A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial
Phase: NA
Conditions: Physical Activity
Sponsor: University of Delaware

PROTOCOL 
 
NCT03228719 
 
Last Updated 09/14/2021 
 
 
 

HUMAN SUBJECTS PROTOCOL  
University of Delaware 
 
Protocol Title: A novel physical therapy administered physical activity 
intervention after TKR  
 
  
 
Principal Investigator   
 
 
Name: Daniel K. White, PT, ScD, MSc 
 
Department/Center: Physical Therapy Department 
 
Contact Phone Number: 302-831-7607 
 
Email Address: dkw@udel.edu 
 
Other Investigators: None 
 
 
Investigator Assurance: 
 
By submitting this protocol, I acknowledge that this project will be conducted in strict accordance 
with the procedures described. I will not make any modifications to this protocol without prior 
approval by the IRB. Should any unanticipated problems involving risk to subjects occur during 
this project, including breaches of guaranteed confidentiality or departures from any procedures 
specified in approved study documents, I will report such events to the Chair, Institutional 
Review Board immediately.   
 
1.  Is this project externally funded? X YES □ NO 
 
If so, please list the funding source: NIH/NICHD K12-HD055931-09, NIH/NIAMS R21-
AR071079-01A1. 
 
 
2. Research Site(s) 
 
X University of Delaware 
□ Other (please list external study sites) 
 
 
Is UD the study lead?  X YES □ NO (If no, list the institution that is serving as the study 
lead) 
3.  Project Staff 
Please list all personnel, including students, who will be working with human subjects on this 
protocol (insert additional rows as needed): 
 
NAME 
ROLE 
HS TRAINING 
COMPLETE? 
Daniel K. White  
Principal investigator/physical 
therapist  
Yes 
Laura Schmitt 
Physical Therapist 
Yes 
Hiral Master 
Research Assistant 
Yes 
Dana Voinier 
Research Assistant 
Yes 
Jason Jakiela 
Research Assistant 
Yes 
Nazim Karaca 
RedCap Administrator 
Yes 

Thomas Bye 
Research Assistant 
Yes 
Jennifer Copson 
Research Assistant 
Yes 
Jéssica Aily 
Research Assistant 
Yes 
 
 
4.  Special Populations 
Does this project involve any of the following; 
 
Research on Children? No 
 
Research with Prisoners? No 
 
If yes, complete the Prisoners in Research Form and upload to IRBNet as supporting 
documentation 
 
Research with Pregnant Women? No 
 
Research with any other vulnerable population (e.g. cognitively impaired, economically 
disadvantaged, etc.)? please describe. No, n/a  
 
5.  RESEARCH ABSTRACT Please provide a brief description in LAY language 
(understandable to an 8th grade student) of the aims of this project. 
 
Total knee replacement (TKR) is a common surgery for people with knee osteoarthritis (OA). 
TKR often relieves pain. However, people remain generally inactive following TKR. Physical 
inactivity can lead to higher risk for heart disease, diabetes, and death. Little is known about 
how best to improve physical activity after TKR.  
 
Physical activity monitors, such as the Fitbit®, are common. These monitors are worn on the 
body. They can accurately record the number of steps you take in a day. As the user, you can 
access these data on smart phones, computers and tablets. These monitors can help people 
increase physical activity. Physical therapists treat patients after TKR. Physical therapists create 
activity goals with their patients. The combination of an activity goal and a Fitbit® device could 
increase physical activity.  We do not know if providing monitors combined with physical activity 
coaching by a licensed physical therapist can increase physical activity during and after 
outpatient rehabilitation. 
 
Our plan is to research the effectiveness of this treatment. Our central hypothesis is that people 
who have an activity goal and Fitbit® will be more active.  
 
6.  PROCEDURES Describe all procedures involving human subjects for this protocol.  Include 
copies of all surveys and research measures. 
 
Participant recruitment: People receiving outpatient physical therapy rehabilitation at the 
University of Delaware Physical Therapy Clinic will be recruited to our study.  Each of these 
patients who has a diagnosis of a unilateral TKR will be given a PT Recruitment Flyer by their 
treating physical therapist. The flyer includes a QR code, which the patient can use to access an 
online Consent to Contact Form. If the patient completes and electronically signs this form, a 
member of the physical activity research team will contact the patient. The researcher will 
contact the patient over the phone to explain the study, verbally confirm their identity, determine 

if the patient is interested in participating in the study, and collect basic information related to 
study eligibility (after obtaining verbal consent for the documentation and storage of basic 
eligibility information using the attached verbal script). If the patient is eligible for the study and 
willing to participate, the researcher will remotely obtain consent from the patient and provide 
them will a copy of their signed informed consent.  
 
Once consented, the patient will be formally enrolled in the study and baseline physical activity 
data will be collected. After physical activity data collection the participant will be randomized 
into a control group and an intervention group. The participants will be randomized using 
computer generated groups (“0” Control group and “1” Intervention group).    
 
To promote recruitment rates, we will provide an Orthopedic Surgeon Recruitment Flyer for 
display and/or available for distribution to potential study participants at community clinics. The 
flyer provides basic information on study eligibility, a brief description of the physical activity 
intervention, and contact information for the study team. 
 
Group Assignment:  
All Participants: All participants in the study will receive the following:  
 
Standardized Physical Therapy Rehabilitation: Participants will receive usual physical therapy 
rehabilitation provided by a licensed physical therapist using the University of Delaware’s 
Rehabilitation Guidelines for Unilateral Total Knee Replacement. See attached documents for 
Rehab Practice Guidelines for: Unilateral Total Knee Replacement.   
 
Home Exercise Program: Participants will be given a University of Delaware binder. Pictures 
and descriptions of the standardized home exercise program and exercise log are located in this 
binder. See attached documents for Home Exercise Program and Exercise Log.  
 
Actigraph: Participants will be asked to wear an accelerometer called an ActigraphGT3X to 
objectively measure physical activity. The size of the Actigraph is 27g; 1.5" x 1.44" x 0.70". The 
Actigraph monitors physical activity in terms of steps per day and time spent in moderate to 
vigorous physical activity. Actigraph monitors will be disinfected prior to wear in accordance with 
EPA guidelines. The monitor will be worn around the participant’s waist with the accelerometer 
located at the person’s right anterior superior iliac spine (ASIS) and the participant will receive 
in-person instructions on how to properly wear this device. The Actigraph will be worn for 
approximately one week (7 days) after the patient enrolls in the study. Participants will also be 
asked to wear the monitor for approximately one week (7 days) after they discharge from formal 
physical therapy rehabilitation, at 6-months after discharge from formal physical therapy, and at 
12-months after discharge from formal physical therapy. The patients will be instructed to put on 
the monitor when they get up in the morning and take off the monitor when they go to sleep in 
the evening. They will be asked to remove the monitor during situations that device could get 
wet, e.g., showering, swimming. See attached documents for Actigraph Instructions. If the 
device is lost or damaged the participant will notify their physical therapist or the physical activity 
research team for a replacement. 
 
Exit Interview: After completing formal physical therapy rehabilitation, participants may be 
contacted via telephone by a researcher. The researcher will read several scripted exit interview 
questions to participants based on their group assignment. The information gathered from the 
exit interview will provide data on how to improve the feasibility of the study.  See attached 
documents for exit interview questions. 

 
Wawa or Amazon Gift Card: Participants will be given a $25 gift card (i.e. Wawa, Amazon) at 
discharge from physical therapy rehabilitation. We will ask participants if they have gift card 
preference, if not we will give them Amazon gift card. We will continue the same gift card 
preference as stated by participant at discharge for 6-month and 12-month follow-up. They will 
be given a $25 gift card for wearing the Actigraph at 6-months and a $50 gift card for wearing it 
at 12-months.  
 
Control group: The control group will receive standardized physical therapy rehabilitation, 
home exercise program, an Actigraph and exit interview.  
 
Intervention group: The intervention group will receive standardized physical therapy 
rehabilitation, home exercise program, an Actigraph and exit interview. They will also receive 
the following:  
 
Fitbit® monitor : Participants in the intervention group will be given a Fitbit® monitor after 
baseline physical activity data collection, approximately one week after enrollment. If a 
participant already has a phsycial activity monitor they can choose to use it instead of the Fitbit® 
monitor. However, they will still be given a Fitbit® monitor regardless if they already have a 
physical activity tracking device or not. They will be asked to wear their Fitbit® monitor daily 
during waking hours to monitor their steps per day.  Participants will be given written instructions 
on how to sync their Fitbit® monitor to their personal smartphone, tablet, or home computer. A 
physical activity researcher will also explain how to set up, sync, and use Fitbit® monitor in-
person. Extra batteries will be provided as needed. If the device is lost or damaged the 
participant will notify their physical therapist or the physical activity research team for a 
replacement. At the end of the 12-month follow up participants will be asked to return their 
Fitbit® monitor with their Actigraph via the mail. See attached documents for Fitbit® monitor 
Instructions.  
 
Steps per Day Goal Setting: Participants will be asked to self-track their steps per day using 
their Fitbit® monitor. The participant will be the only one with access to their Fitbit® log-in for 
their steps per day data. The participant’s physical therapist will rely on the participant to self-
report the steps per day goal. They will be asked to use their tablet, smartphone or home 
computer to either show the physical therapist in-person or have a written log of their weekly 
steps per day. Their steps per day goal will be recorded on their HEP Log. If the participant is 
less than 3-weeks status post-operative TKR they are not expected to increase their steps per 
day. Once the participant is more than 3-weeks status post-operative TKR they will be asked to 
increase their steps incrementally over the course of their rehabilitation with the end goal being 
6,000 steps per day. Progression of weekly steps per day goal will be based on the participant’s 
health status, their physical therapist and if the participant could achieve at least 4 of the 7 days 
per week at or above the prior week’s steps per day goal.  
 
Fitabase: Until the Fitabase service is terminated (11/3/19), participants will be given the option 
to connect their Fitbit account to Fitabase, a secure research platform that enables the research 
team to access, view, and download their Fitbit data. Each participant will be able to review the 
Fitabase Terms of Use and Security and Privacy Information as part of the Informed Consent 
process. 
 
Fitbit Data Collected by Fitabase. Physical activity data will be collected by Fitabase for all 
participants who connect their Fitbit account to the Fitabase platform. Such data includes: 
- 
Daily steps total 

- 
Measured steps per minutes 
- 
Estimated energy expenditure 
- 
Distance moved 
- 
Minutes of vigorous/moderate/light activity 
- 
Minutes of sedentary time 
Fitabase may also collect: 
- 
Personal details that were voluntarily added to your Fitbit account, such as height, 
weight, gender, and age 
 
A participant’s Fitbit username and password will not be accessed, viewed, or stored by 
Fitabase. 
 
Fitabase Authorization. If a participant agrees to authorize Fitabase to acess his/her Fitbit data, 
they will complete the authorization process either 1) in-person, at the time of their initial Fitbit® 
monitor set-up, or 2) online. If they choose to complete the Fitabase authorization process in-
person, a research assistant will be present to assist them. The research assistant will create a 
profile for the participant that includes their assigned, unique study identifier. The research 
assistant will then use an internet-connected computer (laptop) to “manually connect a device” 
to the unique identifier. This will open a Fitbit authorization window in a web browser. The 
participant will be asked to enter their Fitbit login information (username and password) to 
connect their Fitbit® monitor device and authorize Fitabase to read and access their Fitbit data. 
This information will 1) be entered outside of the view of the research assistant and 2) is not 
passed to the Fitabase system as it uses the OAuth protocol established for API authentication. 
When the participant enters their information and connects their Fitbit account to Fitabase, the 
in-person authorization will be completed. This completion also signals an acceptance of the 
Fitabase Terms of Use and Privacy Policy.  
 
If a participant chooses to complete the Fitabase authorization process online, they  
will be asked for a valid email address to send the authorization link. The research assistant will 
then create a profile for the participant that includes their assigned, unique study identifier. A link 
to Fitabase Authorization Page will be emailed to the participant. At the bottom of the online 
Fitabase Authorization Page, a “connect your device” button is present. The participant will be 
asked to read the Authorization Page and if they agree, to connect their Fitbit and authorize 
Fitabase to read and access their Fitbit data. This information will not be passed to the Fitabase 
system as it uses the OAuth protocol established for API authentication. When the participant 
enters their information and connects their Fitbit account to Fitabase, the online authorization 
will be completed. This completion also signals an acceptance of the Fitabase Terms of Use 
and Privacy Policy.  
 
These participants will receive a set of Fitbit® monitor instructions that explain that they must 
sync their Fitbit® monitor with their smartphone, tablet, or computer at least once every 7 days 
in order for Fitabase to collect their data. 
 
If a participant does not authorize Fitabase to access his/her Fitbit data, they are still able 
participate in the study and receive a Fitbit® monitor device. They will not complete the Fitabase 
authorization process.  
 
Study Access to Fitbit Data. The research team has set up a study project within Fitabase for 
generating unique identifiers and connecting participants’ Fitbit® monitor devices to the 
Fitabase system. When a member of the research team logs into the Fitabase system, they will 
be able to see all currently connected devices and the associated study identifiers. Each study 

identifier has a profile that includes their Fitbit data (listed above). Authorization by the 
participant grants the research team access to all data generated by the participant’s use of the 
Fitbit® monitor device up to the study completion date. This data will be downloaded and stored 
on the secure lab server for analysis. No other data will be downloaded. Once the study has 
been completed and the data has been downloaded and scanned for errors, the participant’s 
profile will be deleted and the authorization will be removed. 
 
Thank you notes and phone calls: All study participants will receive a thank you note at 3rd and 
9th month from the discharge to remind them of their upcoming 6-month and 12-month follow-
up, respectively. At the 5th month and 11th month, the research assistant will call all study 
participants to remind them of their upcoming 6-month and12-month follow-up, respectively.  
They will be told to expect in the mail: a pre-stamped envelope, an Actigraph, and a 
questionnaire. They will be asked to wear the Actigraph for one week and then mail it back to 
the research team along with completed questionnaire in the pre-stamped envelope. During 
these phone calls, participants will be asked about any changes in health status since their 
discharge from physical therapy. The research team may also call a participant at any time 
during the study if the participant has a change in health status. The research team will ask the 
participant for information needed to determine if an unanticipated problem, adverse event, or 
serious adverse event has occurred. 
 
Concomitant Medication Log: When the research team contacts each participant during the 
follow up phase of the study (at 5 months and 11 months from PT discharge), they will ask each 
participant if they are currently taking any medications related to knee pain and recovery 
following surgery. The response and pertinent details (i.e. medication, frequency and dosage) 
will be documented in the Concomitant Medications Form.  
 
 
3) Data Collection:  
We will collect data from participant’s medical chart. A research assistant will enter data into 
Redcap, operated by the Delaware Rehabilitation Insitute. Data includes includes the following: 
1) Medical History 
2) Insurance Information 
3) Demographic Data 
4) Geographic Data 
5) Contact Information  
6) Self-Reported Outcome Measures (Knee Outcome Score, Knee Injury and Osteoarthritis 
Outcome Score, Short Form -36, Tampa Scale of Kinesiophobia, Self-Efficacy for Exercise 
Scale, Apathy Scale, Patient Specific Functional Scale, Pain Catastrophizing Scale)  
7) Standardized Examination/Evaluation Data, e.g. six-minute walk test, timed stair climb test, 
muscle strength, Pain, BMI, Range of motion, timed up and go 
 
We will collect the following standardized outcomes at baseline, at discharge and 6-months after 
discharging from physical therapy rehabilitation. In the event a participant is unable to complete 
the data collection of the above paper forms (1-6), an electronic version will be sent to them via 
email through Redcap. This information is typically collected during the course of a physical 
therapy evaluation, re-evaluation, and/or discharge.  These include the following: 
• 
Age 
• 
Height 
• 
Weight 
• 
Blood pressure 
• 
BMI 

• 
Affected Knee 
• 
Type of TKR 
• 
Falls since last evaluation? 
• 
Previous joint replacement? 
• 
Pain scores 
• 
Range of motion 
• 
Timed up and go 
• 
Stair Climbing Test 
• 
Six-minute walk test 
• 
Knee extensor strength 
• 
30 second chair stand test 
• 
Physical therapy and injection use prior to TKR 
• 
Pain medication type 
• 
Function and Disability questionnaire (PROMIS, SF-36, Apathy Scale, PSPS, KOS-ADL, 
Tampa Scale, Self-efficacy for Exercise Scale, KOOS, Pain Catastrophizing Scale) 
• 
Demographics (race, marital status, living alone) 
• 
Health History Questionnaire 
• 
Self-Reported Activity level 
• 
Socioeconomic information 
• 
Level of Education 
• 
Length of Stay 
• 
Number of Physical Therapy Appointments 
• 
Medical Script for Physical Therapy Services 
• 
Billing Information 
• 
Types and Dosage of Physical Therapy Treatment Interventions  
See attached documents Physical Therapy Clinic Health History Form  
 
7.  STUDY POPULATION AND RECRUITMENT 
 
Describe who and how many subjects will be invited to participate. Include age, gender and 
other pertinent information.   
 
The enrollment capacity for this protocol is 173 participants. This includes two projects:  
1. 43 participants enrolled in the pilot phase of this study (9/26/16 – 6/27/17) 
2. 130 participants targeted enrollement for the current study (6/28/17 – ongoing) 
 
Inclusion: 
• 
Participants over the age of 45 
• 
Seeking outpatient physical therapy rehabilitation for a unilateral TKR 
 
Note: Participants are included irrespective of time since surgery as long as they are seeking PT 
for a unilateral TKR 
 
Exclusion: 
• 
No interest in increasing physical activity 
• 
Having had another lower extremity surgery within 6-months  that is unrelated to the 
TKR 
• 
Planning on having another lower extremity surgery within 6-months  that is unrelated to 
the TKR  

• 
Any other medical condition that limits the participant’s ability to participate in physical 
activity.  
Examples of medical conditions that limit physical activity include but are not 
limited to the following: 
1. 
Epilepsy 
2. 
Parkinson’s disease 
3. 
Neuropathy 
4. 
Dementia 
5. 
Require the use of a wheelchair  
6. 
Rheumatoid arthritis  
7. 
Psychiatric disease 
8. 
Alcohol and/or drug abuse  
9. 
Current cancer treatment 
10. 
Uncontrolled diabetes (glycosylated hemoglobin level >7.0) 
11. 
Neurologic, vascular or cardiac problems that limit physical activity  
12. 
Orthopedic conditions that limit physical activity such as lumbar stenosis, 
severe hip or ankle OA 
• 
Previous enrollment in a physical activity intervention study at the University of Delaware 
Physical Therapy clinic  
 
Note: Participants are not excluded based on smart device usage and/or access to internet 
 
Describe what (if any) conditions will result in PI termination of subject participation. 
 
Discontinuation from the physical activity intervention does not mean discontinuation from the 
study, and remaining study procedures should be completed as indicated by the study protocol. 
If a clinically significant finding is identified (including, but not limited to changes from baseline) 
after enrollment, the principal investigator or qualified designee will determine if any change in 
participant management is needed. Any new clinically relevant finding will be reported as an 
adverse event (AE).  
 
An investigator may discontinue or withdraw a participant from the intervention for the following 
reasons:  
• Significant study intervention non-compliance  
• If any clinical AE or situation occurs such that continued participation in the intervention would 
not be in the best interest of the participant  
• If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further participation in the intervention 
 
8.  RISKS AND BENEFITS 
List all potential physical, psychological, social, financial or legal risks to subjects (risks listed 
here should be included on the consent form). 
 
• 
Risks associated with participation are those typically found during a physical therapy 
evaluation, e.g. risk of soreness from testing of muscle strength or length, fluctuating 
knee pain and/or swelling related to recovery from TKR, and fatigue during or following 
the evaluation.   

• 
We will attempt to minimize risks during the evaluation.  A physical therapist will 
appropriately guard the patient and will provide rest breaks as needed to minimize 
soreness and fatigue.   
• 
There is minimal risk for starting a supervised physical activity program, including a mild 
temporary increase in knee pain.  
• 
There is minimal risk for participating in the brief behavioral intervention, including being 
challenged to increase physical activity.  
• 
There are no known risks wearing an Actigraph or Fitbit® monitor 
• 
There is a possibility of a breach of confidentiality if data or identifying information should 
accidently be released.   
 
In your opinion, are risks listed above minimal* or more than minimal? If more than minimal, 
please justify why risks are reasonable in relation to anticipated direct or future benefits. 
 
Minimal risk. 
 
(*Minimal risk means the probability and magnitude of harm or discomfort anticipated in the 
research are not greater than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests) 
 
What steps will be taken to minimize risks? 
 
We minimize this risk of the intervention by having physical activity closely monitored by a 
licensed physical therapist.   
 
Describe any potential direct benefits to participants. 
 
Study participants who increase their physical activity may have benefits including increased 
lower body muscular strength, improved cardiovascular health, and improved quality of life.   
 
Describe any potential future benefits to this class of participants, others, or society. 
 
Our proposed study will provide important pilot data to show levels of physical activity after total 
knee replacement which will be important pilot data for future intervention trials.  
 
If there is a Data Monitoring Committee (DMC) in place for this project, please describe when 
and how often it meets. 
 
We will not establish an external Data Safety and Monitoring Board.  We do have a Data Safety 
and Monitoring Plan. Danie White  will meet with Laura Schmitt, our Clinic Liaison, on a weekly 
basis to discuss any potential adverse events and to ensure ongoing participant safety.  Daniel 
White will be responsible for communication with other members of the research team regarding 
meeting discussions. The occurrence of adverse events or breaches in confidentiality will be 
monitored for each participant on an ongoing basis throughout the study.  If an adverse event 
occurs, it will be reported immediately to the University of Delaware Human Subjects Review 
Board.   
 
9.  COMPENSATION 

 
Will participants be compensated for participation? 
 
Yes 
 
If so, please include details. 
 
Participants who wear the Actigraph monitor after their discharge from physical therapy will be 
given $25.00 as an honorarium. 
 
Participants who wear the Actigraph monitor at 6-months will be given $25.00 as an honorarium, 
and $50.00 if they wear the Actigraph at 12-months. 
 
10.  DATA 
 
Will subjects be anonymous to the researcher?  No 
 
If subjects are identifiable, will their identities be kept confidential? (If yes, please specify how) 
Yes. 
A copy of the consent form will be stored in a locked research cabinet or electronically on the 
lab server and REDCap within the University of Delaware Physical Therapy Department. 
Participant evaluations will be stored as part of their electronic medical record at the University 
of Delaware as required for insurance reimbursement.  
 
Evaluations of individuals who agree to participate in the study will be coded (i.e. name at top of 
evaluation document will be replaced with participant ID number) and this coded evaluation will 
be stored electronically in a single Redcap project on the secure DRI server. Coded data will be 
stored indefinitely and will be accessible only to research personnel. 
 
We will develop separate Redcap project on the secure DRI server that links participant ID 
numbers to participant names. This link will be destroyed three months after the conclusion of 
the study and will be accessible only to research personnel. 
 
We will also develop a separate Redcap project on the secure DRI server that stores identifiable 
participant information. This information will be accessible only to research personnel. 
Identifiable participant information includes: 
- 
Name 
- 
Date of Birth 
- 
Phone number(s) 
- 
Email address 
- 
Home address 
 
To summarize, we will use three separate Redcap projects (all located on the secure DRI 
server). The first project will contain coded evaluation data (with participant ID numbers). The 
second project will contain a file that links participant ID numbers to participant names. The third 
project will contain identifiable participant information (including participant name and contact 
information).  
 
How will data be stored and kept secure (specify data storage plans for both paper and 
electronic files. For guidance see http://www.udel.edu/research/preparing/datastorage.html )    

 
See response above. To reiterate, we will secure informed consents in a locked file cabinet 
within the University of Delaware Physical Therapy Department that is accessible only to 
research personnel. We will store coded data and identifiable participant information 
electronically (using Redcap) on a secure DRI server. 
 
 
How long will data be stored? Indefinitely 
 
Will data be destroyed?  □ YES   X NO (if yes, please specify how the data will be destroyed)  
 
Will the data be shared with anyone outside of the research team?  □ YES   XNO (if yes, please 
list the person(s), organization(s) and/or institution(s) and specify plans for secure data transfer) 
 
How will data be analyzed and reported?  
 
Data will be coded and will be analyzed using appropriate statistical software packages.  We will 
examine whether physical activity as measured by the Actigraph monitor is higher in those 
participants in the treatment versus Actigraph data from published studies. Results will be 
disseminated through written publications in reputable medical journals and professional 
presentations.    
 
An interim analysis will be performed after half of the participant’s 6 month follow-ups are 
completed. It is anticipated that this will be approximately 18 months after the start date. The 
interim analysis will be performed exactly the same as the final analysis. If the effect size of the 
physical activity intervention (which is standard care, a Fitbit™ monitor, individualized step goal, 
and face-to-face feedback with a physical therapist) group is greater than 3.0 (95% confidence 
interval 2.5-3.5), compared with the control group at this time point, then the intervention will 
have been deemed to work and the study will stop recruiting control group participants. Those in 
the control group currently will be asked if they want to switch arms and partake in the 
intervention.  
 
At 18 months after the start of the study, we will conduct an interim analysis with four 
comparisons for adverse outcomes. The two arms of the study will be compared for number of 
AE, SAE, and UP, individually and jointly, if they are definitely or probably related to the 
intervention. If the intervention group is found to have more than 3.0 (95% confidence interval 
2.5-3.5) times the odds of AE, SAE, UP, or their sum compared with the control, then we will 
stop the study. 
 
11. CONFIDENTIALITY 
Will participants be audiotaped, photographed or videotaped during this study? Yes 
 
How will subject identity be protected?   
 
The risk of breaching subject confidentiality will be minimized by identifying all participants by 
code numbers and by securing all data in locked files accessible only to research personnel.  
Neither the participant’s name nor any identifying information will be used in any publication or 
presentation resulting from this study.     
 
Is there a Certificate of Confidentiality in place for this project?  (If so, please provide a copy).  

No 
 
12. CONFLICT OF INTEREST 
(For information on disclosure reporting see: 
http://www.udel.edu/research/preparing/conflict.html ) 
 
Do you have a current conflict of interest disclosure form on file through UD Web forms? Yes 
 
Does this project involve a potential conflict of interest*?  No 
 
* As defined in the University of Delaware's Policies and Procedures ,a potential conflict of 
interest (COI) occurs when there is a divergence between an individual's private interests and 
his or her professional obligations, such that an independent observer might reasonably 
question whether the individual's professional judgment, commitment, actions, or decisions 
could be influenced by considerations of personal gain, financial or otherwise. 
 
If yes, please describe the nature of the interest: Not applicable 
 
13.  CONSENT and ASSENT 
 
_X___ Consent forms will be used and are attached for review (see Consent Template under 
Forms and Templates in IRBNet) 
 
____ Additionally, child assent forms will be used and are attached. 
 
__X__ Waiver of Documentation of Consent (attach a consent script/information sheet with the 
signature block removed). 
We are requesting a Waiver of Documentation of Informed Consent in order to record 
and store eligibility information. The collection of the very basic eligibility criteria presents 
no more than minimal risk of harm to individuals and involves no procedures for which 
written informed consent is normally required. A verbal consent script is attached. 
 
____ Waiver of Consent (Justify request for waiver) 
 
14.  Other IRB Approval 
Has this protocol been submitted to any other IRBs? No 
 
If so, please list along with protocol title, number, and expiration date. Not applicable 
 
15.  Supporting Documentation 
Please list all additional documents uploaded to IRBNet in support of this application. 
 
1) Cover Letter 
2) Amendment Form 
3) CITI Training Certificates (HSP and GCP) for Jéssica Aily 
Rev. 09/2017