Enhancing Well-Being Through Exercise During Old Age
Phase: NA
Conditions: Depression, Osteoarthritis
Sponsor: University of Illinois at Chicago

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Enhancing Well-Being Through Exercise During Older Age 
 
NCT04536727 
1/23/2019 
 
 

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“Enhancing Well-Being Through Exercise During Older Age” 
 
 
 
Principal Investigator: 
 
David Marquez, PhD  
marquezd@uic.edu 
 
 
Sponsors: 
The Midwest Roybal Center for Health Promotion and Translation Pilot Grant Program 
 
Study Locations: 
 
The University of Illinois at Chicago  
1747 W Roosevelt Rd Suite 155, Chicago, IL 60607 MC747 
 
Oakwood Shores 
3859 S. Vincennes Ave, Chicago, IL 60653 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Page 
Table of Contents…………………………………………………………………………….....2 
A. Specific Aims…………………………………………………………………………………3 
B. Background and Significance………………………………………………………………3 
C. Research and Design Methods…………………………………………………………….4 
D. Protection of Human Subjects…………………………………………………………....11 
Citations………………………………………………………………………………………...14 
Table 1…………………………………………………………………………………..……...16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Research Protocol for “Enhancing Well-Being Through Exercise During Older Age” 
Primary Investigator: David X. Marquez, PhD  
Sponsor: The Midwest Roybal Center for Health Promotion and Translation Pilot Grant Program 
Protocol Version 22 
1/23/2019 
 
 
A. Specific Aims 
 
AIM 1. Determine the feasibility of adapting Fit and Strong! to include affect and mood-related 
content and employing this intervention among older adults with a range of depressive 
symptoms. 
HYPOTHESIS 1. Participants will demonstrate (1a) adherence to the Fit & Strong! intervention 
defined as attendance at two-thirds or more of the exercise sessions over a 8-week period and 
(1b) acceptability of the Fit & Strong! intervention as a way to reduce depressive symptoms and 
improve positive affect and reduce negative affect, defined as at least 75% of participants 
reporting positive subjective opinions of the protocol during debriefing session assessments.  
 
AIM 2. Begin to determine whether Fit & Strong! is efficacious as an approach for reducing 
depressive symptoms and improving positive affect and reducing negative affect among older 
adults.  
HYPOTHESIS 2. Compared to wait-list participants, intervention participants will report an 
improvement in positive affect and a reduction in negative affect and depressive symptoms at 9 
weeks as measured by medium to large effect sizes. 
 
AIM 3. We will explore the relationship between negative/positive affect and depressive 
symptoms and maintenance of physical activity between groups at baseline, and 9- weeks, in 
order to determine whether an improvement in positive affect and a reduction in positive affect is 
associated with an increase in physical activity.  
HYPOTHESIS 3. Participants randomly assigned to the intervention arm will demonstrate an 
increase in physical activity at 9- weeks as measured by medium to large effect sizes, and this 
increase in positive affect/reduction in negative affect will be mediated by an increase in 
physical activity. 
 
AIM 4. We will explore the relationship between physical activity and the brain between groups 
at baseline and 9-weeks, in order to determine whether an improvement in brain network 
connectivity and function is associated with an increase in physical activity.  
HYPOTHESIS 4. Participants randomly assigned to the intervention arm will demonstrate an 
increase in physical activity and brain network connectivity and function at 9-weeks.  
 
B. Background and Significance 
 
Affective well-being is typically characterized as the presence of positive feelings and the 
absence of negative feelings over time, and have been showing to be relatively independent 
constructs (Lucas et al., 1996). After the age of 60, negative affect tends to remain stable, (Gross 
et al., 1997) but positive affect decreases (Kunzmann et al., 2000). Positive affect in late life has 
been positively associated with social engagement (e.g., Kunzmann, 2008), while negative affect 
in late life has been linked to self-reported physical health (e.g., Brief et al., 1993). Studies have 
demonstrated that exercise is associated with higher positive affect  and lower negative affect 
(Dua et al., 1992; Rizk et al., 2015) In clinical samples, exercise has long been established as an 

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effective treatment for depression in younger [Krogh et al., 2011] and older adults [Blake et al., 
2009]. Importantly, exercise also addresses vascular risk factors thought to be particularly 
relevant to aging (Blaha et al., 2016), in general, as well as depression in late life [Alexopoulos et 
al., 2006, Sheline et al., 2010]. While there have been several studies demonstrating the benefits 
of exercise on depression in older adults, no known study has examined the positive benefits of 
a structured, group exercise program on mood and well-being in an aging sample. As an 
ancillary aim, we will also examine the impact of a structured exercise intervention on cognitive 
functioning. Fit and Strong!, a physical activity / behavior change program for older adults with 
lower extremity osteoarthritis, has demonstrated efficacy, effectiveness, and ease of 
dissemination for individuals with osteoarthritis living in the community [Hughes et al., 2004, 
2006, 2010]. The goal of this study is to adapt Fit & Strong! for increasing positive affect and 
reducing negative affect and depressive symptoms among older adults residing in the 
community. 
 
C. Research Design and Methods 
C.1 General study design 
We will enroll 40 subjects in this study between the ages of 60 and older, from the community 
who score at least 1 on the Patient Health Questionnaire-8 (PHQ). Up to 20 participants will have 
PHQ-8 scores of 1-4, while up to one-half of participants will have PHQ scores >4. At the outset 
of the study, up to 20 individuals will be randomly assigned to the intervention portion of the study, 
while up to 20 individuals will be randomly assigned to a crossover wait-list group, who will 
undergo the intervention beginning at study week 10. Outcome measures will be administered to 
all participants before the intervention and to the intervention group after they undergo the 
intervention. The wait-list group will complete all of their outcome measures before they begin the 
intervention(see Figure 1).      
 
Figure 1 
 
 
 
 
 
C.2 Phone screen and Study Visits  
 
C2.1  Pre-Study Screen:  

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Before being scheduled to a study visit, potential participants will undergo a phone or in-person 
screen where the aims and structure of the study will be explained to them. The potential 
participants will be allowed to ask specifics about the study and express their interest in the 
study. If they wish to participate in the study, they will undergo a phone screen assessing past 
and current medical and psychiatric history, as well as answer a six-item screener, Patient 
Health Questionnaire-8 and Physical Readiness Questionnaire. Participants will also be 
informed about compensation during the phone screen. If a participant scores 10 or higher on 
the PHQ, but refuses to participate in the study, we will refer them to a list of treatment facilities 
including UIC’s Psychiatry Outpatient Program. Scores above 10 or 11 are thought to be 
indicative of clinical depression (see https://www.ncbi.nlm.nih.gov/pubmed/18752852 or 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943487/ ) Participants who express interest and 
are eligible for the intervention group will also be screened with the MRI Screening document to 
see if they are eligible for the optional MRI component of the study. 
 
 
C2.2. Study Enrollment and Pre-Intervention Measures (approximately 3 hours) 
All eligible individuals will be invited to the University of Illinois at Chicago or to Oakwood Shores 
for their first study visit, which will last approximately two hours.  First, the entire study will be 
described to participants and any questions that they have about the study will be answered. After 
the participant has signed the consent form, they will participate in an interview with a trained 
research assistant. Some of these questions will be of a personal nature and may make the 
participant feel uncomfortable. They can decline to answer any question. Next, they will complete 
a packet of self-report questionnaires and will undergo a neuropsychological (memory/cognitive) 
testing battery and mobility assessment with a trained staff person. Randomized participants of 
the intervention group will be invited to participate in optional MRI testing which will take place 
pre-intervention (Week 0) and post-intervention (Week 9). 
 
 
C2.3. Exercise Intervention. Participants will be invited back to Oakwood Shores for an 8-
week physical activity/behavior change intervention. The intervention will consist of the Fit and 
Strong! program adapted to address the impact of exercise on enhancing positive affect and 
reducing negative affect and depressive symptoms. Exercise classes will meet three times per 
week for 90 minutes per session for eight weeks. Each class is divided into 60 minutes of 
strength training, flexibility, and cardiovascular exercise and 30 minutes of group 
education/discussion, which has been adapted to include affect-oriented content. An outline of 
education topics for each of the 24 sessions can be found in Section C.7. Two sessions of Fit 
and Strong! will be delivered as part of the study; each will be limited to 20 participants. Classes 
will be taught by certified exercise instructors who will undergo 8-hours of training on the Fit & 
Strong! Program. The instructor will be trained to deliver depression specific content by a clinical 
psychologist Program fidelity will be monitored with the Fit and Strong! Plus Implementation 
Checklist and observation of the intervention by study investigators during one Fit & Strong 
class per 8-week session. During the intervention, participants will complete a medication 
adherence and group cohesion measure at baseline, 4 weeks, and 8 weeks.  
 
C2.4. Debriefing Session: Following the intervention, a debriefing session will be held with all 
intervention participants. This session will be used to adapt Fit & Strong! for future study, 
addressing issues around affect and treatment effectiveness. 
 
C2.5. Post-Intervention Measures. During Week 9, participants will undergo the same interview, 
self-report questionnaires (only those bolded in section C.6.3), mobility assessment, and 

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neuropsychological tests they completed during the baseline visit. Participants that were involved 
in the MRI testing component will also undergo the same testing for post-intervention results.  
 
 
C.3 Subject Payment 
All participants enrolled in the study (intervention and crossover wait list group) will be paid $20 
upon completion of their baseline interview and $35 upon completion of their post-test. 
Participants will be paid in cash. Participants involved in the MRI testing will be paid $50 in cash 
upon completion of the scan pre-intervention and post-intervention ($100 total).  
C.4 Entry Criteria for Studies 
C.4.1 Inclusion Criteria:  
Inclusion Criteria for All Participants: a) ages 60+; b) Sufficient visual and hearing capacity to 
follow instructions; c) a score of at least 1 on the Patient Health Questionnaire-8 (Kroenke et al., 
2001); d) Six Item Screener (Callahan, 2002) score > 4; e) pass screening with the EASY scale 
[Cardinal et al., 1996] or have doctor’s clearance to participate; e) no recent (<6 months) joint 
replacements; f) physically inactive (<150 minutes of exercise per week); and g) able to walk at 
least 20 feet (with or without the aid of a cane or walker); speak English proficiently. *In the 
event we need a doctor’s clearance for a subject to participate, we would have the participant 
sign a release of information for us to contact their doctor and then we would contact the doctor 
via pager/phone and get verbal permission to allow them to participate in an exercise study. 
They would then sign a form to document their authorization. 
 
C.4.2 Exclusion Criteria:  
a) Non-proficient in English; b)0  on the Patient Health Questionnaire-8 (Kroenke et al., 2001); 
cb) Six Item Screener < 5 (Callahan, 2005); c) fail screening with the EASY scale and does not 
have doctor’s clearance to participate; d) joint replacement in last 6 months; e) 150+ minutes of 
exercise per week; g) unable to walk at least 20 feet; f) severe medical illness (i.e., metastatic 
cancer, brain tumors, unstable cardiac, hepatic, or renal disease, myocardial infarction or 
stroke) within the 3 months preceding the study; g) Other brain/neurological disorders (i.e., 
dementia or delirium according to DSM-IV criteria, history of severe head trauma, Parkinson’s 
disease or Parkinson’s plus syndromes, multiple sclerosis, epilepsy); h) Conditions often 
associated with depression (i.e., endocrinopathies other than diabetes, lymphoma, and 
pancreatic cancer). 
 
Potential participants for the optional MRI study will be excluded for the following: a) cardiac 
pacemaker or defibrillator: b) metal parts in head, spinal cord, eyes, or chest: d) past operation 
or radiation therapy with skull or brain: e) aneurysm clips: f) dentures that have been surgically 
implanted with magnets, braces: g) claustrophobia: h) heart valve replacement: i) history of work 
with metal resulting in an injury: j) eye injury with metal: k) history of strokes/seizures: l) 
participants in the waitlist group. 
 
 
C.5 Recruitment and Attrition Considerations 
C.5.1 Recruitment:  
Recruitment will take place at the University of Illinois at Chicago campus, Oakwood Shores, 
clinics, churches, parks, free online community resources including Craigslist, and surrounding 
community areas. Recruitment will occur through advertisements about the study to individuals 
through printed brochures, flyers, news papers ads and announcements about the study. This 
will be followed by a telephone call where potential subjects can opt to go through the telephone 
or in-person screening process. The Resident Service Coordinator at Oakwood Shores will aid 
in the distribution of recruitment material and collection of names and numbers of potential 

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participants. The Resident Service Coordinator will not be responsible for conducting screenings 
or the collection of participant data, so will not be listed as authorized research personnel.  
 
C.5.2 Attrition and Study Non-Completers/ Issue of Dropouts:  
We estimate that 33% of subjects will not complete the protocol. While it would be optimal to have 
higher completion rate, this rate appears to represent the nature of the population. Subjects will 
also be financially compensated for each visit. Subjects will receive $55 on via check delivered 
through the mail.. This payment will be in the form of a check and will be mailed to the participants’ 
desired address. The following strategies for subject retention will be used: phone 
reminders/confirmation of visits, and established contact with the study coordinator. We will 
provide participants with a document that includes a list of scheduled appointments on the back. 
Based on these strategies, we anticipate that drop-out will be minimized to 33% of the sample.  
 
C.6 Assessment of Subjects 
 
C.6.1 Screening Measures (35 minutes) 
Screening Form: This questionnaire asks respondents questions about medical and psychiatric 
history, related to the inclusion/exclusion criteria for this study. The screening form will be utilized 
prior to subject enrollment, either in person or over the phone, to determine if someone would be 
a good fit for participation in the study. (15 minutes) 
 
MRI Screening Form: This questionnaire asks respondents questions about their medical history 
and willingness to participate in the MRI testing. The MRI screening will be given either over the 
phone, at the time of the general study screening, or in-person during the baseline visit (5 
minutes). 
 
Exercise Assessment and Screening for You (Resnick, 2008) A self-report questionnaire 
assessing conditions that might prohibit someone from safely engaging in physical activity (2 
minutes). 
 
Six-Item Screener: (Callahan et al., 2002) A brief screen for cognitive impairment and dementia 
that includes three orientation items (year, month, day of the week) and delayed recall of three 
items. When a cut-off score of ≤1 error is used for diagnosing dementia, sensitivity is reported as 
100.0 for community-dwelling elders. (2 minutes) 
 
Patient Health Questionnaire (PHQ-8): A self-report questionnaire assessing symptoms of 
depression and appropriate for use when a clinician is not involved in the assessment. 
  
C.6.2 Clinical Interview (Approximately 15 minutes) 
World Health Organization Disability Assessment Scale (WHO-DAS-II; World Health 
Organization, 2000). A clinician-administered measure of functioning in six-domains (15 minutes). 
 
C.6.3. Self-Report Questionnaires (approximately 50 minutes) 
 
The composite list of questionnaires includes the following outcomes: health and disability 
status, depression and affect, physical activity, sleep and fatigue, falls, history, and balance 
confidence, stress and social/emotional well-being, mobility, and cognitive functioning. 
 
 
Physical Activity Scale for the Elderly (PASE) [Washburn et al., 1993]. A measure of weekly 
physical activity (5 minutes).   

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Western Ontario and McMasters University Osteoarthritis Index [Bellamy et al., 1989]. Set 
of standardized questionnaires used to collect data on arthritis-specific symptoms using 24 
parameters (5 minutes) 
 
Self-Efficacy for Exercise Scale [Resnick and Jenkins, 2000]. A self-report questionnaire 
developed for older adults addressing expectations around self-efficacy regarding the ability to 
continue engaging in exercise in the face of hurdles to exercise (3 minutes). 
 
Chronic Conditions: GERI-AIMS: Checklist of chronic medical conditions (3 minutes) 
 
Cardiovascular Risk Factors Questionnaire: Adapted from the Guidelines of the American College 
of Sports Medicine, ACSM (2000), A brief screening to determine subjects cardiovascular risk 
factors (5 minutes). 
 
The Established Populations for the Epidemiologic Study of the Elderly (EPESE) 
Questionnaire: A Likert-type scale for rating of ability to complete basic and instrumental 
activities of daily living. (5 minutes) 
 
Apathy Evaluation Scale-Self Report: (Marin et al., 1991). 18-item scale asking respondents to 
rate symptoms of apathy on a 4-point Likert scale. (3 minutes) 
 
Snaith-Hamilton Pleasure Scale: 14-items rated on a 4-point Likert scale reflecting experience 
of pleasure over the last two weeks. (3 minutes) 
 
Activities-Specific Balance Confidence Scale (ABC; Powell et al., 1995) The ABC is a self-
administered measure of balance self-efficacy. Participants indicate their level of self-confidence 
on a scale of 0 (no confidence)-100 (completely confident) in maintaining balance for 16 
different activities performed during a typical day. Internal consistency was .96 among 
community-dwelling elders, with 2-week test-retest correlation coefficient of 0.92. (5 minutes)  
 
 
Emotional Well Being Scale:  Asks respondents to rate on a 5-point Likert scale the extent to 
which they experienced 6 positive emotions in the last 30 days. (2 minutes) 
 
Life Satisfaction Survey:  5-item scale that asks respondents to list the extent to which they 
agree (using a 7-point Likert scale) with statements related to life satisfaction. (2 minutes) 
 
Perceived Stress Scale: 10-items rated on a 5-point Likert scale reflecting the perception of 
stress in the last 30 days. (3 minutes) 
 
The Stages of Change Questionnaire: A 4-item scale assessing physical activity. (1 minutes)  
 
Social Provisions: A 24-item scale assessing current social behaviors. (5 minutes) 
 
 
C.6.4: Mobility Measures (19 minutes) 
Timed Up and Go: (Shumway et al., 2000). 
Measures, in seconds, the time taken by an individual to stand up from a standard arm chair 
(approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters 
(approximately 10 feet), turn, walk back to the chair, and sit down (2 minutes). 

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Grip Strength Test: (Gershon et al., 2013): Participants are required to go through a test that 
assesses upper extremity strength with the use of a dynamometer (3 minutes). 
 
Standing Balance Test: Gershon et al., 2013).  This measure enables the detection of a 
participants’ postural sway by an iPad attached to a gait belt (7 minutes).  
 
4 Meter Walk Gait Speed Test: Gershon et al., 2013). Participants walk down an open hallway 
at normal pace while being timed (3 minutes). 
 
9-Hole Pegboard Dexterity Test: (Gershon et al., 2013). Participants are asked to place pegs 
into a pegboard and remove them in a timely manner to assess fine motor dexterity (4 minutes). 
 
 
C.6.5: Neuropsychological Testing Measures (Approximately 40 minutes) 
 
Montreal Cognitive Assessment (MoCA): A timed screening assessment used to assess 
attention and concentration, executive functions, memory, language, visuo-constructional skills, 
conceptual thinking, calculations and orientation (10 minutes). 
 
Picture Sequence Memory Test: Gershon et al., 2013). A measure requiring the subject to 
recreate the picture sequence presented on the screen before them (7 minutes).  
 
Flanker Inhibitory Control and Attention Test: Gershon et al., 2013). Participants are required to 
focus on an arrow (stimuli) while preventing their focus from the stimuli flanking it (3 minutes). 
 
List Sorting Working Memory Test: Gershon et al., 2013).  This measure consists of the task of 
sorting out the images of foods and animals displayed on the screen from smallest to largest (7 
minutes).  
 
Dimensional Change Card Sort Test: Gershon et al., 2013).  A measure requiring participants to 
match a series of bivalent test pictures to the target pictures according to suggested dimensions 
(4 minutes). 
 
Pattern Comparison Processing Speed Test: Gershon et al., 2013). Participants are required to 
compare two side-by- side pictures to determine if they are identical (3 minutes).  
 
Auditory Verbal Learning Test: Gershon et al., 2013).  Measure testing immediate recall. 
Participants are presented with an audio recording of unrelated words and asked to recall as 
many as possible (3 minutes). 
 
Oral Symbol Digit Test: Gershon et al., 2013).  Measures the speed of processing. Participants 
are presented with a screen of symbols associated with certain numbers and then asked which 
number goes with the symbol (3 minutes). 
 
C.6.6: Multimodal Neuroimaging Testing (Approximately 90 minutes) 
 
Subjects participating in the optional MRI component of the study will attend two 90 
minute sessions at the UIC Advanced Imaging Center. Participants will be asked to lie still 
on a padded table and be placed inside of the MRI machine. During each session, the MRI 

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machine will produce imaging of each participant’s brain. Participants will be allowed to request 
earplugs to wear during the procedure, as the machine is quite noisy. In the case that a 
participant should start to feel claustrophobic, the MRI testing will be stopped immediately. The 
total time each participant will be asked to stay inside the machine should be no more than an 
hour. MRI testing will take place at baseline before the exercise intervention and after the 
intervention (week 9). A taxi will be provided to and from the imaging center for participants that 
need it. Participants will be paid $50 at each session ($100 total). 
 
C 6.7. Data Analysis/Interpretation: Participation rates and program acceptability ratings will be 
quantified. Changes in depressive symptoms and positive and negative affect will be analyzed 
using a repeated measures ANOVA model. Between-group analyses will be conducted to 
determine whether significant changes occur in the outcomes between baseline, 9- and 18-
weeks to examine maintenance effects over time. A mixed-effects model will be used to 
determine whether intervention participants significantly increased their participation in physical 
activity between baseline and 9- and 18-weeks. Within-group analyses will also be conducted to 
determine whether participants improved in depressive symptoms, positive and negative affect, 
and physical activity between baseline, immediately following Fit & Strong! participation, and 2 
months post-Fit & Strong! participation.  Finally, the Baron and Kenny Causal Steps approach 
[Baron and Kenny, 1986] will be used to determine whether change in physical activity between 
baseline and immediately post Fit & Strong! mediates the decrease in depressive and positive 
and negative affect. A process evaluation will be conducted to measure aspects of program 
implementation including fidelity, intervention dose received,  participant attrition, and program 
acceptability ratings. [Washburn et al., 1993; Miller et al., 1992; Bellamy, 1989; Hughes et al., 
1991; Resnick and Jenkins, 2000]See Appendix C. [Maust et al., 2013; van Loon et al., 2013] 
 
C 6.8. Data and Safety Monitoring Plan 
Weekly meetings of the research staff of this study will be conducted that will include review of 
accrual, consenting procedures, protocol adherence, adverse events, and quality control of all 
data obtained from the study in the previous week. All changes in protocol design will be 
reviewed by the IRB at the University of Illinois at Chicago before such changes in protocol 
design will take place. All AEs occurring during the course of the study will be reported to the PI. 
All AEs will be evaluated, medically treated or referred to medical treatment, and followed until 
satisfactorily resolved. If deemed necessary by a physician, a subject may be withdrawn from 
the study. AEs will be evaluated for serious adverse event (SAE) as appropriate. The initial 
report will be followed by a complete SAE report and sent to the IRB. If a subject from the study 
or the PI discontinues a subject’s participation due to a SAE, the subject will receive follow-up 
medical care as necessary. Follow-up care will continue until the subject no longer requires 
medical care as necessary. Follow up care will continue until the subject no longer requires 
hospitalization, the condition is stabilized with no future change expected, the problem is 
determined to be unrelated to the study, or the subject dies. The outcome of SAEs will be 
reported to the IRB. 
 
C.7: Fit & Strong Intervention  
C.7.1: Fit & Strong Session Outline (See Table 1, after citations) 
 
C.7.2 Program Fidelity. Program fidelity will be monitored with the Fit and Strong! Plus 
Implementation Checklist and observation of the intervention by study investigators during one  
Fit & Strong class per 8-week session. 
Table 1 
 

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D. Protection of Human Subjects 
D.1 Risks to the Subjects 
D.1.1 Human Subjects Involvement and Characteristics  
We will enroll 40 subjects in this study age 60 and over, all of whom are from the community for 
participation in an adapted version of the Fit & Strong program. Inclusion and exclusion criteria 
are described in the Research Design and Methods section.   
 
D.1.2 Sources of Material  
The research material obtained from the human participants will consist of data in the form of 
diagnostic evaluations and interviews administered by a trained clinician or trained research 
staff, standardized neuropsychological test results, experimenter-administered task responses, 
and self-report questionnaire responses.  These data will be used strictly for research purposes.   
 
D.1.3 Reporting Adverse Events (AEs) 
Bi-weekly meetings of the research staff of this study will be conducted that will include review of 
accrual, consenting procedures, protocol adherence, adverse events, and quality control of all data 
obtained from the study in the previous weeks. All changes in protocol design will be reviewed by 
the IRB at University of Illinois at Chicago before such changes in protocol design take place.  All 
AEs occurring during the course of the study will be reported to the PI.  All AEs will be evaluated, 
medically treated or referred to medical treatment, and followed until resolved satisfactorily.  If 
deemed necessary by a physician, a participant may be withdrawn from the study. AEs will be 
evaluated for serious adverse event (SAE) criteria (defined by the FDA).  If an SAE should occur, it 
will be reported to the R&D and IRB as appropriate.  The outcome of SAEs will be reported to the  
R&D and IRB. 
 
D.1.4 Training in Fair, Responsible, and Ethical Conduct of Research 
The PI and the research team have undergone training in fair and ethical conduct of research in 
general and on human subjects at the University of Illinois at Chicago.  All personnel also up to 
date on this IRB training. The PI and the research team have taken HIPAA training mandated by 
the University of Illinois at Chicago.   
 
D.1.5 Potential Risks  
The structured diagnostic interviews (and questionnaires) are time consuming and may be boring 
to some individuals. These are, however, necessary in order to categorize subjects for study. In 
addition, questions about alcohol/drug use, interpersonal relationships, and questions related to 
history of suicidal and/or homicidal behavior may be considered sensitive by some subjects. The 
collection of such data poses a potential risk of loss of confidentiality around sensitive information 
such as psychiatric status, history of substance abuse, etc. Interviews will be conducted by trained 
staff to conduct assessments who will maintain confidentiality and all data from interviews and 
questionnaires will be numbered so as to conceal the identity of the subject. 
 
If a truly unanticipated result and compelling reason to attempt to inform subjects becomes 
evident - either for an individual or for a group, we will submit a request to the University of Illinois 
IRB to send a letter to ALL subjects enrolled in the study stating that information may be available 
with a phone number and have a trained person available to answer questions. However, we don't 
anticipate any such results. Decisions regarding when something is of importance will be made 
by the study investigators in consultation with a genetic counselor. Study participants will not be 
responsible for the costs of genetic counseling incurred because of this study. 
 

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As with any exercise program, there is always a risk of injury or overexertion.  There is a 
possible risk of physical injury such as risks associated with falls, including muscle or bone 
injury. A trained professional will lead the class in order to decrease the likelihood of this 
occurring.  Also, we encourage all participants to monitor their own safety and inform the 
instructor if they have any concerns.  Participants may have pain in their joints and sore 
muscles due to exercising. We do not expect anyone to feel severe pain, and any pain should 
go away in a few days. The class leader will encourage anyone feeling any pain to take a break 
or stop participating that day or to engage in a type of exercise that is less strenuous. 
Participants will also learn ways to exercise safely so that they do not experience any pain or 
stiffness, and they will learn how to treat pain safely at home.  
 
MRI scans: 
The MRI scans are performed with a powerful magnet, without using x-ray radiation or radioactive 
material.  A specially designed computer converts information from the MRI scan into a visible 
image. The magnetism of the machine attracts certain metals, which could put participants at risk. 
Therefore, participants with pacemakers, infusion pumps, metallic-backed transdermal patches,  
metallic shrapnel, or any other metal in their body, will be excluded from the study.  Participants 
may feel somewhat closed in (claustrophobic) during the MRI procedures. Also, the MRI scans 
will get quite noisy, and this may cause participants some discomfort, which can be aided through 
the provision of earplugs. Participants will be told of the potential discomfort of the scan and given 
a screening form to ensure they meet the physical requirements to participate.  
 
 
D.2. Adequacy of Protection against Risk 
D.2.1 Suicidal Risk  
The clinician, Dr. Olu Ajilore MD, PhD; Associate Professor; Associate Director, Residency 
Training and Education; Co-Director, Adult/Neuroscience Research Track; Department of 
Psychiatry, or research staff may remove a subject from the study if the clinical team thinks that 
the subject is at imminent suicidal risk, which, while not specifically assessed, may come up during 
the course of the study, given that individuals with significant depressive symptoms will be 
enrolled in the study. If the patient is deemed to have specific suicidal ideation during any of the 
visits, the PI and clinician will be immediately notified, and an appropriate clinical decision for 
emergent psychiatric evaluation will be made, including an evaluation of the need for 
hospitalization..  If the potential participant brings up suicidal ideation during the phone screen, 
they will be referred to the suicide prevention hotline. 
 
D.2.1 Informed Consent 
In most cases, potential subjects will learn basic information about the study during a telephone 
or in-person screening, and an informed consent will be mailed to those who are eligible 
for/interested in the study. At the time of initial contact with the study coordinator, subjects will be 
given detailed information about the study and the informed consent form will be reviewed and 
signed. Written consent from the participant will be obtained before the diagnostic interview 
begins. A copy of the document will be given to the study participant and the original informed 
consent document will be kept in a locked cabinet in the principal investigator’s laboratory, 
separate from all other study materials. Other study materials (e.g., assessment measures) will 
be coded by an anonymous identification number. This identification number will be linked to the 
subject’s name in an electronic database that can be accessed only by double password 
authentication. Participants will also be presented with an Informed Consent Addendum form 
addressing the MRI inclusion to the research study. They will be asked if they are willing to 
participate and will be informed of the additional compensation upon completion of each MRI 

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session. Participants will also be informed that refusal to participate in the MRI testing will have 
no effect on their participation in the research study.   
 
D.3 Protections Against Risk  
D.3.1 Protection Against Risk of Psychological and Social Discomfort  
In order to increase the participant’s comfort before, during, and after the study visits, the following 
steps will be taken:  
1) The clinical interview will be conducted by the PI or a well-trained clinician study team 
member in a private exam room.  
2) Neuropsychological testing will be conducted by a trained research assistant/study 
coordinator. The PI will be available at all times during the study visits, and the research 
assistant will be instructed to contact the PI if any problems arise. 
3) If it is found, during the course of the study visit, that the person is in danger of harming 
themselves or someone else, we are legally mandated to alert the proper authorities in 
order to prevent the participant or another person from being harmed. Subjects will be 
informed of this at the initiation of the research study, and a statement about this will be 
included in the informed consent document.  
43) The door to study rooms will be kept closed, with a “do not disturb-testing in progress” 
sign posted on the door.  
4) Subjects will be given breaks as needed, and they may discontinue their participation at 
any time without loss of compensation.  
 
D.3.2 Protection Against Risk of Breach of Confidentiality  
Participants will be identified by number on all data collected during the course of their 
participation except the original signed informed consent document. Their name will be 
connected with their subject ID number in one password protected database, accessible only by 
study team members. Data will need to be linked in order to link information obtained during 
subsequent visits. Informed consent forms will be stored separately from the remainder of the 
data, and these will not be linked in any way. Informed consent forms and hard copies of the 
data will be stored in a locked filing cabinet at UIC. Digital data will be stored on a password 
protected document.  When the results of the research are published or discussed in 
conferences, no information will be included that would reveal the subjects identity.   
 
MR images will be stored on secure machines within the UIC Advanced Imaging Center. The 
MR images will only be accessible to authorized study staff via a login/password. 
D.3.3 Protection Against Risk of Injury, Overexertion, and Pain Associated with and Exercise  
1) A trained professional will lead the class in order to decrease the likelihood of injury or 
overexertion occurring.  Also, we encourage all participants to monitor their own safety and 
inform the instructor if they have any concerns. 
 
2) . The class leader will encourage anyone feeling any pain to take a break or stop 
participating that day or to engage in a type of exercise that is less strenuous. Participants 
will also learn ways to exercise safely so that they do not experience any pain or stiffness, 
and they will learn how to treat pain safely at home.  
 
D.4 Potential Benefits of the Proposed Research to the Subjects and Others   
Participants may or may not benefit from increased physical activity.  
 

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The risks to subjects are no greater than minimal, and every effort will be made to abate these 
risks while maintaining data quality. Thus, the potential benefit to participants and the population 
at large to be gained by the proposed study outweighs the potential for injury or discomfort.  
 
D.5 Importance of Knowledge to be Gained  
The knowledge to be gained about the potential efficacy of exercise as a treatment for depressive 
symptoms among older adults is of great importance to the general population and general 
healthcare. The risks to subjects posed during the course of the study are minimal, and every 
effort will be made to reduce these risks while maintaining data quality. Thus, the importance of 
knowledge to be gained by the proposed study outweighs the potential for injury or discomfort.  
 
D.6 Inclusion of Women and Minorities 
Both women and minorities will be included in the study, and given the demographics of veterans 
in the UIC community, we expect that at least 50% of our research volunteers with be ethnic 
minorities, and at least 50% of our volunteers will be women. Volunteers will not be excluded on 
the basis of gender or minority/ethnic/racial status.  
 
 
 
 
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Topic 
Topic  
1 
1 
Welcome to Fit & Strong! 
Welcome to Fit & Strong! 
2 
Getting Started 
Getting Started 
3 
What to Wear & Foot Care 
What to Wear & Foot Care 
2 
4 
Osteoarthritis 
Depression 
5 
Managing Osteoarthritis 
through Exercise 
Managing Depression through Exercise 
6 
Pain & Osteoarthritis 
Warm Ups 
 
3 
7 
Warm Ups 
Pain & Depression 
8 
Stretching 
Stretching 
9 
Aerobic Exercise 
Aerobic Exercise 
4 10 
Walking 
Fall Prevention 
11 
Strengthening 
Walking 
12 
Resistance Training to 
Improve or Maintain 
Strength 
Strengthening 
5 13 
Cool-Down Exercises 
Exercise as an Energy Booster 
14 
Posture & Bone Health 
Resistance Training to Improve or Maintain 
Strength 
15 
Fall Prevention 
Cool-Down Exercises 
6 16 
Negotiated Adherence 
Contract 
Negotiated Adherence Contract 
17 Other Ways to Do Exercises 
Other Ways to Do Exercises 
18 
Lifestyle Changes 
Lifestyle Changes 
7 19 
Exercise:  A World of 
Options 
Exercise:  A World of Options 
20 
Getting Past Barriers 
Getting Past Barriers 
21 
Diet & Exercise 
Diet & Exercise 
8 22 
Stress Management 
Stress Management 

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23 
Maintaining an Active 
Lifestyle 
Maintaining an Active Lifestyle 
24 
Putting it All Together 
Putting it All Together 
Topic 
Topic