The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain
Phase: NA
Conditions: Non-specific Low Back Pain
Sponsor: University of Central Florida

Page 1 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
 
 
PROTOCOL TITLE: 
The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home 
Exercise Packet in Individuals with Low Back Pain 
 
PRINCIPAL INVESTIGATOR: 
Luk Devorski MS, ATC 
READY Lab 
Institute of Exercise Physiology and Rehabilitation Sciences 
Luk.devorski@ucf.edu 
VERSION NUMBER/DATE: 
Version 1 08/29/2022 
 
REVISION HISTORY 
 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
1 
09/08/22 
Addressed track changes and comments 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 2 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Table of Contents 
1.0 
Study Summary ............................................................................................. 3 
2.0 
Objectives* ..................................................................................................... 5 
3.0 
Background*................................................................................................... 5 
4.0 
Study Endpoints* ........................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ....................................................... 7 
6.0 
Procedures Involved* ..................................................................................... 7 
7.0 
Data and Specimen Banking* ..................................................................... 16 
8.0 
Sharing of Results with Subjects* ............................................................... 16 
9.0 
Study Timelines* .......................................................................................... 16 
10.0 Inclusion and Exclusion Criteria* ................................................................. 17 
11.0 Vulnerable Populations* .............................................................................. 17 
12.0 Local Number of Subjects ........................................................................... 17 
13.0 Recruitment Methods ................................................................................... 17 
14.0 Withdrawal of Subjects* ............................................................................... 18 
15.0 Risks to Subjects* ........................................................................................ 19 
16.0 Potential Benefits to Subjects* .................................................................... 19 
17.0 Data Management* and Confidentiality ...................................................... 19 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ............. 20 
19.0 Provisions to Protect the Privacy Interests of Subjects .............................. 20 
20.0 Compensation for Research-Related Injury ................................................ 21 
21.0 Economic Burden to Subjects ..................................................................... 21 
22.0 Consent Process.......................................................................................... 21 
23.0 Process to Document Consent in Writing ................................................... 22 
24.0 Setting .......................................................................................................... 22 
25.0 Resources Available .................................................................................... 22 
26.0 Multi-Site Research* .................................................................................... 23 
 
 
 

Page 3 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Study Summary 
 
Study Title 
The Effects of a Gamified Rehabilitation Protocol 
Compared to an At-Home Exercise Packet in 
Individuals with Low Back Pain 
Study Design 
Randomized Controlled Trial  
Primary Objective 
To measure the change in pain and disability before, 
during and after a competitive home exercise program 
compared to a take home packet exercise program. 
Secondary 
Objective(s) 
To quantify adherence and compliance of individuals 
completing a competitive, gamified home exercise 
program compared to a traditional autonomous 
exercise program. 
 
To measure the change of Ultrasound thickness and 
onset of muscle activation of the lateral abdominal wall 
in individuals with non-specific low back pain during 
static and exercise positioning following a 6-week 
home exercise program 
 
 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
None 
IND/IDE #  
N/A 
Study Population 
Individuals aged 18-45 with non-specific low back pain 
Inclusion Criteria: ages 18-45, biological sex of 
Male or Female, self-reported low back pain 
within the previous 6 months or greater than 3 
episodes within the past 3 years 
Exclusion Criteria: Currently seeing and or 
receiving care from an athletic trainer, physical 
therapist, or other rehabilitation specialist in the 
previous 6 months, low back pain conditions 
such as lumbar spondylosis, herniated disc, 
spondylolisthesis, previous spine surgery, 
currently pregnant, experiencing neurological 
symptoms or other muscular abnormalities.  
Unable to assume the exercise starting position.  
Current use of lidocaine patches or prescription 
pain medicine. 
 

Page 4 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Sample Size 
40 
Study Duration for 
individual 
participants 
6-week intervention + 12, 18, 24-month follow-ups 
 
Study Specific 
Abbreviations/ 
Definitions  
NSLBP: non-specific low back pain;  
ODI: Oswestry Disability Index;  
NPRS; Numeric Pain Rating Scale;  
SUS: System Usability Scale;  
EARS: Exercise Adherence Rating Scale;  
CES: Credibility and Expectancy;  
PCS: pain catastrophizing scale;  
PBP: Prone Bridge Plank;  
GROC; Global Rating of Change Scale;  
TESP: Torso Elevated Side Plank;  
FESP: Foot Elevated Side Plank;  
TrA: Transverse abdominis;  
IO: Internal oblique;  
EO: External oblique 
 
 

Page 5 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Objectives* 
 
The purpose of the study is to measure the change in pain and 
disability, quantify adherence and compliance before, during 
and after a competitive home exercise program compared to a 
traditional home exercise program. Additionally, to measure 
the change of ultrasound thickness of the lateral abdominal 
wall before and after a competitive home exercise program 
compared to a take home packet exercise program.  
 
We hypothesize that the individuals in the gamified, 
competitive home exercise program will have decreased pain 
and disability, increased adherence and increased lateral 
abdominal wall activation compared to the traditional home 
exercise program during and after the 6-week protocol. 
Background* 
 
Non-specific low back pain (NSLBP) can be defined as low 
back pain with the absence of a known cause.1 NSLBP 
diagnoses are concluded when all other pathologies (specific 
spinal pathology and radicular syndrome) are excluded. In the 
primary care setting, 90-95% of all low back cases are non-
specific.2 Individuals of all ages experience NSLBP and are 
affected at a societal level and personal level.1 Recent 
recommendations to decrease low back pain include exercise 
interventions such as trunk strengthening and endurance, 
trunk muscle activation, aerobic exercise and multimodal 
interventions.3 Other guidelines recommend maintaining a 
physically active lifestyle.4 In many cases, maintaining a 
physically active lifestyle requires exercises to be completed at 
home via prescribed home exercise programs.5 In order for 
the efficacy of the home exercise program to be achieved, 
consistent exercise adherence must occur. Individuals who 
adhere to their exercise programs have a greater increase in 
physical function compared with those who have a lack of 
adherence.6 Unfortunately, up to 70% of individuals who suffer 
from chronic low back pain do not adhere to prescribed home 
exercise.7–10 
The lateral abdominal wall is commonly evaluated in 
individuals that experience NSLBP. The transverse abdominis, 
internal oblique and external oblique create the lateral 
abdominal wall. In individuals with NSLBP, the onset of activity 
of the deep abdominal muscles is delayed.10,11 The use of 
ultrasound imaging can measure the onset of muscle 
activation as well as muscle thickness of the lateral abdominal 
wall.10–12 Ultrasound imaging is a non-invasive method to 
visualize and measure muscle thickness. Images can be 

Page 6 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
produced during static (non-moving) and functional (moving) 
positions, demonstrating the change in muscle thickness 
during rest and during movement. Muscle thickness can be 
obtained during brightness-mode (B-mode) and Motion-mode 
(M-mode) by measuring the distance between fascial borders 
(outward tissue layer of the muscle). M-mode ultrasound is 
unique as it can also detect the onset of muscle activation.13 
Ultrasound imaging can be implemented to understand trunk 
strengthening, endurance as well as trunk activation to 
complement the previous recommended guidelines for 
decreasing low back pain. 
 
Preliminary data includes muscle activation of the rectus 
abdominis, middle trapezius, middle deltoid, external oblique 
(EO), erector spinae, gluteus medius, latissimus dorsi during 
the prone bridge plank (PBP), torso elevated side plank 
(TESP), and foot elevated side plank (FESP) completed until 
discontinuation.14 The rectus abdominis and external oblique 
elicited moderate to high activation during the 3 exercises.14 
This preliminary data also included subjective measures of 
reasoning of termination, and in relevance to the present 
study, only 5.8% of individuals terminated the TESP due to 
back pain.14 
General exercise that includes trunk strengthening and 
endurance, trunk muscle activation, and multimodal 
interventions are recommended for individuals with NSLBP.3 
Sixty six percent of people who seek treatment for low back 
pain will have a reoccurrence in the same year.15 Individuals 
may not seek additional medical treatment due to time and 
financial constraints. The implementation of home exercise 
has increased tremendously over the past years, allowing 
individuals to stay active in the comfort of their home.16  
3.3  Specifically, exercises such as the PBP,TESP, FESP, dead 
bug, and bird dog are commonly used to target the muscles of 
the core and aid in progression of rehabilitation.14,17,18 
Although the implementation of home exercise has increased, 
exercise adherence remains to be an issue. A lack of 
adherence influences the effects of outcomes in research as 
well as patient-oriented outcomes such as pain and disability. 
With up to 70% of individuals not adhering to their prescribed 
home exercise programs, home exercise methodology must 
change to increase adherence and decrease pain and 
disability. Although home exercise has increase in the past 
years, exercise duration and intensity has decreased.19,20 
Duration and intensity of exercise may increase by focusing on 
task and ego-oriented goals.21,22 Individuals can focus on the 

Page 7 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
proper completion of the exercise as well as their performance 
compared to others. The implementation of a gamified, 
competitive home exercise program may increase the efficacy 
and adherence to home exercise while decreasing pain and 
disability in the NSLBP population. The use of a leaderboard 
creates a “game” between the participants as they are 
comparing their hold times to the average and top hold times 
of others. A leaderboard that includes exercise average hold 
times, top hold times and reference values, creates a 
competitive environment with the participants goal to increase 
their exercise hold times.  
Study Endpoints*  
 
For this study, the endpoint is defined as collecting 40 NSLBP 
individuals. 
 
N/A 
 
N/A 
Study Intervention/Investigational Agent 
 
5.1 There will be two groups in this study, the leaderboard group, 
and the take-home packet group. The leaderboard group and 
the take-home packet group will be completing the same 
exercise program throughout the 6-weeks. The exercises 
included the PBP, TESP (left and right side), FESP (left and 
right side), dead bug and bird dog exercise until 
discontinuation. The exercises will increase with repetitions 
every two weeks and that outline is listed below in procedures 
involved. The leaderboard group will have on demand video 
access to the exercises and the take-home packet group will 
have a take-home packet. The leaderboard group will also be 
receiving weekly leaderboards of average and top exercise 
durations of the leaderboard group participants. The audio 
description of exercise in the on-demand video group is the 
same script as the written description in the take-home packet. 
Both groups will be completing the same questionnaires which 
are described later.  
 
 
6.0 Procedures Involved* 
6.1 This 6-week randomized controlled trial includes two groups 
completing at-home exercise program of the PBP, TESP (left 
and right side), FESP (left and right side), dead bug and bird 
dog exercise until discontinuation. The exercises will be 

Page 8 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
completed 3 times a week for 6 weeks. The leaderboard group 
will be receiving on demand videos of the exercises and 
weekly leaderboards of exercise duration. The weekly 
leaderboards are what make the leaderboard group 
competitive and gamified. Competition is created with the 
comparison between ones hold times to top hold times and 
average hold times in the group as well as reference values. 
The take-home exercise packet group will receive take home 
at-home exercise packet. The participants in both groups will 
complete the first exercise session and last exercise session 
in the READY laboratory. The other exercise sessions will be 
completed on the participant’s own. The take-home exercise 
packet group will be using a take-home packet to refer to the 
exercises (PBP, TESP, FESP, dead bug and bird dog) they 
are to complete within the 6-weeks. The leaderboard group 
will be using on-demand videos to refer to the exercises (PBP, 
TESP, FESP, dead bug and bird dog) they are to complete 
within the 6-weeks. The leaderboard group will also be 
receiving weekly leaderboards of average and top exercise 
durations of the leaderboard group participants. 
Participants will be randomized into the two separate groups 
using a random number generator and allocation will be 
concealed in opaque envelopes prior to data collection.  
 
Weeks 1 to 2 individuals will complete 3 exercise sessions of 1 
repetition of the 7 exercises.   
Weeks 3 to 4 individuals will complete 3 exercise sessions of 2 
repetitions of the 7 exercises  
Weeks 5 to 6 individuals will complete 3 exercise sessions of 3 
repetitions of the 7 exercises.  
 
 
First and Last Exercise Session - Upon Arrival: 
Participants will be advised to park near the Education 
Complex and either use UCF parking pass (if they already 
have one) or will pay to park using a kiosk. They will be 
instructed to enter the Education Complex doors facing the A 
and I parking garages/parking lot.  
Only 1 participant will be scheduled for a 1.5-2-hour period, as 
the data collection could take up to 2 hours. Reminders about 
collection will be sent on the day before and if applicable (e.g., 
afternoon collection) on the same morning.  
The reminder emails will provide an opportunity for 
participants to confirm or reschedule.  

Page 9 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Subjects will report to the Rehabilitation, Athletic assessment 
Dynamic, Imaging (READY) laboratory in the Institute of 
Exercise Physiology and Rehabilitation Science for the 
beginning of the study procedures and first and last exercise 
sessions.  
Consent and Screening: (~15-20min) 
Informed consent will be obtained for all subjects as outlined in 
the consent process selection for this protocol. The informed 
consent document will ask the participant to self-report any 
exclusion criteria that is listed. After obtaining informed 
consent, subjects will fill out a questionnaire asking previous 
and current health history (health history form). Demographic 
information will also be collected at this time, including, age, 
sex, height, and weight (basic demographic form) . 
Participants will also complete questionnaires asking about 
their low back pain (NumericPainRatingScale_Question), 
disability (ODI2.1a_QuestionnairesRCTLBP), credibility and 
exercise expectancy (CEQ_questionnairesRCTLBP), Pain 
Catastrophizing questionnaire (PCS_QuestionnairesRCTLBP) 
and fear avoidance beliefs (FABQ_QuestionnairesRCTLBP). 
The remaining study procedures will begin immediately after 
eligibility determination or subjects can return at another date 
to complete the remainder of the study procedures. Consent, 
questionnaires, and surveys will be collected using REDCap. 
Exercise familiarization (Up to ~10 min) 
The PBP, TESP, FESP, dead bug, and bird dog will be 
demonstrated by the researcher. The researcher will 
demonstrate and teach the participants how the exercises are 
expected to be performed. The exercises are pictured below.  
 
Dynamic Ultrasound setup and exercise completion (up to 
~45 min) 
 
The ultrasound transducer will be placed 10cm from the 
umbilicus over the right lateral abdominal wall with the 
thoracolumbar fascia visible on the ultrasound screen. The 
transducer will be secured with a nylon belt and foam block.  
• 3 images of the PBP static position and 3 images of the 
PBP starting position will be obtained.  
• 3 images of the TESP static position and 3 images of 
the TESP starting position will be obtained.  
• 3 images of the FESP static position and 3 images of 
the FESP starting position will be obtained.  

Page 10 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
• 3 images of the dead bug static position and 3 images 
of the dead bug starting position will be obtained 
• 3 images of the bird dog static position and 3 images of 
the bird dog starting position will be obtained.  
A total of 30 images for the right abdominal wall will be 
obtained. The ultrasound transducer will then be moved to the 
participants left lateral abdominal wall and pictures will be 
repeated.  
Upon the collection of 60 images, the ultrasound transducer 
will be taken off the participant and they will complete the 
PBP, TESP, FESP, dead bug and bird dog until 
discontinuation. The TESP and FESP will be completed 
bilaterally so the left and right elbow will be placed on the 
ground.   
 
PBP static position and starting position: 
TESP static position and starting position: 
 
 

Page 11 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
FESP static position and starting position: 
 
 
 
 
 
 
Dead bug static position and starting position: 
 
 

Page 12 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Bird dog static position and starting position: 
 
 
 
 
Ultrasound, transducer, nylon belt and foam block to 
secure to lateral abdominal wall. 
 

Page 13 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
 
 
Protocol Description and Participant Reporting (up to ~ 20 
min) 
Upon completion of the exercises, participants will be 
explained the weekly exercise form that each participant in 
both groups will be completing and reporting back to the 
researcher via REDCap. The form will include exercise 
duration and an exercise form rating (Weekly Exercise Form). 
This is also the time weekly meetings will be discussed. We 
will get in touch with the participants weekly either using zoom 
(video call) or by email to answer any comments or concerns 
regarding the exercise completion. The participants email will 
be provided to the principal investigator when they email 
showing interest in the study or listed on the 
“basicdemographic_questionnaire”.  Additionally, this is the 
time when the exercise videos are emailed to the participants 
in the leaderboard group. The email will contain private 
YouTube links only accessible via the link provided to them 
(ExerciseVideoLinksEmail). The weekly exercise form is 
described below.  
 
Weekly Exercise Completion Form  
 
A blank weekly exercise form will provide to the participants via email during the 
first exercise session and another blank form can be provided if participants 
misplace or delete the form. The participants will then be emailed a link via 
REDCap to upload their weekly exercise form once the week is over.  
 
Week 1 
Repetitions  
Day 1 Time 
Day 2 Time 
Day 3 time 
PBP 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
TESP (R) 
Rep 1 
 
 
 

Page 14 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
TESP (L) 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
FESP (R) 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
FESP (L) 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
Dead bug 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
Bird dog 
Rep 1 
 
 
 
 
Rep 2 
 
 
 
Rep 3 
 
 
 
 
 
 
 
 
 
 
Leaderboard Distribution  
Upon receiving the exercise forms, a leaderboard will be 
constructed and sent out over that exercise week’s following 
weekend to the individuals in the leaderboard group. The de-
identified leaderboard for week 1 – week 2 will contain each 
participant’s average exercise durations of the 7 exercises. 
Weeks 2 – weeks 6 will contain each participants average 
session times and will be stratified into 3 categories. The 
weekly leaderboard contains reference times from healthy 
individuals who have completed the same exercises until 
discontinuation. The reference values come from a previous 
data collection by the principal researcher and are from a 
different study population. Healthy, active participants 

Page 15 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
completed the same exercises in this study until 
discontinuation.  
 
Weekly Leaderboard  
 
 
• All questionnaires and surveys that will be collected from the 
subjects are listed below.  
Patient Reported Outcomes (Subjective Questionnaires) 
Each group will be completing the ODI, NPRS, CEQ, FABQ, 
PCS, Hooper and MacKinnon and Pain Catastrophizing 
questionnaire at baseline, after 3 weeks and after 6 weeks. 
The SUS, EARS will be completed after 3 weeks and 6 weeks. 
The GROC will be completed after the 6th week. All 
questionnaires will be completed again through REDCap at 
the 12, 18, and 24-month time points.  
Lateral abdominal wall muscle thickness will be collected 
during the baseline session and during the last exercise 
session of the 6th week.  
6.4 Data collected during the study will include the ODI, NPRS, 
CEQ, FABQ, Hooper and MacKinnon and PCS questionnaire 
at baseline, after 3 weeks and after 6 weeks. The SUS, EARS 
will be completed at 3 weeks and 6 weeks. The GROC will be 
completed after the 6th week. All questionnaires will be 

Page 16 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
completed again through emails notification for participants to 
complete through REDCap. 
6.5 All questionnaires will be completed again through REDCap at 
the 12, 18, and 24-month time points.  
6.6 N/A 
 
7.0 Data and Specimen Banking* 
7.1 Ultrasound data will be stored on password protected lab 
computer for measurement. All data will be de-identified at all 
stages of collection and analysis. There will be a separate file 
that includes the name of a participant and participant number 
that will stored separately. This file will also be destroyed at 
least 5 years after the study closure (ParticipantIdentifierDoc).  
De-identified data will be stored until study closure, then will 
be maintained on password protected lab computer and stored 
for at least 5 years after study closure, then destroyed. All 
questionnaire information will be recorded and kept through 
REDCap, which requires a UCF login with NID and password. 
Only members of the study team will have access to the 
REDCap forms and data associated with this protocol.   
7.2  The data to be stored with each participant will include the 
ultrasound images, weekly exercise forms, questionnaires.  
7.3  Data will be stored and maintained through analysis by the 
study team and will not be released for any reason.  
8.0 Sharing of Results with Subjects* 
8.1 Results will not be shared with subjects unless any incidental 
findings arise and only the PI will notify the subject directly of 
the finding and consult with them and discuss if they believe 
they should seek further medical attention if appropriate. 
Results will not be shared with any other medical providers 
without the subject’s knowledge or permission within the 
scope of this study. The investigators do not anticipate this 
situation to occur frequently due to the nature of this protocol.  
9.0 Study Timelines* 
9.1  This is 6-week randomized controlled trial that consists of all 
subjects to complete 2 in person visits of 1.5-2 hours in the 
READY Laboratory (first and last exercise sessions). There 
are planned follow up visits with questionnaires through 
REDCap at 12-, 18-, and 24-months following completion of 
the intervention. We expect to enroll and collect data for all 
subjects within a 4-month time frame from the start of 
enrollment. We estimate this study to be completed and 

Page 17 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
primary analyses to be completed within 8 months of the start 
of enrollment.  
 
10.0 Inclusion and Exclusion Criteria* 
10.1 Individuals will be screened for inclusion and exclusion criteria 
by self-reporting while reading the consent form and prior to 
giving consent. 
10.2 Inclusion Criteria: ages 18-45, biological sex of Male or 
Female, self-reported low back pain within the previous 6 
months or greater than 3 episodes within the past 3 years 
Exclusion Criteria:  
• Currently seeing and or receiving care from an athletic 
trainer, physical therapist, or other rehabilitation specialist in 
the previous 6 months,  
• low back pain conditions such as lumbar spondylosis, 
herniated disc, spondylolisthesis, previous spine surgery, 
currently pregnant, experiencing neurological symptoms or 
other muscular abnormalities.  
• Unable to assume the exercise starting position.  
• Current use of lidocaine patches or prescription pain 
medicine. 
10.3 Adults unable to consent, pregnant women, prisoners, and 
individuals who are not yet adults, including, infants, children, 
and teenagers will not be allowed to participate in this study.  
11.0 Vulnerable Populations* 
 
N/A 
12.0 Local Number of Subjects 
12.1 Based on previous research regarding home exercise and 
disability with low back pain we determine that 40 participants 
(20 in each group) will be necessary, alpha set a priori to .05. 
40 participants include a 15% attrition rate. 
12.2 A total of 34 individuals (17 per group) will be adequate with 
80% power at an alpha level of .05. We include a 15% attrition 
rate which results in a total sample size of 40 individuals, 20 in 
each group 
13.0 Recruitment Methods 
13.1 Potential subjects will be recruited from the local 
community and university area through flyer advertisements, 

Page 18 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
emails, social media (twitter, Instagram and facebook), digital 
advertisement on the College of Health Professions and 
Sciences Research Participant Website as well as word of 
mouth. The same advertisement will be used for flyers, social 
media, and digital. Individuals interested in the study will use 
the email listed on the advertisement flyer. Upon receiving an 
email for a potential participant, the initial email will be sent to 
schedule an appointment for the first visit for screening and 
consent (initial email doc). Reminders about collection will be 
sent on the day before and if applicable (e.g., afternoon 
collection) on the same morning. The reminder emails will 
provide an opportunity for participants to confirm or reschedule 
(ReminderEmailRCTLBP).  
13.2 Subjects will be from the local community and that may consist 
greatly of the university community. 
13.3 Emails (containing the advertisement flyer) and social media 
advertisements (same text for both) will be posted to university 
groups throughout the Institute of Exercise Physiology and 
Rehabilitation Science (which is where the PI’s laboratory is 
located) as well as targeted toward active groups on campus, 
i.e. Campus Recreation. All content is the same for the flyer 
that will be used for email and social media recruitment.  
13.4 Printed advertisements, email, and social media (twitter, 
Instagram and facebook) advertisement will be utilized and are 
included in the IRB submission. All advertisements will be that 
of the flyer uploaded under "Recruitment materials" 
13.5 Participants will be paid up to $75 in gift cards for their time 
and effort. $20 will be given after week 3, then $25 will be 
given after week 6 and then $10 for each of the long term 
follow up times at 12, 18 and 24 months. Due to the lengthy 
protocol, the completion of 3 weeks, 6 weeks and long term 
follow up times will be used as times the participants get paid 
in the event a subject withdraws.  
14.0 Withdrawal of Subjects* 
14.1 If subjects no longer meet eligibility requirements or injure 
themselves, they will be withdrawn from the study by the 
principal investigator.  
14.2 N/A 
14.3 When subjects withdraw, data collected prior to collection may 
be used for analysis, however they may exit the study at any 
point. Due to the compensation for the week 3, week 6, and 
long term follow up benchmarks, the subjects should be able 
to withdraw with no major issues.  

Page 19 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
15.0 Risks to Subjects*  
15.1 There is a minimal risk for injury. Minimal risks that may occur 
related to study participation include muscle soreness during 
or after exercise, discomfort in joints of lower and upper 
extremity during or after exercise, which both are expected to 
occur infrequently.  
15.2 N/A  
15.3 N/A 
15.4 N/A  
16.0 Potential Benefits to Subjects* 
16.1 Potential benefits that individual participants may experience 
from taking part in the research include decrease in pain and 
disability.  
16.2 N/A.  
17.0 Data Management* and Confidentiality 
17.1 For this study, the endpoint is defined as based on previous 
research regarding home exercise and disability with low back 
pain we determine that 40 participants (20 in each group) will 
be necessary, alpha set a priori to .05. 40 participants include 
a 15% attrition rate. Descriptive statistics will be used for age, 
height, mass. Mean differences, confidence intervals and 
effect sizes will be used to analyze questionnaires. An 
activation ratio will be used for the lateral abdominal wall 
measurements. The static positioning measuring will be used 
as the numerator and the exercise starting position will be 
used at the denominator to calculate a ratio.  
17.2 All computers storing electronic data will be password 
protected and only study team members will have access to 
the passwords. Computers will always remain behind locked 
doors when not supervised by study team members. All 
external hard drives used to back up storage will be password 
protected. Only study team members will have access to these 
passwords. These passwords will be changed frequently and 
will be changed immediately if compromised at any point in 
time.  
Participant numbers will be generated by using the IRB # and 
will be assigned a number (i.e. IRB#12345_001) as they are 
enrolled in the study. This number will be utilized in place of 
any other identifier for the remainder of the study.  

Page 20 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
Identifiers with de-identified coding will be stored electronically 
on Redcap and will be deleted after a minimum of 5 years 
from the time the study closes.  
17.3 To ensure quality control of collected data, the 7 exercises 
performed by participants at their home setting will be 
demonstrated and taught during the first exercise session with 
the researcher. Weekly video calls through zoom and emails 
will be conducted to answer any comments or concerns 
regarding the exercise completion. We will get in touch with 
the participants weekly either using zoom (video call) or by 
email to answer any comments or concerns regarding the 
exercise completion. The participants email will be provided to 
the principal investigator when they email showing interest in 
the study.  The leaderboard group will have on demand video 
that can be accessed at any time and the control take-home 
packet group will have a packet with pictures and descriptions 
of the exercises.  
17.4 Questionnaire data will be collected electronically through 
REDCap. All data will be de-identified at all stages of 
collection and analysis. Data will be stored until study closure, 
then will be maintained on password protected lab computer 
and de-identified for at least 5 years. Signed electronic 
consent forms will be stored for a minimum of 5 years before 
being destroyed as well. All questionnaires and surveys will be 
kept in de-identified electronic folders on REDCap, separate 
from electronically signed consent forms, also for a minimum 
of 5 years before being destroyed. Only the PI and study team 
will have access to the data. Ultrasound measurements of the 
lateral abdominal wall will be de-identified and stored on 
password protected laboratory computer. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Subjects*  
18.1 N/A 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 In order to protect subjects’ privacy interests, the study team is 
small and trained to communicate with the subject that the 
READY laboratory is a quiet and private area where their 
information will be protected.  
19.2 Subjects will be given as much time as necessary to review 
and look over any forms or questionnaires to determine 
comfort level and ask any questions or express concerns 

Page 21 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
throughout the study. The READY Lab is in a private area 
where others will not be able to observe their participation in 
the study if that is a concern for the subject. If there is an 
overwhelming sense of intrusiveness, the subject always has 
the right to remove themselves from the study at any time. The 
study team takes all measures to keep the READY Lab quiet, 
private, and welcoming for all individuals to feel comfortable 
participating, but also understands that the nature of some 
questioning and procedures may provoke an early exit for a 
subject. All questionnaires completed not in the laboratory will 
be recorded and kept through REDCap, which requires a UCF 
login with NID and password. Only members of the study team 
will have access to the REDCap forms and data associated 
with this protocol.   
19.3 The research team will not be accessing any source of 
information not self-reported by the subject for this protocol. 
  
20.0 Compensation for Research-Related Injury 
20.1 N/A 
20.2 N/A 
21.0 Economic Burden to Subjects 
21.1 Subjects will be responsible for any travel and parking costs 
incurred getting to and from the data collection session. All 
testing and questionnaires will be provided free of charge to 
the subjects.  
22.0 Consent Process 
22.1 Written informed consent will be obtained for all subjects 
electronically on REDCap.  
The consenting process, including answering any questions 
and obtaining verbal consent as well as electronic consent, will 
take READY laboratory in the Education Complex on the UCF 
Main Campus. There will be no waiting period between 
informing the prospective subject and obtaining the consent. 
This protocol will follow the “SOP: Informed Consent Process 
for Research (HRP-090).” 
The READY Lab is in a private area where others will not be 
able to observe their participation in the study if that is a 
concern for the subject. If there is an overwhelming sense of 
intrusiveness, the subject always has the right to remove 
themselves from the study at any time. 

Page 22 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
The researcher will be close by to answer any questions and 
concerns about the consent process. This aid in minimizing the 
risk of coercion or undue influence as well as ensuring the 
subjects understanding. 
23.0 Process to Document Consent in Writing 
23.0 Electronic consent will be obtained. A signed copy of the 
consent will not be provided to the participant. 
24.0 Setting 
24.1 In person research will be conducted in the READY laboratory 
in the Education Complex on the main campus of the 
University of Central Florida.  
Potential subjects will be recruited from the local community 
and university area. Research procedures will be performed in 
the READY laboratory main campus of UCF and at 
participants home exercise environment. There is no 
community advisory board involved in this study. 
 
25.0 Resources Available 
25.1 Due to the number of individuals in the university area and 
surrounding East Orlando community, recruiting, and enrolling 
40 healthy subjects within a 4-month timeframe is very 
feasible. Out of the number of students, faculty, and staff on 
the main campus in general, we do not foresee an issue with 
recruitment.  
 
The PI will be the primary contributor in conducting and 
completing the research.    
The Rehabilitation Athletic assessment & Dynamic Imaging 
Laboratory is located in the Education Complex on the first 
floor in Room 174. It is a 7x11 foot space equipped with a GE 
NextGen Logiq e ultrasound unit, Delsys Trigno Avanti 
Electromyography+Inertial Measurement Unit+Biofeedback 
System, hand-held dynamometer, digital inclinometer, 
adjustable high/low treatment table, and rehabilitation and 
exercise equipment.  
There is an automated external defibrillator (AED) located just 
outside of the READY Lab in the hallway leading to Room 174 
and a first aid kit for any small wounds. The PI is also a 
certified and licensed Athletic Trainer in the state of Florida, as 
well an American Red Cross Certified Professional Rescuer in 
CPR/AED and First Aid. We are also located near Student 
Health and CAPS, if the subject happens to be a UCF student, 
and study team members are also trained to call 911 in case 

Page 23 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
of any emergency. Any events that would result in an 
emergency would be reported to the IRB appropriately.  
All study team members have thoroughly read and studied the 
protocol and are up to date on all appropriate training. They 
have met and discussed with the PI their role and clearly 
described and agreed to that designated in the protocol. They 
were given time to answer questions to insure they had time to 
fully understand or clear up any misunderstanding prior to 
contact with any subjects or commencement of the protocol.  
 
N/A 
  
Multi-Site Research* 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REFERENCES 
1. 
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 
2017;389(10070):736-747. doi:10.1016/S0140-6736(16)30970-9 
2. 
Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a 
practical approach for primary care. Med J Aust. 2017;206(6):268-273. 
doi:10.5694/mja16.00828 
3. 
George SZ, Fritz JM, Silfies SP, et al. Interventions for the management of 
acute and chronic low back pain: revision 2021. J Orthop Sports Phys Ther. 
2021;51(11):CPG1-CPG60. doi:10.2519/jospt.2021.0304 

Page 24 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
4. 
Tonosu J, Takeshita K, Hara N, et al. The normative score and the cut-off 
value of the Oswestry Disability Index (ODI). European Spine Journal. 
2012;21(8). doi:10.1007/s00586-012-2173-7 
5. 
National Collaborating Centre for Primary Care (UK). Low Back Pain: Early 
Management of Persistent Non-Specific Low Back Pain. Royal College of 
General Practitioners (UK); 2009. Accessed June 9, 2022. 
http://www.ncbi.nlm.nih.gov/books/NBK11702/ 
6. 
Di Fabio RP, Mackey G, Holte JB. Disability and Functional Status in 
Patients With Low Back Pain Receiving Workers’ Compensation: A 
Descriptive Study With Implications for the Efficacy of Physical Therapy. 
Physical Therapy. 1995;75(3):180-193. doi:10.1093/ptj/75.3.180 
7. 
Friedrich M, Gittler G, Halberstadt Y, Cermak T, Heiller I. Combined exercise 
and motivation program: Effect on the compliance and level of disability of 
patients with chronic low back pain: A randomized controlled trial. Archives 
of Physical Medicine and Rehabilitation. 1998;79(5):475-487. 
doi:10.1016/S0003-9993(98)90059-4 
8. 
Härkäpää K, Järvikoski A, Mellin G, Hurri H, Luoma J. Health locus of 
control beliefs and psychological distress as predictors for treatment 
outcome in low-back pain patients: results of a 3-month follow-up of a 
controlled intervention study. Pain. 1991;46(1):35-41. doi:10.1016/0304-
3959(91)90031-R 
9. 
Reilly K, Lovejoy B, Williams R, Roth H. Differences between a Supervised 
and Independent Strength and Conditioning Program with Chronic Low Back 
Syndromes. Journal of Occupational and Environmental Medicine. 
1989;31(6):547-550. 
10. Hodges PW. Is there a role for transversus abdominis in lumbo-pelvic 
stability? Man Ther. 1999;4(2):74-86. doi:10.1054/math.1999.0169 
11. Hodges P, Cresswell A, Thorstensson A. Preparatory trunk motion 
accompanies rapid upper limb movement. Exp Brain Res. 1999;124(1):69-
79. doi:10.1007/s002210050601 
12. Bunce SM, Moore AP, Hough AD. M-mode ultrasound: a reliable measure of 
transversus abdominis thickness? Clinical Biomechanics. 2002;17(4):315-
317. doi:10.1016/S0268-0033(02)00011-6 
13. Bunce SM, Hough AD, Moore AP. Measurement of abdominal muscle 
thickness using M-mode ultrasound imaging during functional activities. 
Manual Therapy. 2004;9(1):41-44. doi:10.1016/S1356-689X(03)00069-9 
14. Devorski L, Bazett-Jones D, Mangum LC, Glaviano NR. Muscle activation in 
the shoulder girdle and lumbopelvic-hip complex during common therapeutic 

Page 25 of 25 
 
UCF HRP-503 Template v.5/1/2020 
 
 
 
exercises. Journal of Sport Rehabilitation. 2021;1(aop):1-7. 
doi:10.1123/jsr.2020-0485 
15. Ferreira GE, Lin CWC, Stevens ML, et al. Exercise Is Medicine, But Perhaps 
Not for Preventing Low Back Pain: A Randomized Trial of Exercise and 
Education to Prevent Low Back Pain Recurrence. J Orthop Sports Phys 
Ther. 2021;51(4):188-195. doi:10.2519/jospt.2021.10187 
16. Vancini RL, Andrade MS, Viana RB, et al. Physical exercise and COVID-19 
pandemic in PubMed: Two months of dynamics and one year of original 
scientific production. Sports Med Health Sci. 2021;3(2):80-92. 
doi:10.1016/j.smhs.2021.04.004 
17. McGill SM, Karpowicz A. Exercises for spine stabilization: motion/motor 
patterns, stability progressions, and clinical technique. Archives of Physical 
Medicine and Rehabilitation. 2009;90(1):118-126. 
doi:10.1016/j.apmr.2008.06.026 
18. Durall CJ, Greene PF, Kernozek TW. A comparison of two isometric tests of 
trunk flexor endurance. The Journal of Strength & Conditioning Research. 
2012;26(7):1939-1944. doi:10.1519/JSC.0b013e318237ea1c 
19. Flanagan EW, Beyl RA, Fearnbach SN, Altazan AD, Martin CK, Redman 
LM. The impact of COVID-19 stay-at-home orders on health behaviors in 
adults. Obesity (Silver Spring). 2021;29(2):438-445. doi:10.1002/oby.23066 
20. The impact of coronavirus on global activity. Fitbit Blog. Published March 24, 
2020. Accessed January 27, 2022. https://blog.fitbit.com/covid-19-global-
activity/ 
21. Nicholls JG. Achievement motivation: Conceptions of ability, subjective 
experience, task choice, and performance. Psychological Review. 
1984;91(3):328-346. doi:10.1037/0033-295X.91.3.328 
22. Bugten JB, Lugo RG, Steptoe K. Validation of the need for competing 
inventory. Frontiers in Psychology. 2021;12. Accessed January 26, 2022. 
https://www.frontiersin.org/article/10.3389/fpsyg.2021.721903