Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Rush University Medical Center

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
 
Title: KICK OUT PD: Karate Intervention to Change Kinematic Outcomes in Parkinson’s  
Disease 
NCT: NCT03555695 
Document date: 04/30/2018 
 

Rush University Medical Center 
_____________________________________________________________________________________ 
 
Title:   
KICK OUT PD: Karate Intervention to Change Kinematic Outcomes in Parkinson’s Disease 
Short Title:  
KICK OUT PD 
S#:  
 
18012313-IRB01 
 
 
Principal Investigator:  Jori Fleisher, MD MSCE 
Rush University Parkinson’s Disease and Movement Disorders Program 
Phone: 312-563-2900 
Jori_fleisher@rush.edu  
 
 
 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
ABBREVIATIONS 
DST 
Digit Span Test 
FRT 
Functional Reach Test 
HADS 
Hospital Anxiety and Depression Scale 
HY 
Hoehn and Yahr Scale 
PD 
Parkinson’s Disease 
PDQ-8 
Parkinson’s Disease Questionnaire – Short Form 
PGIC 
Patient Global Impression of Change 
PHI 
Personal History Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SDMT 
Symbol Digit Modalities Test 
TMT 
Tinetti Mobility Test 
TUG 
Timed Up & Go test 
UPDRS 
Unified Parkinson's Disease Rating Scale  
 
 
 

I. 
Project Rationale and Description 
I.a. Purpose of the Study 
The aim of this study is to test whether and to what degree a community-based karate class tailored for 
individuals with early- to middle-stage Parkinson’s Disease (PD) 1) is feasible; and 2) improves objective 
and patient-reported outcomes. The benefits of exercise for general health and wellbeing in older adults 
are well-established. Balance exercises such as tai chi and yoga, along with resistance training, can 
improve or maintain physical function in older adults and enhance muscle strength. Furthermore, 
aerobic activity is critical for maintaining and improving cardiovascular and functional health. Non-
contact boxing has recently seen a surge in popularity among individuals with PD, with components of 
both aerobic and balance exercise. While participants anecdotally note improvements in stress and 
physical function, this has only been minimally studied. However, drawing on this experience and the 
combined aerobic, balance, and mindfulness practices that comprise karate, we hypothesize that 
participation in structured karate programs may offer similar or greater benefits. In particular, the 
aerobic, resistance, and balance aspects of karate may be beneficial for physical and cognitive wellbeing, 
and the mindfulness exercise may improve overall wellbeing. Therefore, we propose a pilot, 10 week-
long study of a structured karate exercise program for people with early to middle PD, with pre- and 
post-intervention assessment of mobility, gait, balance, falls, attention, quality of life, patient-reported 
global impression of change, and mood. We will assess feasibility with measurement of attendance at 
each class, and will assess preliminary sustainability with a six-month follow-up phone call to assess 
continued engagement in karate classes or other regular exercise. We will gather qualitative data on 
expectations and experience with the classes through pre-intervention and post-intervention focus 
groups.  
We hypothesize: 1) Subjects will show improved mobility after 10 weeks of twice weekly karate classes, 
as measured by change in Timed Up & Go (TUG)1; 2) The majority of subjects will report a positive 
change from baseline in their overall wellbeing, as measured by a response of “very much improved”, 
“much improved” or “minimally improved” on the Patient Global Impression of Change Scale (PGIC)2 
following 10 weeks of classes; 3) Feasibility will be high, as measured by >75% attendance rate and a 
response of “yes” to either “Would you recommend this program to someone else with PD?” or “If 
available, would you continue to participate in this or a similar karate class?” Exploratory outcomes will 
include measures of gait and balance, including change in functional reach test (FRT)3 and change in 
Tinetti Mobility Test (TMT)4,5, along with change in anxiety and depression, as measured by the Hospital 
Anxiety and Depression Scale (HADS), and measures of attention such as the Symbol Digit Modalities 
Test (SDMT) and the Digit Span Test (DST)6 
I.b. Background 
Parkinson’s Disease, the second most common neurodegenerative condition7 presents a significant 
health concern and the progressive, incurable course of the disease impacts functional abilities of the 
patient and quality of life for both the patient and caregivers. Exercise is an established supplement to 
pharmacologic PD treatment and various modalities have demonstrated benefits in gait, balance, PD 
symptoms, and quality of life measurements.8,9,10 Research has encompassed many forms of exercise, 
including aerobic activities and mindfulness-based practices. Vigorous, aerobic activity has been 
repeatedly shown to have disease-modifying effects ranging from quality of life to overall cognitive and 
physical improvement.10 Mindfulness-based practices, such as tai chi, have seen a recent surge in 
interest and an overall beneficial effect for participants.11,12 A notable trial compared resistance training, 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
stretching and tai chi interventions among Parkinson’s patients and while both the resistance and tai chi 
arms showed improvements on multiple measures of physical ability, tai chi demonstrated a 
significantly greater impact in measures of balance and postural stability.13 Furthermore, resistance 
training and tai chi were both correlated with improved patient-reported outcomes and participants in 
the tai chi group who reported benefits were more likely to continue their exercise programs.14  
In addition to scholarly efforts, efforts to incorporate various forms of activity into PD care have gained 
popularity in the community at large, with notable examples including Rock Steady Boxing, a non-
contact, PD-focused boxing class that has garnered national media attention. Anecdotal reports of the 
benefits of these vigorous, goal oriented, exercise classes are numerous; however, it has been minimally 
studied from the academic perspective. A case series describing six patients attending Rock Steady 
boxing classes reported at least some improvement in gait, balance, activities of daily living, and quality 
of life.15 A randomized trial with 31 patients comparing traditional exercise and boxing demonstrated 
significant improvements in balance, movement, and quality of life measures among both interventions, 
with greater gains in gait among the boxing group.16 Similar to boxing, karate for patients with PD has 
received some popular attention and media coverage both within the United States and internationally.  
Karate is a martial art that incorporates the vigorous activity of aerobic and resistance exercise, mindful 
practice similar to tai chi, and is taught as large, directed movements in a class-based, communal 
environment. Karate as an adjunct therapy in PD has not yet been investigated, although one study 
reports improvements in cognitive speed and subjective mental health among healthy older adults 
participating in karate training compared to others in a mindfulness intervention without exercise. 17 The 
combined benefits of exercise, mindfulness-based practice, and the popularity and promise of these 
types of interventions lead us to believe that karate is a promising exercise modality for PD patients and 
warrants further investigation. There is significant opportunity to document the potential benefits of the 
physical activity and mindfulness components of karate training and begin filling in this gap in the PD 
and exercise literature.  
I.c. Study Design 
This is a non-randomized, open-label, non-blinded, 10-week pilot study of a novel intervention, namely, 
non-contact karate, for early to middle stage PD. The intervention—namely, karate classes—are  
developed for and will include only  patients with Parkinson’s disease. Eligible subjects will engage in 
twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage 
PD, focused on incorporating upper and lower limb movements in multiple directions, increasing 
awareness throughout the body, shifting body weight and rotation, relaxation of the muscles, improving 
reaction time, using complex repetitive actions to improve coordination, footwork training and centered 
weight shifts to help with fall prevention, and striking shields for self-defense and stress relief.  
 
Each subject will attend a pre-intervention focus group, at which time the study logistics will be 
reviewed, informed consent process will occur, the subject will complete a brief, individual pre-
intervention assessment focused on overall mobility, gait, balance, attention, mood, and quality of life, 
and the subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness 
practices in general and in PD specifically, and any expectations or preconceptions that they have 
regarding karate classes for PD. The focus group sessions will be audiotaped.  After the sessions the 
information recorded will be transcribed into electronic documentation for later review and analysis. At 
the end of the study, the audiotapes will be destroyed.  
 

Following 10 weeks of twice weekly classes, the subjects will have a post-intervention assessment and 
focus group, in which the pre-intervention assessments (TUG, FRT, TMT, PDQ-8, HADS, SDMT, DST) will 
be re-administered, along with the PGIC for the subject’s global impression of change. Subjects will be 
prompted to share their thoughts on how the intervention impacted their overall wellbeing, balance, 
and mindfulness; whether the intervention achieved their expectations; and they will be asked to 
provide feedback for improvements. Finally, the study team will contact subjects 6 months post-
intervention to assess continued engagement in karate or related activities and again, the subject’s 
quality of life and global impression of change.  
 
The PI and research team will collaborate with a professor of Cinema and Television Arts from Columbia 
College Chicago, IL to develop a documentary to educate others about karate as an interactive form of 
exercise and its potential benefits on the symptoms and quality of life of people with PD. To capture the 
groups’ journey over 10-weeks, portions of the pre-intervention focus group, the karate classes, and the 
post-intervention focus group will be videotaped. For a more in-depth look, two to three subjects will be 
followed during the entire study and interviewed to provide a personal narrative of their experiences 
with the karate classes and living with PD. The interviews will be videotaped. 
 
 
We will recruit 30 individuals with PD diagnosed by a neurologist, ages 30-90, living in Chicago, and with 
Hoehn & Yahr (HY) stage 1 (unilateral symptoms, no balance issues), stage 2 (bilateral symptoms, no 
balance issues), or stage 3 (bilateral symptoms, some postural or balance involvement). Subjects will be 
assigned to one of two cohorts of 15 subjects each, based on dojo location and class schedule. For 
example, one cohort may take classes Tuesday and Thursday nights at the Wilmette dojo, and the 
second cohort may take classes Wednesday and Saturday mornings at the Glenview dojo, however class 
times and locations are to be determined.  
II. 
Characteristics of the Research Population  
II.a. Number of Subjects 
Total Number of Subjects: 30 
This is a pilot study; our power analysis (see table below) is based on the TUG, with the following 
assumptions: mean TUG score for individuals with PD is 14.8 seconds with standard deviation of 5.8 
seconds, alpha of 0.05, and correlation between baseline and follow-up assessments of 0.5. We 
calculated sample sizes necessary with various minimum clinically important difference values for the 
TUG, which ranges from 2 seconds to 5 seconds in various studies1,18, and varying for power between 
80-90%. With a sample size of 30, we will have 80% power to detect a change of 3 seconds in the TUG, 
and will be more than 90% powered to detect a change of 4 seconds or greater.   
Baseline 
mean TUG 
Baseline SD 
TUG 
Min. clin. 
Important 
difference  
Correlation b/w 
baseline, 
follow-up 
Power 
Sample size  
14.8s 
5.8 
2s 
0.5 
.9 
89 
 
 
 
0.5 
.8 
67 
14.8 
5.8 
3s 
0.5 
.9 
40 
 
 
 
0.5 
.8 
30 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
14.8 
5.8 
4s 
0.5 
.9 
23 
 
 
 
0.5 
.8 
17 
14.8 
5.8 
5s 
0.5 
.9 
15 
 
 
 
0.5 
.8 
11 
II.b. Gender of Subjects  
There will be no exclusion of subjects based on gender. 
II.c. Age of Subjects  
Subjects will be 30-90 years of age. 
II.d. Racial and Ethnic Origin  
There will be no exclusion of subjects based on racial or ethnic characteristics. However, subjects must 
be fluent in English to participate in the karate classes, as that is the language of instruction, and due to 
the general lack of appropriately translated neurological and neuropsychological assessments and 
appropriate normative comparison samples. These factors are critical for accurate administration, 
scoring, and interpretation of neurological and neuropsychological test data. 
II.e. Inclusion Criteria for All Subjects: 
1. Each subject must be between 30-90 years of age.  A subject may be of either gender, any 
race/ethnicity. 
2. Subjects will be those diagnosed with Parkinson’s Disease by a treating neurologist; if the subject is 
seen at Rush University Medical Center, this will be verified via chart review. If the subject is seen 
elsewhere, he or she will be asked to have their neurologist sign a form confirming the diagnosis of 
Parkinson’s Disease and indicating the subject’s HY stage (with definitions of each stage provided on 
the form for providers who may not be familiar with HY staging) at the most recent visit, to be sent 
back to the study coordinator for eligibility verification. 
3. English speaking. 
4. Living within the Chicago area. 
5. Subjects may be untreated for Parkinson’s Disease, or may be taking any individual PD medication or 
combination thereof. Subjects may or may not have had Deep Brain Stimulation. Subjects may or 
may not be receiving physical or occupational therapy. Subjects will be encouraged to maintain their 
same medication regimen throughout the duration of the 10-week study, however if emergent 
issues arise requiring medication changes, the subject will not be disqualified.  
 
II.f. Exclusion Criteria for All Subjects 
1. Subjects requiring an assistive device (cane, walker, wheelchair) or the assistance of another person 
in order to ambulate. 
2. Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder. 
3. Subjects unable to commit to attending, or to travel to, two classes weekly for 10 weeks. 
4. Subjects previously participating in a karate or other martial arts program, including boxing 
programs for PD, in the past 30 days.  

5. Subjects with atypical parkinsonism, including Progressive Supranuclear Palsy, Multiple System 
Atrophy, Dementia with Lewy Bodies, Corticobasal Syndrome, drug-induced parkinsonism, vascular 
parkinsonism, or atypical parkinsonism not otherwise specified, according to the referring 
neurologist.  
 
II.g. Vulnerable Subjects – This study will not include children, prisoners, and homeless persons.  The 
consent form will state that participation in our study will not affect their clinical care.  
III. Methods and Procedures 
Study Visits 
Screening Phone Call 
Subjects who are interested in participating based on review of printed or electronic recruitment 
materials will be directed to contact the study coordinator by phone, who will provide them with 
information about the study and the opportunity to ask questions about it in detail; those who express 
continued interest in participation will be screened for eligibility and ability to attend the scheduled 
classes, held at one of the five Fonseca Martial Arts Dojos in Glenview, Wilmette, Park Ridge, Evanston 
and/or Roscoe Village. Classes will occur twice weekly for ten weeks, between June through August 
2018, and subjects can select from participating in either a weekend/weekday daytime class, or a 
weekday/weekday evening class, depending on their availability and proximity to each dojo’s geographic 
location. Screening will occur on a rolling basis until the 15 slots in each class are filled. 
 
Pre-Intervention Focus Group 
Prior to the first class, subjects will attend a pre-intervention focus group, at which time the study team, 
including Principal Investigator, Research Coordinator, and research assistants, will review the study 
design and flow, informed consent process, and each subject will be individually visited by a member of 
the study team to review and sign the informed consent form (ICF).  
 
Subjects will then complete a brief demographic questionnaire, including duration of PD diagnosis in 
years, baseline activity level, prior involvement with karate or other martial arts, number of falls in the 
past 12 months, and subjects will complete the Parkinson’s Disease Questionnaire-8 (PDQ-8)19, a brief, 
validated, PD-specific 8-item measure of quality of life. Subjects will complete the Hospital Anxiety and 
Depression Scale (HADS). Subjects will also write their response to the open-ended prompt, “What do 
you hope to achieve in this class?”  
 
Subjects will then meet with a study team member to complete the TUG (see description below), FRT, 
and TMT. Next, the subject will meet with the PI or another study team member in a private room for a 
brief assessment of bradykinesia, tremor, rigidity, and postural stability in order to determine baseline 
HY stage. Lastly, subjects will meet with a study team member to complete short attention assessments 
with a SDMT and DST. Once all subjects have completed the pre-intervention written and physical 
assessments, the focus group will commence.  
 
Subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness practices 
in general and in PD specifically, and any expectations or preconceptions that they have regarding 
karate classes for PD. 
 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
Intervention 
Each karate class will follow a structured curriculum, as shown in Appendix 1, with complexity of 
movements and movement patterns increasing over the 10-week study period. Classes will take place 
twice weekly, and subjects will be required to attend their assigned class time/location. Each class will 
last approximately 45-60 minutes. Attendance will be recorded in hard copy by the instructors at each 
class, with recordings only of the subject’s name, not linked to their unique study ID; the attendance log 
will be shared with the study coordinator following the final class. A member of the study staff will be 
present at each class in order to answer questions and to support participants and instructors should 
any questions about protocol or PD safety arise.  
 
Post-intervention focus group 
In the week prior to the 10th class, the study team will contact subjects to remind them of the date and 
time of the final class and the post-intervention focus group. The post-intervention assessment will 
consist of a repeated TUG, FRT, TMT, HADS, PDQ-8, SDMT, DST, brief question about falls in the past 10 
weeks, and PGIC. Each subject will receive their initial response to the “What do you hope to achieve in 
this class?” prompt, and will be asked to reflect in a written, open-ended manner on whether they feel 
that they achieved their goal. In addition, subjects will indicate their response to the following questions 
regarding feasibility:  “Would you recommend this program to someone else with PD?” and “If available, 
would you continue to participate in this or a similar karate class?” 
 
Subjects will then participate in a focus group, similar to the pre-intervention focus group, in which they 
be asked to share and reflect on how the intervention affected their overall attitude towards exercise; 
how it affected their balance and falls; how it affected their mindfulness; any other positive or negative 
benefits; any impact on their care partner(s) (if applicable); and suggestions for changes to the 
intervention for the future. Depending on availability of space, the post-intervention focus group may 
take place at Rush University, or may take place immediately following the last class at the respective 
dojo. 
 
Documentary 
Portions of the focus groups and karate classes, and the entire in-depth interview will be videotaped by 
the Columbia filmmakers using personal equipment. Subjects may choose to not participate in the 
documentary project which means subjects will not participate in the in-depth video interviews, and 
they will not be included in individual or group video shots during the focus groups and karate classes. 
To ensure confidentiality, subjects will be placed in one of two groups, Group A or Group B, depending 
on whether they decide to participate in the documentary or not. Subjects who agree to be videotaped 
and possibly interviewed will be part of Group A while subjects who choose not to be videotaped or 
interviewed will be in Group B. Subjects may not switch groups after the study begins with the pre-
intervention focus group. Participation in the karate classes and focus groups will not be affected if a 
subject does not wish to be videotaped or interviewed. Subjects will not be penalized if they decide to 
not take part in the documentary 
 
Six month follow-up phone call 
The study team will contact the subjects by phone six months after the final class to ask whether the 
subject has continued to participate in any structured karate or martial arts classes; if yes, frequency 
and location will be asked. If no, reasons for lack of participation will be asked. Finally, PGIC will be 
administered a final time.    
 
 

Assessments: Subjects who agree to be part of the study and sign the Informed Consent Form will be 
asked to complete a series of assessments to assess their current neurological status and overall 
wellbeing. There is no known risk associated with participation in these assessments, and they are a part 
of routine clinical care for these conditions. These tests are typically experienced as interesting to 
subjects. Administration of these assessments should take 15 minutes per subject immediately prior to 
the first class, and 15 minutes per subject immediately after the final class. All or some of the following 
assessments and self-report measures may be administered but are not limited to:  
 
• 
Demographic/disease questionnaire: This brief, one-page questionnaire will ask for the subject’s 
name, phone number (for 6-month follow-up call), age, gender, race, ethnicity, PD duration in 
years, prior exposure to karate or martial arts classes, baseline activity level, and number of falls 
in the past 12 months. There will be one open-ended question asking, “What do you hope to 
achieve in this class?” 
 
• 
Hoehn and Yahr Scale (HY): A system used for describing how Parkinson's symptoms progress 
and the relative level of disability. There are five stages: Stage 0 – No signs of disease; Stage 1 – 
Unilateral disease; Stage 1.5 – Unilateral plus axial involvement; Stage 2 – Bilateral disease, 
without impairment of balance; Stage 2.5 – Mild bilateral disease with recovery on pull test; 
Stage 3 – Mild to moderate bilateral disease; some postural instability; physically independent; 
Stage 4 – Severe disability; still able to walk or stand unassisted; Stage 5 – Wheelchair bound or 
bedridden unless aided.20 
 
• 
Timed Up and Go (TUG): A well-validated, brief measure of mobility. Administered by a study 
team member with a stopwatch who has previously measured out the distance between a 
standard arm chair and a taped line on the ground 10 feet (3 meters) away, subjects sit in a 
standard arm chair and are instructed that when the team member says “Go”, they should stand 
up from the chair, walk at their normal pace to the line, turn, walk back to their chair at a 
normal pace, and sit down again. The study team member will record the TUG results in seconds 
using a stopwatch. This is a recommended test of balance in PD.21    
 
• 
Functional Reach Test (FRT): This brief, valid, reliable, and practical assessment of balance 
involves a yardstick being mounted on a wall at shoulder height. The subject is asked to stand 
next to the yardstick, extend the arm closest to the wall at 90 degrees of shoulder flexion, and 
the distance is recorded. The subject is then asked to reach as far as he or she can forward 
without taking a step, and the distance is recorded again. The difference between start and end 
position is the reach distance.3 This is a recommended test of balance in PD.21    
 
• 
Tinetti Mobility Test (TMT): This balance scale has strong psychometric properties and consists 
of 2 subscales: balance tests (9 items, scored from 0-16) and gait tests (7 items, scored from 0-
12), where higher scores reflect better performance.5 This meets criteria for a “suggested” scale 
in PD.  This is a recommended test of balance in PD.21    
 
• 
Hospital Anxiety and Depression Scale (HADS): Brief, 14-item highly validated scale for 
measuring anxiety (7 items) and depression (7 items), where scores of >8 for either anxiety or 
depression indicate probable symptoms.6 The HADS was selected due to its use in prior peer 
mentoring studies and strong psychometric profile 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
• 
Modified Unified Parkinson’s Disease Rating Scale (UPDRS): A shortened version of the UPDRS 
motor subscale will be conducted by the PI or study staff, assessing only rigidity, resting tremor, 
and bradykinesia in all four extremities and the head/neck, as well as postural stability, in order 
to determine the subject’s HY stage. 
 
• 
Patient Global Impression of Change (PGIC): This single-item rating scale administered only at 
the post-intervention assessment asks subjects to rate their overall response to the intervention 
using a 7-point rating scale, with the options of “very much improved”, “much improved”, 
“minimally improved”, “no change”, “minimally worse”, “much worse” and “very much worse”. 
Recommendations for assessing importance of this scale include reporting the percentages of 
subjects endorsing each of the 7 response options.  
 
• 
Parkinson’s Disease Questionnaire- Short Form (PDQ-8): A validated and shortened version of 
the PDQ-39, with 8 items each representing one domain of the PDQ-39, also with a summary 
index score standardized to a scale of 0-100, with higher scores signifying worse quality of life; 
this scale is recommended for use in PD by the Movement Disorder Society. 
 
• 
Symbol Digit Modalities Test: This uses a reference key while the examinee has 90 seconds to 
pair specific numbers with given geometric figures. Responses can be written or oral, and for 
either response mode, administration time is 5 minutes. The WPS AutoScore Test Form 
simplifies scoring. SDMT allows the opportunity to compare written and spoken responses from 
the same individual. The Manual provides separate norms for written and oral administrations 
of the test. Norms for adults are separated by age group and level of education. 
 
• 
Digit Span Test: This tests the number of digits a person can absorb and recall in correct serial 
order after hearing them or seeing them. Here the person has to remember a small amount of 
information for a relatively short time, and the order of recall is important. To test the auditory 
digit span of a person, the administer says numbers slowly in one second intervals, in a 
monotone voice. For example, the administer will say 6-1-5-8 and have the person repeat it back 
in the order it was given or the reverse order. If the person is able to say a 4 digit sequence back 
correctly 75% of the time on the first try, it will be considered a short term memory of 4, and is 
the same for each higher digit. The average in our society for a seven-year old to adult is 7. 
 
 
III.b. Data Analysis and Data Monitoring 
 
Oversight of the Data: Karate for PD will be maintained by the Principal Investigator. The Principal 
Investigator will review study procedures annually and report any concerns in the IRB continuation 
application. This is a Level I, Low, Minimal Risk study; therefore, there is minimal risk of unanticipated 
problems with the exception of breaches in confidentiality. The quantitative data for the study will be 
entered into a secured database using an electronic data capture program, Research Electronic Data 
Capture (REDCap).22 The database will be stored on a secure password-protected server and not on 
individual desktop computers. The code sheet will be password protected and the password will be 
updated annually. Breaches of confidentiality will be reported to the IRB immediately with the 
“Reportable Event/Unanticipated Problem Form.”  
 
Data will be exported from REDCap in de-identified format for statistical analysis, with all PHI stripped 
from the dataset prior to analysis by statisticians. We will summarize categorical variables by 

frequencies and percentages and will assess continuous variables for normality, summarized by 
mean/standard deviation, or median/interquartile range. We will report the basic descriptive statistics 
of the cohort, including baseline TUG, FRT, TMT, HADS, PDQ-8, SDMT, and DST, stratified by HY stage. 
We will report on attendance, defined as the percentage of classes attended, where 20 is the 
denominator. We will analyze the change in TUG, FRT, TMT, HADS, PDQ-8, SDMT, and DST, respectively, 
from pre- to post-intervention, using paired t-tests or nonparametric Wilcoxon sign rank tests, as 
appropriate, stratifying for HY stage. We will report on the percentage of subjects endorsing each of the 
7 PGIC response options, stratifying for HY stage. We will report the descriptive statistics concerning 
whether subjects’ individual predefined goal for the class was achieved (binary outcome), and will 
present de-identified qualitative comments noted in the feedback at the post-intervention assessment. 
We will report descriptive statistics on continued interest and likelihood of recommending the program 
to someone else with PD. After the 6-month follow-up call, we will analyze descriptive statistics on 
continued involvement in karate/martial arts, and will again report the percentage of subjects endorsing 
each PGIC response option.  
 
The qualitative data from the focus groups will be audio-recorded and transcribed, with all identifying 
information stripped from the transcripts. Once transcribed, the audio recordings will be destroyed. The 
qualitative data will be analyzed using a grounded theory approach to identify pertinent themes, with 
data stored as password-protected files behind the Rush firewall, accessible only to study staff.  
 
All video footage will be the sole property of the PI. Videos will have identifying information (i.e. image 
of patient’s face, first name). Video files will be stored and password-protected behind the Rush and the 
Columbia firewall. The video along with the data collected from the focus groups and karate classes may 
be used as part of the dissemination of the study results and for educational purposes. 
 
The PI, co-investigators, and/or study staff will review all data collection forms on an ongoing basis for 
data completeness and accuracy as well as protocol compliance.  The data will be reviewed on a 
quarterly basis: 
• 
Subject accrual (including compliance with enrollment criteria) 
• 
Status of all enrolled subjects 
• 
Adherence data regarding study visits and procedures 
 
Safety data (AEs and SAEs) will be reported to the Principal Investigator and reviewed per occurrence 
and in accordance with the IRB’s regulations. Any significant findings (i.e. protocol deviations) will be 
reported to the IRB in accordance with requirements and will be documented accordingly. 
III.c. Data Storage and Confidentiality  
All subjects will be assigned unique ID numbers. All research data files will be stored at the Rush 
University Parkinson’s Disease and Movement Disorders Program in secured file cabinets, including hard 
copies of case report forms, informed consent forms and informed consent documentation checklists. 
Data will be entered into a secured database (REDCap). The database will be stored on a secure 
password-protected server and not on individual desktop computers. The code sheet will be password 
protected and the password will be updated annually. Hard copies of case report forms and informed 
consent documentation checklists will be labeled with the study ID only and maintained in individual 
files by study ID number. Signed informed consent forms, containing subject names, will be stored 
separately in the regulatory binder, which will be stored in a locked file cabinet in the PI’s office. Class 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
attendance records will be maintained using name only, not subject ID, by the class instructors. These 
records will then be given to the study coordinator following the final class, who will then link the 
attendance information with the subjects’ data using the code sheet. Attendance information will be 
entered into REDCap, after which time, the hard copies of the attendance information will be destroyed. 
 
Before videotaping begins, subjects who agree to participate in the documentary must sign their name 
on the informed consent form.  Participating in the documentary is voluntary. Informed consent forms 
will be stored in the regulatory binder, which will be stored in a locked file cabinet in the PI’s office. The 
PI and the Columbia Cinema and Television Arts filmmakers will have access to the video files to perform 
activities only related to the study. 
 
 
Only the PI and research staff will have access to the database and hard copies of study documents. 
Data will be stored in a format suitable for research inquiries by the PI who might make use of the data 
in a retrospective manner for other Rush-based research studies. If a particular researcher/collaborator 
has an interest in a study population, then the PI will review the database to identify eligible subjects 
that meet the study inclusion criterion and the potential participant(s) will then be contacted by a 
member of this study team whom the subject has already met to see if they are interested in 
participating in the particular study. If a participant is interested, he or she will be referred to that Rush 
study team and will be scheduled for a separate consent procedure with the individual Rush researcher 
for that particular study and at that point the participant can choose whether to participate or not in 
that particular study. The results of the Karate for PD study may be published in a book, journal, and 
other media or used for teaching purposes. However, all published data will be made anonymous.  
 
IV. 
Risk/Benefit Assessment  
 
IV.a. Risk 
There are no known risks from participating in neurological or neuropsychological tests. Subjects may 
experience mild boredom or cognitive fatigue; however, most individuals with like symptoms find the 
tests interesting and are able to tolerate up to two-hour duration of testing well. There is, however, a 
risk of falls or injury associated with participation in any exercise, including karate, for which subjects 
will sign a liability waiver used for all karate class participants at the Fonseca Martial Arts dojos. The risks 
will be minimized to the extent possible by 1) having all instructors undergo basic instruction in 
principles of PD by the PI prior to the first class; 2) having all classes held at quieter times in the dojo, so 
as to avoid overcrowding and risks of falls or freezing of gait in crowded, busy situations; 3) having small 
instructor to subject ratios (2 instructors per 15 subjects) to allow for maximal supervision and guidance; 
4) having study staff present to assist with mobility issues at as many classes as possible.  
 
Another possible risk is the loss of confidentiality by participating in the video because the subject’s 
image may be captured. However full names will not be used during interviews with the two or three 
subjects who agree to answer questions about their experiences with the karate classes. 
 
IV.b. Potential Benefit to Subjects 
 
Potential benefits to subjects include the following: 1) cognitive and physical improvements in PD 
symptoms related to both vigorous physical activity and mindful exercise; 2) benefits of mindful exercise 
on quality of life; 3) the enjoyment of participating in a new activity in a social environment with other 
individuals with PD; 3) the satisfaction of learning a new skill; 4) the knowledge that by participating, 

subjects are contributing to the understanding of how karate impacts individuals with PD; 5) the 
altruistic benefit of contributing to the development of a fun, novel intervention for themselves and 
potentially others. Additional benefits include the opportunity to be active in the community and form 
relationships with peers. The positive effects on subjects with PD also have the potential to impact the 
wellbeing of their families and caregivers, as this karate class offers a new option for fun, therapeutic 
activity. The potential benefits to society include furthering the involvement of individuals with chronic 
diseases in community activities and the potential physical benefits may help modify the disease 
progress for the many affected by PD.  
 
V. 
 Subject Identification, Recruitment, and Consent/Assent 
V.a. Method of Subject Identification and Recruitment 
Individuals will be recruited via posted fliers, print and electronic newsletter postings, and social media 
postings from the Rush University Parkinson's Disease and Movement Disorders Program, electronic 
newsletter postings in the Rush University Medical Center Research Newsletter, Rush clinical trials 
website, via electronic and printed copies of fliers sent to Rush University Medical Center (1725 W 
Harrison St Ste 755 Chicago, IL 60612), Rush Oak Park Hospital (520 S Maple Ave Oak Park, IL 60304), 
Northwestern University (710 N Lake Shore Dr Abbott Hall, 11th Fl Chicago, IL 60611), University of 
Chicago (5841 S Maryland Ave MC 2030 Chicago, IL 60637), University of Illinois-Chicago (1801 W Taylor 
St Ste 4E Chicago, IL 60612), Jesse Brown Veterans Affairs Hospital (820 S Damen Ave Chicago, IL 60612), 
Captain James A. Lovell Federal Health Care Center (3001 Green Bay Rd North Chicago, IL 60064), 
Edward Hines Jr. VA Hospital (5000 5th Ave Hines, IL 60141), Evanston Hospital (2650 Ridge Ave. 
Evanston, IL 60201), Glenbrook Hospital (2100 Pfingsten Road, Glenview, IL  60026), Highland Park 
Hospital (777 Park Ave. West, Highland Park, IL 60035), Skokie Hospital (9600 Gross Point Road, Skokie, 
IL 60076) general neurologists and movement disorder specialists. Information will be disseminated to 
PD patients at monthly support group meetings and other educational and research fairs, as they arise. 
If possible, the IRB-approved recruitment fliers will be shared with the Parkinson Foundation for 
possible distribution through their electronic newsletters and social media avenues to increase reach to 
other potential subjects throughout the Chicago area. We will also post to clinicaltrials.gov within 30 
days of starting enrollment.  
 
V.b. Process of Consent  
At the time of the pre-intervention focus group, the study team, including Principal Investigator, 
Research Coordinator, and research assistants, will review the study design and flow, informed consent 
process, and each subject will be individually visited by a member of the study team to review the 
informed consent form (ICF), engage in capacity assessment as described below, and assuming capacity, 
sign the ICF, witnessed by the study team member. The study team member will complete an ICF 
documentation checklist, as well.   
 
V.c. Subject Capacity 
Capacity to consent will be assessed by the designated trained research staff member and/or the PI. 
Throughout the consent process, the study staff member will assess the participant’s comprehension by 
asking the participant to verbally summarize key elements of the consent form particularly the sections 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
of the consent form that explains that they are being asked whether they agree to be contacted for 
other studies, as well as aspects of the consent form that explain the inclusion of PHI in the database, 
how their confidentiality will be protected, and how their data will be stored for future use.  Subject’s 
capacity is not expected to fluctuate significantly during the 10 weeks of the study, and would not be 
expected to be significantly impaired in early to middle stage PD.  
During the consent process, subjects will have the opportunity to indicate whether they wish to be 
contacted for participation in future studies conducted by researchers at Rush and their collaborators. 
Subjects who agree to participate in the program will also have an opportunity to authorize having their 
Personal History Information (PHI) shared with our collaborators. PHI data will NOT be shared unless 
written authorization is obtained from the subject. Subjects will be given a copy of the signed IRB 
approved Informed Consent Form for their future reference.   Signed consent forms will be stored in a 
locked cabinet in the PI’s office at Rush, separate from the study data.   
V.d. Debriefing Procedures 
 
Subjects will be debriefed about the aims and study hypotheses following administration of all study 
procedures; this will occur at the end of the six-month follow-up phone call in order to avoid introducing 
bias into subjects’ responses to questions.  
 
V.e. Documentation of Consent   
 
A Consent Process Documentation Form will be included in the subjects’ research chart that will 
document the informed consent process that took place.   
 
V.f. Costs to the Subject 
  
Subjects will not receive any inducements before, or rewards or compensation (i.e. cash, taxi fares, 
medical care, gifts, etc.) after the study. There will be no cost to subjects associated with participation in 
this study. Subjects will wear their own comfortable workout clothing; they will not need to purchase 
traditional uniforms for this karate class.  
VI. References 
1.  Dal Bello-Haas V, Klassen L, Sheppard MS, Metcalfe A. Psychometric Properties of Activity, Self-
Efficacy, and Quality-of-Life Measures in Individuals with Parkinson Disease. Physiother Can. 
2011;63(1):47-57. doi:10.3138/ptc.2009-08 
2.  ECDEU assessment manual for psychopharmacology : Guy, William : Free Download & Streaming : 
Internet Archive. https://archive.org/details/ecdeuassessmentm1933guyw. Accessed January 16, 
2018. 
3.  Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of 
balance. J Gerontol. 1990;45(6):M192-197. 
4.  Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr 
Soc. 1986;34(2):119-126. 

5.  Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the Tinetti Mobility Test 
for individuals with Parkinson disease. Phys Ther. 2007;87(10):1369-1378. doi:10.2522/ptj.20070007 
6.  Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J Clin Res Ed. 
1986;292(6516):344. 
7.  Vincent P. Calabrese MD. Projected number of people with Parkinson disease in the most populous 
nations, 2005 through 2030. Neurology. January 2018. http://n.neurology.org/content/projected-
number-people-parkinson-disease-most-populous-nations-2005-through-2030. Accessed January 
23, 2018. 
8.  Grazina R, Massano J. Physical exercise and Parkinson’s disease: influence on symptoms, disease 
course and prevention. Rev Neurosci. 2013;24(2):139–152. 
9.  Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise 
interventions for people with Parkinson’s disease: A systematic review and meta-analysis. Mov 
Disord. 2008;23(5):631–640. 
10.  Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 
2011;77(3):288–294. 
11.  Kwok JYY, Choi KC, Chan HYL. Effects of mind–body exercises on the physiological and psychosocial 
well-being of individuals with Parkinson’s disease: A systematic review and meta-analysis. 
Complement Ther Med. 2016;29:121-131. doi:10.1016/j.ctim.2016.09.016 
12.  Bega D, Zadikoff C. Complementary & Alternative Management of Parkinson’s Disease: An Evidence-
Based Review of Eastern Influenced Practices. J Mov Disord. 2014;7(2):57-66. 
doi:10.14802/jmd.14009 
13.  Li F, Harmer P, Fitzgerald K, et al. Tai Chi and Postural Stability in Patients with Parkinson’s Disease. 
N Engl J Med. 2012;366(6):511-519. doi:10.1056/NEJMoa1107911 
14.  Li F, Harmer P, Liu Y, et al. A randomized controlled trial of patient-reported outcomes with tai chi 
exercise in Parkinson’s disease. Mov Disord. 2014;29(4):539-545. doi:10.1002/mds.25787 
15.  Combs SA, Diehl MD, Staples WH, et al. Boxing training for patients with Parkinson disease: a case 
series. Phys Ther. 2011;91(1):132–142. 
16.  Combs SA, Diehl MD, Chrzastowski C, et al. Community-based group exercise for persons with 
Parkinson disease: a randomized controlled trial. NeuroRehabilitation. 2013;32(1):117–124. 
17.  Jansen P, Dahmen-Zimmer K, Kudielka BM, Schulz A. Effects of karate training versus mindfulness 
training on emotional well-being and cognitive performance in later life. Res Aging. 
2017;39(10):1118–1144. 
18.  Huang S-L, Hsieh C-L, Wu R-M, Tai C-H, Lin C-H, Lu W-S. Minimal detectable change of the timed “up 
& go” test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011;91(1):114-
121. doi:10.2522/ptj.20090126 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
19.  Jenkinson C, Fitzpatrick R. Cross-cultural evaluation of the short form 8-item Parkinson’s Disease 
Questionnaire (PDQ-8): results from America, Canada, Japan, Italy and Spain. Park Relat Disord. 
2007;13(1):22-28. doi:10.1016/j.parkreldis.2006.06.006 
20.  Goetz CG, Poewe W, Rascol O, et al. Movement Disorder Society Task Force report on the Hoehn 
and Yahr staging scale: status and recommendations. Mov Disord Off J Mov Disord Soc. 
2004;19(9):1020-1028. doi:10.1002/mds.20213 
21.  Bloem BR, Marinus J, Almeida Q, et al. Measurement instruments to assess posture, gait, and 
balance in Parkinson’s disease: Critique and recommendations. Mov Disord. 2016;31(9):1342-1355. 
doi:10.1002/mds.26572 
22.  Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)--a metadata-driven methodology and workflow process for providing translational 
research informatics support. J Biomed Inf. 2009;42(2):377-381. doi:10.1016/j.jbi.2008.08.010 
 
 
 
 
 
 

Appendix 1:  Sample Karate Class Curriculum  
Curriculum Sample: 
Warm-ups: 
Single knee ups 
Double knee ups 
Alternating knee ups 
Knee swings (inside-out) 
Knee rotations 
One leg squat, with other leg doing toe taps (forward, backward, side) 
Squats with arms extended 
Hip circles 
Body rotation 
Arm side swings 
Arm circles 
Rotator cuff  
 
Strikes from Ready Stance (feet shoulder width apart, knees slightly bent): 
Deep breathing with palms extended 
Double palm strike 
Single palm strike (alternate arms) 
Single punching (alternate arms) 
Rising block (two count) 
Rising block (one count) 
Downward block (same arm with other hand on hip) 
Downward block (alternating arms) 
Knee strike (alternate legs) 
Front snap kick (same leg) 
Front snap kick (alternating) 
 
Strikes from Fighting Stance (switch feet and repeat): 
Jab (stationary) 
Reverse (stationary) 
Jab-Reverse (stationary) 
Jab with front foot step 
Reverse with front foot step 
Jab-Reverse with single front foot step 
 
Stance Work: 
Front stance (moving forward) 
Front stance (moving backward) 
Double palm strike slowly (two count, then one count) 
Front punch (two count, then one count) 
Rising block (two count, then one count) 
Downward block (two count, then one count) 
Knee strike (forward only) 
Front snap kick (forward only) 
 

PI: Jori Fleisher, MD MSCE 
Version date: Protocol 2018_April_30 
Study #: 18012313-IRB01 
Mitt/Paddle Work: 
Jab (mitt stationary and flashing for reaction) 
Reverse (mitt stationary and flashing for reaction) 
Jab-Reverse (mitt stationary and flashing for reaction)