............................................................................. 20 
G2 
ANALYSIS PLAN ...................................................................................................................... 21 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
3 
G3 
STATISTICAL METHODS........................................................................................................... 21 
G4 
MISSING OUTCOME DATA ....................................................................................................... 21 
H 
DATA HANDLING AND RECORD KEEPING ......................................................................... 21 
H1 
CONFIDENTIALITY AND SECURITY ........................................................................................... 21 
H2 
TRAINING ............................................................................................................................... 21 
H3 
RECORDS RETENTION.............................................................................................................. 21 
H4 
PERFORMANCE MONITORING................................................................................................... 21 
I 
STUDY ADMINISTRATION ...................................................................................................... 21 
I1 
ORGANIZATION AND PARTICIPATING CENTER .............................................................................. 21 
I2 
FUNDING SOURCE AND CONFLICTS OF INTEREST .......................................................................... 22 
I3 
SUBJECT INCENTIVES................................................................................................................... 22 
J 
PUBLICATION PLAN................................................................................................................. 22 
K 
ATTACHMENTS ......................................................................................................................... 23 
K1 
TABLES .................................................................................................................................. 23 
L 
REFERENCES ............................................................................................................................. 27 
 
 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
4 
A Introduction 
Falls are an escalating public health issue that drastically interrupt the healthy aging of 
older adults functionally and economically.1-3 Falls remain the leading cause of fatal 
death among older adults.2 Falls also cause an estimation of 2.8 million injuries and 
800,000 hospitalizations annually4. Exercise programs can effectively reduce falls by 
increasing balance and lower extremity muscle strength5, but translation of these 
programs into clinical practice remains sparse6. Older adults, especially those who live in 
medically underserved areas7 with few primary care providers and/or high rates of 
poverty are less likely to benefit from evidence-based exercise programs due to lack of 
exposure and access.8, 9 Lack of translation and delivery of evidence-based interventions 
to medically underserved populations increase health inequities at the individual and 
community levels.10-13   
To fill this gap, we propose to adapt the Lifestyle-integrated Functional Exercise (LiFE) 
program for medically underserved older adults. LiFE has demonstrated high rates of fall 
reduction (31%) and adherence (80%) for community-dwelling older adults in Australia. 
14 This highly effective program uses habit formation strategies to enhance long-term 
behavior changes. Evidence, including our own preliminary data, suggest LiFE could be 
highly effective to reduce falls for medically underserved older adults, who commonly 
face economic hardship and other barriers to accessing health care.15 To address the 
cultural and behavioral differences between medically underserved older adults in the 
US and more affluent older adults in Australia,16-18  we will conduct a feasibility pilot 
study to test the feasibility of a randomized control trial (RCT) in preparation for larger 
trials for medically underserved older adults in the US. 
A1 
Study Abstract 
The purpose of this study is to pilot test the feasibility of a study design for future larger 
trial of Adapted LiFE among medically underserved older adults. We will evaluate if : 1) 
Adapted LiFE is feasible for medically underserved older adults, and 2) the study design 
is feasible with working randomization module and appropriate measurements. 
Feasibility outcome measures include reach, acceptance, adherence, fidelity, safety, and 
appropriate efficacy outcome selection for balance, lower extremity muscle strength, and 
habit formation.  
We will conduct a pilot RCT with an attentional control group. The treatment (Adapted 
LiFE) group (n=8) will receive 7-sessions of culturally Adapted LiFE over 12 weeks, 
while the attentional control group (n=8) will receive the same amount from an 
interventionist with a gentle flexibility program “Go4life”19 developed by the Nation 
Institute on Aging during intervention period.  
We will recruit older adults who: are age 70 or older; self-report falls in the past 12 
months; and reside in a medically underserved area. We will exclude participants who: 
have attention and memory impairment (Short Blessed Test score ≥ 8), are unable to 
stand with assistive devices, are severely depressed (The Geriatric Depression Scale 
≥10), and have serious health conditions for which exercise is contraindicated. Paired t-
tests will be used to test time effects, and independent t-tests will be used to test group 
effects of Adapted LiFE. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
5 
A2 
Purpose of the Study Protocol 
The purpose of this study protocol is to establish a clear and detailed record of the 
objectives, design, methodology, statistical analysis plan to ensure the safety of the trial 
participants and integrity of the data collected. 
B Background 
B1 
Prior Literature and Studies 
Research has evaluated the efficacy of various fall prevention programs, and exercise 
has been shown to be one of the most effective interventions to reduce falls.5, 20 
However, evidence-based exercise programs encounter multiple barriers that lower the 
effectiveness of implementing interventions for medically underserved populations.  
Medically underserved older adults are defined as older adults who live in a medically 
underserved area,7, 15 designated by the US government with indicators of higher poverty 
level and fewer healthcare providers. Medically underserved older adults often belong to, 
but are not limited to, groups that have low income, are Medicaid-eligible, or are facing 
cultural or linguistic barriers to healthcare.21 Medically underserved older adults, who 
already experience more health inequities,22, 23 are underrepresented in clinical trials,24 
and evidence-based interventions are less likely to be designed to meet their needs.25  
It is also unknown whether exercise programs will translate to be effective for medically 
underserved older adults.8 To capture and describe the body of work on how medically 
underserved older adults are engaged in physical activity (PA) participation and whether 
exercise interventions have been specifically designed for this population, we have 
conducted a scoping review to explore and map the nature/extent of research conducted 
for medically underserved older adults 26. A total of 423 articles was identified with the 
search terms, 392 went through title and abstract review, 87 articles went through full 
text review. A final yield of 60 articles were included for data extraction. Twenty-one 
identified studies were intervention studies, only 4 of which specifically targeted 
underserved older adults aged 60 years and above. Three of these 4 studies were 
feasibility studies27-29 indicating that strategies to increase reach, retention, and 
adherence for medically underserved older adults are needed.  
A gap exists in translating research into practice as few evidence-based programs have 
been implemented for low-income, minority populations.30, 31 Challenges in translating 
evidence-based programs for these groups may result from uncontrolled moderating 
factors that hinder the implementation and effectiveness of evidence-based 
interventions.32-34 If health researchers leave these challenges unattended, health 
disparities are predicted to increase within a growing and increasingly diverse US 
population.35 To meet these challenges, we need to reduce implementation barriers 
early on in research design to ensure external validity for diverse populations.30, 31  
B2 
Rationale for this Study 
The Lifestyle-integrated Functional Exercise (LiFE) program has the potential to 
eliminate implementation barriers for medically underserved older adults through its 
design. LiFE is an evidence-based fall prevention program that embeds balance and 
lower extremity strength training activities into daily routines at home.14, 36-38 We have 
targeted LiFE because it has strong face validity for medically underserved older adults39 
and potentially controls for common moderating factors, such as time, resources, and 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
6 
transportation constraints. Compared to structured exercise programs, LiFE provides a 
flexible and easy-to-adopt approach that can motivate medically underserved older 
adults who might otherwise perceive traditional exercise with highly structured routines 
as less appealing.14, 36-38, 40-42 LiFE demonstrated high rates of both adherence and fall 
reduction in previous clinical trials among Australian older adults.  
However, we anticipate differences between our target population and the original LiFE 
participants.43, 44 Differences in socioeconomic status and race/ethnic backgrounds will 
affect acceptance and uptake of the program, thus requiring adaptation of the original 
LiFE program to ensure external validity when generalizing research to a different 
population.9 It is critical to conduct a cultural adaptation process to achieve the goal of 
translating LiFE for medically underserved older adults.  
Before investing large amount of resources and money into the main study, we aim to 
conduct a pilot study to assess the feasibility for a larger study design.45-47 The results of 
the feasibility pilot studies will inform researchers if it is reasonable to proceed with the 
main study.  
C Study Objectives 
C1 
Primary Aim 
The primary aim of this study is to establish feasibility of Adapted LiFE and a RCT 
design.  
WE hypothesis that the feasibility pilot study will have high reach (60% recruitment and 
80% retention rate of targeted participants), acceptance (80% of participants rating high 
satisfaction with Adapted LiFE), adherence (80% of all exercise activities achieved 
during the intervention period for each participant), fidelity (90% consistency of elements 
delivered by occupational therapists throughout the study period), safety (no adverse 
events caused by Adapted LiFE), and appropriate efficacy measurement selection (70% 
of the participants do not show floor/ceiling effects among balance, muscle strength, and 
habit outcomes at pre- and/or post-tests).  
C2 
Rationale for the Selection of Outcome Measures 
The feasibility outcomes will inform future studies if Adapted LiFE has the potential to 
reduce barriers for implementation. Outcomes have been selected based on literature 
review and the preclinical pilot study (see D1 for preliminary data). The feasibility 
outcomes were selected based on the Reach, Efficacy, Adoption, Implementation, and 
Maintenance (RE-AIM) framework including reach, acceptance, adherence, fidelity, 
safety, and appropriate efficacy measurement selection. 48, 49 Preliminary efficacy 
outcomes of balance, muscle strength, and habit formation measures are selected 
based on literature review on fall prevention and evidence-based exercise interventions 
for older adults. 50-52  
D Investigational Agent  
D1 
Preclinical Data 
We conducted a mixed method study to adapt LiFE initially. The mixed-methods study 
consisted of two phases. At the first phase, a qualitative study was conducted to explore 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
7 
Pre-test (t0) 
Post-test (t2) 
1-month phone follow-up (t3)  
LiFE intervention period (t1) 
Session 1- 7 
stakeholders’ opinion towards LiFE that included medically underserved older adults and 
occupational therapists (OT).53, 54 Themes regarding intervention acceptance and 
concerns were used to adapt LiFE materials. Based on the themes emerging from the 
qualitative study, two changes to the LiFE user manual were made in the initial 
adaptation of LiFE. First, a graph explaining why fall prevention is important and how 
LiFE works was added to the beginning of user manual. We also reduced the number of 
words and pages by replacing text information with pictures in the manual.  Second, 
pictures of African American older adults were used to reflect the demographic 
characteristics of medically underserved older adults in the city of St. Louis.55  
At the second phase, a single-group pilot study was 
conducted to test the feasibility of Adapted LiFE (Figure 
1). Feasibility outcomes were selected based on the 
Reach, Efficacy, Adoption, Implementation, and 
Maintenance (RE-AIM) framework to evaluate initial 
Adapted LiFE (Table 1). Eight medically underserved 
older adults were recruited by convenience sampling 
from one senior apartment building in a health provider 
shortage area. Inclusion criteria were: (1) age 60 or 
older; (2) living independently; and (3) self-reported a 
slip, trip or fall in the past 12 months or were “concerned 
or worried about falling in the future.” Exclusion criteria were: (1) Short Blessed Test 
score ≥10, indicating cognitive impairment consistent with dementia; (2) inability to stand 
independently with a walking device; and (3) a serious health condition for which 
exercise is contraindicated. Participants were recruited through flyers and information 
sessions held in the senior apartment building. After consent, an occupational therapist 
would conduct a pre-test of preliminary efficacy outcomes and then start the first session 
of Adapted LiFE. Once participants completed all 7 sessions, a post-test was conducted 
by the OT immediately after the last in-home intervention session. The result showed 
that Adapted LiFE demonstrated good feasibility among the target participants. Eight 
older adults completed the pilot study (mean age 66.4 ± 5.6, 4 males, 3 African 
Americans, 5 Caucasians). The recruitment rate was 44% (11 enrolled out of 25 
screened). The retention rate was 89% (8 completed out of 9 enrolled). Participants had 
high acceptance of adapted LiFE with a mean satisfaction score of 6.89 ± 0.38. The 
average adherence rate was 81.3%. For fidelity, 98% of components were delivered 
during the intervention period.  
Thus, we regard the Adapted LiFE has the potential to have high acceptance and 
adherence rate among medically underserved older adults. Future studies should aim to 
evaluated the efficacy of Adpated LiFE with larger trials.  
D2 
Dose Rationale and Risk/Benefits  
The Adapted LiFE has an updated user manual but it retains the essential components 
and dose of the original LiFE (Table 2). In addition to practicing a set of structured 
exercise, participants learn to embed functional exercise activities into their daily 
routines that include balance and muscle strengthening training. For example, a 
participant could practice one-leg stands while waiting for food to heat up in the 
microwave. Participants also learn to gradually increase the difficulty of balance and 
muscle strengthening activities included in LiFE (see E3, and table 3).   
 
Figure 1 Overview of single group pilot study 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
8 
Clinical trials of LiFE,14, 36, 56 where comparing LiFE to structured exercise program, 
indicated the risk of participating in LiFE is no more than minimal risk.14 The benefit of 
LiFE has been proven in past study indicating LiFE could reduce falls, enhance balance 
and muscle strength among older adults.14, 36, 56 We hypothesize Adapted LiFE will have 
the same effect as the original trial.  
 
E Study Design  
E1 
Overview of Study Design  
The pilot study will use RCT with an attentional 
control design (Figure 2). The purpose of the pilot 
study with the same design as the future main study 
is to test the study protocol, estimate 
recruitment/retention rate, and validate tools.57, 58 This 
study design is appropriate for a future larger study 
because Adapted LiFE has strong face validity, good 
feasibility, and minimal risk when compared with 
structured exercise programs for medically 
underserved older adults.  
We will recruit 16 participants and randomize them to 
receive 7 sessions of home visit and 1 booster phone 
call one month after the last session of Adapted LiFE 
or attention control (AC) intervention. Once an eligible 
participant is screened and consented in his/her home 
(T0 visit), the OT interventionist will either conduct or 
schedule the pre-test (T1). All pre- and post-tests will 
be conducted in participants’ homes. After T1, the OT 
interventionist will randomize the participants to 
Adapted LiFE or the attention control group. The intervention period will start 
immediately after randomization and consist of seven sessions over 12 weeks. Post-
tests (T2) will be conducted by a blinded OT rater after the last intervention session at 
the participant’s home. Phone follow-ups (T3) will be conducted one month after post-
test by a blinded OT rater. Any additional questions from the participants will also be 
addressed in the phone follow-up. 
 
Feasibility outcomes such as reach, adherence, fidelity, and safety will be evaluated 
throughout the study session. Efficacy outcome such as balance and muscle strength 
will be evaluated at pre- test (T1), and post-test (T2). Habit formation will also be 
evaluated at T1, T2, and 1-month after post-test via phone.   
 
E2 
Subject Selection and Withdrawal  
2.a 
Inclusion Criteria  
Medically underserved older adults will be recruited by convenience sampling. Referrals 
from OT staff and members of a community advisory board of the Participation, 
Post-test (T2) 
Pre-test (T1) 
Adapted LiFE  
(n=8) 
Screening + Consent (T0) 
Randomized 1:1  
Attention Control  
(n=8) 
1-Month booster/  
phone follow-up (T3)  
Figure 2. Overview of the feasibility pilot study 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
9 
Environment & Performance Laboratory (PEPL) will be the main channels for recruiting 
medically underserved older adults. Inclusion criteria include:  
 
(1) age 70 or older;  
(2) live independently;  
(3) live in a medically underserved/health professional shortage area; 
(4) self-report two falls or one injurious fall in the past 12 months. The definition of a 
fall and injurious fall are described in Table 4. 
2.a 
Exclusion Criteria  
Exclusion criteria include:  
(1) Short Blessed Test score ≥8, indicating cognitive impairment consistent with 
dementia;  
(2) inability to stand independently with a walking device; 
(3) having a serious health condition with a physician’s order where exercise is 
contraindicated. 
2.b 
Ethical Considerations  
We will use convenient sampling to recruit medically underserved older adults, and we 
will not limit the number of participants due to their race/ethnic background. 
2.c 
Subject Recruitment Plans and Consent Process 
Purposeful sampling was used to recruit MU older adults in the greater St. Louis area.  
Potential participants will also be identified from the control group from a previous study. 
Participants will be recruited by word of mouth or at two Shepard senior apartment 
buildings (see letter of supports in attachments). Flyers will be distributed and study 
members will be available in the lobby and at events scheduled in the building to provide 
information on the study (study members will be contacted and invited by the building 
service coordinator). 
Participants who are referred and contact study staff via phone or in person will be able 
to ask questions about the study procedures. If they are interested, study staff will start 
the screening process by phone or in person.  
If the individual is eligible, a copy of the large-print informed consent document will be 
mailed or delivered, and an initial home visit will be scheduled. At the home visit, a 
trained staff member will obtain written informed consent.  
To minimalize the possibility of coercion or undue influence during the consent process, 
all elements of consent will be reviewed with older adults prior to enrolling in the study. 
Elements such as the purpose of the study, risks, benefits, alternatives to the study, how 
confidentiality will be maintained, the PI’s contact information, no consequences to 
withdrawal, and how study results will be shared are written in plain language. In 
addition, all staff members have participated in cultural competence training and are 
trained to interview older adults, which is particularly important for older adults with low 
vision, or low literacy levels. Written informed consent to participate in the study will be 
obtained before any test or measurements are performed. The consent form will be 
signed by a witness and will be stored in the office of the PI under double locks. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
10 
2.d 
Randomization Method and Blinding 
After the consent process, the pre-test could be administered immediately or be 
scheduled at a different day. After pre-test, participants will be randomized immediately 
by a pre-programed REDCap (Research Electronic Data Capture) module. REDCap 
(Research Electronic Data Capture) is a secure, web-based application designed 
exclusively to support data capture for research studies. A blinded rater will conduct the 
post-test and phone follow-up.  
 
Participants will not be blinded to which group they are in. The REDCap module uses a 
blocked randomization design in which gender will be stratified to ensure balanced group 
sizes. A block size of 2 and an allocation ratio of 1:1 based on gender. Then, based on 
group allocation, the occupational therapy (OT) interventionist will start either Adapted 
LiFE or the attention control intervention.  
 
2.e 
Risks and Benefits 
Minimization of Risks and Confidentiality 
We are a HIPPA covered entity and comply with all HIPPA regulations. To protect 
against and minimize potential risks, participants will be carefully screened and 
evaluated for eligibility by research coordinator. Participants may have the risks of 
feeling tired or disrupted by home visits, sore muscles after practicing exercise activities, 
feeling worn out, or confidential information of participants may be accidently disclosed. 
Participants may take a break at any time during participation and will be instructed to 
notify the rater or interventionist if they experience any discomfort.  
An ID number will be assigned to each participant. All data collected from a participant 
will be labeled with the ID number. All participant electronic and hard-copy data will be 
kept under double-lock protection. All hard copy forms that contain personal identifiers 
(e.g., name, address, phone numbers) will be stored in a separate locked file drawer 
under double-lock protection. No publication or presentation of the study data will 
uniquely identify or provide sufficient information to uniquely identify participants. 
To guard against unauthorized data access, all shared-use computer systems at the 
Washington University School of Medicine are protected with passwords, which are 
changed at 4-month intervals. Only individuals with a particular "need to know" status 
are given access, and system privileges are carefully restricted. All personal computers 
to be used in the Administrative Unit are located within a secure area, and the system is 
locked when not in use. SAS and SPSS software packages will be used for data 
management and analysis. Datasets generated from these programs will be password 
protected, which will make accessing study data difficult even in the event of 
unauthorized computer access occurs.  
There is no proven benefit from being in this study. However, benefits to the participants 
enrolled in the proposed study are free in-home exercise sessions provide by OT 
interventionists. Participants in treatment group (Adapted LiFE) may be able to improve 
balance and muscle strength, and participants in the control group may be able to 
improve flexibility. 
2.f 
When and How to Withdraw Subjects  
Participants will be told that their involvement in this research study is voluntary and that 
they may choose not to participate or withdraw their consent at any time. There will be 
no penalty or loss of benefits to which participants are otherwise entitled. Participants 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
11 
will be withdrawn if there is a serious adverse event (SAE) that may impact participant’s 
safety (see F5). 
2.g 
Data Collection and Follow-up for Withdrawn Subjects  
Data is directly entered into a REDCap database. REDCap servers are securely housed 
in an onsite, limited-access data center managed by the Division of Biostatistics at 
Washington University. All Web-based information transmission is encrypted. All data 
are stored on a private, firewall protected network. All users are given individual user IDs 
and passwords, and their access is restricted on a role-specific basis. REDCap was 
developed specifically around Health Insurance Portability and Accountability Act 
security guidelines and is implemented and maintained according to Washington 
University guidelines. Study data will be collected via tablet in the field and managed 
using REDCap electronic data-capture tools hosted at Washington University. REDCap 
is a secure, Web-based application designed to support data capture for research 
studies.  If a participant is withdrawn from the study, his/her information will be kept in 
REDCap securely until the study is completed.  
 
E3 
Study Intervention 
The treatment group will receive Adpated LiFE, and the control group will receive 
equivalence attention and time with an flexibility intervention program from Go4life.19 
3.a 
Treatment: Adapted LiFE 
Adapted LiFE teaches older adults to embed balance and lower extremity exercise 
activities into daily routines. The objective of LiFE is to form a habit to complete balance 
and muscle strength activities daily to improve balance and lower extremely muscle 
strength. A short summery of Adapted LiFE is at Table 2.   
Participants will learn 10 exercise principles and 19 activities to increase balance and 
muscle strength during a 12 week intervention period (Table 3). For balance training, the 
core principle is to continue to practice a challenging balance activity, manage it, and 
then progress to another more challenging activity. For muscle strength training, the core 
principles are to overload muscles by adding weight, increasing repetitions, and moving 
slower to make the muscles progressively work harder.  
Adapted LiFE is an intervention that aims to enhance self-efficacy through goal setting 
and creating appropriate outcome expectations to enhance participants’ ability to 
repeatedly perform a target health behavior, which, in this case, is to form and adhere to 
a habit of exercise. Therefore, OT interventionists will guide participants to review the 
user manual and use a self-monitoring calendar (Adapted LiFE calendar) to plan and 
implement planned training activities.  
The dose (visits and time) of Adapted LiFE consists of five weekly sessions and two 
booster sessions, which will be delivered by the OT interventionist in 12 weeks. Each 
session will last 40-60 minutes. The two booster sessions will be scheduled based on 
the needs of participants. If a participant has not finished learning all the activities after 
the fifth session, one or both booster sessions will be used to teach and implement the 
remaining activities, which will be conducted in the same manner as previous sessions. 
If a participant has completed learning all the activities, the first booster session (the 6th 
session) will be conducted with at least a two-week break after the 5th  session. The 
second booster session (the 7th session) will be conducted at least a four-week break 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
12 
after the 6th session. A phone follow-up call will be made after one month of the last 
intervention session as a booster session for participants to ask questions. feasibility 
outcome such as enrollment status, fidelity of intervention delivery will be documented 
by rater/interventionist log throughout the study period. 
3.b 
Control: Go4life  
Participants in the attention control group will receive a gentle exercise intervention that 
consists of flexibility activities. Materials are modified from the Go4Life program (an 
online material developed for general older adults by National Instituted of Aging).  
Participants will learn 19 gentle stretching activities during a 12 week intervention period. 
The OT practitioner will teach participants to gently stretch neck, shoulder, upper arm, 
upper body, chest, back, foot, leg, and hip. The OT practitioner will not actively guide or 
request participants to set goals or record activities. 
The dose (visits and time) of the attention control intervention is the same as Adapted 
LiFE, which consists of five weekly sessions and two booster sessions. Each session will 
last 40-60 minutes. Nineteen gentle flexibility activities from Go4Life will be taught to 
participants.  The OT interventionist will deliver the Go4Life user manual to the 
participant during the first visit and serve as a consultant for participants to ask questions 
about the flexibility activities. The self-monitoring calendar will be removed because self-
monitoring is an active ingredient of the treatment effect of Adapted LiFE. The OT 
interventionist will not actively guide or request participants to set goals or record 
activities. feasibility outcome such as enrollment status, fidelity of intervention delivery 
will be documented by rater/interventionist log throughout the study period. 
3.c 
Subject Compliance Monitoring  
Subject compliance is regarded as one of the feasibility outcome “adherence “ in this 
study (see F2). 
3.d 
Blinding  
Participants and OT interventionist will not be blinded to the purpose of testing Adapted 
LiFE, and will be informed at the consent visit.  
 
Raters will be blinded from the study. At baseline, raters will be blinded by randomizing 
participants after pre-test. At post-test, a blinded rater will be assigned to conduct the 
assessments.  At one-month phone follow-up: a blinded rater will conduct the follow-up 
questionnaires.  
F Study Procedures  
1.a 
Screening for Eligibility 
The screening process is for confirming eligibility to enrollment. Potential participants will 
be screened by phone or in-person using a script by a trained interviewer (See appendix 
1). All in person screenings will take place in the potential participant's apartment, or 
other private area (whichever the potential participant prefers for privacy and 
convenience). The trained interviewer will screen participants eligibility by asking 
participants’ age, how many time the participant had falling in the past year in a 
screening log (appendix 2), and evaluate if participants had attention/memory 
impairments with the Short Blessed Test (appendix 3).  

 
 
 
 
 
 
______________________________________________________________________________________ 
 
13 
1.b 
Consent visit and Pre-test   
An OT interventionist will visit all participants who meet the inclusion criteria and invite 
them to participate in the study. The informed consent form will be administered to all 
patients interested in participating in the study. During the consent process, participants 
will: (1) have what the study is about and what is expected of them explained in detail; 
(2) discuss potential problems that could interfere with participation; and (3) have their 
questions answered; and (4) receive a summary of the study, and contact information for 
the PI and study coordinator. The consent form will be signed by a witness and will be 
stored in the office of the PI under double locks. Participants will be advised in the 
consent form that there is a possibility that their medical research record, including 
identifying information, may be inspected and photocopied by officials of federal or state 
government agencies and the Washington University Human Research Protection Office 
(HRPO).  
Written informed consent to participate in the study will be obtained before any test or 
measurements are performed. After the participant signed the consent form, the OT 
interventionist will start the pre-test immediately or re-schedule another time for pre-test.  
At pre-test, a demographic questionnaire will be used to collect general information 
about the participant. A set of questionnaires and performance-based assessment will 
be conducted to evaluate participants attitude and abilities. After pre-test, participants 
will be randomized in the field.  
Table. Materials and assessments for consent and pre-test   
Construct  
Assessments  
Time 
Primary endpoints  
 
Static balance 
• 
Four-Stage Balace Test* 
T1, T2 
 
• 
Center of pressure (CoP) path 
measured by BTracks Balance Board 
Dynamic balance 
• 
Timed tandem walk*  
 
 
• 
Short Physical Performance Battery-
Balance Test (SPPB)* 
 
 
• 
Berg Balance Scale (BBS)  
 
Muscle strength  
• 
Lower extremity muscle strength 
measured by dynamometers* 
 
Secondary 
endpoints  
 
 
Habit formation 
• 
Self-Reported Habit Index (SRHI)  
T1, T2 , 
T3 
Balance efficacy  
• 
The Activities-specific Balance 
Confidence 
T1, T2, 
T3 
Note. * indicated assessment was used in the original LiFE study 
(Clemson et al., 2012) 
 
1.c 
Intervention Sessions  
Participants in both treatment or control group will start treatment session after 
randomization. The first session could be conducted immediately after pre-test or 
scheduled at another time if the participant is tired.  
A. Treatment: Adapted LiFE sessions  
The following content are modified and copied from the trainer manual of original 
LiFE. A fidelity checklist of the activities of Adapted LiFE is listed in appendix 5.  
I. 
Adapted LiFE Session 1 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
14 
The aim of session 1 is to evaluate participant’s daily routine, and introduce them 
to the principles of the Adapted LiFE program. This session will take 40 to 60 
minutes. OT interventionist will conduct following activities:  
(1) Assess the participant’s ability and opportunity to embed training activities: 
The OT interventionist will assess participants ability by the LiFE assessment 
tool, and ask what is “a typical week” of the participant and record the 
opportunities to embed exercise activities with the Daily Routine Chart.  
(2) Introduce participants to the program and user manual: The OT 
interventionist will use the user manual to explain how Adapted LiFE work 
with learning key concepts and exercise principles.  
(3) Teach key concepts of Adapted LiFE: embedding activities into daily routine, 
changing habits, looking for opportunities to perform the activities, using 
event or environmental cues to remind the participants to do the activities, the 
concept of grading, and review the safety section in the user manual to inform 
participants safety first while participating in Adapted LiFE.  
(4) Teach the exercise principles and selected activities: after teaching the 
principles (table 3), ask participants to pick 1-2 balance and 1-2 muscle 
strengthening activities. Demonstrate and practice with participants at the 
appropriate level.  
(5) Plan and record how, when, where the activities will be performed: The OT 
interventionist will introduce participant to the Adapted LiFE activity planner 
and explain the importance of planning and recording these plans. The OT 
interventionist prompt the participant to find opportunities in his/her daily 
routine to embed  the selected balance and muscle strengthening activities 
(see an example at Figure 3).  
(6) Wrap-up: The OT interventionist will make sure the participants understand to 
do the activities, check the boxes daily for the planned activities, and beware 
of safety (do not encourage the participants to upgrade activities at this 
session).  Participants will receive a 10-dollar gift card after session 1 is 
completed.  
 
 
 
Figure 3. An example of recording an activity in the LiFE activity planner 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
15 
II. Adapted LiFE Session 2-5 (week 2-6) 
The aim of session 2-5 is to finish teaching all the principles and activities.  
Session 2-4 should be conducted weekly, and session 5 should be conducted 
after a break of at least one week to allow participants to have some autonomy in 
setting and adjusting the program. Participants should also learn how to 
gradually increase their autonomy in managing the program.  
The OT interventionist will also facilitate the participants to come up with their 
own ideas of where activities might be embedded. Each participant will be 
upgraded differently according to their setting levels and their progress. In the 
early stages, participants should check with the interventionists before upgrading 
their activities. However, participants should be able to safely upgrade their own 
activities. OT interventionist will conduct following activities during session 2-5:  
(1) Review the balance and strength activities commenced previously with the 
LiFE activity planner.  
(2) Check for problems and problem solve. 
(3) Reinforce the integration/link to daily tasks and routine. 
(4) Upgrade activities as appropriate.  
(5) Introduction an additional one to two balance/strength activities. 
(6) Develop plans for embedding the activities into the participants’ daily routine. 
(7) Complete the LiFE activity planner.  
(8) Wrap-up 
  
At the end of session 2, participants should:  
• 
be able to do between 2-4 additional balance/strength activities,  
• 
have begun to identify for themselves daily tasks where LiFE activities can be 
embedded.  
At the end of session 5, participants should: 
• 
be able to do 10 or all activities,  
• 
complete the LiFE activity planners correctly,  
• 
identified areas/ activities where they will be able to embed LiFE activities into 
their daily routine, 
• 
manage to independently continue the program safely. 
III. Adapted LiFE Session 6-7 (booster sessions, week 8-12) 
 
If the participant has been able to learn all the activities and integrate them into 
 
their daily routines by session 5, then session 6 and 7 should be used to 
 
reinforce the program and to check on the progress and safety of the participant 
 
as required. Timing of session 6 (week 8) is suggested to be 2 weeks after 
 
session 5 (week 6), and session 7 (week 12) to be 4 weeks after session 6.  
 
However, these 2 sessions will be scheduled depend on the need of the 
 
participant. Participants will receive a 60-dollar gift card after session 7 is 
 
completed. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
16 
 
If the participants has not been able to learn all the activities, then the OT 
 
interventionist should used session 6 and/or session 7 to continue teach and 
 
implement the activities as previous sessions.  
 
The aims, objectives and components of session 6 and 7 are in line with session 
 
2-5. However, at the end of session 7, participants should be fully autonomous in 
 
embedding, performing and upgrading the activities in the LiFE program.  
B. Attention control Intervention (Control) Sessions  
 
The aims and objectives of the attention control intervention is to teach 
 
participants 19 gentle flexibility activities from Go4LiFE. A fidelity checklist of the 
 
activities of Go4LiFE is listed in appendix 5.  
I. 
Go4LiFE Session 1 
The aim of session 1 is to give an overview of the flexibility activities. The 
interventionist will introduce participants to Go4LiFE. This session will take 40 to 
60 minutes. OT interventionist will conduct following activities:  
(1) Introduce participants to the program and user manual: The OT 
interventionist will use the Go4LiFE user manual to explain what are the 
19 flexibility activities are. 
(2) Teach participants to conduct flexibility activities: after introducing the 19 
flexibility activities, the interventionist will ask participants to pick 3 
activities, and then demonstrate and practice with participants.  
(3) Wrap-up: The interventionist will make sure the participants understand to 
do the activities safely, and suggest the participants to do each activities 
3-5 times (but do not encourage the participants to upgrade activities at 
this session).  Participants will receive a 10-dollar gift card after session 1 
is completed. 
The interventionist will not encourage participants to actively document 
how many times they performed the session and will not provide balance 
and muscle strengthening training.  
II. Go4LiFE Session 2-5 (week 2-6) 
The aim of session 2-5 is to finish teaching all the flexibility activities.  Session 2-
4 should be conducted weekly, and session 5 should be conducted after a break 
of at least one week to match the timing of the treatment group. OT 
interventionist will conduct following activities during session 2-5:  
(1) Check for problems and problem solve. 
(2) Introduce 3-4 flexibility activities.  
(3) Demonstrate and practice the activities with participants. 
(4) Wrap-up  
III. Go4LiFE Session 6-7 (week 8-12) 
 
If the participant has been able to learn all the activities and integrate them into 
 
their daily routines by session 5, then session 6 and 7 should be used to check 
 
on the progress and safety of the participant. Timing of session 6 (week 8) is 
 
2 weeks after session 5 (week 6), and session 7 (week 12) is 4 weeks after 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
17 
 
session 6. Participants will receive a 60-dollar gift card after session 7 is 
 
completed. 
 
If the participants has not been able to learn all the activities, then the OT 
 
interventionist should used session 6 and/or session 7 to continue teach the
 
flexibility activities as previous sessions.  
1.d 
Post-test  
After the last session, a blinded rater OT interventionist will start the post-test 
immediately or re-schedule another time if participant is unavailable. A set of 
questionnaires and assessments similar to pre-test will be administered except the 
demographic questionnaires. The feasibility questionnaire with open-ended questions 
will be conducted by the rater to explore participants’ perspective of the programs.  
1.e 
One-month phone follow-up   
Both treatment and control group will receive a follow-up phone call one month after the 
last session. The objectives of this phone call is to check if participants have any 
questions or problems of the program.  
1.f 
Safety and Adverse Events  
To avoid or minimize adverse events, we will ask participants to notify the rater or 
interventionist if they experience any discomfort (see 2.e risks and benefits). Testing and 
interviews will be terminated if participants develop fatigue, agitation, or emotional 
distress. Participants will be trained in exercise principles and recognize environment 
barriers and situations that is not safe to conduct the activities at the first visit.  
1.g 
Safety and Compliance Monitoring 
Ms. Hu will be responsible for reviewing study progress and outcomes including 
recruitment, data quality, safety and efficacy with the supervision of Dr. Stark.  
Because risk in the proposed study is considered minimal, the data monitoring plan will 
include continuous, close monitoring by the study investigator with prompt reporting of 
any adverse events. Given the small number of subjects undergoing treatment, 
problems will become more readily apparent through close monitoring of individual 
participants. In this study, Dr. Stark will monitor the study for adverse advents and 
adherence to the protocol and safety. 
1.h 
Definitions of Adverse Events 
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, 
sign (including an abnormal laboratory finding), syndrome or disease which either occurs 
during the study, having been absent at baseline, or if present at baseline, appears to 
worsen. Adverse events are to be recorded regardless of their relationship to the study 
intervention.  
Serious adverse event (SAE). An SAE is generally defined as any untoward medical 
occurrence that results in death, is life threatening, requires inpatient hospitalization or 
prolongation of existing hospitalization, results in persistent or significant 
disability/incapacity, is a congenital anomaly or is another condition which investigators 
judge to represent significant hazards 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
18 
1.i 
Data Collection Procedures for Adverse Events 
Adverse events will be recorded in rater/interventionist log within the same day of the 
visit or phone call. Ms. Hu and Dr. Stark will discuss if the participants need to be 
withdraw when an adverse event occur within 2 days.  
Should there be a serious adverse event that occurs that increases the risks to the 
participants, the study will be stopped, an investigation will be conducted, and a findings 
report will be generated before the study is resumed(see 5.d). 
Data of the withdrawn subjects other than reasons of withdrawal and demographic 
information will be deleted and excluded from data analysis.  
1.j 
Reporting Procedures  
All serious adverse events will be reported to the HRPO in the following time frames: a) 
death – immediately; b) life-threatening within 7 calendar days; c) all other SAEs within 
15 calendar days using the Electronic Serious Adverse Event Reporting System. Should 
there be a serious adverse event that occurs that increases the risks to the participants, 
the study will be stopped, an investigation will be conducted, and a findings report will be 
generated before the study is resumed. 
1.k 
Adverse Event Reporting Period 
The adverse event reporting period will starts from participant enrollment to one-month 
phone follow-up.  
F2 
Study Outcome Measurements 
Feasibility outcomes include reach, acceptance, adherence, fidelity, safety, and 
appropriate efficacy outcome selection are described below. Feasibility outcomes will be 
assessed by the visit-by-visit grid, rater/interventionist log, the LiFE activity planner, and 
the feasibility questionnaire.  
Reach is defined by recruitment and retention rate. Recruitment rate will be measured by 
the percentage of residents successfully enrolled in the study. Retention rate will be 
defined by the percentage of enrolled participants who complete the program. Reach will 
be documented by OT interventionists in interventionist logs and visit-by-visit grids in 
REDCap. 
Acceptance will be surveyed by the feasibility questionnaire at the last session. The 
questionnaire contains a question, “Are you satisfied with the Adapted LiFE program?,” 
using a seven-point Likert scale from one (very unsatisfied) to seven (very satisfied). 
Follow-up questions will be asked to explore what makes the program satisfying or 
unsatisfying to the participant. 
Adherence will be defined as the average percentage of exercise activities achieved 
during the intervention period that are recorded in the Adapted LiFE activity planner.  
Fidelity will be assessed as the delivery of active and essential ingredients of the 
program as recorded by OT interventionists in visit-by-visit grids in REDCap. OT 
interventionists will meet weekly with the principle investigator to review the delivery of 
essential and active ingredients of Adapted LiFE for quality assurance.  
Safety of the program will be evaluated by the number of adverse events documented 
throughout the study duration. This will be documented by OT interventionists in 
interventionist logs and visit-by-visit grids in REDCap. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
19 
 
The visit-by-visit grid is a checklist of all the elements that the interventionist 
should cover during each session. The interventionist will fill out the grid after every 
session is completed.  
 
The rater/interventionist log is a survey that each rater/interventionist need to fill 
out after each visit to document any adverse event or special notes from a participant.  
   
The LiFE activity planner is a weekly calendar for participants to fill out during the 
intervention sessions. Participants will record and check off the activities that they have 
completed.   
 
The feasibility questionnaire consist of open-ended questions for participants and 
interventionists to review their experience in the study period.  
Appropriate efficacy outcome selection are defined as few difficulties to administer 
questionnaires and assessments for balance, muscle strength and habit formation, 
which will be the primary and secondary endpoints of future larger trials. The second half 
of the feasibility questionnaire will also be filled out by the rater/interventionist to review if 
the questionnaires/assessments are easy to administer or not.   
 
Balance will be evaluated to capture the nature of posture control and change of 
intervention. The literature suggests static balance and dynamic balance are both critical 
to prevent falls. Static balance will be measured by the Four-Stage Balance Test and the 
Center of pressure (CoP) path. Dynamic balance will be assessed using the timed 
tandem walk test, the Short Physical Performance Battery-Balance Test, and the Berg 
Balance Scale. Balance self-efficacy will be measured by the Activities-specific Balance 
Confidence Scale. 
 
The Four-Stage Balance Test consists of four progressively more challenging 
stances (narrow base stand, half tandem stand, tandem stand, and one-leg stand). Each 
stance represents a different level of static balance ability.59, 60 It is validated to screen 
for increased fall risk and functional decline.60  The inability to hold the fourth stage or 
one-leg stand for five seconds further predicts injurious falls.61 Participants will be 
categorized into low fall risk (passing the third stage tandem stand) or high fall risk 
(failure to pass the third stage tandem stand).62 A balance board BTrackS63 will be used 
to quantify the trajectory of center of pressure (CoP) while participants are being 
evaluated with The Four-Stage Balance test along with wide stance. The BTracKS 
balance board is portable and steady with customized software to evaluate the CoP 
trajectory of participants.   
 
The Short Physical Performance Battery-Balance Test (SPPB) is an assessment 
of lower extremity function with three subtests: (1) standing balance, (2) four-meter gait 
speed, and (3) five repetitions of sit-to-stand motion. Subtest scores are added to obtain 
a summary score that represents mobility function.64 The SPPB has been shown to be 
reliable (intraclass correlation coefficients [ICC]: 0.88-0.92), valid, and sensitive to 
change.65 
 
The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic 
balance. Performance quality, time, and assistance required are rated on a scale of 0-4 
based on pre-specified criteria 66, 67. Total scores range from 0-56, with a score of 45 or 
below indicating high risk of falls.68 The BBS has excellent test-retest reliability (ICC= 
0.91) and intra-rater reliability (ICC = 0.98) 69 as well as good criterion validity.70 It has 
82.5% sensitivity and 93% specificity for predicting falls among older adults.71  

 
 
 
 
 
 
______________________________________________________________________________________ 
 
20 
 
CoP parameters were measured by the Balance Tracking System (BTrackS).63 
BtracKS is operated with a portable balance place, and the BTracKS software. The 
BTracKs software calculates CoP parameters such as total COP path length (cm) and 
mean CoP velocity (cm/s). The BTracKs system has good concurrent validity (r > 0.9) 
and test-retest reliability (ICC = 0.83) for community dwelling older adults63, 72. 
Participants were instructed to stand on the balance plate and perform 4 quiet standing 
conditions: (1) hip-width stand, eyes open; (2) hip-width stand, eyes closed; (3) narrow 
stand, eyes open; (4) narrow stand, eyes closed72. For each task, participants were 
instructed to stand still with hands naturally on the side of the hip. Each task was tested 
for three 30-second trials in order. Participants could chose to take a break after each 
trial.    
 
Dynamic balance was assessed using the timed forward tandem walk test over a 
3-meter course. The participant was instructed to place one foot in front of the other 
making sure that, with each step, the heel of one foot was directly in front of the toes of 
the other foot. The participant was told to walk forward as fast as possible without falling 
or making any mistakes. The average time recorded to the nearest 0.1 seconds from 2 
trials was used in the analysis. In addition to time, the number of mistakes 
(misplacement of steps) was also recorded.73  
 
The Activities-specific Balance Confidence (ABC) Scale is a 16-item assessment 
of balance confidence. Participant self-reports percentage points on the scale from 0% 
(no confidence) to 100% (very confident) of performing various ambulatory activities 
without falling or experience sense of unsteadiness. The final score is an average of the 
16 items. The higher the percentage, the more confident a person is. The ABC is 
internally consistent and demonstrated good test–retest reliability, convergent and 
criterion validity.74 
 
Muscle Strength. The literature suggests lower extremity muscle strength is 
critical in preventing falls. Muscle strength training is a core component of Adapted LiFE. 
Lower extremity muscle strength will be assessed using a Lafayette 01165 
dynamometer.  This measure has been selected based on the pilot study to avoid a 
ceiling effect. The dynamometer is an objective and accurate tool to assess lower 
extremity muscle strength. A standardized protocol will be used by all raters to guide 
strength measurements of hip flexion, knee extension, and ankle dorsiflexion using 
dynamometry. The groups of muscles responsible for these movements are critical for 
mobility and balance to prevent falls.36  
 
Habit formation, will be measured using the Self-Reported Habit Index (SRHI). 
This 12-item assessment incorporates constructs such as habit strength, frequency, 
relevance to self-identity, and automaticity. Items are self-rated by participants using a 
seven-point Likert scale. Higher scores indicate that a behavior is more strongly habitual. 
42, 75      
G Statistical Analysis Plan  
G1 
 Sample Size Determination and Power 
The goal of the pilot is to test the feasibility of the Adapted LiFE for medically 
underserved population, and is not hypothesis testing.  Thus, sample size calculation are 
not necessary.76, 77 We select to set our sample size at 16 to evaluate feasibility and 
effect size for future study.     

 
 
 
 
 
 
______________________________________________________________________________________ 
 
21 
G2 
 Analysis Plan 
Data will be entered into REDCap. Descriptive statistics will be used to identify any 
trends in demographics, and feasibility outcomes.  
G3 
Statistical Methods  
To detect effect of intervention. Wilcoxon signed rank tests will be used to identify trends 
in levels of balance, muscle strength, and habit formation. 
 
To detect effect of intervention. Wilcoxon signed rank tests will be used to identify trends 
in levels of balance, muscle strength, and habit formation. 
G4 
 Missing Outcome Data 
For feasibility outcomes, all data will be used in the final data analysis. Participants who 
have missing data will still be included.  
H Data Handling and Record Keeping  
H1 
Confidentiality and Security 
We will protect participants’ information with password protected data in REDCap, and 
HIPPA trained staffs.  Data limited access to research team only. See 2e for details.  
H2 
Training  
All research staff are covered entity and comply with all HIPPA regulations. 
H3 
Records Retention 
Records will be kept only during study intervention. Data and records will be de-identified 
after and filed comply to HIPAA regulation after the study is completed.   
H4 
Performance Monitoring  
Weekly staff meeting lead by Dr. Stark will monitor performance of all raters and 
interventionists. Data on REDCap and secured in the lab will be monitored and managed 
by Ms. Hu to ensure data safety and quality. 
 
I Study Administration 
I1 
Organization and Participating Center 
The clinical translational research of the Participation, Environment and Performance 
Laboratory (PEPL) focuses on the unique contribution that the environment can make 
toward improving the performance, participation and quality of life for persons living with 
functional limitations. Dr. Stark and her team study how the environment accounts for 
the differences between what individuals are capable of doing and their actual 
participation in society.  The PEPL lab will provide study assessments, and research 
support including secured computer and storage spaces. 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
22 
Two buildings of Shepherds senior apartments will collaborate with us to conduct this 
study. The Shepherds senior apartments resides in a medically underserved zipcode, 
and most of the residents aged 62 or over. The social service coordinator Ms. Billie 
Johnson will coordinate with us to provide space and time to recruit eligible participants.  
  
I2 
Funding Source and Conflicts of Interest 
The funding for interventionist/rater hours and incentives for participant are provided by 
the Rehabilitation and Participation Science program (Occupational Therapy Program), 
Washington University School of Medicine. 
 
None of the staff has conflicts of interest to disclose.  
I3 
Subject incentives  
Participants will receive a $10 gift card after they finish the first intervention session, a 
$60 gift card after the last intervention session (7th session), and a $10 gift card after one 
month phone follow-up.  
J Publication Plan  
We plan to published the results of this pilot study in a peer-reviewed, rehabilitation 
focused journal to disseminated our findings.  

 
 
 
 
 
 
______________________________________________________________________________________ 
 
23 
 
K  Attachments  
K1 
 Tables  
Table 1. Feasibility outcomes and measures of preliminary pilot study  
Construct 
 Instrument 
Time 
Reach 
Rater/interventionist log and visit-by-
visit grid 
t0, t1, t2, t3 
Acceptance 
Feasibility questionnaire  
t2 
Adherence 
The LiFE activity planner 
t1, t3 
Fidelity 
Rater/interventionist log and visit-by-
visit grids 
t1 
Preliminary efficacy 
Balance Tinetti gait and balance instrument 
(POMA)78 
t0, t2 
Muscle strength Manual Muscle Testing (MMT)79 
t0, t2 
Habit formation Self-Reported Habit Index (SRHI)75, 80 
t0, t2, t3 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
24 
Table 2. Adapted LiFE intervention for medically underserved older adults 
Intervention composition 
Dosage and timing 
Seven 40-60 minute sessions over 12 weeks (5 
weekly session and 2 booster sessions).  
One follow-up phone call 1 month after tha last 
session  
Essential 
ingredients  
• 
Iterative practice of goal setting and achieving 
outcome expectations to increase self-efficacy  
• 
Behavior change elicited by habit formation 
strategies  
Active ingredients  
• 
Exercise principles to increase balance and 
muscle strength 
• 
Cognitive capacity to remember and carry out 
planned activities  
Approach 
• 
Goal setting of exercise activities begins at low 
frequency   
• 
OT as a collaborative partner 
Standardized 
elements of tailored 
approach 
• 
Seven sessions to add 1-2 exercise activities 
to participant’s routine 
• 
In-home training, active practice 
Note. OT = occupational therapist. 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
25 
Table 3. Adapted LiFE balance and strength training principles and activities 
Balance Principles  
Balance Activity  
Decreasing base of support 
Tandem stand 
Tandem walk 
One-leg stand 
Shifting weight and moving to the limits of 
stability 
Leaning side to side  
Leaning forwards and back wards 
Stepping over objects 
Stepping forwards and backwards 
Stepping side to side  
Strength Principles  
Strength Activity  
Bend your knees 
Bend knees 
Sit to stand 
Normal chair 
Low chair  
On your toes 
Stand on toes 
Walk on toes 
On your heels 
Stand on heels 
Walk on heels 
Up the stairs  
Up the stairs 
Move sideways 
Step sideways 
Tighten muscles 
Move ankles  
Bend / Straighten knees 
Tighten / Relax buttocks 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
26 
Table 4. Definitions of a fall and injurious fall as inclusion criteria 
Construct 
Definition  
Fall 
A fall is an unexpected event in which a person comes to rest on the 
ground, floor, or a lower level 
Injurious fall  
An injurious fall is a fall with a physical injury, which can be 
categorized as minor, moderate, or serious injury 
minor  Had minor bruises or abrasions not requiring health professional 
assistance and that caused reduction in physical function (e.g. due 
to pain, fear of falling)  
moderate Had wounds, bruises, sprains, cuts requiring a medical/health 
professional examination, such as a physical examination, x-ray, or 
suture 
serious Had a medically recorded fracture, head or internal injury requiring 
emergency or inpatient treatment 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
27 
 
 
L References 
1. 
Fuller GF. Falls in the elderly. Am Fam Physician 2000;61:2159-2168, 2173-
2154. 
2. 
Heinrich S, Rapp K, Rissmann U, Becker C, König H-H. Cost of falls in old age: a 
systematic review. Osteoporosis international 2010;21:891-902. 
3. 
Sterling DA, O'Connor JA, Bonadies J. Geriatric falls: injury severity is high and 
disproportionate to mechanism. The Journal of trauma 2001;50:116-119. 
4. 
Centers for Disease Control and Prevention. National Center for Injury 
Prevention and Control. [online]. Available at: https://www.cdc.gov/injury/wisqars/. 
Accessed August 5. 
5. 
Gillespie LD, Robertson MC, Gillespie WJ, et al. Interventions for preventing falls 
in older people living in the community. Cochrane Database Syst Rev 2012;9. 
6. 
Child S, Goodwin V, Garside R, Jones-Hughes T, Boddy K, Stein K. Factors 
influencing the implementation of fall-prevention programmes: a systematic review and 
synthesis of qualitative studies. Implementation science 2012;7:91. 
7. 
The Health Resources and Services Administration. Shortage Designation: 
Health Professional Shortage Areas & Medically Underserved Areas/Populations 
[online]. Available at: 
https://datawarehouse.hrsa.gov/topics/HrsaInYour/factSheetNation.aspx. Accessed 
December 15, 2016. 
8. 
Ferraro KF, Shippee TP. Aging and Cumulative Inequality: How Does Inequality 
Get Under the Skin? The Gerontologist 2009;49:333-343. 
9. 
Green L, Nasser M, Brownson R, Colditz G, Proctor E. Furthering dissemination 
and implementation research: The need for more attention to external validity. 
Dissemination and implementation research in health: Translating science to practice 
2012:305-326. 
10. 
Kulinski K, DiCocco C, Skowronski S, Sprowls P. Advancing Community-Based 
Falls Prevention Programs for Older Adults—The Work of the Administration for 
Community Living/Administration on Aging. Frontiers in Public Health 2017;5:4. 
11. 
Shojania KG, Grimshaw JM. Evidence-based quality improvement: the state of 
the science. Health affairs 2005;24:138-150. 
12. 
Ahmed SM, Lemkau JP, Nealeigh N, Mann B. Barriers to healthcare access in a 
non-elderly urban poor American population. Health & social care in the community 
2001;9:445-453. 
13. 
Kullgren JT, McLaughlin CG. Beyond Affordability: The Impact of Nonfinancial 
Barriers on Access for Uninsured Adults in Three Diverse Communities. Journal of 
Community Health 2010;35:240-248. 
14. 
Clemson L, Fiatarone Singh MA, Bundy A, et al. Integration of balance and 
strength training into daily life activity to reduce rate of falls in older people (the LiFE 
study): randomised parallel trial. BMJ (Clinical research ed) 2012;345. 
15. 
Resources. USDoHaH. Medically Underserved Areas and Populations [online]. 
Available at: https://bhw.hrsa.gov/shortage-designation/muap. Accessed December 15, 
2016. 
16. 
Marsiglia FF, Booth JM. Cultural Adaptation of Interventions in Real Practice 
Settings. Research on social work practice 2015;25:423-432. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
28 
17. 
Barrera M, Castro FG, Strycker LA, Toobert DJ. Cultural Adaptations of 
Behavioral Health Interventions: A Progress Report. Journal of consulting and clinical 
psychology 2013;81:196-205. 
18. 
Domenech-Rodriguez M, Wieling E. Developing culturally appropriate, evidence-
based treatments for interventions with ethnic minority populations. Voices of color: First 
person accounts of ethnic minority therapists 2004:313-333. 
19. 
Herman SW. Go4life:< http://go4life. nia. nih. gov>. Journal of Consumer Health 
On the Internet 2014;18:271-278. 
20. 
Batra A, Page T, Melchior M, Seff L, Vieira ER, Palmer RC. Factors associated 
with the completion of falls prevention program. Health Education Research 
2013;28:1067-1079. 
21. 
Clark DO, Frankel RM, Morgan DL, et al. The meaning and significance of self-
management among socioeconomically vulnerable older adults. J Gerontol B Psychol 
Sci Soc Sci 2008;63:S312-319. 
22. 
Ansai JH, Aurichio TR, Gonçalves R, Rebelatto JR. Effects of two physical 
exercise protocols on physical performance related to falls in the oldest old: A 
randomized controlled trial. Geriatrics & gerontology international 2015. 
23. 
Williams DR, Mohammed SA, Leavell J, Collins C. Race, Socioeconomic Status 
and Health: Complexities, Ongoing Challenges and Research Opportunities. Annals of 
the New York Academy of Sciences 2010;1186:69-101. 
24. 
Mosenifar Z. Population issues in clinical trials. Proceedings of the American 
Thoracic Society 2007;4:185-188. 
25. 
Durant RW, Davis RB, St. George DMM, Williams IC, Blumenthal C, Corbie-
Smith GM. Participation in Research Studies: Factors Associated with Failing to Meet 
Minority Recruitment Goals. Annals of Epidemiology 2007;17:634-642. 
26. 
Hu Y-L, Junge K, Nguyen A, et al. Evidence to Improve Physical Activity among 
Medically Underserved Older adults: A Scoping Review. The Gerontologist 
2018:gny030-gny030. 
27. 
Mihalko SL, Wickley KL, Sharpe BL. Promoting physical activity in independent 
living communities. Medicine & Science in Sports & Exercise 2006;38:112-115 114p. 
28. 
Resnick B, Shaughnessy M, Galik E, et al. Pilot testing of the PRAISEDD 
intervention among African American and low-income older adults...People Reducing 
Risk and Improving Strength through Exercise, Diet and Drug Adherence. Journal of 
Cardiovascular Nursing 2009;24:352-361 310p. 
29. 
Steinman BA, Pynoos J, Nguyen AQ. Fall risk in older adults: roles of self-rated 
vision, home modifications, and limb function. J Aging Health 2009;21:655-676. 
30. 
Glasgow RE, Lichtenstein E, Marcus AC. Why Don’t We See More Translation of 
Health Promotion Research to Practice? Rethinking the Efficacy-to-Effectiveness 
Transition. American Journal of Public Health 2003;93:1261-1267. 
31. 
Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: 
understanding time lags in translational research. Journal of the Royal Society of 
Medicine 2011;104:510-520. 
32. 
Frieden TR. A framework for public health action: the health impact pyramid. 
American journal of public health 2010;100:590-595. 
33. 
Morelli V. An Introduction to Primary Care in Underserved Populations: 
Definitions, Scope, and Challenges. Primary Care: Clinics in Office Practice 2017;44:1-9. 
34. 
Lattimore D, Wilcox S, Saunders R, et al. Self-reported barriers of middle-aged 
and older adults entering a home-based physical activity program. Californian Journal of 
Health Promotion 2011;9:15-28 14p. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
29 
35. 
Braveman PA, Cubbin C, Egerter S, Williams DR, Pamuk E. Socioeconomic 
Disparities in Health in the United States: What the Patterns Tell Us. American Journal 
of Public Health 2010;100:S186-S196. 
36. 
Clemson L, Singh MF, Bundy A, et al. LiFE Pilot Study: A randomised trial of 
balance and strength training embedded in daily life activity to reduce falls in older 
adults. Australian Occupational Therapy Journal 2010;57:42-50. 
37. 
Delbaere K, Valenzuela T, Woodbury A, et al. Evaluating the effectiveness of a 
home-based exercise programme delivered through a tablet computer for preventing 
falls in older community-dwelling people over 2 years: study protocol for the Standing 
Tall randomised controlled trial. BMJ Open 2015;5:e009173. 
38. 
Sherrington C, Fairhall N, Kirkham C, et al. Exercise and fall prevention self-
management to reduce mobility-related disability and falls after fall-related lower limb 
fracture in older people: protocol for the RESTORE (Recovery Exercises and STepping 
On afteR fracturE) randomised controlled trial. BMC geriatrics 2016;16:34. 
39. 
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-
implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and 
Implementation Research to Enhance Public Health Impact. Medical care 2012;50:217-
226. 
40. 
Neal DT, Wood W, Labrecque JS, Lally P. How do habits guide behavior? 
Perceived and actual triggers of habits in daily life. Journal of Experimental Social 
Psychology 2012;48:492-498. 
41. 
Fritz H, Cutchin MP. Integrating the Science of Habit Opportunities for 
Occupational Therapy. OTJR: Occupation, Participation and Health 2016;36:92-98. 
42. 
Gardner B, de Bruijn G-J, Lally P. A Systematic Review and Meta-analysis of 
Applications of the Self-Report Habit Index to Nutrition and Physical Activity Behaviours. 
Annals of Behavioral Medicine 2011;42:174-187. 
43. 
Nazroo JY. Genetic, cultural or socio-economic vulnerability? Explaining ethnic 
inequalities in health. Sociology of Health & Illness 1998;20:710-730. 
44. 
Egede LE. Race, Ethnicity, Culture, and Disparities in Health care. Journal of 
General Internal Medicine 2006;21:667-669. 
45. 
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: 
recommendations for good practice. Journal of evaluation in clinical practice 2004;10. 
46. 
Eldridge SM, Lancaster GA, Campbell MJ, et al. Defining feasibility and pilot 
studies in preparation for randomised controlled trials: development of a conceptual 
framework. PLoS One 2016;11:e0150205. 
47. 
Tickle-Degnen L. Nuts and Bolts of Conducting Feasibility Studies. The American 
Journal of Occupational Therapy 2013;67:171-176. 
48. 
Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for 
evaluating interventions: what can it tell us about approaches to chronic illness 
management? Patient education and counseling 2001;44:119-127. 
49. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health 
promotion interventions: the RE-AIM framework. American journal of public health 
1999;89:1322-1327. 
50. 
Murphy SL. Review of physical activity measurement using accelerometers in 
older adults: Considerations for research design and conduct. Preventive Medicine 
2009;48:108-114. 
51. 
Robinson L, Newton JL, Jones D, Dawson P. Self-management and adherence 
with exercise-based falls prevention programmes: a qualitative study to explore the 
views and experiences of older people and physiotherapists. Disability and rehabilitation 
2014;36:379-386. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
30 
52. 
Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent 
falls in older adults: an updated meta-analysis and best practice recommendations. New 
South Wales public health bulletin 2011;22:78-83. 
53. 
Currie RR, Seaton S, Wesley F. Determining stakeholders for feasibility analysis. 
Annals of Tourism Research 2009;36:41-63. 
54. 
Domenech Rodríguez MM, Baumann AA, Schwartz AL. Cultural adaptation of an 
evidence based intervention: From theory to practice in a Latino/a community context. 
American journal of community psychology 2011;47:170-186. 
55. 
Greever-Rice T, Mayfield W, Blodgett J, Canfield S, Murray E, Wilson K. Seniors 
Count of Greater St. Louis: Needs Assessment. . 
56. 
Weber M, Belala N, Clemson L, et al. Feasibility and effectiveness of intervention 
programmes integrating functional exercise into daily life of older adults: a systematic 
review. Gerontology 2018;64:172-187. 
57. 
Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. 
BMC Medical Research Methodology 2010;10:1. 
58. 
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size 
for a pilot randomised trial to minimise the overall trial sample size for the external pilot 
and main trial for a continuous outcome variable. Statistical methods in medical research 
2016;25:1057-1073. 
59. 
Centers for Disease Control. STEADI-older adult fall prevention [online]. 
Available at: https://www.cdc.gov/steadi/. Accessed March 6, 2018. 
60. 
Phelan EA, Mahoney JE, Voit JC, Stevens JA. Assessment and Management of 
Fall Risk in Primary Care Settings. The Medical clinics of North America 2015;99:281-
293. 
61. 
Vellas BJ, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. 
One-leg balance is an important predictor of injurious falls in older persons. Journal of 
American Geriatrics Society 1997;45:735-738. 
62. 
Shubert TE, Smith ML, Goto L, Jiang L, Ory MG. Otago Exercise Program in the 
United States: Comparison of 2 Implementation Models. Physical Therapy 2017;97:187-
197. 
63. 
O’Connor SM, Baweja HS, Goble DJ. Validating the BTrackS Balance Plate as a 
low cost alternative for the measurement of sway-induced center of pressure. Journal of 
biomechanics 2016;49:4142-4145. 
64. 
Guralnik JM, Simonsick EM, Ferrucci L, et al. A Short Physical Performance 
Battery Assessing Lower Extremity Function: Association With Self-Reported Disability 
and Prediction of Mortality and Nursing Home Admission. Journal of Gerontology 
1994;49:M85-M94. 
65. 
Ostir GV, Volpato S, Fried LP, Chaves P, Guralnik JM. Reliability and sensitivity 
to change assessed for a summary measure of lower body function: Results from the 
Women's Health and Aging Study. Journal of Clinical Epidemiology 2002;55:916-921. 
66. 
Berg K, Wood-Dauphinee S, Williams JI. The balance scale: Reliability 
assessment with elderly residents and patients with an acute stroke. Scandinavian 
Journal of Rehabilitation Medicine 1995;27:27-36. 
67. 
Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the 
elderly: Validation of an instrument. Canadian Journal of Public Health 1992;83:S7-11. 
68. 
Bogle Thorbahn LD, Newton RA. Use of the Berg Balance Test to predict falls in 
elderly persons. Physical therapy 1996;76:576-583. 
69. 
Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and 
laboratory measures of postural balance in an elderly population. Archives of physical 
medicine and rehabilitation 1992;73:1073-1080. 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
31 
70. 
Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability 
for falls in community-dwelling older adults. Phys Ther 1997;77:812-819. 
71. 
Lajoie Y, Gallagher SP. Predicting falls within the elderly community: comparison 
of postural sway, reaction time, the Berg balance scale and the Activities-specific 
Balance Confidence (ABC) scale for comparing fallers and non-fallers. Archives of 
Gerontology and Geriatrics 2004;38:11-26. 
72. 
Levy SS, Thralls KJ, Kviatkovsky SA. Validity and reliability of a portable balance 
tracking system, BTrackS, in older adults. Journal of geriatric physical therapy 
2018;41:102-107. 
73. 
Nelson ME, Layne JE, Bernstein MJ, et al. The Effects of Multidimensional 
Home-Based Exercise on Functional Performance in Elderly People. The Journals of 
Gerontology: Series A 2004;59:M154-M160. 
74. 
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. 
The Journals of Gerontology: Series A 1995;50A:M28-M34. 
75. 
Gardner B, Abraham C, Lally P, de Bruijn G-J. Towards parsimony in habit 
measurement: Testing the convergent and predictive validity of an automaticity subscale 
of the Self-Report Habit Index. International Journal of Behavioral Nutrition and Physical 
Activity 2012;9:102. 
76. 
Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility 
study? A review of current practice and editorial policy. BMC Med Res Methodol 
[Internet] 2010;10. 
77. 
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: 
recommendations for good practice. Journal of evaluation in clinical practice 2001;10. 
78. 
Tinetti ME, Williams CS. Falls, injuries due to falls, and the risk of admission to a 
nursing home. New England journal of medicine 1997;337:1279-1284. 
79. 
Peterson-Kendall F, Kendall-McCreary E, Geise-Provance P, McIntyre-Rodgers 
M, Romani W. Muscles testing and function with posture and pain. Philadelphia: 
Lippincott Williams & Wilkins, 2005. 
80. 
Verplanken B, Orbell S. Reflections on past behavior: A self-report index of habit 
strength. Journal of Applied Social Psychology 2003;33:1313-1330.