Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
Phase: NA
Conditions: Neurological Disorder
Sponsor: University of Southern California

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  Protocol and Statistical Analysis Plan: Cover Page 
 
 
 
Monitoring Physical Activity in Hispanic Women With Chronic 
Neurological Disorders 
 
HS-18-00993 
NCT : not issued. 
Date: March 24, 2021 
Investigator:  Dr Giselle M Petzinger 
                      Email:  petzinge@med.usc.edu 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL NUMBER: 
 
 
 
TITLE: Monitoring Physical Activity in Hispanic Women with Chronic Neurological Disorders 
 
 
PRINCIPAL INVESTIGATOR(S): 
 
Giselle Petzinger, MD   USC. Dept. of Neurology 
 
Address   1333 San Pablo, LA CA 90033 
 
Telephone 323- 442-5710 
 
Fax 
323-442-5794 
 
 
 
CO-INVESTIGATOR(S): 
 
 
Alexander Garbin, DPT, Division of Biokinesiology 
 
Janina Morrison, MD   Medical Director of The Wellness Center 
 
Jesus Diaz, PhD USC Dept. of Occupational Therapy 
            Lilyana Amezcua, MD Dept of Neurology 
            Charles Kaplan, PhD,  USC Suzanne Dworak-Peck School of Social Work 
 
Beth Fisher, PT, PhD,  Dept of Neurology 
 
Vy Bui, Dept of Neurology 
 
 
 
 
 
Coordinator: 
            Vanessa Marroquin , The Wellness Center  
 
 
 
 
Sponsor: USC Zumberge Diversity Grant 
 
 
PARTICIPANTS/Locations:  
The Wellness Center at The Historic General Hospital 
 
 
 
 

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1. BACKGROUND AND HYPOTHESIS 
 
1.1.  Physical Activity in Hispanic Women Population 
 
In the last decade, regular physical activity (PA), particularly exercise, has been shown to 
play an important role in improving the disease course of many chronic neurological 
conditions, such as Parkinson’s disease, Multiple Sclerosis, and headache. Unfortunately, 
the generalizability of these findings to other diverse populations is unclear since the vast 
majority of clinical research has been conducted in non-Hispanic men with affordable 
access to medical care. In addition, studies examining the population of people regularly 
engaged in physical activity in this country have indicated that lack of physical activity is 
particularly prevalent in Hispanic groups compared to non-Hispanic white individuals. In 
terms of gender, a significantly high percentage (74%) of Hispanic women do not participate 
in exercise activities and this number climbs with age. While there a number of reasons for 
this occurrence, a significant contributor includes lack of resources and accessibility to 
programs that promote PA and exercise. 
 
1.2. Role of Physical Activity in Chronic Neurological Disorders 
 
Neurological disorders, including stroke, headache, Parkinson’s disease (PD) and multiple 
sclerosis represent the most common cause of disability world-wide7. While there are 
treatments available for many disorders, these medications often provide modest relief and 
are expensive with limited accessibility to this population we serve. There also remain no 
effective cures.  In the last decade, published studies have supported the vital role of PA  
(particularly exercise) in many chronic neurological disorders by improving neurological 
outcomes, quality of life, and potentially modifying disease course1,8. A limitation is that the 
majority of studies have been conducted in non-Hispanic white populations.  In addition, PA 
is known to be significantly lacking in the Hispanic population overall, particularly in Hispanic 
women. This application will begin to address this gap by examining the role of coaching and 
wearable devices in promoting PA in Hispanic women population with chronic neurological 
conditions.  
 
  
1.3. The Wellness Center at the Historic General Hospital 
 
The Wellness Center at the Historic General Hospital (TWC) located next to Los Angeles 
County/University of Southern California (LAC +USC) medical center, serves a large and 
diverse ethnic population, many of whom are Hispanic and live within close proximity to 
LAC+USC hospital. TWC serves as a community center and is also a referral for patients 
seen at the LAC/USC Outpatient Neurology Clinics. TWC offers an opportunity to engage 
this diverse ethnic population of patients in an educational exercise program, along with 
coaching and social support, factors that have been shown to promote behavioral change.  
 
1.4. Hypothesis 
 
The primary goal of this proposal is to demonstrate the feasibility of using a Fitbit charge to 
monitor and promote physical activity in a diverse population of Hispanic women with chronic 
neurological disorders. Hispanic women will also receive behavioral coaching using a 
Lifestyle Redesign approach (see below) to enhance physical activity in their daily lives. The 
secondary goal of this proposal is to investigate whether changes in physical activity are 
associated with (i)  quality of life including perception of health and well- being and (ii)  

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frequency of hospital and county clinic visits.  
 
 
2. OBJECTIVES AND PURPOSE 
 
2.1 Primary Objective 
 
This pilot study will provide feasibility on use of wearable technology for tracking and self-
monitoring PA as well as preliminary data to support our overall approach for promoting PA 
and improving disease status in a Hispanic women population. A larger application will be 
submitted to the NIH, DoD, or other federal agency focused on investigating the impact of 
PA on chronic neurological diseases in a diverse and inclusive Hispanic population in LA 
County.  
 
 
2.1.1 Specific Aim 1 
Specific Aim 1 establishes feasibility of this approach by measuring adherence and 
change in PA using a Fitbit Alta HR activity monitor in Hispanic women with chronic 
neurological diseases.  Adherence will be determined through: (i) the average 
hours/day of use; and (ii) the length of time (percent of total study days) of usage 
throughout the 16-week study. Adherence defined as (i)  5 or more days/week  of use 
and (ii) 10 or more hours of use during the day.  
 
2.1.2 Specific Aim 2 
Specific Aim 2 tests the hypothesis that an increase in physical activity will be 
correlated with a decrease in LA County (LAC) Facilities health care use  (hospital 
and clinic visits). Physical activity will be assessed by change in either: (i) the average 
number of steps/week; and (ii) average time spent in sedentary, light, or moderate to 
vigorous intensity based on MET (metabolic expenditure) of physical activity/week. 
Methods: Changes in PA outcome metrics over the 16-week period will be correlated 
with the total number of hospital/outpatient clinic visits. Total hospital use will be 
determined through the LAC/DHS (Department of Human Services) electronic 
medical records and will include outpatient provider visits, emergency room and 
urgent care visits, total hospitalizations, and days spent in hospital. 
 
2.1.3 Specific Aim 3 
Specific Aim 3a tests the hypothesis that increase in physical activity is associated 
with an increase in the quality of life (QOL). Physical activity will be measured through: 
(i) the average number of steps/week; and (ii) average intensity of physical 
activity/week.  QOL will be determined through measures of self-rated health and 
well-being.  These Spanish validated surveys will  include illness perception 
questionnaire and health and well-being questionnaire  
 
 
3.0 STUDY DESIGN 
 
3.1 Overall Study Design  
 
This is a 16-week single group study of PA promotion and monitoring along with its effect 

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on Neurological Health.  Twenty Hispanic women seen at LAC/USC Neurology clinic will 
be referred to TWC and invited to participate in a physical activity (PA) study for 16 weeks. 
Participants will receive individualized Fitbit Charge activity monitors at baseline and 
instructed on its usage and maintenance.  Adherence to activity monitor use and amount 
and level of PA will be determined.  All assessments that include quality of life, exercise 
behaviors, and self-rated health and mood will be made at baseline and at 16 weeks at 
TWC. Educational/coaching will take place through (i) individualized instruction on 
exercise at baseline and at the end of week 4 at TWC and (ii) weekly calls from TWC to 
promote PA goal setting as well as Fitbit use. At the end of week 1, participants will be 
asked to return to the TWC to review instructions on Fitbit App use and to receive further 
education on the benefits of exercise through a brief Power Point presentation. Patient 
may also receive text messages throughout the study to remind them of upcoming 
appointments or deadlines. General Neurological Health status will be determined 
through use of Electronic medical records to determine hospital and outpatient clinic visits 
through the 16 weeks. At study completion, participants will be allowed to keep their Fitbit 
activity monitor and will receive a 3-month follow up post-study call to assess the 
continued usage of the Fitbit charge activity monitor and a quality of life questionnaire. 
 
3.2 Enrollment Plan 
 
Twenty (20) Hispanic women with a chronic neurological disorder will be recruited from 
our LAC/USC Neurology Clinic.  We expect to achieve this goal by 2 months from study 
start. 
 
3.3 Participant Identification and Informed Consent 
 
For this study, Drs. Petzinger or Morrison will screen all potential participants according 
to the list of inclusion/exclusion criteria.  This will include talking to the referral neurology 
doctor from the neurology clinic to determine there are no limitations to physical 
activity/exercise (see exclusion below) .The principal investigators and members of the 
research team will explain the purpose, risks, procedures, and date of the study. If the 
subject is interested in participating, she will be given the Informed Consent to read or if 
they cannot read, our coordinator will read the informed consent to her.  Subjects and 
their family members will be allowed sufficient time to read and/or think about the 
Informed Consent Form and be given the opportunity, and encouraged, to ask questions 
before signing the document. Following the patient giving informed consent (signing the 
document) she will be able to participate in the study. If the investigator or study team 
members have any reason to suspect that the subject does not fully comprehend the 
informed consent or the study, the individual will not be considered as a possible 
participant of the study. The study will be conducted after having Institutional Review 
Board (IRB) approval at USC. 
 
3.4 Fitbit Charge HR2 Activity Monitor 
Participants will be provided a Fitbit Alta HR and wall charger. Each participant will be given 
a unique ID# that will be assigned at baseline and used to set-up the Fitbit data acquisition. 
The Fitbit app will also be set up on their smartphone to allow self-monitoring of activity. The 
Fitbit device includes both an accelerometer and heart rate monitor and is capable of 
continuous measuring and storing data at up to a 1-second sampling rate for up to 5 days. 
Fitbit data will be passively downloaded through either a WiFi and/or smartphone connection 

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to Fitabase. Fitabase (Fitabase, San Diego, Ca) is a research friendly application 
programming interface and comprehensive data management program that allows the 
device data from all users to be identified through a uniquely assigned ID# and transmitted 
in a secure fashion to the data acquisition and integration center.  
The Fitbit Alta will be worn on the wrist every day during the course of the 16-week study. 
While the Fitbit is water resistant, participants will be asked not to wear the device while 
bathing or swimming. Participants will be instructed on self- monitoring, usage and 
maintenance of the Fitbit at the baseline visit. Participants will be monitored for Fitbit 
compliance by (i) weekly phone calls; and (ii) monitoring of passively downloaded Fitbit 
data through Fitabase data collection server. Further instructions will also be given 1 
week into the study, to ensure proper compliance. Participants will be allowed to keep 
their Fitbit monitor at the end of the study. Follow-up phone call at 3-months post-study 
will assess continued use of the Fitbit activity monitor.  
 
3.5 Educational/Behavioral Coaching on Exercise (Lifestyle Redesign) 
 
Participants will receive individualized goal setting and a guide to increase exercise at 
the beginning of the study (baseline) and at week four (week four visit) at TWC. The 
Occupational therapist (OT) will administer a well published approach for promoting PA 
called Lifestyle Redesign which addresses physical, psychosocial and environmental 
barriers to health and incorporate self-care strategies and goal setting. Coaching will be 
administered by a bilingual OT (Dr. Jesus Diaz) and in language (Spanish or English) 
preferred by participant.  Based on studies examining PA and brain health, the 
Occupational Therapist (OT) will guide the participant through a goal setting process for 
moderate to vigorous intensity of physical activity including a specific guide plan to 
achieve these goals of 10,000 steps per day and/or 150 minutes/week of moderate to 
vigorous activity. Participants will also receive weekly calls from the TWC (supervised by 
OT) to review PA and goal setting for each week over the course of the 16-week study. 
 
 
3.5.1 Motivation to Exercise 
 
 
Participants will be given a brief Power Point presentation titled “Promoviendo un 
Cerebro Sano En las Enfermedades Neurologicas, el Rol Del Ejercicio”. The purpose 
of this presentation is the educate participants on the importance of exercise for brain 
health and increase motivation throughout the study. This presentation will be given 
at baseline visit, week 1, and week 4 follow up. 
 
3.6 Primary Outcome Measures 
 
3.6.1 Baseline Demographic Data 
Following inclusion and exclusion and after obtaining informed consent, 
baseline demographic data will be obtained which will include age, recent 
healthcare visit frequency, medical history, medication, years of education, 
and tobacco use.   
 
3.6.2 Physical Activity, Adherence Assessment 
Data gathered from Fitbit based device will be stored, visualized and 
aggregated through a commercially available service (Fitabase Inc, 
Https:/www.Fitabase.com). Fitabase is a research friendly application 

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programming interface that allows the device data from all users to be 
identified through a uniquely assigned ID# and transmitted in a secure fashion 
to the data acquisition and integration center. Data is downloaded from 
Fitabase in a de-identified matter and is ready for statistical analysis (i.e. CSV 
files that are SPSS ready). The Fitabase one-time set-up process (taking 
approximately five minutes) will take place at the wellness center to establish 
a continuous, passive and secure data stream of all measures. The following 
measures will be obtained during the course of the study: (i) step count, (ii) 
time spent in sedentary, light, moderate, and vigorous activity, and (iii) length 
of wear. 
 
3.6.3 Determination of  LA County Facilities Health Care Use  
We will utilize electronic medical record (EMR) system of LA County 
Department of Health Services (DHS) to determine the number of hospital 
visits including Emergency room and urgent care visits, outpatient clinic visits, 
hospital stays and days within the hospital. HIPPA guidelines will be followed. 
 
3.7 Secondary Outcome Measures (scales in Spanish and English)  
All scales will be offered to patient in their preferred language of Spanish or English. 
For patients who are illiterate, the coordinator will read the scales to the patient and 
record their answer. 
 
3.7.1 Quality of Life (QOL) 
This measure assessed participants’ views of their health, how well they feel, 
and well they are able to complete their usual activities. 
 
3.7.2 Spanish Acculturation 
The purpose of this questionnaire is to assess the level to which participants 
acculturate or adopt the attitudes, values, customs, beliefs, and behaviors of 
another culture. 
 
3.7.3 Brief Illness Perception Questionnaire (BIPQ)  
The purpose of this questionnaire is to assess participants’ perceptions of 
their health and well-being. 
 
3.7.4 Patient Activation Measure (PAM) 
This measure assesses participants’ knowledge, skill, and confidence for 
managing one's health and healthcare. 
  
3.7.5 Spanish Physical Activity Questionnaire 
This self-administered questionnaire determines total physical activity (MET-
h week-1 ) and total number of hours sitting down across a week to evaluate 
the levels of participants’ physical activity and sedentary lifestyle.  
 
3.7.6 FitBit Wear Technology Questionnaire 
The purpose of this questionnaire is to ascertain the participants’ opinions on 
how intuitive and useful the FitBit phone application and FitBit Alta HR activity 
monitor are and whether they think the device might be helpful in encouraging 
them to exercise or improve their physical fitness.  
 

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4.0 SELECTION AND WITHDRAWAL OF SUBJECTS 
 
4.1 Inclusion Criteria  
 
Inclusion Criteria includes (1) Women of Hispanic origin; (2) established patient of the 
neurology clinic defined as clinic visits at the LAC/USC Neurology Clinic that have 
spanned greater than one year; (3) age > 30 (4) willing and able to utilize a Fitbit activity 
Monitor; (5) own a smart phone device; (6) ambulatory without assistance; (7) willing and 
able to provide informed consent; (8) within commuting distance to the wellness center 
and LAC/USC hospital; (9) reads or comprehends Spanish;  (10) weekly internet access. 
 
4.2 Exclusion Criteria 
 
Exclusion Criteria includes (1) Clinically significant neurological or psychiatric illness 
including mental retardation, dementia or severe depression/anxiety; (2) any physical 
condition that precludes engagement in exercise, including significant heart disease. 
 
4.3 Withdrawal Criteria 
 
Participants may withdraw from the study at any time for any reason without affecting 
his/her care. 
 
5.0 ASSESSMENT OF EFFICACY AND SAFETY 
 
5.1 Potential Risks of the Proposed Research to the Subject 
 
The potential risks are low and rare; however, the following are possible complications or 
adverse reactions related to study participation.  Participation in this study may involve 
some discomfort. These include feelings of frustration or embarrassment which may 
occur while completing the outcome measures. 
 
5.2 Protection Against Risk 
 
All participants will be monitored by certified personnel throughout study visit to ensure 
subject safety. Research data collected from the study will be kept confidential in secure 
locked cabinets located in the Wellness Center.  
 
5.3 Potential Benefits of the Study to the Participants and Others 
 
Participants could potentially benefit from education on how to incorporate PA into their 
lifestyles and from learning how the FitBit Alta HR activity monitor can help in doing so. 
Findings from this study could support policies for establishing the overall need to 
educate, prescribe, and make available exercise programs and facilities to participants 
within LA County, such as wellness centers within communities and county health 
facilities. As collaborators on this study we gain important knowledge regarding best 
practices for our participants with neurological disorders and insight regarding how to 
help support and monitor physical activity in our patient population. 
 
5.4 Adverse Event Reporting 

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All unexpected adverse events will be reported to the IRB.  Serious adverse events (SAE) 
will be reported within 24 hours, first by phone and then followed by a written statement 
to the IRB.  All serious adverse events will be followed to resolution and noted in the 
subject’s chart.  The following are defined as serious adverse events: 
• 
Death 
• 
Threat to life 
• 
Inpatient hospitalization or prolongation of any existing hospitalization 
Persistent or significant disability/incapacity 
 
6.0 CLINICAL EVALUATIONS AND STUDY CALENDAR 
 
Parameter 
Screening 
Visit 
Baseline 
Visit  
Weeks  
1-4 
Week 
4 
Weeks 
5-16 
Week 
16 
Week 
28 
Demographic Information 
 
X 
 
 
 
 
 
Lifestyle Redesign Coaching  
 
X 
 
X 
 
 
 
Fitbit Charge Activity Monitor Instruction 
 
X 
 
 
 
 
 
Quality of Life (QOL) 
 
X 
 
 
 
X 
 
Spanish Acculturation 
 
X 
 
 
 
 
 
Brief Illness Perception Questionnaire (BIPQ) 
 
X 
 
 
 
X 
 
Patient Activation (PAM) 
 
X 
 
 
 
X 
 
Physical Activity Questionnaire 
 
X 
 
 
 
X 
 
FitBit Wear Technology Questionnaire 
 
 
 
 
 
X 
 
Phone Call for FitBit Use 
 
X 
X 
X 
X 
X 
 
Post-Study Phone Call on FitBit Use 
 
 
 
 
 
 
X 
 
7.0 DATA COLLECTION AND MONITORING 
Data review will be ongoing by the study investigators to ensure scientific integrity of the study.  
A summary of study activity will be sent to the IRB annually with the continuing renewal 
submission.  Quarterly reviews will take place to: 
• 
determine whether all adverse events (if applicable) were appropriately reported 
• 
check the Case Report Forms for legibility, accuracy and completeness 
• 
validate the contents of the Case Report Forms against source 
• 
oversee study progress and compliance  
• 
verify that written Informed Consent and HIPAA authorization was obtained prior 
to patient’s participation  
 
8.0 STATISTICAL CONSIDERATIONS 
 
8.1 Statistical Methods 
 
Preliminary analyses will begin with an examination of the distribution of key variables to 
assess their characteristics (means, standard deviations, skewness, and kurtosis), to 
provide descriptive statistics of the study population. Continuous measures will be tested 
for normality and homogeneity of variance. Non-normally distributed variables will be 
transformed to meet the normal distribution assumption for linear statistical models.   
 
8.1.1 Specific Aim 1 

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The percent of valid days of FitBit use and length of time will be calculated. We 
will then examine the percentage of participants who had acceptable adherence 
as defined as over 5 or more days/week of valid use and 10 or more hours/day 
length of time. 
 
8.1.2 Specific Aim 2 
Given the small sample size power to detect significant associations between 
physical activity and number of hospital visits will be low. Therefore, these 
analyses will purely exploratory. We will generate change scores from baseline to 
16 weeks for both physical activity variables by subtracting week 16 scores from 
baseline scores. We will use Poisson regression analyses to examine the 
associations between changes in physical activity with our dependent variable 
hospital visit outcomes.  Poisson regressions will be fit to account for the fact that 
our dependent variable (hospital visits) is a count variable and non-normally 
distributed. All regression models will adjust for baseline level of physical activity.  
Significance level will be set at 0.05. 
 
8.1.3 Specific Aim 3 
All analyses described for aim 3 are also exploratory in nature as the proposed 
analyses will be underpowered to detect a significant association. Change scores 
in Quality of life, symptoms of anxiety and depression will be calculated by 
subtracting week 16 scores from baseline scores. Linear regression analyses will 
be run examining the associations between change in PA and our dependent 
variable of change. 
 
9.0 ETHICAL AND REGULATORY CONSIDERATIONS 
 
All institutional and Federal regulations concerning the Informed Consent form will be fulfilled.  
The study will be conducted in adherence to ICH Good Clinical Practice. 
 
10.0 
REFERENCES 
 
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(2) Motl, R. W. and B. M. Sandroff (2015) Benefits of Exercise Training in Multiple Sclerosis, Curr 
Neurol Neurosci Rep 15:9, 585.  
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regulation, exercise, and mild traumatic brain injury, Neurology 
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Hispanic adults, J Environ Public Health 2012:156435.  
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