Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)
Phase: NA
Conditions: Exercise, Physical Activity, Accidental Fall, Motivation, Older Adults
Sponsor: University of Minnesota

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Study Protocol 
Community-based Intervention Effects on Older Adults' Physical Activity 
NCT03326141
October 31, 2023

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Table of Contents 
Contents 
CHAPTER 1- OBJECTIVES ......................................................................................................................... 7 
1.1: PURPOSE ......................................................................................................................................... 7 
CHAPTER 2 - BACKGROUND .................................................................................................................... 8 
2.1 SIGNIFICANCE OF RESEARCH QUESTION/PURPOSE .............................................................. 8 
2.2 EXISTING LITERATURE ................................................................................................................. 8 
CHAPTER 3 - STUDY OUTCOMES .......................................................................................................... 11 
3.1 PRIMARY OUTCOME ................................................................................................................... 11 
3.2   SECONDARY OUTCOME(S) ......................................................................................................... 12 
3.3: EXPLORATORY OUTCOME(S)...................................................................................................... 12 
CHAPTER 4 - STUDY INTERVENTION .................................................................................................... 12 
4.1: DESCRIPTION ................................................................................................................................ 12 
CHAPTER 5 – PROCEDURES INVOLVED ............................................................................................... 15 
5.1 STUDY DESIGN ............................................................................................................................... 15 
5.2 STUDY PROCEDURES ................................................................................................................... 15 
5.4 FOLLOW-UP..................................................................................................................................... 19 
CHAPTER 6 – DATA BANKING ................................................................................................................ 19 
CHAPTER 7 – SHARING OF RESULTS WITH PARTICIPANTS ............................................................. 19 
7.1 DISSEMINATION ............................................................................................................................. 19 
CHAPTER 8 – STUDY DURATION ........................................................................................................... 19 
CHAPTER 9 – STUDY POPULATION ....................................................................................................... 19 
9.1 INCLUSION CRITERIA .................................................................................................................... 19 
9.2 EXCLUSION CRITERIA ................................................................................................................... 20 
9.3 SCREENING..................................................................................................................................... 20 
CHAPTER 10 – VULNERABLE POPULATIONS ...................................................................................... 21 
CHAPTER 11 – NUMBER OF PARTICIPANTS ........................................................................................ 21 
11.1: NUMBER OF PARTICIPANTS TO BE CONSENTED .................................................................. 21 
CHAPTER 12 – RECRUITMENT METHODS ............................................................................................ 21 
12.1 RECRUITMENT PROCESS ........................................................................................................... 21 

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12.2: SOURCE OF PARTICIPANTS ...................................................................................................... 22 
12.3: IDENTIFICATION OF POTENTIAL PARTICIPANTS .................................................................... 22 
12.4: RECRUITMENT MATERIALS ....................................................................................................... 22 
12.5: PAYMENT...................................................................................................................................... 22 
CHAPTER 13 – WITHDRAWAL OF PARTICIPANTS ............................................................................... 23 
13.1: WITHDRAWAL CIRCUMSTANCES .............................................................................................. 23 
13.2: WITHDRAWAL PROCEDURES .................................................................................................... 23 
13.3: TERMINATION PROCEDURES ................................................................................................... 23 
CHAPTER 14 – RISKS TO PARTICIPANTS ............................................................................................. 23 
14.1: FORESEEABLE RISKS ................................................................................................................. 23 
14.2: REPRODUCTION RISKS .............................................................................................................. 25 
14.3: RISKS TO OTHERS ...................................................................................................................... 25 
CHAPTER 15 – INCOMPLETE DISCLOSURE OR DECEPTION ............................................................. 25 
CHAPTER 16 – POTENTIAL BENEFITS TO PARTICIPANTS ................................................................. 25 
16.1: POTENTIAL BENEFITS ................................................................................................................ 25 
CHAPTER 17 – DATA MANAGEMENT .................................................................................................... 25 
17.1: DATA ANALYSIS PLAN ................................................................................................................ 25 
17.2: POWER ANALYSIS ....................................................................................................................... 26 
17.3: DATA INTEGRITY ......................................................................................................................... 27 
17.4: DATA SECURITY .......................................................................................................................... 27 
CHAPTER 18 – PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS .......................................................................................................................................... 30 
18.1: DATA INTEGRITY MONITORING ................................................................................................ 30 
18.2: DATA SAFETY MONITORING ...................................................................................................... 30 
CHAPTER 19 – PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS .......... 34 
19.1: PROTECTING PRIVACY .............................................................................................................. 34 
19.2: ACCESS TO PARTICIPANTS ....................................................................................................... 35 
CHAPTER 20 – CONSENT PROCESS ..................................................................................................... 35 
20.1: CONSENT PROCESS (When consent will be obtained): ............................................................. 35 
20.2 COMPENSATION OF RESEARCH RELATED INJURY ................................................................ 36 
20.3 CONTRACT LANGUAGE ............................................................................................................... 36 
20.4: WAIVER OR ALTERATION OF CONSENT PROCESS ............................................................... 36 
20.5: NON-ENGLISH SPEAKING PARTICIPANTS ............................................................................... 36 

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20.6: PARTICIPANTS WHO ARE NOT YET ADULTS .......................................................................... 36 
20.7: COGNITIVELY IMPAIRED ADULTS, OR ADULTS WITH FLUCTUATING OR DIMINISHED 
CAPACITY TO CONSENT ..................................................................................................................... 36 
20.8: ADULTS UNABLE TO CONSENT ................................................................................................ 37 
CHAPTER 21 – SETTING .......................................................................................................................... 37 
21.1: INTERNATIONAL RESEARCH ..................................................................................................... 37 
21.2: COMMUNITY-BASED PARTICIPATORY RESEARCH ................................................................ 37 
21.3: RESEARCH SITES ....................................................................................................................... 38 
CHAPTER 22 – MULTI-SITE RESEARCH ................................................................................................ 39 
CHAPTER 23 – REFERENCES ................................................................................................................. 40 
 
 
 
 

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ABBREVIATIONS 
 
ANCOVA 
Analysis of Covariance 
CDC 
Centers for Disease Control and Prevention 
EASY 
Exercise and Screening for You 
IRB 
Institutional Review Board 
HIPAA 
Health Insurance Portability and Accountability Act 
NIA 
National Institute on Aging 
PA                    
Physical Activities  
PHI 
Patient Health Information 
QOL 
Quality of Life 
SPPB 
Short Physical Performance Battery 
WMT 
Wellness Motivation Theory 
REDCap 
Research Electronic Data Capture 
RAPA 
Rapid Assessment of Physical Activity 
RA 
Research Assistant 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
UMN 
University of Minnesota 
NNINR 
National Institute of Nursing Research 
RE-AIM 
Reach- Effectiveness –Adoption- Implementation-Maintenance 
SAS 
A statistical analysis software 
SPSS 
A statistical analysis software 
 
 
 
 

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STUDY SUMMARY 
 
Study Title 
Community-based intervention effects on older adults’ 
physical activity & falls 
Study Design 
2 x 2 factorial experimental design 
Primary Objective 
Determine which experimental intervention 
component(s) increase physical activity (PA) among 
community-dwelling older adults post-intervention: 
immediately, 6 months, and 12 months 
Secondary Objective(s) 
Determine which experimental intervention components 
decrease fall occurrence and increase quality of life 
(QOL) among community-dwelling older adults 12 
months post-intervention 
Primary Study Intervention 
or Interaction 
An 8 week PA intervention that includes the following 
components: 
1. Two sets of behavioral strategies:  interpersonal 
and intrapersonal 
2. Otago PA protocol  
3. PA-monitor (Fitbit Accelerometers)  
4. Attention Control Content: Health & Age Topics 
from the National Institute on Aging (NIA) 
Study Population 
Older adults  ≥ 70 years of age 
Sample Size (number of 
participants) 
N = 308  
Study Duration for 
Individual Participants 
15 to 18 months 
 
 
 
 

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CHAPTER 1- OBJECTIVES 
1.1: PURPOSE 
Purpose, specific aims, or objectives. 
Our research team will conduct a 2 x 2 factorial experiment testing the individual and combined 
effects of two empirically and theoretically relevant sets of behavior change strategies on 
community-dwelling older adults' physical activity. To do this we will randomize participants  
> 70 years old (n = 308) to 1 of 4 experimental conditions. All conditions include an evidence-
based physical activity protocol endorsed by Centers for Disease Control and Prevention (CDC) 
for use by all older adults, including those with frailty and multiple co-morbidities and the 
commercially available physical activity monitor (e.g., Fitbit) to augment intervention delivery. 
Intervention components that are experimental and vary by condition are the sets of behavior 
change strategies which will be combined with the physical activity protocol and the physical 
activity monitor. Condition 1 has no specific behavior change strategies; Condition 2 includes an 
intervention component comprised of 5 interpersonal behavior change strategies, such as 
facilitating social support and social comparison; Condition 3 includes an intervention 
component comprised of 5 intrapersonal behavior change strategies, such as setting personally 
meaningful goals; and Condition 4 includes both sets of behavior change strategies -- 5 
interpersonal strategies combined with 5 intrapersonal behavior change strategies.  
 
To fully examine the effects of these experimental components, we have delineated Primary, 
Secondary and Exploratory Aims: 
 
Primary Aim: Determine which experimental intervention component(s) increase PA among 
community-dwelling older adults post-intervention: immediately, 6 months, and 12 months. 
Hypothesis: Participants receiving the interpersonal set of behavior change strategies will have 
clinically meaningful increases in PA post- intervention (at all 3 time-points), compared to 
participants not receiving these strategies. 
 
Secondary Aim: Determine which experimental intervention component(s) decrease fall 
occurrence and increase quality of life (QOL) among community-dwelling older adults 12 
months post-intervention. Hypotheses: Participants receiving the set of interpersonal behavior 
change strategies will have clinically meaningful reductions in falls and increases in QOL, 12 
months post-intervention, compared to participants not receiving these strategies. 
 
Exploratory Aim: Evaluate experimental intervention component effects on targeted 
psychosocial constructs (social support; readiness; self-regulation) and physical constructs 
(functional leg strength and balance), which are theorized as mechanisms of change--and 
whether these mechanisms mediate the effects of experimental intervention components on PA 
and falls. Hypotheses: Receiving the interpersonal behavioral change strategies, relative to not 
receiving these strategies, will elicit increases in targeted psychosocial constructs and increases 
in physical constructs, which in turn will mediate the intervention’s effects on PA behavior and 
falls. 
 

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CHAPTER 2 - BACKGROUND 
2.1 
SIGNIFICANCE OF RESEARCH QUESTION/PURPOSE 
A description of the relevant prior research and gaps in current knowledge for your research 
question. 
Every year, 1 in 3 people aged 65 and older falls; 25% of which result in serious injury or death 
and have devastating effects on QOL.1, 5 Despite evidence that PA targeting leg strength and 
balance reduce falls, less than 12% of older adults engage in these activities on a regular basis 
and fall rates continue to increase.7 Research examining intervention strategies that motivate 
older adults to engage in PA is scarce and inconclusive. There is a compelling need to identify 
specific behavioral change strategies that effectively and efficiently motivate older adults to 
sustain increased levels of PA. 
 
Several behavioral change strategies have the potential to motivate older adults to engage in 
PA, such as facilitating social support;19 barriers management;27 goal-setting;28 habit formation 
;29 and self-monitoring outcomes.30 To date, intervention studies typically combine 7-10 
strategies and evaluate them as part of an “intervention package” compared to a control group. 
Thus, it is not known which strategy, or set thereof, are effective and should be included in 
efficient and translatable interventions. The objective of this proposal is to identify 
behavioral change strategies that elicit increased PA, sustained for 12 months and, in 
turn, lead to a reduction in falls and improved QOL. Building on prior research, the proposed 
study will use a factorial experimental design to test the relative influence of behavioral change 
strategies separated into two components. These components are comprised of distinct sets of 
behavioral change strategies that represent two different ways of motivating people to take 
action: interpersonal and intrapersonal, consistent with theories of behavioral change16, 22 and 
lifespan development, 46 as well as empirical evidence.33 The components will be combined with 
core intervention content that includes Otago, 10 an evidence-based fall- reducing PA protocol, 
and a PA-monitor for self-tracking. 
 
2.2 
EXISTING LITERATURE 
Scientific background for, rationale for, and significance of the research based on the existing 
literature and how will it add to existing knowledge. 
Fall rates continue to increase and PA rates remain low among older adults. The complex 
public health problems of falls and inactivity create significant social and economic burdens. 
Every year, 1 in 3 people aged 65 and older falls; 25% result in serious injury or death.1  
Injurious and fatal fall rates increase exponentially with age, particularly after age 70.1  Serious 
injuries caused by falls, such as traumatic brain injuries and fractures, 2 often require intense 
healthcare services within emergency rooms, hospitals, and nursing homes.3 They also 
increase fear of falling, 4 decrease mobility, and decrease QOL.5 The direct healthcare costs of 
fall-related injuries in older adults are $34 billion annually.1 Decreased leg strength, poor 
balance, and altered gaits are the most common causes of falls. These causes can be mitigated 
with the regular practice of leg strengthening and balance-challenging activities.6 Walking and 
flexibility movements augment these activities. Previous research demonstrates that 
approximately 35% of injurious/fatal falls can be prevented with fall-reducing PA,6 and that PA is 
associated with improved QOL.5 Despite public health efforts to disseminate and implement this 

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evidence, less than 12% of people aged 65+ engage in PA as recommended 7 and fall rates 
continue to rise. Thus, knowledge of fall-reducing PA has not translated to increased PA rates in 
the community of older adults, or made an impact on falls. It is essential to augment what is 
known; the types and doses of PA that reduce falls, with what is not known; intervention 
strategies that motivate older adults to sustain increased PA.8 
Fall-reducing PA interventions. In a Cochrane review, Gillespie and colleagues identify fall-
reducing PA among the most effective fall prevention interventions, yet few studies describe or 
evaluate strategies to increase “uptake” of and “adherence” to fall-reducing PA.6 The dozens of 
fall-reducing PA intervention studies conducted over the last several decades have generated 
substantial knowledge about which PAs work to reduce falls and injuries among older adults, 
including those with multiple chronic conditions, pain, and frailty.9 Meta-analyses show the 
effects of fall-reducing PA interventions on fall rate ratios range from 0.56 to 0.82.6,10,11 One 
example of an evidence-based program emerging from this literature is the Otago protocol, 
which is cost-effective when delivered 1:1 in home settings 12 and when delivered in small 
groups.13 Otago and other similar PA protocols include instruction and supervisory strategies, 
but not content to increase the initiation or maintenance of PA. The few intervention studies that 
have included such content show conflicting results due, in part, to the use of self-report PA 
measures.9,14 Future studies need to build upon existing evidence-based, fall-reducing PA 
protocols by combining them with evidence-based strategies to motivate older adults’ PA, and 
estimate their effects on objectively measured PA (e.g., accelerometer). Below we identify 
fundamental building blocks that inform such progress. 
Motivation for fall-reducing PA. Motivation, simply defined as why one moves to action, is a 
key determinant of older adults’ PA and a dynamic process dependent on key constructs.15-18 
For instance, social support for PA from important others (e.g., friends, neighbors, family, 
providers) is known to influence PA engagement.19,20 Readiness for PA refers to the 
identification of goals consistent with personal values and health-related behavior, as well as 
commitment and confidence for attaining those goals.21,22 Self-regulation refers to self-
monitoring progress toward goal attainment,23 identifying discrepancies between what is desired 
and what is achieved, and adjusting plans accordingly.24 Together, as postulated by the 
wellness motivation theory (WMT),25 and consistent with some research,26 these constructs 
influence the maintenance of personally valued health behaviors, such as PA. Despite strong 
evidence and theoretical explanations of motivation as a PA determinant, there is a dearth of 
fall-reducing PA research that evaluates motivational constructs.6,9 Motivational constructs, 
based on empirical evidence and theory, can be targeted in new multi- component fall-reducing 
PA interventions, using behavior change strategies. 
Which behavioral change strategies have potential to motivate older adults to sustain 
increased PA? Prior research, in the field of PA, indicates that many behavioral change 
strategies target motivational constructs and have the potential to increase older adults’ PA, 
such as facilitating social support; 19 barriers management; 27 goal-setting; 28 habit formation; 29 
and self-monitoring outcomes.30 To date, intervention studies have typically included 7-10 
strategies and evaluate them as part of an “intervention package” compared to control groups. 
To address questions about which of these strategies have an impact on key outcomes, meta-
analyses have been conducted to examine effects of individual and sets of similar behavioral 
change strategies, but show mixed results due to difficulties disentangling intervention content 
post- experiment.31,32 The studies do suggest that different strategies, or sets of strategies, may 
benefit older adults more than younger adults,33 and may result in sustained increases in PA.32 
A weakness of prior research is that it has not produced sufficient evidence to understand which 

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strategies should, or should not, be included in streamlined multicomponent fall-reducing 
interventions. A strength of prior research is that it highlights important methodological 
strategies that can be used in future research to improve reproducibility and scientific rigor, such 
as a) clearly describing each strategy used and how it is operationalized; and b) separating 
behavioral change strategies into distinct intervention components based on theoretical, 
empirical, and practical rationale, so that the contributions of each component may be examined 
experimentally. 
Questions about which behavioral change strategies motivate older adults to sustain 
increased fall-reducing PA warrant factorial experimental design. Factorial experiments are 
a practical approach to optimizing interventions for effectiveness, efficacy, and translatability 
through the identification of intervention components that meaningfully contribute to overall 
intervention effects. Components refer to distinct intervention features related to content (e.g., 
sets of behavioral change strategies), delivery, or other logistics. Other experimental designs, 
such as multiple arm comparative experiments and two arm randomized controlled trials, cannot 
directly address specific questions about the individual and combined effects of intervention 
components, and thus would be inefficient in the context of investigating their relative 
contributions.35 Factorial experiments are the best choice for future research that investigates 
combining fall-reducing PA interventions with behavioral change strategies, separated into 
distinct components, because these experiments enable answering questions about the 
individual and combined effects of intervention component(s) and thus also optimize the 
intervention for efficiency. 
PA-monitors can facilitate intervention delivery and data collection. Numerous 
commercially available PA-monitors (e.g., Fitbit) are affordable, acceptable and useful to older 
adults, 36 and have the potential to facilitate PA.37 Additionally, recent evidence suggests that 
PA-monitors, Fitbit OneTM in particular, provide accurate measurement of steps, PA duration 
and intensity.38-41 There are no fall-reducing PA intervention studies that we are aware of, with 
the exception of our preliminary studies that describe integrating PA-monitors. Evidence about 
commercially available PA-monitors can be used to inform intervention design and 
measurement methods. 
Community-based fall-reducing PA interventions have the potential to improve PA 
promotion efforts. Prior research suggests that community engaged research yields more 
meaningful collaborations; improved interventions that are more sustainable; and improved 
health outcomes on both individual and community levels.42 Fall-reducing PA interventions that 
are community-based provide a means for developing research-community partnerships, as 
well as interventions with potential to be more sustainable. 
In sum, this proposal addresses two serious, common, and preventable public health 
problems: falls and low PA, by integrating strengths and limitations of prior research. 
The intervention combines an evidence-based fall-reducing PA protocol targeting leg strength 
and balance; plus key behavioral change strategies targeting motivational constructs. These key 
behavioral change strategies, which are empirically based and theoretically informed, are 
separated into two intervention components comprised of distinct sets of intervention strategies: 
interpersonal (e.g., fostering social support for PA; facilitating friendly social comparison) and 
intrapersonal (e.g., facilitating the development of goals and plans). The individual and 
combined effects of these components on long-term outcomes, and motivational constructs, will 
be tested using a factorial experiment. Commercially available PA-monitors will be integrated 
into the intervention and the accelerometers built in to the monitors will be used to objectively 

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measure PA. The successful implementation of this proposal relies on partnerships with 
community stakeholders, which our team has established over the last three years. This 
proposal’s research will optimize a multicomponent intervention whose behavioral change 
strategies produce meaningfully sustained effects on increased PA, reduced falls, and improved 
QOL. This contribution will be significant because it is expected to foster the integration of 
biomechanically-oriented fall-reducing PA protocols with behavioral change strategies that 
impact health outcomes. 
Innovation. The design of this proposal’s study, and methods used to achieve its aims, 
are highly innovative. The design, driven by the inter-related problems of falls and low 
PA rates in older adults, engages the science of behavior change and gerontology to 
identify and test strategies that potentially motivate sustained PA, and in turn reduce falls 
and improve QOL. As illustrated in Figure 2, the conceptual model for this intervention 
includes critical elements that guide the serial assessment of mechanisms and 
outcomes, which will enable us to observe and describe intervention effects, as well as 
patterns of change over time. The design of this proposal is consistent with systematic 
approaches to optimizing behavioral change interventions that increase understanding of 
what works, when, and how; and that lead to effective, efficient, and translatable 
programs.43,44 Such approaches are a novel enhancement to existing fall-reducing PA 
protocols. Factorial experimental methods used within this proposal complement the 
design described here and allow us to directly test each aim’s working hypotheses.35 
The proposed research is innovative, in our opinion, because it represents a substantive 
expansion of biomechanically-oriented fall-reducing PA protocols to a) examine which 
behavioral change strategies elicit sustained effects (e.g., 12 months) on increased PA, 
as well as on falls, and QOL; and b) explore underlying mechanisms of PA and falls. 
Successful completion of this research is expected to strengthen PA promotion efforts in 
older adult populations by identifying strategies that support older adults to 
autonomously sustain increased PA, and by gaining an understanding of mechanisms 
that enable the application of our study results to other areas of health.45 
 
CHAPTER 3 - STUDY OUTCOMES 
3.1 
PRIMARY OUTCOME 
 The primary study endpoint, event, or outcome we will be evaluating or observing. 
The primary outcome is the quantity of PA: the average minutes of total PA per week (light, 
moderate and vigorous intensities) measured objectively and via self-report. 

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3.2   SECONDARY OUTCOME(S) 
Secondary study endpoints, events, or outcomes you will be evaluating or observing. 
Secondary outcomes include: 
● Fall rates 
● Quality of life 
3.3: EXPLORATORY OUTCOME(S) 
Other exploratory variables include: 
● Functional strength and balance 
● Social resources 
● Readiness 
● Self-regulation 
● Pain (intensity and impact on function) 
● Medication inventory 
● Sex as a biological variable 
● Covid 19 (impact of mitigation/ containment efforts on health and physical activity) 
CHAPTER 4 - STUDY INTERVENTION 
4.1: DESCRIPTION 
Intervention description.  
Dose and delivery. We carefully considered the dose of 8 weekly contacts, each lasting 
90 minutes, based on triangulated data from our prior research and feedback from 
community stakeholders. Our prior research 9 and the CDC compendium of fall 
prevention interventions 61 describe a broad range of doses that elicit promising effects 
with 8 weeks-12 contact hours on the low side of the range and 52 weeks-104 contact 
hours on the high side of the range. Also, our preliminary studies showed intervention 
session attendance was good across conditions and in post-intervention interviews, 
participants indicated this dose was acceptable: some even suggested we increase 
intervention duration to 12 weeks. Community stakeholders including older adults, center 
leaders, and healthcare providers advised us to increase the amount of time spent 
during contacts from 60 minutes to 90 minutes to ensure participants did not feel 
“rushed.” They also advised us to conduct intervention and data collection meetings 
between 9 am and 4 pm, and to limit group size to 4-6. 
Adjustments for Coronavirus: March 17, 2020 
Intervention visits in this study are done in small group (4 to 6 people) gatherings during 
which we practice the Otago Exercise Program movements together, and a coach 
facilitates discussions focused on behavior change strategies being tested. We enroll 
one cohort of 16 to 24 participants at a time, so they can complete the 8-week course. In 

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light of the current situation, we will delay future cohorts until we are able to deliver the 
small group intervention in person again.  
However, our current cohort (11 of 13) is in week 6 of the 8-week intervention. Thus, we 
plan to conduct these by phone conferencing using UMN Zoom. We will not use the 
video portion of Zoom because not all participants have access to the internet.  We will 
conduct each meeting according to our intervention manual, which delineates topics for 
discussion and exercise per Otago protocol. Similar to in-person intervention meetings 
and when participants perform these exercises at home independently (2 times per week 
to every day), there is a small risk of discomfort or injury.  Consistent with our protocol 
and the Otago Exercise Program manual we will minimize the risk using several 
strategies. First, the exercises in Otago are considered safe for older adults, including 
those with frailty and multiple chronic conditions. Second, we will ensure that all phone 
conference participants have water, and are near sturdy structures during the exercises, 
such as a non-rolling chair or a counter.  Third, we will remind participants to stop 
exercising if they feel discomforts such as joint pain or shortness of breath. Finally, at 
this point in the intervention, all participants who will participate in the conference call 
have mastered the exercises and know how to personally adapt them according to 
ability, comfort, and preferences. 
Table 3 highlights condition and content by time. Each contact is 90 minutes: 10 for 
questions and answers; 40 for 
Otago PA; 20 for interpersonal 
behavior change strategies; 
20 for intrapersonal behavioral 
change strategies; and, in lieu 
of behavioral change 
strategies--20-40 for attention 
control topics related to Health 
& Age, based on the National 
Institute of Aging website, Health & Aging.62 
The social milieu in each small group meeting will support friendly and positive 
interactions and discussions guided by curricula topics and objectives. All content 
(experimental, attention control, core) is summarized in the next six paragraphs. 
Experimental component: Interpersonal content. In the interpersonal component, a 
dialogue between small group participants will be facilitated focusing on their knowledge 
and experiences integrating fall-reducing PA into their social routines, providing and 
receiving social support for exercise, and using relevant community resources. Non-
competitive, friendly, social comparison and exchange will also be facilitated, focusing 
on sharing different ways to practice fall-reducing PA; PA patterns derived from personal 
PA-monitor data; what others think about PA; and sharing PA data with important others 
(e.g., family, friends, providers). 
Experimental component: Intrapersonal content. The intrapersonal component 
discussions will focus on guiding participants to develop, and modify as needed, 
personally meaningful goals and plans, using the National Institute on Aging’s Go4Life63 
goal- setting and weekly planning PA worksheets. Discussions will also address 
personal barriers management; habit formation; coping with potential setbacks; and self-
monitoring PA outcomes, congruent with personal goals. 

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Attention control content: Health & Age. Similar to our preliminary research, we will 
provide attention control topics about Health & Age, from the National Institute of Aging 
website including information about falls, pain, nutritional supplements, sleep, hearing, 
memory, and vaccinations. 
Core content: Otago (PA protocol). The evidence-based Otago protocol guides the core fall-
reducing PA content in this study. It is feasible and effective in community-dwelling older adults, 
including those with multiple chronic conditions (e.g., osteoporosis), pain, and frailty.10, 13, 64 Our 
team and others have successfully implemented the Otago PA protocol in small groups.13, 49 The 
overarching goal of Otago in this study is to facilitate participants’ mastery and individualization 
of specific movements and exercises so they can self-direct their practice of these outside the 
small group setting. The program includes 5 flexibility movements (back extension and ankle, 
head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip 
abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, 
backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one 
leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and 
a walking plan. The number, intensity and duration of movements are gradually increased.65 
Thus, time spent on the combined movements and exercises slowly increase across the 8-week 
intervention from approximately 15 to 35 minutes per meeting. We encourage participants to 
increase their walking time by 20% of their baseline average -up to 30 minutes per day. We also 
encourage participants to self-direct their practice of Otago PA that they have mastered, outside 
the small group meetings. Some choose to practice their leg-strengthening and balance PA 
during one timeframe. Others choose to practice different types of PA at different times of the 
day (e.g., balance exercises while waiting for coffee to brew, leg-strengthening exercises while 
watching TV). Similarly, some choose to take 30-minute walks once per day, others prefer to 
take break their walking time up into 10 minute bouts. In total, participants are encouraged to 
practice their personalized Otago PA protocol every other day ( approximately 70 minutes per 
week) and to walk approximately 30 minutes per day (150 minutes per week), which is 
consistent national and international PA guideline recommendations for minimal PA among 
older adults, including those with multiple chronic conditions.59 When participants cannot 
practice the amounts of PA recommended in Otago due to health conditions, they are 
encouraged to be as physically active as their abilities and conditions allow.59,66 
Core content: PA-monitor. We will use Fitbit, a commercially available PA-monitor. Matt 
Buman, Ph.D. (Consultant) is an expert in mobile health who will advise our research team 
about the model of Fitbit and provide input about managing and analyzing accelerometer data, 
which we accomplished in the past using Fitabase.67 Features of PA-monitors that were 
important to participants in our preliminary studies include displays with real-time feedback in 
the form of actual steps and distance, as well as positive messages that encourage about 
PA.36,50 Features essential for researchers include built-in accelerometers that accurately 
measure steps and PA duration. Each device will be set up and programmed prior to 
distributing. We will assign a unique monitor identification number to each monitor; not related to 
participant’s study ID or personally identifying information. Also, we will program monitor 
parameters (e.g., step goals) to minimal levels. During the baseline data collection meeting, we 
will provide each participant with a PA-monitor and a 15-20-minute orientation to review and 
demonstrate its basic functions: wearing, charging, and reading the display. Participants will 
also have the opportunity to return demonstrate. In addition, RAs will be available to help 
participants troubleshoot, as needed, via telephone and in person, after intervention meetings. 

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Intervention meetings include discussions about the PA-monitors, but topics vary per assigned 
condition (see Table 4) above.  
CHAPTER 5 – PROCEDURES INVOLVED 
5.1 STUDY DESIGN 
Experimental. We will address this proposal’s aims and hypotheses using a 2x2 factorial 
experiment where one factor represents receipt of an interpersonal intervention component (No 
vs Yes) and the second factor represents receipt of an intrapersonal intervention component 
(No vs Yes). Three hundred and eight community-dwelling older adults will be randomized to 1 
of 4 conditions, which represent distinct combinations of experimental components (sets of 
interpersonal and intrapersonal behavior change strategies) and core intervention content 
(evidence based physical activity protocol and a physical activity monitor). The study will be 
implemented in 13 waves over 48 months, within Minneapolis and St. Paul community centers. 
Interventions for each condition will be delivered to small groups of participants (4-6) 
randomized to the same condition. These small groups will meet every week for approximately 
90 minutes over the course of 8 weeks.  
5.2 STUDY PROCEDURES 
Figure 3 outlines an overview of participant activities in this study.  Participants at least 70 
years old with self-reported physical activity (PA) levels below national recommendations will be 
recruited from the Minneapolis-St. Paul, Minnesota metro region. Participants who respond to 
newspaper advertisements or fliers will call a central project telephone number to be scheduled 
for initial eligibility screening by the study coordinator.  
 
 
Screening. Potential participants who respond to newspaper advertisements or fliers will call a 
central project telephone number to be scheduled for initial eligibility screening by a trained 
study coordinator using the screening case report form in the Research Electronic Data Capture 
(REDCap). Screening questions will include: 
● Age and date of birth 
● History of lower extremity surgery  
● Fall risk factors 

Page | 16  
 
 
 
 
● Three surveys: 
1. The Exercise and Screening for You (EASY)56 
2. The Rapid Assessment of Physical Activity (RAPA) 54 
3. A six-item screener for cognitive function (name three items; recall three 
items; year; month; day of the week) 
Consenting and Baseline Data Collection. If potential participants are eligible and interested, 
trained study staff will meet them in person to obtain written informed consent. 
Once consenting is complete, the trained study staff will conduct baseline measures: (a) an 
interview including self-report measures (50 minutes); (b) observation of functional gait and 
balance (10 minutes); (c) initial or orientation to PA monitor--Fitbit (20 minutes); (d) after a one 
week practice period, participants and RA will meet again to confirm that the PA- monitor is 
acceptable and usable, and to begin the baseline 7 day PA data capture period (15 minutes); 
(e) after wearing the PA-monitor for 7-10 days, at least 10 hours each day, participants and 
study staff will meet again to complete the PA-data capture (15 minutes). Combined, the 
baseline procedures will require approximately 2 hours, and be completed over the course of 2 
weeks. 
 
Randomization: Once potential participants have provided consent and baseline data 
collection is complete, they will be formally randomized to 1 of 4 study conditions. They will 
begin the 8-week intervention within 8 weeks of enrollment/ randomization. 
 
There will be rare situations when a participant is enrolled and randomized in the study, but is 
unable to begin or complete the 8-week intervention due to unforeseen changes in their life 
such as the death of a family member or the sudden need for medical treatments. In such 
situations, participants will be given the option to: (a) delay their participation in the 8-week 
intervention portion of the study, (b) withdraw from the 8-week intervention, but undergo one or 
more of the post-intervention data collection meetings, or (c) withdraw from all aspects of the 
study. Trained study staff will identify and track such situations in REDCap.  
 
If participants choose option (a), they will not be re-randomized. Rather, researchers will invite 
them to an 8-week intervention course/ condition to which they were originally randomized, but 
that is scheduled to occur in a later time-frame.  
 
Research staff will repeat screening to determine continued eligibility. 
• 
If participants remain eligible, research staff will repeat baseline assessments within 8 
weeks of the participant’s delayed start of the 8-week intervention.   
• 
If participants become ineligible---, reason(s) for ineligibility will be documented. 
 
The analyst will compare and report the results of repeated baseline measures for subjects who 
choose option (a) and remain eligible for the study. If the differences between the repeated 
baseline measures are not significant, the first set of values will be used in inferential analyses. 
If the differences between the repeated baseline measures are significant, the second set of 
values (those most proximal to the intervention delivery) will be used in inferential analysis. A 
description of this will be included in all reports. 

Page | 17  
 
 
 
 
Research Outcome Data Collection. Trained research assistants will collect all data. They will 
be trained to accurately collect and manage data and to interview older adults in ways that are 
non-threatening, friendly, and respectful. Data will be derived from in-person interviews, 
observations, monthly fall calendars, and objectively measured PA parameters from 
accelerometers within participant’s commercially available PA-monitors. 
In-person interviews include scripted, structured interviews asking questions from these 
validated tools (all widely used) at the following time points: 
• 
Baseline only: Demographic* 
• 
Biological 
• 
Baseline; immediately post-intervention; 6 months’ post-intervention; and 12 months 
post-intervention: 
• 
Pain via the Brief Pain Inventory-short form (Tan, 2004; Mendoza, 2006) 89,90 
• 
Medication Inventory (see Appendix 2) 
• 
Self-reported health and Fall Risk (Stevens, 2013; Kunkel, 2011) 55,75 
• 
Impact of the COVID-19 Pandemic and Accompanying Mitigation Efforts on 
Older Adults’ physical activity and wellbeing110_ 
• 
Social Support and Exercise Survey (Family and Friends) (Sallis et.al , 1987)80 
• 
Duke--UNC Functional Social Support Questionnaire* 
• 
Index of Readiness (Fleury, 1994) 22 
• 
Self-Efficacy for Exercise (Resnick & Jenkins, 2000)81 
• 
Index of Self-Regulation (Fleury, 1998)84 
• 
Physical Activity Enjoyment Scale-8 
• 
Behavioral Regulation in Exercise Questionnaire (Markland & Tobin, 2004)83 
• 
Life-Space Mobility111 
• 
Physical Function-Short Form-6b (PROMIS; Rose, 2008)79 
• 
Physical Activity Scale For The Elderly PASE72 
• 
Health and Physical Activity Resources Survey (CIRS)112 
• 
Group Cohesion** 
• 
Quality of Life: Global Health Scale Patient-Reported Outcomes Measurement 
Information System, including items that address physical and social function 
(PROMIS) (Hays, 2009)76 
*Administered at baseline only 
**Administered immediately post-intervention only 
 
Coronavirus adjustments: March 17, 2020 
Assessment visits, which are structured interviews lasting approximately 45 to 90 minutes, will 
occur over the phone for the duration of new Coronavirus recommendations. We will notify the 
participants of this change. Our researchers will adjust their schedules according to our 
participants' availability and mail them information as needed. 
 
The SPPB portion of the assessments, which require in person observation, will be delayed until 
Coronavirus restrictions are lifted. 
 
Observations of functional strength and balance include the Short Physical Performance 
Battery at baseline; immediately post-intervention; 6 months’ post-intervention; and 12 months 
post-intervention.77 This battery includes timed repeated chair stand, semi-tandem, side by side, 
tandem balance testing, and a timed walk. Scores for each item are summed for a total score 

Page | 18  
 
 
 
 
ranging from 0-12 (12 indicates no impairments). The gradient of resulting scores validly reflects 
variation in lower extremity strength in older adult populations, and is predictive of progressive 
disability. It also demonstrates that the timed walk is predictive of catastrophic disability. The 
test will be discontinued if either the participant or the RA perceives it is unsafe to proceed. 
Fall calendars will be sent to participants monthly with instructions to document injurious and 
non-injurious falls by day of the month, as well as related circumstances and consequences on 
the questionnaires, which are located on the back of each calendar.73,74 They are mailed to 
participants one week prior to the beginning of each month. Participants will document 
prospectively on the calendars throughout the month, and then return them to the research 
team in the stamped, addressed return-envelope provided. We will call participants who do not 
return calendars to identify and problem-solve barriers to using them. We will also call 
participants who report falls to further explore fall circumstances and consequences. 
Objectively measured PA will be captured via the commercially available PA-monitors at 
baseline; immediately post-intervention; 6 months post-intervention; and 12 months post-
intervention. In this study we will use Fitbit OnesTM unless they are not available; in which case 
we will choose another equivalent Fitbit model. Participants will be asked to wear their Fitbits 
during data collection periods for up to 10 hours daily, for 7-10 consecutive days. Each of their 
PA-monitors will be assigned an alphanumeric ID and will be registered under that ID, which is 
not connected to their study documents or personally identifiable information. Data, PA intensity 
classifications and number of steps walked (day total, hour, and minute-by-minute intervals) will 
be captured by Fitabase, a fully hosted, cloud-based software that implements robust industry 
standards to maintain secure research databases and keeps data private.67 Fitabase enables 
the aggregation, reduction, visualization and management of data prior to downloading it into 
Research Electronic Data Capture (REDCap). Both databases meet privacy and security 
required when conducting research responsibly. 
Process evaluation. Because this is a behavioral randomized control trial we will evaluate, 
formatively and summatively, processes involved with implementing the intervention as planned. 
In particular, we will (a) examine the extent to which the intervention was delivered as planned 
by each interventionist using indices of procedural consistency by the interventionist and by the 
principal investigator (PI) reviewing randomly selected audiotapes of intervention meetings, as 
well as field notes from each meeting; (b) the extent to which individual participants received 
and enacted the intervention using attendance records, tracking progress of each participant's' 
exercises (tracking tools for this are part of the evidence based PA protocol); and, (c) multilevel 
factors (e.g., individual, social, environmental and institutional) that may influence intervention 
implementation and effects using semi-structured interviews of randomly selected study 
participants (n=30), from the perspectives of leaders within community centers that host this 
intervention (n= 5).  These interviews will be audiotaped and analyzed using content analyses. 
Attendance after each meeting documented by the interventionist. If a participant misses more 
than one meeting, trained study staff will call them to discuss and problem solve any barriers to 
attendance.  
The interventionists will document attendance and field notes after each meeting. They will also 
track individual participant progress with the exercises that are included in the evidence-based 
protocol, which is part of the standard administration procedures of the protocol. 
After completing the 8-week intervention, participants will be scheduled for data collection 
meetings immediately post-intervention (e.g., during the week after the intervention ends); 6 

Page | 19  
 
 
 
 
months post-intervention; and 12 months post-intervention. Procedures used during these data 
collection meetings will be similar to the aforementioned baseline procedures, minus the 1 week 
practice period. Combined, post-intervention procedures will require 4.5 hours (90 minutes per 
data collection time point). 
Semi-structure interviews to ascertain participants' perspectives of multi-level Barriers and 
Facilitators of implementation and effect immediately post study. 
 
5.4 FOLLOW-UP 
Please Refer to section 5.3 above 
CHAPTER 6 – DATA BANKING 
 
Not Applicable 
 
CHAPTER 7 – SHARING OF RESULTS WITH PARTICIPANTS 
7.1 DISSEMINATION 
We will share protocol content and study findings with interested participants, community 
partners, and public health officials in Minnesota. Our dissemination plan has three main facets. 
First, we will publicly present information about all aspects of this proposal; study protocol; 
intervention content; recruitment and retention strategies; and findings local meetings within 
community centers. We will also make annual presentations locally through the UMN School of 
Nursing’s Annual Research Conference; during meetings with community partners; and during 
Minnesota’s annual Fall Awareness Day.101 Second, we will develop a website for the study 
where we will post information about PA and falls and post summaries of our presentations on 
this Web site, written in plain language for a general audience. Third, we will provide 
participants with a report of their personal results pertaining to their balance, leg strength and 
PA.  
CHAPTER 8 – STUDY DURATION 
● The duration anticipated for an individual participant’s participation in the study: 
15 to 18 months 
● The duration anticipated to enroll all study participants: 4 years 
● The duration anticipated to complete all study procedures and data analysis: 6 
years (given COVID-19) 
CHAPTER 9 – STUDY POPULATION 
9.1 INCLUSION CRITERIA 
All potential participants will be screened by trained study staff for inclusion based on the 
following criteria: 
Inclusion Criteria: 

Page | 20  
 
 
 
 
● ≥70 years of age 
● English speaking 
● Low PA as determined by the Rapid Assessment of Physical Activity Survey54 
o Aerobic sub score 1-4 – Does not participate in endurance exercise such 
a walking more than 150 minutes per week, and / or 
▪ 
Strengthening/Balance activities sub score of 0 – Does not 
participate in strengthening and/or balance exercises more than 
once per week 
 
● One or more fall risk factors as determined by CDC, Steadi fall risk screener 55 
o One or more falls in the last year 
o Unsteadiness when standing or walking 
o Worries about falling 
● Participants who self-report the following symptoms will require clearance from a 
primary provider (as guided by the Exercise and Screening for You 
Questionnaire):56 
o Pain, tightness or pressure in chest during PA (walking, climbing stairs, 
household chores, similar activities) that have not been checked and/ or 
treated by a healthcare provider 
o Current dizziness that have not been checked and/ or treated by a 
healthcare provider 
o Current, frequent falls that have not been checked and/ or treated by a 
healthcare provider 
 
9.2 EXCLUSION CRITERIA 
Exclusion criteria for participation in this study include: 
● Lower extremity surgery within the past 6 weeks 
● Inability to walk 
● Formal diagnosis of neurocognitive impairment or Callahan Dementia Screener 
score of < 5. 
 
9.3 SCREENING 
Screening: A trained study staff will screen potential participants via telephone 
interviews using the screening case report form in Research Electronic Data Capture 
(REDCap), which includes questions about: 
● Age 

Page | 21  
 
 
 
 
● History of lower extremity surgery Fall risk factors 
● Three short surveys: 
1. The Exercise and Screening for You (EASY) 56 
2. The Rapid Assessment of Physical Activity 54 
3. The Callahan Screener for Cognitive Dysfunction 113 
▪ 
Repeat the following words (apple, table car) 
▪ 
What is the year 
▪ 
What is the month 
▪ 
What is the day 
▪ 
Remember the words we just talked about (apple, table, car) 
CHAPTER 10 – VULNERABLE POPULATIONS 
This study does not include vulnerable populations; however, we will not exclude 
older adults with variable levels of functional capacity or the economically 
disadvantaged. Approximately 36% of older Americans report having difficulty 
performing one or more activities of daily living; and 9.5% report incomes below the 
poverty level. 108 Thus, these populations should not be excluded from intervention 
studies designed to increase PA, reduce falls, and improve QOL. 
CHAPTER 11 – NUMBER OF PARTICIPANTS 
11.1: NUMBER OF PARTICIPANTS TO BE CONSENTED 
308 
CHAPTER 12 – RECRUITMENT METHODS 
12.1 RECRUITMENT PROCESS 
.Recruitment strategies will combine ones employed in our successful preliminary study 
with strategies that can reach senior groups within the many neighborhoods from which 
we recruit. In collaboration with community partners and experts from the University of 
Minnesota (UMN) Clinical Translation Science Institute (CTSI), we will design 
advertisements and fliers to place in neighborhood and city-wide newspapers and 
locations frequented by older adults (e.g., coffee shops; clinics). Thus, recruitment 
efforts will extend to the immediate neighborhoods of the community centers as well as 
the surrounding townships and suburbs. 
We will also create a study website and a Facebook page that will include information 
about the study for potential volunteers. The Facebook page content will be taken 
primarily from the current website. Through Facebook, we will reach out to senior groups 
who also have Facebook pages to let them know about the study. 

Page | 22  
 
 
 
 
If recruitment is slower than anticipated, we will employ an additional strategy for 
recruitment – we will send letter to mailings from Fairview (FV) to potential participants 
(see letter in recruitment attachments). This mailing process begins with a request to 
University of Minnesota's Clinical Data Repository for data to support preparatory 
research work (recruitment). Data from this request will include US mail addresses of 
individuals who are alive, over 70, and without dementia. Data will be de-identified to the 
PI and research team. The Pl /research team will not contact people directly. Rather, 
Fairview/ UMN research services will be employed to send mailings to potential 
volunteers living in zip codes near community center hosting the study. Mailings will 
include a letter from FV (explaining the nature of the mailing, FV’s role) and the letter 
from Pl (briefly explaining the current study and how to learn more about it). 
12.2: SOURCE OF PARTICIPANTS 
Participants will be recruited from the community at large.  
12.3: IDENTIFICATION OF POTENTIAL PARTICIPANTS 
Participants will self-identify in response to the recruitment methods described in section 12.1 
above. 
 
Trained study staff, including study coordinator, RAs, and a licensed nurse, will make initial 
contact with potential participants.  
No private or protected medical records will be used in this research.  
12.4: RECRUITMENT MATERIALS 
Refer to section 12.1 above and attached recruitment materials 
12.5: PAYMENT 
We will offer to coordinate and subsidize transportation to data collection and intervention 
meetings, upon request from participants in need.  
 
Participants will receive $50.00 after each of the four PA data collection periods (approximately 
7 days each) and $20.00 after each of the 4 data collection meetings (interviews).  
 
The 8-week intervention meetings will be free of charge and participants will be encouraged to 
keep and use workbooks, ankle weights, and PA-monitors they receive as part of this 
intervention.  
 
Forty participants will also be invited to participate in a semi-structured interview within 6 months 
of completing the study and will receive an additional $20.00 after that interview.  
 
Therefore, the total possible compensation for participating in the study ranges from $280.00 to 
$300.00. 
 
Compensation will go directly to the participant and Research Experience Points will not be 
awarded. 
 

Page | 23  
 
 
 
 
Compensation schedule. Participants will be reimbursed immediately after each data 
collection period as scheduled bellowed: 
● Structured Interview 1 (Baseline): $20.00 
● Structured Interview 2 (Immediately post-intervention): $20.00 
● Structured Interview 3 (6 months post-intervention): $20.00  
● Structured Interview 4 (12 months post-intervention): $20.00 
● PA data collection period 1: (Baseline): $50.00 
● PA data collection period 2: (Immediately post-intervention): $50.00  
● PA data collection period 3: (6 months post-intervention): $50.00  
● PA data collection period 4: (12 months post-intervention): $50.00 
● PROCESS Evaluation: Post-study completion: $20.00 
o 25 to 30 participants (from each condition) will be selected, at random, to 
participate in a 30-45-minute interview addresses barriers and facilitators of 
intervention implementation and effect. 
CHAPTER 13 – WITHDRAWAL OF PARTICIPANTS 
13.1: WITHDRAWAL CIRCUMSTANCES 
We anticipate all withdrawals from our study will be voluntary, based on our two pilot studies 
during which there were no involuntary withdrawals (out of 130 participants).  
13.2: WITHDRAWAL PROCEDURES 
When participants withdraw from the intervention, but continue to participate in 
data collection, we will:  
● Document their withdrawal from the intervention and reason(s) for withdrawal 
(e.g., change in schedule, illness, family responsibilities)  
○ We will use intention to treat, such that data from these participants will 
be included in the analysis.  
13.3: TERMINATION PROCEDURES 
Because the risks involved in this study are very low, we do not anticipate study 
termination. Should the study be terminated for administrative reasons, the study team 
will communicate to all participants, community partners and all study team members the 
timing and rationale for termination. Additionally, they will ensure data collected to date 
is managed, cleaned and available to investigators, IRB, NIH/NINR for reporting 
purposes.  
CHAPTER 14 – RISKS TO PARTICIPANTS 
14.1: FORESEEABLE RISKS 
The minimal risks in this study relate to psychological or social discomfort as well as 
mild temporary muscle soreness or discomfort.  
The potential risk for minimal psychological or social discomfort may occur when 
completing surveys and attending small group intervention meetings. This risk is 

Page | 24  
 
 
 
 
considered minimal; the alternative is to not answer the questions or to not participate in 
the small group conversations that elicit discomfort. 
 The small potential risk for mild, temporary muscle soreness or discomfort when first 
performing the exercises. This is an expected, transient symptom and considered a 
minimal risk, not a serious risk. The risk of injury when performing exercises and 
movements in the Otago physical activity protocol is similar to risk of injury with 
everyday movements and activities of daily living, and considered to be a minimal risk. 
The alternative is to not engage in the exercises and movements in the Otago protocol 
or similar, which creates a risk of musculoskeletal disuse and, in turn, higher risks of 
falls. 
Minimizing risk 
To minimize research-associated risk, the protocol will be conducted fully in keeping with 
the manual of operation, approved by the IRB, and summarized in the consent form. The 
consent process informs each volunteer about the study, indicates the participation is 
voluntary and she/ he has the right to stop at any time. Risks are enumerated in the 
informed consent form and described verbally during the consent process. In addition, 
the design of the intervention integrates strategies to minimize risks: 
To minimize the risk of psychological or social discomfort we will implement three 
main strategies. First, all research staff successfully complete required training 
and maintain competence to facilitate 1:1 interviews (e.g., for data collection) and 
group discussions (e.g., intervention meetings) with older adults in ways that are 
non-threatening, friendly and respectful. Second, study participants will be 
reminded, verbally and via the written materials, that they do not have to 
complete any question they do not want to answer; that 1:1 interviews may be 
terminated at any time per their wishes; that they do not have to participate in 
any small group conversation they do not want to; and, that they are free to leave 
any intervention meeting at any time per their wishes. Finally, we will also inform 
all participants that they may choose to withdraw from the study at any time 
without negative consequences or without risking loss of present or future care 
they receive or access they have to community center resources. 
To minimize the risk of mild, temporary muscle soreness or discomfort or injury 
while performing exercises and movements in the study, we will implement three 
main strategies. First, the evidence-based physical activity protocol used in this 
study is effective and safe across older adult populations, including those with 
multiple chronic conditions and frailty. Second, participants will be informed, 
verbally (during intervention meetings) and in writing (via their workbooks) about 
what to expect, how to minimize risks of mild, temporary muscle soreness or 
discomfort, and how to prevent injury. Third, the PI has extensive experience 
leading Otago and is a board certified gerontological nurse practitioner. She and 
Becky Olson-Kellogg DPT, an expert in gerontological PT, will review training 
plan and monitoring for interventionists in this study. She will be available to 
assessors (e.g., for the SPPB) and interventionists for consultation throughout 
the study.  

Page | 25  
 
 
 
 
14.2: REPRODUCTION RISKS 
Not Applicable 
14.3: RISKS TO OTHERS 
Not Applicable 
CHAPTER 15 – INCOMPLETE DISCLOSURE OR DECEPTION 
Not Applicable 
CHAPTER 16 – POTENTIAL BENEFITS TO PARTICIPANTS 
16.1: POTENTIAL BENEFITS 
We believe participation in this research will yield benefits for participants. Mastery of physical 
activities within the Otago PA protocol will provide participants with skills and knowledge to 
practice these exercises safely at home or in other environments of their choice. The behavioral 
change strategies in the intervention have the potential to motivate participants continued 
engagement in PA.  Participants will also receive a PA-monitor for self-tracking and support to 
use it as well as interpret its data.  
CHAPTER 17 – DATA MANAGEMENT 
17.1: DATA ANALYSIS PLAN 
Statistical analysis. Descriptive statistics (means, standard deviations, ranges for 
continuous variables and counts/ percentages for categorical variables) will be used to 
summarize biologic, demographic, outcome, and exploratory measures by treatment 
arm, actual and projected accrual, attendance and retention rates, quality control data 
(e.g., missing data), and fidelity data. Tables, graphs and charts will be used to visualize 
data when appropriate. Enrollment summaries will be reviewed at weekly research staff 
meetings throughout enrollment phases and every month during non-enrollment phases. 
Differences by randomly assigned condition will be assessed with one-way ANOVA tests 
for continuous and Fisher’s exact test or chi-square tests for categorical variables as 
appropriate. Any identified confounders will be adjusted for in subsequent analyses. All 
analyses will be pre-planned and conducted while masked to condition.  
We will include all cases in analyses, regardless of intervention attendance rates or 
attrition. Missing data will be analyzed. We anticipate, based on preliminary research 
that the rate of missing data will be low and similar across conditions, but that it may be 
associated with severe illness that leads to dropout or inability to capture follow- up PA 
data. Thus, similar to preliminary analyses, we will conduct a sensitivity analysis of 
complete cases and imputing worst case carried forward.   
Primary Aim: Intervention component effects on PA will be assessed using 2x2 full 
factorial ANCOVA models with duration of total PA as the outcome (average minutes per 

Page | 26  
 
 
 
 
week). The factors, or independent variables, are interpersonal and intrapersonal 
components; each with two levels indicating exposure (No vs Yes). Different models will 
be developed for PA measured objectively. PA will also be measured via self-report. 
Each model will include baseline PA values as a covariate. Main and interaction effects 
of the components on the duration of PA will be tested immediately, 6 months, and 12 
months post- intervention. Further, we will apply multilevel longitudinal data analyses to 
examine the variation of component effects across time-points (baseline; immediately 
post-intervention; 6 months’ post-intervention; and 12 months’ post- intervention), 
including interactions between components (e.g. interpersonal x intrapersonal x time), 
which will allow us to see when an older adult might benefit from additional support to 
maintain PA.  
Secondary Aim: The secondary outcome of Falls will first be described using the 
number of falls, fallers, fall rate, and time to first fall post-intervenion.74 Given the 
expected distribution of falls, we will use negative binomial regression models to 
estimate the between-group difference in fall rates 12 months’ post-intervention. Quality 
of Life data will be assessed using 2x2 full factorial ANCOVA and longitudinal analyses 
described for Aim 1 with total mean QOL as the outcome variable.  
Exploratory Aim: The exploratory aim of the study is to investigate the nature of 
relationships between receipt of one or more intervention component and outcome 
variables. We will assess if this study’s intervention component(s) changed mediator 
variables, and in turn caused increased PA or reduced falls. In this study, the putative 
mediators of PA are Motivational Constructs: a) social support (support from family and 
friends for physical activity); b) readiness (Index of Readiness, Self-Efficacy for Exercise 
Scale); and c) self-regulation (index of self-regulation, goal attainment, Behavioral 
Regulations in Exercise Questionnaire-3). The putative mediators of falls are Physical 
Markers of Fall Risk: leg strength and balance (SPPB, Physical Function SF 6b). Using 
the general approach to mediation analysis described by MacKinnon,96 we will assess 
the effects of intervention components on mediators, and the effects of mediators on 
outcomes, as well as the total direct and indirect effects of intervention components on 
PA and falls. Counterfactual approaches described by Vanderweele and colleagues97 
will be used if nonlinearities or interactions between exposure and mediator variables 
are observed. 
Additional exploratory analyses: pain, medication, and sex as a biological variable: 
Although this study is not designed to conduct confirmatory subgroup analyses of covid-19, 
pain, medication, or sex,98,99 we will conduct stratified, exploratory analyses to assess effect 
modification by these variables. We will report values for these variables as well as differences 
observed, which may be valuable for future research and meta-analyses 
17.2: POWER ANALYSIS 
Sample size and power.  The primary aim of the proposed study is to detect clinically 
meaningful intervention effects on PA from baseline to 12 months’ post-intervention. 
Meta- analyses in the field of PA and older adults describe standardized effect sizes that 
range from .18 31 to .26, 92 which translate to 670 to 870 additional steps per day or 73 to 
94 additional minutes of PA per week. Although these effects are small, they are 
considered to be clinically important in older populations whose overall activity levels are 
low; often sedentary.93 Thus, we based our sample size estimates on a small 

Page | 27  
 
 
 
 
standardized effect size of .20. We also anticipate 15% attrition at 12 months, based on 
our preliminary studies which showed 7% attrition at 6 months. Considering these 
assumptions, a sample size of 308 (77 per condition) will enable us to detect small but 
clinically meaningful main effects of the interpersonal or intrapersonal components as 
well as their interaction (effect sizes of .20), with 80% power, under a two-tailed 
hypothesis test at a significance level of .05.94 This sample size will also enable us to 
detect medium to large effects on our secondary outcome of falls (fall rate ratios of .40 to 
.70), with 80% power, under a two-tailed hypothesis test, at a significance level of.05, 
which is consistent with prior research that shows Otago PA reduces falls (fall rate ratios 
0.56 to 0.79).10 
17.3: DATA INTEGRITY 
Data Monitoring. Ongoing quality control procedures will be implemented for data 
collection, storage and processing. The data manager will conduct monthly monitoring of 
the study database and generate a report for the PI to review at team meetings. 
Standing agenda items for these meetings will include participant recruitment and 
retention, serious adverse events, unexpected adverse events, expected adverse 
events, protocol deviations, data integrity, and overall study conduct. 
CHAPTER 18 – CONFIDENTIALITY 
17.4: DATA SECURITY 
Data Collection. All data from participants screened for the study will be entered and 
stored in an electronic study database. Designated research staff will collect and enter 
required data (written informed consent, responses to interview data) onto electronic 
study data forms. Screened participants who do not meet study eligibility will have 
specific screening data entered the study database as this data will be helpful in 
examining the patient population and feasibility of enrollment criteria and will include 
gender, age, race and reason for exclusion. All dates will be shifted and other Personal 
Health Information (PHI)--which in this study includes self-reported medical history, fall 
risk, and medication regimen--will be removed from the study database upon study 
completion. All data obtained from this study will be used for research purposes only and 
will not include data from electronic health records. 
Interview and observational data will be entered directly into a Research Electronic Data 
Capture (REDCap) database from encrypted, password protected iPad tablet 
computers. Physical activity data will be downloaded into REDCap (link to REDCap at 
University of Minnesota: https://sites.google.com/a/umn.edu/redcap-help/) from Fitabase 
(link to Fitabase: https://www.fitabase.com/), a research database for accelerometer 
data captured from Fitbit. Fitabase captures, aggregates, and securely stores de-
identified accelerometer data from Fitbit monitors. Participants receive unique Fitbit 
research identification numbers; different from their study identification numbers and 
personal identifying information. Our team has extensive experience using both REDCap 
and Fitabase in previous research. 
Case Report Forms. All proposed study specific case report forms (source documents) 
for data collection will be designed by the PI within the electronic Case Report Forms 
(eCRFs) for use in the study’s REDCap database. All study specific eCRFs source 
documents and collected data will be organized by the participant’s unique study 

Page | 28  
 
 
 
 
identification number in the participant research record, available only to the PI and 
study coordinator. Completed paper consent forms that require signature will be 
scanned and uploaded into the study database as well as maintained on file in 
accordance with University of Minnesota Institutional Review Board (IRB) policies and 
applicable National Institutes of Health (NIH) Federal Regulations for the Conduct of 
Human Participant Research. 
Binders. The study coordinator will prepare and maintain a binder for each participant 
containing all non- eCRFs records. Regulatory files will also be maintained to include the 
IRB- approved Protocol, original Informed Consent documents, and other study-related 
regulatory documents. 
Binders and all study related records will be stored in a locked file cabinet within a 
School of Nursing research office located on the University of Minnesota campus. The 
research office and the building housing this office, (Dinnaken, room 120, 925 Delaware 
St SE, MPLS, MN 55414), are both secured 24 hours per day, 7 days per week. Also, 
the building and the nursing research office within the building are access controlled with 
card readers, granted by the PI only. Additionally, the building is monitored by the 
University of Minnesota security services 24 hours per day, 7 days per week. This 
building also houses research offices for other departments and centers in the University 
of Minnesota such as the Transplant Research Organization. 
Access to the research records, study database and PHI’s will be restricted to study personnel 
as approved by the PI and IRB. As with all studies conducted at the University of Minnesota, 
this study is also eligible for a random audit by University of Minnesota’s Office of Compliance, 
as well as NIH, National Institute of Nursing Research (NINR). 
Data Processing. This study will use REDCap for data capture and management. 
Data Security. Data entered directly into our REDCap database via tablet computers 
(e.g., IPad) used exclusively for research, which are encrypted and protected by strong 
passwords. We will use a University of Minnesota, School of Nursing established policy 
and procedure for using research-only computer tablets that includes details about 
security, access to internet, and access to REDCap, transport, and storage. When not 
being used in data collection meetings, these research-only tablet computers will be 
stored in research office space housed in the Dinnaken Office Building. Details about the 
security and monitoring of this office and building are described above under Binders.  
REDCap uses a MySQL database via a secure web interface with data checks used 
during data entry to ensure data quality. REDCap includes a complete suite of features 
to support HIPAA compliance, including a full audit trail, user-based privileges, and 
integration with the institutional Lightweight Directory Access Protocol server. The 
MySQL database and the web server will both be housed on secure servers operated by 
the University of Minnesota Academic Health Center’s Information Systems group. The 
servers are in a physically secure location on the University of Minnesota campus and 
are backed up nightly, with the backups stored in accordance with the AHC-IS retention 
schedule of daily, weekly, monthly tapes retained for 1 month, 3 months, and 6 months, 
respectively. Weekly backup tapes are stored offsite in Minnesota. The AHC-IS servers 
provide a stable, secure, well-maintained, and high-capacity data storage environment, 
and both REDCap and MySQL are widely-used, powerful, reliable, well-supported 
systems. 

Page | 29  
 
 
 
 
Data Entry. Each participant will be assigned a unique study identifier in REDCap, all 
PHIs will be masked, and data exports will be limited to the PI and the data manager for 
generating reports and the conduct of statistical data analysis. 
Security and privacy information: a statement from Fitabase. As a research platform that 
collects data from internet connected consumer devices, Fitabase takes security and privacy 
seriously. Fitabase is a fully hosted, cloud-based software solution that implements robust 
industry standards to maintain secure databases and keep data private. Fitabase code and 
databases physically reside on the Microsoft Windows Azure platform 
(www.windowsazure.com). We rely on the robust security, both physical on premise guarding, 
and over network, provided as part of that platform. From Microsoft 
(http://www.windowsazure.com/en-us/support/trust-center/security/): Windows Azure runs in 
data centers managed and operated by Microsoft Global Foundation Services (GFS). These 
geographically dispersed data centers comply with key industry standards, such as ISO/IEC 
27001:2005, for security and reliability. They are managed, monitored, and administered by 
Microsoft operations staff that have years of experience in delivering the world’s largest online 
services with 24 x 7 continuity. In addition to data center, network, and personnel security 
practices, Windows Azure incorporates security practices at the application and platform layers 
to enhance security for application developers and service administrators. In addition to the 
primary copies of our databases, Small Steps Labs LLC maintains snapshot archives of our 
database for disaster recovery purposes. Our backup copies reside on hardware only 
accessible to Small Steps Labs LLC and our employees. Our backup copies are encrypted and 
password protected. Fitabase uses Secure Sockets Layer (SSL) for all authentication (logins), 
billing, and administration of the site. The user's browser establishes the authenticity by 
requesting an SSL certificate that verifies the identity of Fitabase. Once that SSL certificate is 
recognized, a Secure Sockets Layer (SSL) connection is established for security, encrypting 
data transmitted between browser and web server. Passwords: Fitabase stores passwords in 
encrypted form. When an administrator attempts to log in to Fitabase.com, their attempted 
password is encrypted and if matched, the user is allowed in to the site. This practice prevents 
unauthorized usage of the site. If the database were to be compromised, passwords would not 
be retrievable. Fitabase logs all site usage, including attempts to access restricted data, or log in 
to accounts of others. We maintain security policies to block / freeze accounts that appear to be 
compromised until we are able to make contact via the email address used to set up the 
administrator account. Fitabase allows groups wishing to collect data anonymously the option to 
do so by associating device data with their own alphanumeric identifiers. To best accomplish 
this, groups should set up the Fitbit.com account that corresponds with each device using an 
anonymous email address not linked to a real person. Fitabase does not collect personally 
identifiable information beyond what it is provided by Fitbit.com. 
Additionally Fitabase does not collect IP addresses from synced participant devices. Fitabase 
stores information provided to it by the Fitbit API (dev.fitbit.com). This information about: 
Data is stored and indexed in the Fitabase SQL Server database in day total, hour, and 
minute-by-minute intervals. Our database servers are IP firewalled and whitelisted such 
that they refuse any connection from IP addresses not preprogrammed by us. No GPS 
or other location information is collected. 

Page | 30  
 
 
 
 
CHAPTER 18 – PROVISIONS TO MONITOR THE DATA TO ENSURE 
THE SAFETY OF PARTICIPANTS 
This study introduces a minimal risk to participants, 
18.1: DATA INTEGRITY MONITORING 
The Data Safety Monitoring Plan (DSMP) for this trial will focus on close monitoring by the PI in 
conjunction with research staff and an Independent Safety Monitor who will be available to 
review and recommend appropriate action regarding individual reports of serious adverse 
events, adverse events, and other safety issues. 
The Principal Investigator (PI). The PI will have the primary responsibility to monitor this 
study. The PI will review data on such aspects as participant enrollment, study procedures, 
forms completion, data quality, losses to follow-up, and other measures of adherence to the 
protocol. The PI will review all possible and real events, and seek recommendations from the 
Independent Safety Monitor in real time regarding all serious adverse events and adverse 
events. The PI will also be responsible for submitting necessary reports to NINR and the 
University of Minnesota institutional IRB within 72 hours and 5 working days of each serious 
adverse event and adverse event. 
Research Staff. The trained and IRB certified research staff, including RAs, a study 
coordinator and interventionist, will continuously monitor safety and immediately apprise 
the PI of all possible or real events so that appropriate communication and action can be 
taken in a timely manner. The data manager will prepare tables with data related to 
enrollment, retention, adherence on a monthly basis for review by the PI and her 
research team. 
Independent Safety Monitor: Diane Treat Jacobsen PhD, FAAN, Chair of the University of 
Minnesota’s School of Nursing Adult and Gerontological Cooperative. She is an adult / 
gerontological clinical nurse specialist and experienced researcher in randomized, controlled 
intervention studies for older adults that focus on physical activity to reduce peripheral arterial 
disease, as well as quality of life. She has received external funding for more than 8 years to 
support her research in clinical and community settings. Dr. Treat-Jacobsen is independent of 
the current study and is available in real time to review and recommend appropriate action 
regarding serious adverse events, adverse events, and other safety issues.  
The primary responsibilities of the safety monitor will be to evaluate the performance of this 
study, the safety of the participants, and to determine if continuation of the study is appropriate; 
scientifically and ethically. The PI will have several meetings with the safety monitor. The first 
meeting will be held prior to recruiting participants to evaluate the protocol, consent process and 
analysis plan. The second meeting will occur after 30 participants have enrolled (10% of 
expected enrollment) and then every six months to review progress on this project. The PI, and 
the safety monitor will also meet on an as-needed basis to review any possible or real adverse 
events.  
18.2: DATA SAFETY MONITORING 
The investigators of this study have established a data safety and monitoring plan. Data 
Monitoring. Ongoing quality control procedures will be implemented for data collection, storage 
and processing. The trained study staff will conduct monthly monitoring of the study database 
and generate a report for the PI to review at team meetings. Standing agenda items for these 

Page | 31  
 
 
 
 
meetings will include participant recruitment and retention, serious adverse events, unexpected 
adverse events, expected adverse events, protocol deviations, data integrity, and overall study 
conduct. 
 
Monitoring Study Safety. To monitor safety, indicators for each aspect of the scientific process 
will be tracked in real time then summarized and evaluated on a monthly basis. Aspects of the 
scientific process that will be tracked include initial screening of participant by inclusion and 
exclusion criteria; adherence to informed consent procedures; provision of study instructions to 
participants; provision of instructions to research staff for Good Clinical Practices, regulations 
pertaining to the Conduct of Human Participant Research, intervention delivery, and weekly as 
as-needed contact with participants for troubleshooting technology; protocol fidelity monitoring; 
and all possible serious adverse events and adverse events. 
 
Data Monitoring. Ongoing quality control procedures will be implemented for data collection, 
storage and processing within REDCap. The trained study staff will conduct monthly monitoring 
of the study database and the data manager will generate a report for the PI to review at team 
meetings. Standing agenda items for these meetings will include  
● participant recruitment and retention 
● serious adverse events 
● unexpected adverse events 
● expected adverse events 
● protocol deviations 
○ Screening 
○ Enrollment 
○ Randomization 
○ Intervention delivery 
○ Data collection 
○ Privacy protection 
○ Confidentiality 
● data integrity 
● overall study conduct 
 
Monitoring schedule. Safety data will be collected real-time, and summarized and reviewed 
monthly by the PI, research team and investigator teams.  
 
Auditing selected cases. The research team will be prepared to accommodate requests from 
NINR or University of Minnesota IRB, as well as NIH, NINR to audit selected cases for 
compliance with IRB requirements, conformance with informed consent requirements, 
verification of source documents, and investigator compliance. 
 
Adverse Events. Potential risks identified for participants are outlined in the Protection of 
Human Participants and will also be outlined in the IRB-approved informed consent document. 
Additional unknown risks may occur and, if so, will be identified through weekly diligent 
monitoring by the PI throughout the conduct of this study. During the informed consent process, 
participants will be advised of the potential minimum risks of participation as identified in the 
IRB-approved informed consent document. Also, participants will be reminded to promptly 
inform the researchers about any concerns regarding potential serious adverse events or 

Page | 32  
 
 
 
 
adverse events during intervention meetings, during data collection meetings, and via written 
materials: participant workbooks, meeting schedules, fall calendars. Participants will also be 
instructed to notify the PI and/or designee of any suspected serious adverse events or adverse 
events immediately, if possible. The PI will maintain an electronic record of all reported serious 
adverse events and adverse events. In addition to recording events, the PI will notify the 
Independent Safety Monitor of all reportable events as they occur, as well as submit this 
information to the UMN IRB and NIH, NINR. 
 
Procedures for reviewing adverse events and unanticipated problems. Serious adverse 
events, expected adverse events, and unexpected adverse events will be assessed and graded 
by Independent Safety Monitor using the University of Minnesota IRB’s Adverse Event 
Reporting Policy ( http://www.research.umn.edu/irb/guidance/ae.html) and these criteria and this 
information will be given to the UMN IRB, as well as NIH, NINR within 5 working days of the 
event: 
o Serious—an adverse event that results in death, is life threatening, or places the 
participant at immediate risk of death from the event as it occurred, requires or prolongs 
hospitalization, causes persistent or significant disability or incapacity, or Is another 
condition which investigators judge to represent significant hazards. 
o Expected/Anticipated—Identified in nature, severity, or frequency in the current protocol, 
informed consent, investigator brochure, or with other current risk information. 
o Unexpected/Unanticipated—not identified by nature, severity or frequency in the 
investigator’s brochure, or current University IRB-approved research protocol or 
informed consent document, taking into account the characteristics of the participant 
population being studied.  
We anticipate, based on health U.S. health trends and consistent with our preliminary research, 
that 45% the study population will have more than two chronic conditions, 25-76% will have 
pain, 85% will take more than one medication while 35% will take more than 5 medications. 
Thus, we will focus on determining the relationship of serious adverse events, expected adverse 
events, and unexpected adverse events to behavioral intervention being tested, categorized as: 
o Unrelated—there is not a reasonable possibility that the adverse event may have been 
caused by the behavioral intervention being tested. 
o Possibly related—the adverse event may have been caused by the behavioral 
intervention being tested, however there is insufficient information to determine the 
likelihood of this possibility. 
o Related—there is a reasonable possibility that the adverse event may have been caused 
by the behavioral intervention being tested. 
Procedures for identifying adverse events and unanticipated problems. The PI will be 
responsible for ensuring that all serious adverse events, expected and unexpected adverse 
events are reported to the University of Minnesota’s IRB, as well as NIH, NINR in compliance 
with their requirements. Within 72 hours after a reportable serious adverse event, expected or 
unexpected adverse event has been reported by the participant or study staff, it will be graded 
by the PI, forwarded to the study’s Independent Safety Monitor for review, and submitted by the 
PI to the University of Minnesota’s IRB. The Institutional Official(s) will review the event and 
discuss the report with the IRB Chair and the Director of the Office of Research Integrity. Within 
72 hours, after IRB review and acknowledgement, the PI will forward a copy of the reportable 

Page | 33  
 
 
 
 
serious adverse event, expected adverse event and unexpected adverse event, together with 
the IRB acknowledgement letter to the NIH, NINR Program Officer through the University of 
Minnesota’s School of Nursing, Office of Research. In addition, all cumulative reportable serious 
adverse event, expected adverse event and unexpected adverse event will be included in the PI 
and research team’s monthly reports and will be submitted to the University of Minnesota’s IRB 
and NIH, NINR in the PI’s Annual Progress Reports. 
Examples of Potential Reportable Adverse Events. Serious adverse event, expected adverse 
event, and unexpected adverse events are reportable if they meet all of the following criteria: (a) 
is serious and/or suggests that the research places participants or others at a greater risk of 
psychological or physical harm than was previously known or recognized (b) is related and/or 
possibly related, or (c) is unexpected. Additionally, per University of Minnesota’s IRB policy, all 
participant deaths, protocol deviations, complaints about the research, and breaches of 
confidentiality are reportable events. 
An example of an adverse event would be a breach of physical activity data, which has never 
happened in any of our previous studies. We have taken numerous steps to prevent this. The 
physical activity data is online, so there is no paper file to access. Each participant has a Fitbit 
OneTM registered using a unique research, not personal, name and password. Data; physical 
activity intensity classifications and number of steps walked (day total, hour, and minute-by-
minute intervals) for each participant are captured by Fitabase, a fully hosted, cloud-based 
software that implements robust industry standards to maintain secure research databases and 
keeps encrypted data private (link to Fitabase: https://www.fitabase.com/). Fitabase enables the 
creation of unique Fitbit identification numbers, as well as aggregation, reduction, visualization 
and management of data--prior to downloading it into Research Electronic Data Capture 
(REDCap) (link to REDCap at University of Minnesota: 
https://sites.google.com/a/umn.edu/redcap-help/). Both Fitabase and REDCap meet privacy and 
security required when conducting research responsibly. Were someone to gain access to the 
physical activity data, they would not be able to identify the participants because these files use 
unique Fitbit identification numbers only, not study identification numbers or personally 
identifying information. If this unlikely event happens, we will report it using procedures outlined 
above. Steps would then be taken to identify how the breach occurred and what needs to be 
done to correct it.  
 An example of a serious adverse event includes the possibility of physical or psychological 
distress during the administration of the Short Physical Performance Battery (SPPB), an 
observational measure of functional strength and balance. To minimize this risk, research staff 
are trained and their continued competence to perform the SPPB, according to a standard 
protocol, is monitored monthly. The standardized protocol incudes instructions to elicit 
participant’s comfort and willingness to proceed with each movement. If the participant or the 
research assistant are not comfortable proceeding, the movement is not pursued. Participants 
are offered a verbal and written copy of their SPPB scores. The SPPB is established as a safe 
test to use across older populations. Participants in our studies have not had serious adverse 
events, expected adverse events or unexpected adverse events during the SPPB. If this unlikely 
event happens, we will report this using procedures outlined above.  Steps would also be taken 
to identify how the event occurred and what needs to be done to correct it. 
  
Another example of a serious adverse event would be the death of a participant from chronic 
heart failure. While viewed as unexpected and unrelated to the behavioral intervention, death 

Page | 34  
 
 
 
 
from heart failure would nonetheless be a reportable, serious event. No further steps would be 
taken except to review, grade and report the event using procedures outlined above.  
 
An example of an unanticipated problem would be if a participant became immobile during their 
participation in the study. As immobility is an exclusion, we would withdraw the subject from the 
study. This event will be reviewed, graded, and reported using procedures outlined.  
 Assessment of External Factors 
The PI will conduct a semiannual assessment of external factors through a review of literature 
related to new developments in the areas of fall prevention, fall-reducing physical activity, 
behavior change strategies, and other approaches that may have an impact on the safety of 
participants or on the ethics of the study. 
 Interim Analysis 
This study aims to test the effects of behavior change strategies combined with an evidence-
based physical activity protocol. As such, the PI and study coordinator will generate semi-
annual qualitative interim analysis reports on data obtained during phone calls and end-of-study 
surveys to understand issues related to the uptake, usability, and adoption of this intervention 
among this population: community-dwelling older adults. We will evaluate the screening and 
enrollment procedures, barriers to participation and retention, functional impact, acceptability, 
technology problems encountered if any, and user feedback from the participants, 
interventionists and community centers. Information gained from this structured process will be 
used to both guide the refinement of the current protocol and to inform the design of a larger 
implementation trial. There are no planned stopping rules for this study.  
CHAPTER 19 – PROVISIONS TO PROTECT THE PRIVACY INTERESTS 
OF PARTICIPANTS 
 
19.1: PROTECTING PRIVACY 
Several facets of our research plan contribute to the protection of participants’ privacy interest. 
First, trained research staff will interact with study participants. Only staff responsible for 
scheduling intervention meetings or data collection meetings will have formal access, via 
REDCap, to personal information such as address and phone numbers 
Study Staff Training  
Curricula and enduring training materials will center on a) the interventionist role; b) data 
collection and management; and c) PA-monitor support. Interventionists will be trained to deliver 
all manualized intervention content and gain these core competencies (renewed on an annual 
basis): facilitating small group discussions; maintaining a positive social milieu; delivering 
interpersonal (5) and intrapersonal behavioral change strategies (5); and delivering Otago.  
Research assistants will be trained to collect and manage data and gain these core 
competencies: conduct structured interviews with older adults in ways that are non-threatening, 
friendly, and respectful and that enable the accurate collection of data for questionnaires and 
physical measurements; the accurate documentation and storage of data data using secure 

Page | 35  
 
 
 
 
iPads and REDCap. Additionally, RAs will also be trained to manage PA-monitors by gaining 
these core competencies: PA-monitor set-up; initial 1:1 orientation of participants to PA-monitor 
use; assist participants to troubleshoot PA-monitor; secure PA data collection and storage using 
the Fitabase research database.67  
Experts within our research team will evaluate training curricula prior to delivery. The courses 
will be delivered via a combination of online and in-person strategies. All study staff will have 
continual access to the training course, manuals of procedures, and to the PI for reference and 
consultation as needed, as well as a Physical Therapist who specializes in older adult physical 
function, the SPPB, and the Otago protocol.  
Finally, all study staff are trained regarding the responsible conduct of research, REDCap use, 
and good clinical practice for social and behavioral research.  
To ensure good practices are maintained throughout the study during intervention meetings and 
data collection meetings, all study staff will be directly and indirectly supervised. Supervision will 
include observing that privacy of each participant is protected. Monthly process reports include 
a summary of privacy protection. 
Second, intervention meetings will occur in rooms reserved for small group meetings. Such 
rooms are private, in that conversations within these rooms can only be heard by small meeting 
participants (study volunteers and trained interventionists). Visitors or other community center 
personnel or members will not be involved with these meetings. Interventionists have skills and 
abilities to facilitate small group conversations so that privacy is protected.  
Third, data collection meetings will take placed between trained study staff, research assistants, 
and individual participants. These meetings will occur either in a private room within a 
community center or within the participant’s home, whichever is preferred by the participant.  
 
19.2: ACCESS TO PARTICIPANTS 
 
This project does not require access to medical records, student records, or any other sources 
of private information. However, the project does entail collected self-reported health as well as 
names and addresses, which are needed to coordinate intervention delivery, fall calendar 
mailings and data collection meetings. Date of birth is needed to calculate age at the beginning 
of the study, which is a demographic baseline characteristic; the aggregate of which we will 
report as part of the study findings. 
 
Not Applicable 
CHAPTER 20 – CONSENT PROCESS 
 
20.1: CONSENT PROCESS (When consent will be obtained): 
Consent will occur between screening and enrollment. Within 10 days of being screened 
for eligibility, those potential volunteer participants who qualify for participation and 
remain interested, will receive a copy of the informed consent for the study via US mail 

Page | 36  
 
 
 
 
and meet in person with study staff who are trained in consent procedures. During the 
informed consent meeting, the trained will explain the project in detail to each potential 
participant. The study will be described, including its purpose; procedures, data 
collection, randomization, the intervention; use of the PA-monitor; potential risks and 
benefits; time required; and who to contact if there are concerns about the study. Eligible 
participants, their families, partners, or providers will be encouraged to ask questions or 
meet with the PI privately to further clarify questions, prior to providing consent. The 
participant may also take the consent form home again to look it over and ask questions 
of the trained research or PI at a time that is convenient to them. Interested persons will 
be under no time constraints to join or decline their participation.  
Participants who provide verbal and written consent will be enrolled in the study. The 
consent form will also be signed by trained study staff or the PI, Dr. McMahon and filed 
in REDCap.  
In addition to obtaining consent prior to study enrollment, ongoing consent will be 
ensured. During data collection meetings, trained research staff will remind participants 
that answering all questions is voluntary: they may refuse to answer any question within 
the interview and may discontinue the interview at any time. Similarly, the trained 
interventionist will remind participants during small group meetings that participation in 
intervention meetings is voluntary: they may choose to not participate or leave any of the 
8 intervention meetings.  
20.2 COMPENSATION OF RESEARCH RELATED INJURY 
 
Not Applicable 
20.3 CONTRACT LANGUAGE 
Provide a copy of the contract language, if any, relevant to compensation for research-
related injury. 
20.4: WAIVER OR ALTERATION OF CONSENT PROCESS 
Not Applicable 
20.5: NON-ENGLISH SPEAKING PARTICIPANTS 
Not Applicable 
20.6: PARTICIPANTS WHO ARE NOT YET ADULTS 
Not Applicable 
20.7: COGNITIVELY IMPAIRED ADULTS, OR ADULTS WITH FLUCTUATING 
OR DIMINISHED CAPACITY TO CONSENT 
Not Applicable 

Page | 37  
 
 
 
 
20.8: ADULTS UNABLE TO CONSENT 
Not Applicable 
 
CHAPTER 21 – SETTING 
 
21.1: INTERNATIONAL RESEARCH 
Not Applicable 
21.2: COMMUNITY-BASED PARTICIPATORY RESEARCH 
We will conduct the proposed study in community centers located in the four quadrants 
of Minneapolis (see letters of support from Tweed, Marinkov-Omorean, and 
Schoenberger within the supporting documents in ETHOS).  
All research will be performed by UMN key personnel and staff, under the auspices of 
the UMN IRB. Community centers will host meetings during which UMN research staff 
will collect data and conduct intervention meetings. We chose these 4-community center 
locations for 4 primary reasons. First, we have longstanding partnerships (3+ years) with 
each center that include the conduct of our preliminary studies. Second, each 
community center has goals that are congruent with this proposal's objective. Third, 
each center serves ethnically and socioeconomically diverse populations. Fourth, each 
center has environments conducive to small group discussions and practicing fall-
reducing PA, is accessible via public transportation, and has free parking. 
Each center will host the small-group intervention meetings during 2 to 4 of the 13 study 
waves. Community-research teams will establish times and days for intervention 
meetings one month prior to the first intervention meeting. Although meetings will be 
hosted within the community centers, staff there will not coordinate participant 
attendance, collect data, lead, or participate in the small group meetings. The centers 
are listed below: 
● Sabathani Community Center, Minneapolis, Minnesota 
● Volunteers of America, Minneapolis, Minnesota 
● Southwest Community Center, Minneapolis, Minnesota 
● Park Elder Center, Minneapolis, Minnesota 
● East Side Neighborhood Services, Minneapolis, Minnesota 
● St. Paul Parks and Recreation locations including Highland Park Community 
Center; Linwood Community Recreation Center, Palace Community Center 
● Minneapolis Public Libraries including Hosmer and Pierre Bottineau 
● Lutheran Redeemer Church, Saint Paul, Minnesota 
● West 7th Community Center, Saint Paul, Minnesota 
● University of Minnesota Urban Research and Outreach-Engagement Center, 
Minneapolis, Minnesota 
 
We chose these community center locations for 4 primary reasons. First, we have 
longstanding partnerships (3+ years) with each center that include the conduct of our 
preliminary studies. Second, each community center has goals that are congruent with 

Page | 38  
 
 
 
 
this proposal's objective. Third, each center serves ethnically and socioeconomically 
diverse populations. Fourth, each center has environments conducive to small group 
discussions and practicing fall-reducing PA; is accessible via public transportation; and 
has free parking.  
The PI and community center leaders will meet prior to the beginning of the study and 
then quarterly and as-needed meetings throughout all phases of this project. Similar to 
our preliminary studies, the research – community teams will review recruitment and 
retention plans; establish communication procedures for the reservation of private rooms 
for data-collection and intervention meetings; and local dissemination based on each 
center’s preferences. Each year, one of the quarterly meetings will include a project 
progress report.  
Additionally, the research team will interview a representative from each community 
center about facilitators and barriers to providing this program in the future. Interview 
topics will be framed using the reach- effectiveness –adoption- implementation-
maintenance framework (RE-AIM), a system for evaluating this intervention’s potential 
for translation.  
Finally, we will seek advice about our community engagement at least every six months 
throughout the study from Milton Eder, PhD and experts in the UMN, CTSI’s Community 
Engagement to Advance Research and Community Health (see letter of support). 
21.3: RESEARCH SITES 
The research will be conducted and administered through the University of Minnesota, School of 
Nursing. Potential research participants will be identified and recruited from the communities 
within Minneapolis, primarily through newspaper advertisements.  
Research procedures will be performed primarily in the University of Minnesota, Nursing 
Research Space.  
● The School of Nursing is housed in Weaver-Densford Hall, which includes approximately 
35,000 square feet of teaching, research, and office facilities. Space for Dr. McMahon 
and her research team is also available at the 120 Dinnaken Office Building located 
approximately four city blocks from faculty and administrative offices. Available 
resources within the School of Nursing include offices, conference rooms, telephone, 
WebEx, fax, and secure confidential data storage areas. 
 
○  Dr. McMahon’s office in the School of Nursing is approximately 125 square feet 
and is equipped with a personal computer (including the necessary statistical 
software), laser printer, Web camera, telephone access, and ample locked file 
space to conduct the proposed evaluation. The computer has LAN access 
○ Dr. McMahon and trained study staff for this project also have 4 research offices 
at the 120 Dinnaken Building on campus, with work space, computers, telephone 
access, and secure file cabinets for  

Page | 39  
 
 
 
 
Additionally, private rooms will be used by trained research staff to conduct data collection 
interviews and deliver the small group intervention. Private rooms will be reserved for these 
meetings within the following community centers, per participant availability and intervention 
schedules. These community centers do not have site-specific regulations or customs affecting 
the research. Because each community center is not conducting the research, they do not 
require local scientific or ethical review:  
CHAPTER 22 – MULTI-SITE RESEARCH 
 
N/A 
 
 
 

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CHAPTER 23 – REFERENCES 
1. Centers for Disease Control and Prevention. Reporting system (WISQARS). National Center 
for Injury Prevention and Control, Centers for Disease Control and Prevention 
(producer).Available from: URL: www.cdc.gov/ncipc/wisqars. 
2. Campbell AJ, Borrie MJ, Spears Gf, Jackson SL, Brown JS, Fitzgerald Jl. Circumstances and 
consequences of falls experienced by a community population 70 years and over during a 
prospective study. Age Ageing. 1990; 19(2):136-141. 
3. Tinetti ME, Williams CS. Falls, injuries due to falls, and the risk of admission to a nursing 
home. N Engl J Med. 1997; 337(18):1279-1284. 
4. Liddle J, Gilleard C. The emotional consequences of falls for older people and their families. 
Clin Rehabil. 1995;9(2):110-114. 
5. Hartholt KA, van Beeck EF, Polinder S, et al. Societal consequences of falls in the older 
population: Injuries, healthcare costs, and long-term reduced quality of life. The Journal of 
Trauma and Acute Care Surgery. 2011;71(3):748-753. 
6. Gillespie LD, Robertson MC, Gillespie WJ, et al. Interventions for preventing falls in older 
people living in the community. The Cochrane Library. 2012. Cochrane Database Syst Rev 2, 
no. CD007146. 2012 
7. Centers for Disease Control and Prevention. Wide-ranging online data for epidemiologic 
research, DATA2010 the healthy people 2010 database; focus area 22-physical activity and 
fitness. http://www.healthindicators.gov/Indicators/Selection. 
8. Hughes SL, Leith KH, Marquez DX, et al. Physical activity and older adults: Expert consensus 
for a new research agenda. Gerontologist. 2011;51(6):822-832. 
9. McMahon S, Fleury J. External validity of physical activity interventions for community‐
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