Physical Exercise for Augmenting Cognitive Health
Phase: EARLY_PHASE1
Conditions: Cognitive Aging, Adverse Childhood Experiences
Sponsor: University of Pittsburgh

 
 
 
2022 
Physical Exercise for 
Augmenting 
Cognitive Health 
(PEACH) 
NCT Number: NCT04922710 
JAN 3, 2022 

 
1 
Reversibility Network Pilot of Home-Based Aerobic Exercise among Adults 
Exposed to Threat-related Adversity 
 
Corresponding PI: Chelsea M. Stillman, PhD (Pitt) 
Co-PI: Terrance Forrester, PhD (UWI) 
 
1.0 Background and Aims: 
Early life adversity (ELA) encompasses a range of negative experiences during childhood 
and adolescence, including poverty, abuse, parental maladjustment, and inadequate 
nutrition, which interfere with neurocognitive and socioemotional development. 
Unfortunately, ELA is common in both economically distressed and wealthy countries, 
though the specific nature of ELA may differ by country. It is estimated that 40-60% of 
individuals are exposed to at least one form of ELA, and a quarter of individuals experience 
multiple adversities1–3. Exposure to ELA exerts profound and long-lasting effects on health 
and well-being that persist into late adulthood. Globally, ELA accounts for up to 30% of 
incident psychiatric disorders in adulthood3, and increases risk for the development of 
numerous chronic health conditions such as Type II diabetes, obesity, and cardiovascular 
disease4,5. More recent evidence suggests that ELA also negatively impacts brain health 
in mid- and late life, accelerating the rate of age-related cognitive decline and heightening 
susceptibility to neurological illnesses such as Alzheimer’s Disease6. Further, 
retrospective studies have observed a link between ELA and brain structure and function 
in adulthood7–10. These data suggest that the effects of ELA on brain health are enduring 
and may underlie ELA-related susceptibility to psychological, cardiometabolic, and 
neurocognitive illness. In order to improve the health and well-being of the millions of 
individuals impacted by ELA, it is necessary to establish whether it is possible to reverse 
or mitigate the effects of ELA through interventions delivered in adulthood. Yet, despite 
this pressing need, there is a paucity of research exploring this question. 
 
Physical activity (PA), particularly aerobic exercise, may be an effective, low-cost 
approach to remediate the long-term negative health consequences of exposure to ELA. 
In addition to the well-documented benefits of PA for reducing chronic disease risk11, there 
is growing evidence that PA improves cognitive and brain health12, even among adults 
experiencing illness or aging13–17. Numerous randomized controlled trials in adults have 
demonstrated PA-related benefits in a number of cognitive domains, including memory18, 
attention and processing speed17 and executive functions19. Crucially, PA also modulates 
structure and function of brain regions that support cognitive and psychological processes 
influenced by ELA, most notably the hippocampus and prefrontal cortex20–23.Thus, PA 
holds great promise as a means of improving brain health among adults who have 
experienced ELA.  
 
Despite the promise of PA, few studies have examined whether ELA exposure moderates 
the impact of PA on brain health. This is driven in part by the unique challenges associated 
with conducting research among individuals who have been exposed to ELA. Adverse 
childhood experiences increase vulnerability to adversities in adulthood, including lower 
socioeconomic status and higher risk of work disability24,25. The socioeconomic and 
socioemotional consequences of ELA are significant barriers to participation in research, 
particularly time intensive clinical trials of PA that may require numerous in-person visits 
each week over the course of several months. Therefore, to better serve this population, 
the format in which PA is delivered must be adapted to accommodate the challenges 
associated with ELA. The proposed research aims to address this issue by conducting a 
pilot 12-week PA intervention delivered remotely using aerobic exercise bikes 

 
2 
programmed to connect users with a trainer via an app. We will recruit individuals between 
the ages of 30-55 years (N = 20) from a well-characterized cohort of adults in Jamaica 
with early-childhood exposure to malnutrition and other forms of ELA (e.g., poverty) 
confirmed by contemporaneous medical records who continue to participate in research 
led by Co-Investigators and Reversibility Network members Terrence Forrester and Kirk 
Erickson. A comparison sample (N = 20) of age, sex, and race matched adults with an 
ELA history will be recruited in Pittsburgh, and a harmonized battery of cognitive, fitness, 
and psychosocial measures will be collected in both samples at baseline and following the 
12-week intervention. 
 
We have assembled a highly creative, productive, and interdisciplinary team with 
extensive experience conducting exercise interventions and evaluating indicators of brain 
health in multiple vulnerable populations (e.g., older adults with cognitive impairment, 
adults with a history of malnutrition). We will test the following aims:  
 
Aim 1: Determine the feasibility and acceptability of a remote PA intervention among 
adults exposed to threat-related ELA living in Pittsburgh and Jamaica It is hypothesized 
that the remote format of the intervention will enhance the feasibility of conducting a PA 
trial among individuals with a history of threat-related ELA. 
 
 Aim 2: Determine whether the remote PA intervention promotes improvements in 
cognitive and psychological functioning. It is hypothesized that cognitive and 
psychological functioning will improve over the course of the intervention and 
improvements will be greatest among those with the highest adherence rates. 
 
The proposed research addresses the central goal of the NIA Reversibility Network to 
develop and test feasible interventions that may mitigate ELA-related risk for adverse 
health outcomes in adulthood. This pilot feasibility trial will set the groundwork for a larger-
scale future R01 application that will test the efficacy of a remote PA intervention for 
improving brain health among adults who have been exposed to ELA. Further, the 
proposed research will provide an initial test of the impact of country-level factors (e.g., 
poverty rates, prevalence of more severe ELA such as malnutrition) on ELA-related 
disease burden in adulthood, information which may be leveraged to tailor interventions 
to meet the specific needs of the target population. 
 
1.1 Overview of Methods: 
 
1.1.1. Subject recruitment, Pittsburgh: We expect to advertise through numerous 
outlets in order to enhance our ability to successfully recruit for the study. 
Participants (N=20) will be recruited via methods found to be effective in other 
studies, including the University of Pittsburgh online research registry (Pitt+Me) 
and community presentations at local community centers. We will also advertise 
on 
the 
Brain 
Aging 
and 
Cognitive 
Health 
(BACH) 
lab 
website 
(http://bachlab.pitt.edu/), lab social media accounts (Facebook & Instagram), and 
will post flyers and other ads around the Pittsburgh community. 
 
1.1.2. Subject recruitment, Jamaica: Participants (N=20) will be recruited from across 
Jamaica, particularly from the areas within and surrounding Kingston, Jamaica 
where the University of the West Indies is located. Participants will be age, sex, 
and race matched across sites. 
 

 
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1.1.3. Eligibility criteria: Inclusion criteria will be as follows: 1) adults aged 30-55 years, 
2) exposure to at least one form of threat-related ELA (e.g., exposure to violence; 
physical abuse) prior to the age of 10 as documented by retrospective self-report 
(described in detail below), 3) self-identified Black or African American race, 4) 
access to high-speed internet, and 5) sedentary lifestyle (<60 minutes of 
PA/week). Exclusion criteria will include: 1) psychosis, 2) significant suicide risk 
(i.e., current, active suicidal ideation with a plan), 3) engaging in moderate-intensity 
exercise >=20 min per day, >=3 times per week, 4) current treatment for cancer, 
5) neurological condition (e.g., MS, Parkinson’s, Dementia, MCI) or brain injury 
(e.g., stroke), 6) substance use disorder in the past 3-months, 7) current treatment 
for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other 
cardiovascular event, 8) myocardial infarction, coronary artery bypass grafting, 
angioplasty or other cardiac condition in the past year, 9) sensory impairment that 
would preclude neuropsychological testing, 10) not fluent in English, 11) travelling 
consecutively for 2+ weeks during the study, 12) uncontrolled hypertension, 13) 
insulin-dependent Diabetes Mellitus, and 14) self-identified as any race other than 
Black or African American.  
 
1.1.4. Phone screening: When a prospective participant indicates interest in the study, 
a brief phone screening will be conducted to determine provisional eligibility. The 
total time to administer phone screening questions is ~15-20 minutes. The phone 
screening process will also provide details of the study and participants will have 
the opportunity to ask questions about these details during this phone call. Staff 
will also confirm with the participant that they will not be travelling for two or more 
consecutive weeks during their participation period. If individuals are deemed 
provisionally eligible based on the phone screen, they will be scheduled for a 
videoconference call via the HIPAA-compliant version of the Zoom software, 
during which informed consent will be obtained. 
 
1.1.5. Informed Consent: Informed consent will be obtained remotely over a video 
conference call, during which a staff person will go through the details of the 
consent form and answer any questions posed by the participant. The consent 
document will be signed electronically using REDCap, a secure data management 
platform licensed by the University of Pittsburgh. This system enables participants 
to review and sign the consent form electronically, and the signed document is 
then stored in the REDCap system in a secured archive. Participants will have the 
ability to download an electronic copy of their signed e-consent form and 
investigator contact information will be listed on the e-consent form in the event 
that participants wish to ask further questions.  After informed consent has been 
obtained, self-reported history of adversity and health history/current health 
(measures described below), will be evaluated via REDCap. These measures, 
described in detail below, will be used to determine full eligibility. 
 
1.1.6. Secondary screening for eligibility determination:  
 
1.1.6.1. 
ELA will be evaluated via several well-validated retrospective self-report 
measures that capture complementary information about childhood adversity, 
including type, timing, and severity of adverse experiences. We will administer 
the Childhood Trauma Questionnaire (CTQ)26, a 28-item survey which 
assesses the severity of five domains of childhood maltreatment, including 
emotional neglect, physical neglect, emotional abuse, physical abuse, and 

 
4 
sexual abuse. We opted to use the CTQ because, unlike other ELA measures, 
it has been validated in numerous countries and cultures27,28. In addition, 
participants will complete the Maltreatment and Abuse Chronology of Exposure 
(MACE) scale29, a 52-item self-report measure of the timing and severity of 
multiple forms of ELA, some of which are not covered by the CTQ, including 
bullying and intra-parental violence. Finally, to evaluate childhood 
socioeconomic disadvantage, participants will be asked to estimate childhood 
household income and report parent/guardian occupation and education. 
Childhood socioeconomic status will not be used as an index of adversity but 
will be collected for the purpose of fully characterizing participants’ childhood 
context. Responses on these assessments will be used to form a composite 
score reflecting degree of ELA exposure. Exploratory analyses that 
decompose the specific types of ELA will also be performed.  
 
1.1.6.2. 
Health history will be evaluated to determine whether an individual has a 
history of or is currently experiencing any health conditions that may preclude 
them from participating in a physical activity intervention. This information will 
be obtained via the phone screening as well as through a Health History 
Questionnaire administered electronically with the CTQ and MACES. This 
questionnaire asks questions about medical symptoms participants have 
experience in the past 6 months related to cardiovascular disease and 
musculoskeletal injuries as well as other related measures (e.g., alcohol 
consumption). 
 
1.1.7. Remotely administered questionnaires. Those deemed eligible based on 
responses to the above measures will then be provided with secure links to 
complete a number of questionnaires via REDCap. Questionnaires will evaluate 
psychological functioning and behaviors such as physical activity. The following 
questionnaires will be administered via survey link: 
 
1.1.7.1. 
Psychological Functioning: 
 
• 
Perceived Stress Scale (PSS): a 14-item measure that assesses 
experiences of daily life stress. The PSS is an instrument on which 
respondents use a 0 (“never”) to 4 (“very often”) Likert scale to rate the 
degree to which daily life events are perceived to be uncontrollable, 
unpredictable, or unmanageable. Responses are summed to form a total 
score (maximum possible score of 56; ~3 min) 
 
• 
State Trait Anxiety Inventory (STAI): a 40-item measure with two subscales 
assessing state and trait anxiety symptoms rated along a 1 (“Almost 
Never”) to 4 (“Almost Always”) scale. Higher subscale scores indicate more 
severe anxiety. (~5 min). 
 
• 
Center for Epidemiological Studies Depression Scale (CES-D): a measure 
of the frequency of 20 common depressive symptoms rated along a 0 
(“rarely or none of the time”) to 3 (“most or all of the time”) Likert scale. 
Responses are summed to yield a total symptom score (maximum possible 
score of 60) with higher scores reflecting more severe depressive 
symptoms (~3 min). 
 

 
5 
• 
Positive Affect Negative Affect Schedule (PANAS): This scale consists of 
a number of words that describe different feelings and emotions. 
Participants are instructed to rate the degree to which each word describes 
them. State negative and positive affect are assessed (~ 5 min). 
 
• 
Index of Race Related Stress-Brief: This inventory consists of 17 items that 
measure stress associated with common, day to day racial hassles 
experienced by Black Americans, emphasizing the ubiquitous and chronic 
presence of racism in the United States. Participants are asked to indicate 
their experience with and reaction to the events depicted in each item using 
a 5-point Likert-type scale (0 = this never happened to me; 1 = this event 
happened but did not bother me; 2 = this event happened, and I was slightly 
upset; 3 = this event happened, and I was upset; 4 = this event happened, 
and I was extremely upset). Items are summed to yield a total score (range 
0-68), and higher scores indicate respondents endorsing a greater degree 
of stress because of their encounters with racism. The IRRS-B is one of 
the most widely used measures to assess race-related stress among Black 
Americans (~5 min). 
 
1.1.7.2. 
Other assessments: 
 
• 
MacArthur SES Questionnaire: This scale includes 12 questions regarding 
perception of subject's status relative to their community and the country 
as a whole, their living situation, level and degree of education obtained, 
job status, income and debt (~3 min). 
 
• 
Exercise Self Efficacy (EXSE): a questionnaire measuring participant's 
confidence in their ability to complete the exercise intervention (~5 min). 
 
• 
Exercise Benefits/Barriers Scale: a 43-item questionnaire assessing 
perceived barriers and benefits to engaging in physical activity. The 
benefits subscale is composed of 29 items, while the barriers subscale is 
composed of 14 items. Respondents rate their agreement with each 
statement on a 4-point scale from 1 (“Strongly Disagree”) to 4 (“Strongly 
Agree”). A total score can be derived by reverse coding barrier items, or 
individual subscale scores for benefits and barriers can be obtain by 
summing the items of each subscale (~4 min).  
 
• 
Paffenbarger Physical Activity Questionnaire (PPAQ): a seven-day activity 
recall survey that evaluates the amount of physical activity due to activities 
of daily living (e.g., walking) and leisure activity that involves physical 
exertion (e.g., gardening, jogging). The PPAQ is a widely used instrument 
for assessing habitual PA that exhibits good reliability and has been shown 
to correlate highly with objective measures of body composition and 
physical activity. (~10 min) 
 
• 
Childhood socioeconomic status: participants will be asked to estimate 
childhood household income and report parent/guardian occupation and 
education. Childhood socioeconomic disadvantage will not be used to 
evaluate inclusion or exclusion on the basis of ELA exposure, but will be 

 
6 
collected for the purpose of fully characterizing participants’ childhood 
context. 
 
• 
We will also collect basic demographic information, including current and 
childhood socioeconomic status. 
 
1.1.8. In-person assessment. Participants will then be invited for an in-person visit that 
will last approximately two hours, during which they will complete assessments of 
cognitive and psychological functioning. This session will be completed in person 
at the Brain Aging and Cognitive Health Lab in a private room that will be occupied 
by the study staff and subject only. Cognitive tests and questionnaires will be 
scored after the session is completed by the staff who administered the visit. A 
second staff member will also score the tests to ensure reliability and validity of the 
session. All measures described below will be completed at baseline and post-
intervention.  A description of the proposed assessments and questionnaires are 
provided as follows: 
 
1.1.8.1. 
Cognitive functioning:  
1.1.8.1.1. The Cognitive Portion of the NIH toolbox is a computer-based program that 
assesses Executive Function, Attention, Episodic Memory, Language, 
Processing Speed and Working Memory. This computer program was 
designed by NIH for the purpose of collecting standardized cognitive data in 
studies like this and takes approximately 30-40 minutes to complete. Some of 
the tasks that may be completed as part of the toolbox: 
 
• 
Dimensional Card Sort: (6 minutes) A task that measures cognitive 
flexibility and attention. Two target pictures are presented that vary along 
two dimensions (e.g., shape and color). Participants are asked to match a 
series of bivalent test pictures (e.g., yellow balls and blue trucks) to the 
target pictures, first according to one dimension (e.g., color) and then, after 
a number of trials, according to the other dimension (e.g., shape). The 
relevant dimension for sorting is indicated by a cue word (e.g., “shape” or 
“color”) that appears on the screen for all participants.    
 
• 
List Sort Working Memory: (10 minutes) This task assesses working 
memory and requires the participant to recall and sequence different 
visually and orally presented stimuli. Pictures of different foods and animals 
are displayed with both an accompanying audio recording and written text 
that name the item. The participant is asked to say the items back to the 
examiner in size order from smallest to largest.  
 
• 
Picture Sequence: (5 minutes) In this measure of episodic memory, 
sequences of pictures objects and activities are presented in a particular 
order. The participants are asked to reproduce the sequence of pictures 
that is shown on the screen. 
 
• 
Flanker: (4 minutes): This is a measure of inhibitory control and attention. 
The task requires the participant to focus on a particular stimulus while 
inhibiting attention to the stimuli flanking.  
 

 
7 
• 
Picture Vocabulary Test (4 minutes): Measures receptive vocabulary 
administered in a computer-adaptive test (CAT) format. Respondents 
select the picture that most closely matches the meaning of the word. 
 
• 
Pattern Comparison (3 minutes): Assesses the amount of information that 
can be processed within a certain unit of time. Items are simple so as to 
purely measure processing speed. 
 
 
1.1.8.2. 
Height and weight will also be measured using a calibrated stadiometer and 
digital scale respectively. These values will be used to calculate body mass 
index (BMI). 
 
1.1.9. Activity monitoring: At the end of the baseline assessment visit, eligible 
participants will be fitted with a commercially available physical activity monitoring 
device (ActiGraph Link), worn on the wrist. ActiGraph Link provides information 
about movement, rotation, and body position, that is used to determine intensity 
and amount of physical activity. Activity monitoring will be completed one-week 
prior to and one-week after completion of the intervention. 
 
1.1.10. Exercise training session: After completion of the initial assessment visit and the 
activity monitoring period, two study team members will schedule a time to 
transport a study stationary bike to the participant’s home via a university-owned 
vehicle, set-up the bike in the participant's home, and monitor the participant’s first 
home-based exercise session in-person. Participants will also be provided with a 
study-owned tablet loaded with the application (described below) that will be used 
to administer and monitor their exercise regimen throughout the intervention. 
 
 
1.1.11. Participants will complete one onsite exercise session, during which they will work 
with the exercise physiologist to determine the appropriate peddling speed 
corresponding to a moderate-intensity exercise zone based on the American 
College of Sports Medicine Guidelines. Heart rate and blood pressure will be 
monitored during this session to ensure that the participant does not exceed ACSM 
guidelines for safe activity.  
 
 
1.1.12. Exercise intervention: The intervention will use personalized physical activity 
regimens that are remotely administered by exercise staff using an application 
called Neotiv. Neotiv has been programmed by a research group in Germany who 
have agreed to make it freely available for this pilot study. Neotiv is integrated with 
the stationary bike, allowing for the collection of data about speed, resistance, and 
duration of cycling. We will use Neotiv to monitor adherence to the intervention 
protocol and to adjust the protocol as needed. The participant will complete three 
exercise sessions per week on the bike at home for 12-weeks, which will gradually 
increase in duration from 15- to 50-minutes over the first month of the intervention. 
The final weekly exercise goal will be set to 150 minutes.  
 
Prior to initiating each exercise session, the participant will wear a Polar heart rate 
monitoring band around their chest, open the Neotiv application on the study tablet, 
at which time they will be prompted to rate their current mood using the Exercise 

 
8 
Induced Feeling Inventory (EFI)30, which prompts respondents to rate the extent to 
which 12 different emotion words describe how they feel in the moment on a scale 
from 0 (“Do not feel”) to 4 (“Feel very strongly”). Example words include “Calm”, 
“Tired”, “Revived”, “Happy”, and “Fatigued”. The participant will then press the start 
button on the tablet application and begin exercise, at which time data from the 
exercise bike and the heart rate monitor will begin continuous transfer to the tablet 
in one-second intervals, via Bluetooth and ANT+ technology. Pleasant and 
relaxing images will be presented via the tablet during the exercise sessions to 
maintain interest and adherence. At the end of each exercise session, participants 
will be prompted to again rate their mood on the EFI and to rate their perceived 
exertion using the Borg scale from 6 to 20. After completion of the session the 
participant will press the end button on the tablet application and put the tablet in 
standby mode, unplug the stationary bike, and engage in 10-minutes of a 
stretching regimen taught by the exercise physiologist during the training session.  
 
After completion of each exercise session, the following data will be sent to a 
subject-folder (named by study id) on a secure cloud-based platform (google 
firebase database set up for the study), which will be accessible to study staff: 1) 
heart rate per second 2) bike resistance per second, 3) peddling speed (rotations 
per minute), and 4) duration of exercise session. Study exercise staff will review 
these exercise data on a daily basis to monitor intervention adherence and will 
modify the exercise regimen (i.e., bike resistance) as required to ensure the 
participant is engaging in moderate-intensity exercise for the majority of each 
exercise session. 
 
A study team member will check-in with participants via weekly emails or calls with 
participants via phone or HIPAA-compliant videoconferencing software to 
troubleshoot issues that arise during exercise, discuss participants' subjective 
exercise experience, and problem-solve barriers to adherence. The format of these 
check-ins will be determined by the participant’s preference, progress, and needs, 
and may change over the course of the intervention as warranted. Exercise safety 
will also be reviewed during these weekly check-ins and participants will be 
encouraged to reach out to the study staff if any safety-related concerns arise. 
Participants will also be asked about whether there have been any issues with their 
bike or other equipment. Should damage occur, two staff people will schedule a 
time to visit the participants home to fix the issue(s) noted or to collect the bike to 
be returned to the manufacturer for repair. In the event that the bike must be 
returned to the manufacturer for repair, participants will be furnished with a 
replacement bike within 5 days of the removal of the original bike, and any exercise 
sessions missed as a result will either be made up within the following week or 
marked as absences that will not be counted toward the participant's 
attendance/adherence bonus numbers. 
 
1.1.13. Follow up assessment: All of the baseline assessments will be repeated at 
follow-up after completing the 12-week intervention, including cognitive and 
psychological functioning, and physical activity monitoring (see descriptions 
above). We will not administer CTQ or MACE questionnaires at follow-up given 
that scores on these questionnaires should not change. 
 
1.1.14. Bike return: Following the completion of the 12-week intervention, the study PI 
and a staff member will return to participants' homes to collect the study-issued 

 
9 
stationary bike, tablet, and heart rate monitor. Any needed repairs will be made 
and equipment will cleaned for use by another participant. 
 
1.2. 
Statistical Analysis Plan: This intervention is a pilot feasibility investigation. 
Therefore, the primary focus is on evaluating how successful we are at recruitment 
and retention, and whether we are able to keep participants engaged in the 
intervention. Although we will evaluate the effect of the intervention on cognitive 
and psychological functioning, is not intended to be statistically powered to 
address questions regarding the effectiveness of the intervention for improving the 
outcomes among adults exposed to early life adversity. 
 
Aim 1a. The feasibility of this intervention will be assessed by examining average 
adherence rate over the course of the intervention, operationalized as a 
combination of number of sessions attended and average duration of each 
session. Average number of minutes spent in the ‘moderate-intensity’ heart-rate 
zone per session will also be examined. Threshold analysis will be conducted to 
understand whether exercise adherence declines after a certain time point in the 
intervention (e.g., 6-weeks). In an exploratory analysis, ActiGraph data will be used 
to assess whether engagement in the intervention results in an increase in physical 
activity from pre- to post-intervention. 
 
Aim 1b. Intervention acceptability will be assessed through a self-report 
questionnaire completed post-intervention, including questions about satisfaction 
with various aspects of the intervention (i.e., intervention duration, interaction with 
study staff, use of technology to remotely guide intervention, overarching feedback 
about intervention, willingness to continue engaging in exercise). 
 
Data related to 1) study enrollment and 2) summaries of weekly video/phone calls 
to monitor exercise adherence and engagement will be documented. The 
recruitment process (e.g., proportion of participants screened who enrolled in the 
study) and participants’ experience in the intervention based on weekly phone 
sessions and the satisfaction questionnaire at the completion of the study will be 
qualitatively examined. 
 
Aim 2. Paired sample T-tests will be used to assess change in cognitive and 
psychological functioning over the course of the 12-week intervention. 
 
Aim 3: Attendance and adherence rates, as well as participant satisfaction ratings, 
will be compared using Paired sample T-tests to determine whether there are 
differences in these metrics across sites. Statistical tests performed to assess Aim 
2 will be repeated separately for each site to evaluate whether effect sizes differ 
by site. 
 
1.3. 
Minimization of Risks: 
1.3.1. To reduce the risk for breach of confidentiality we will separate all information 
obtained during the screening period from identifying documents. All research data 
will be de-identified. These documents will be stored in a separate location from 
the data and the screening information in locked filing cabinets in a locked and 
secure room that only lab personnel have access to. Data that is saved 
electronically (computer system) is protected by the University of Pittsburgh 
firewalls. Regarding heart rate data collected via the Polar app, these data will only 

 
10 
be stored on the app temporarily (i.e., during the exercise session) in order to 
continuously monitor safety. This information will be transferred to our secure 
server as soon as possible after each session to minimize risk of breached 
confidentiality. 
1.3.2. Subject privacy will be maintained in this research study by having all participants 
answer questions and perform cognitive tasks in an isolated and private room. All 
of the information that we will collect in this protocol is essential for the research 
questions we are posing. In this way, there will be no unnecessary personal 
information collected from these participants. 
1.3.3. We will ensure participant confidentiality by coding all participants' data according 
to a numbering system and separating it from the informed consent and other 
documents that contain personal information. All informed consent documents and 
other forms with personal information (such as payment receipts) will be kept in a 
locked cabinet in a locked room that only researchers involved in the project will 
have access to. All data collection pertaining to the individual will be stripped of all 
identifying information. Data files (paper based) pertaining to subject data 
collection will be kept in a locked cabinet in a separate locked room that only 
researchers involved in the project will have access to. For data records that are 
computer based, multiple levels of password protection (e.g., record, file, directory, 
server, and computer levels) are employed to ensure data security. All personnel 
involved in the study will be approved through the IRB and will sign a statement 
agreeing to protect the security and confidentiality of identifiable information. 
1.3.4. Regarding exercise procedures, the most common injuries resulting from exercise 
are strained ligaments, muscles and joints along with delayed onset of muscle 
soreness. An exercise physiologist with a Master’s degree in Exercise Science 
(George Grove) and who has extensive experience monitoring exercise behaviors 
in normal and at risk populations will remotely monitor participants during all 
scheduled exercise sessions. Data to be monitored include heart rate (as collected 
via the Polar heart rate monitor), speed of pedaling, duration of exercise session, 
and ratings of perceived exertion. To avoid injuries, participants will gradually 
increase their exercise session duration and study intervention staff will be made 
fully aware of any pre-existing physical conditions that would require careful 
monitoring. All exercise sessions will be programmed to include a warmup and 
cool down period. Participants will also be reminded and encouraged to wear 
proper footwear and comfortable and appropriate workout attire for their exercise 
sessions. Potential problems such as dehydration, heat exhaustion and heat 
stroke are very uncommon and usually occur in athletes and others involved in 
extremely vigorous exercise. To prevent heat related illnesses, participants will be 
encouraged to regularly hydrate during exercise sessions, wear appropriate 
clothing, to open windows or turn on fans as needed, and to cease exercising if 
they feel they are becoming overheated. Prior to the start of the intervention, 
participants will be instructed about signs and symptoms of overexertion so that 
they can appropriately self-monitor during exercise sessions and stop exercising if 
needed. 
1.3.5. With regards to exercise equipment malfunctions, these will be minimized by the 
fact that stationary bikes will only be used by on person for the duration of time 
that person is involved in the intervention. Staff will also be made available to 
complete repairs as needed and will query participants about any repair needs 
during weekly check-in calls. 
1.3.6. Occasionally someone may develop heart trouble during exercise. Occurrence of 
such an event is extremely rare (as described in potential risks section above). 

 
11 
However, to reduce the risk of heart troubles during exercise, participants with a 
history of heart disease will be ineligible to participate in this study. The study will 
follow ACSM guidelines in regards to contraindications to perform exercise, 
including systolic blood pressure > 190 mm Hg, diastolic blood pressure > 100 mm 
Hg, or heart rate > 100 beats per minute. These parameters will be evaluated 
during the exercise training session prior to the start of the intervention and 
participants will be disqualified if they exceed these recommendations. Once the 
intervention has begun, heart rate will be routinely monitored by exercise staff. If 
heart rate is observed to be abnormally high during home-based exercise 
sessions, exercise staff will contact the participants to discuss concerns and 
modify the exercise protocol as appropriate. If excess heart rate continues after 
modifications, exercise may be discontinued until the participant has been 
evaluated by a physician and has provided documentation of medical clearance to 
continue. 
1.3.7. Exercise staff have completed a degree in Exercise Science or related field (e.g., 
kinesiology) and / or have a fitness certification from a reputable organization. All 
staff will have a minimum of 2 years of experience in exercise supervision and 
prescription. The exercise prescription level is moderate in intensity and the risk of 
a cardiac event occurring during exercise is 1 in 400,000 – 800,000 hours of 
exercise. Given this low level risk, it is not feasible to have a physician on site at 
each exercise session. All staff involved in the exercise intervention will review the 
emergency protocol of the hosting community centers. In addition, each session is 
staffed by individuals who are trained and certified in First-Aid, CPR, and AED use 
and oxygen administration. Both centers have first-aid kits, AED’s and oxygen 
available at all times. Subjects will start with 10 - 15 minutes of moderate exercise 
and gradually increase as they can tolerate more. Level of increase will be 
individually based. This gradual increase is done to prevent injury. If subject 
becomes injured, they will need clearance from their physician in order to return to 
the intervention. 
1.3.8. Regarding use of the physical activity monitoring device, participants will be guided 
through the use of the device at the exercise testing session. We will help 
participants through the fitting process of the device and alert them to the sound 
the device will make when it is properly adjusted and ready to collect data. We will 
ensure that participants understand how the device works and how to correctly 
wear it so as to avoid any discomfort or incorrect usage. We will also instruct 
participants to notify us if any discomfort occurs. If any discomfort does arise as a 
result of wearing the physical activity monitoring device, we will instruct participants 
to discontinue use of the device. 
1.3.9. Cognitive and psychological assessments: In order to alleviate any fatigue which 
may occur, participants will be offered breaks during testing periods. Any person 
scoring highly on the depression or anxiety items or those who report childhood 
trauma will be provided with referrals to local treatment providers, including free 
and reduced cost options, and offered additional consultation with Dr. Donofry (Co-
PI), a licensed clinical health psychologist. 
1.4. 
Data Management: 
We appreciate the challenges associated with the organization, execution, 
management, and analysis of a study of this kind and recognize the importance of 
frequent communication between staff, students, analysts, and investigators. 
Protection of subject privacy and safety, meticulous quality control, and prudent 
organization is the bedrock for success of a study like this. For this study, PI 
Stillman will maintain overall responsibility for data management and quality 

 
12 
control but we have constructed a plan that distributes database and analysis 
workload across labs and specialization. IT staff will control permissions to the 
database to ensure proper access and DM by staff, students, and investigators. 
We will store and link all behavioral and assay data on a HIPPA secure cloud-
based server (REDcap). REDcap allow investigators at all sites to access data and 
coordinate analyses. Data entry to the REDcap database will be completed at the 
University of Pittsburgh. The data forms in REDcap are similar to the actual paper 
version of the forms that will be completed by participants and staff. All participant 
data will be stored and archived on a secure server at the University of Pittsburgh. 
By having the data base on REDCap, all data is secure is case of a natural disaster 
in which the server would be completely undamaged.   
 
1.5. 
Dissemination Plan: 
1.5.1. ClinicalTrials.gov. The University of Pittsburgh is strongly committed to 
supporting compliance with the NIH Policy on the Dissemination of NIH-Funded 
Clinical Trial information. As such, the University of Pittsburgh Office for 
ClinicalTrials.gov (http://rcco.pitt.edu/clinicaltrialsgov) provides resources and 
procedures to assist Responsible Parties with fulfilling the requirements for 
submission of clinical trial information to ClinicalTrials.gov.  Monitoring by the 
University of Pittsburgh Institutional Review Board (IRB) and Research Conduct 
and Compliance Office (RRCO) ensures that all clinical trial registrations and 
results information are obtained in compliance with NIH policy requirements and 
reported on ClinicalTrials.gov. Per NIH’s requirements, the PI will register the 
proposed clinical trial on ClinicalTrials.gov no later than 21 days after the first 
participant is enrolled. The PI will also ensure that summary results from the 
proposed clinical trial are submitted to ClinicalTrials.gov for public posting no later 
than one year after the trial’s primary completion date. Per NIH’s policy, this 
summary information will include participant flow, demographic and baseline 
characteristics, outcomes and statistical analyses, adverse events, the protocol, 
statistical analysis plan, and administrative information. Clinical trial information 
submitted to ClinicalTrials.gov will be verified, updated, and corrected in 
accordance with all applicable deadlines established in the Final Rule for Clinical 
Trials Registration and Results Information Submission (42 CFR 11.64). Informed 
consent documents will also include a specific statement relating to posting of 
clinical trial information at ClinicalTrials.gov.  
 
1.5.2. Publications. Findings from the proposed study, including baseline observations 
and intervention outcomes, will be published to scientific journals with broad 
audiences. I will specifically target journals specializing in health psychology, 
sports medicine, behavioral medicine, and clinical science. Examples include 
Psychosomatic Medicine, Health Psychology, Translational Behavioral Medicine, 
and Clinical Journal of Sports Medicine. 
 
1.5.3. Presentations at meetings. Results from the proposed study will be presented at 
annual scientific meetings of the Society for Behavioral Medicine, American 
Psychosomatic Society, and American Psychological Association. I will also 
present findings at local conferences and symposia, such as the Health 
Psychology brown bag series at the University of Pittsburgh. As appropriate, 
findings may also be shared at public community events in an effort to engage the 
public in scientific discussions and provide information about research activities 
occurring at the University. 

 
13 
 
1.5.4. Websites. The Department of Psychology maintains an active website where 
faculty 
research 
findings 
and 
accomplishments 
are 
highlighted, 
and 
announcements for scientific presentations are posted. As findings emerge from 
the proposed study, they may be featured on the departmental website. In addition, 
in collaboration with staff members in Dr. Kirk Erickson’s lab with web 
programming experience, I will create a website dedicated to the proposed study. 
This website will serve as a public access point for information about the study, 
including details about the study protocol, any publications or presentations based 
on findings obtained from the study, and information about how to participate.   
 
1.6. 
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