A Study Evaluating the Feasibility of a Peri-Operative Rehabilitation Program for Inguinal Hernia Repair Surgery to Reduce Risk of Post-Surgical Pain
Phase: NA
Conditions: Inguinal Hernia
Sponsor: University of Alberta



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Date: September 22, 2021 7:56:48 AM
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1.1  Study Identification
All questions marked by a red asterisk * are required fields. However, because the mandatory
fields have been kept to a minimum, answering only the required fields may not be sufficient
for the REB to review your application.
Please answer all relevant questions that will reasonably help to describe your study or
proposed research.
1.0
* Short Study Title (restricted to 250 characters):
Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery
2.0
* Complete Study Title (can be exactly the same as short title):
A Study Evaluating the Feasibility of a Peri-Operative Rehabilitation Program for
Inguinal Hernia Repair Surgery to Reduce Risk of Post-Surgical Pain
3.0
* Select the appropriate Research Ethics Board (Detailed descriptions are
available at here):
Health Research Ethics Board - Health Panel
4.0
* Is the proposed research:
Funded (Grant, subgrant, contract, internal funds, donation or some other source of
funding)
5.0
* Name of local Principal Investigator:
Douglas Gross
6.0
* Type of research/study:
Faculty/Academic Staff
7.0
Investigator's Supervisor(required for applications from undergraduate students,
graduate students, post-doctoral fellows and medical residents to REBs 1 & 2. HREB
does not accept applications from student PIs):
8.0
Study Coordinators or Research Assistants: People listed here can edit this
application and will receive all email notifications for the study:
Name
Employer
Robert Piper
Student
9.0
Co-Investigators: People listed here can edit this application and will receive email
notifications (Co-investigators who do not wish to receive email, should be added to
the study team below instead of here).
If your searched name does not come up when you type it in the box, the user does
not have the Principal Investigator role in the online system. Click the following link
for instructions on how to Request an Additional Role.

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1.2  Additional Approval
 
Name
Employer
Omar Farooq
MH Surgery
10.0
Primary Admin Contact (a member of study team):
11.0
Study Team: (co-investigators, supervising team, and other study team members) -
People listed here cannot view or edit this application and do not receive email
notifications.
Last
Name
First
Name OrganizationRole/Area of
ResponsibilityPhoneEmail
Macedo
Luciana McMaster
University
Co-Principal
Investigator
 
macedol@mcmaster.ca
Bostick
Geoff
Department of
Physical
Therapy
Co-investigator
 
bostick@ualberta.ca
Durand-
Moreau
Quentin
Division of
Preventive
Medicine
Co-Investigator
 
durandmo@ualberta.ca
Piper
Robert
Chad
Department of
Physical
Therapy
Graduate
Student Co-
investigator
 
robertch@ualberta.ca
Shologan Anna
AHS
Co-investigator
 
akshologan@gmail.com
 
 
 
1.0
* Departmental Review: Please note only ONE Department Review is
required. Please ensure that this section reflects only the PRIMARY
Department of the study PI.
RM Physical Therapy
2.0
Internal Review (If the Principal Investigator is in the Department of

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1.3  Study Funding Information
 
Medicine complete the Department of Medicine Request for Internal
Approval form and upload it to the “Documentation” section of this
application under item 11.0 “Other Documents”. Note that all fields in the
form are required. The form is available at here): 
 
1.0
* Type of Funding:
Grant (external)
 
2.0
* Indicate which office administers your award. (It is the PI’s responsibility to provide
ethics approval notification to any office other than the ones listed below)
University of Alberta - Research Services Office (RSO)
To connect your ethics application with your funding: provide all identifying
information about the study funding – multiple rows allowed. For Project ID, enter
a Funding ID provided by RSO/PeopleSoft Project ID(for example, RES0005638,
G018903401, C19900137, etc).Enter the corresponding title for each Project ID.
 
Project ID TitleGrant
StatusSponsor
Project
Start
Date
Project
End
Date
PurposeOther
Information
View RES0055232  
 
 
 
 
 
 
3.0
* Funding Source
3.1  Select all sources of funding from the list below:
Medtronic of Canada Ltd.
MCL
 
 
 
3.2  If your source of funding is not available in the list above, click "Add" below
and write the Sponsor/Agency name(s) in the free text box that pops up.(Nore:
You may reflect multiple sources of funding by continuing to click "Add" to add each
additional source of funding).
There are no items to display
4.0
* Indicate if this research sponsored or monitored by any of the following:
Not applicable
The researcher is responsible for ensuring that the study complies with the
applicable US regulations. The REB must also comply with US Regulations.

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1.4 Conflict of Interest
 
Important
If you answered YES to any of the questions above, you may be asked for more
information.
1.0
* Are any of the investigators or their immediate family receiving any
personal remuneration (including investigator payments and
recruitment incentives but excluding trainee remuneration or graduate
student stipends) from the funding of this study that is not accounted
for in the study budget?
  ! Yes " No
2.0
* Do any of investigators or their immediate family have any
proprietary interests in the product under study or the outcome of the
research including patents, trademarks, copyrights, and licensing
agreements?
  ! Yes " No
3.0
* Is there any compensation for this study that is affected by the study
outcome?
  ! Yes " No
4.0
* Do any of the investigators or their immediate family have equity
interest in the sponsoring company? (This does not include Mutual
Funds)
  ! Yes " No
5.0
* Do any of the investigators or their immediate family receive
payments of other sorts, from this sponsor (i.e. grants, compensation
in the form of equipment or supplies, retainers for ongoing
consultation and honoraria)?
  ! Yes " No
6.0
* Are any of the investigators or their immediate family, members of
the sponsor’s Board of Directors, Scientific Advisory Panel or
comparable body?
  ! Yes " No
7.0
* Do you have any other relationship, financial or non-financial, that, if
not disclosed, could be construed as a conflict of interest?
  ! Yes " No
Please explain if the answer to any of the above questions is Yes:

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1.5  Research Locations and Other Approvals
 
2.1  Study Objectives and Design
 
1.0
* List the locations of the proposed research, including recruitment
activities. Provide name of institution, facility or organization, town, or
province as applicable
Fort Saskatchewan Community Hospital - Dr. Farooq's clinic
Corbett Hall, University of Alberta
2.0
* Indicate if the study will use or access facilities, programmes,
resources, staff, students, specimens, patients or their records, at any
of the sites affiliated with the following (select all that apply):
Alberta Health Services Institutions and Facilities
List all health care research sites/locations:
Fort Saskatchewan Community Hospital - Dr. Farooq's clinic
3.0
Multi-Institution Review
* 3.1 Has this study already received approval from another REB?
  ! Yes " No
4.0
If this application is closely linked to research previously approved by
one of the University of Alberta REBs or has already received ethics
approval from an external ethics review board(s), provide the study
number, REB name or other identifying information. Attach any
external REB application and approval letter in the Documentation
Section – Other Documents.
 
1.0
* Provide a lay summary of your proposed research which would be
understandable to general public
Inguinal hernia repair is one of the most common surgeries, with more than
20 million performed globally each year. It is estimated that approximately
15% of patients undergoing inguinal hernia repair will experience persistent
post-surgical pain that could last months to years. Evidence from related
procedures indicates that better surgical preparation through pre-operative
exercise and education (i.e. Prehabilitation) followed by ongoing post-
surgical rehabilitation leads to more rapid recovery, return to activities and
lower likelihood of persistent post-surgical pain. We will determine the
feasibility of a peri-operative rehabilitation program (pre- and post-surgery)

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and our study protocol for patients undergoing inguinal hernia repair
surgery. We hypothesize that: 1) our peri-operative intervention will be
feasible and safe to undertake within a clinical setting; 2) we will enrol
adequate numbers to justify a larger trial; and that 3) our outcome
measurement protocol will provide meaningful information with high
response rate and low attrition after 3 months.   
Implications
This study is novel and timely given the current healthcare focus on
improving strategies for the prevention of chronic pain. The obvious
potential benefits for patients with inguinal hernia is the development of a
program with the potential to improve post-surgical outcomes and reduce
likelihood of post-surgical pain. Our findings will inform a larger, multicenter
clinical trial to evaluate this intervention approach in patients undergoing
inguinal hernia repair. 
2.0
* Provide a full description of your research proposal outlining the
following: 
Purpose
Hypothesis
Justification
Objectives
Research Method/Procedures
Plan for Data Analysis
Purpose
The aim of the proposed project is to determine the feasibility of a peri-
operative rehabilitation program (pre- and post-surgery) and our study
protocol for patients undergoing inguinal hernia repair surgery. We will
answer the following question:  Is a study of a peri-operative
rehabilitation program feasible in terms of recruitment rate, treatment
adherence, timelines, data collection procedures, patient follow-up
and resources required?
Hypothesis
We hypothesize that: 1) our peri-operative intervention will be feasible and
safe to undertake within a clinical setting; 2) we will enrol adequate numbers
to justify a larger trial; and that 3) our study protocol will provide meaningful
information with high response rate and low attrition after 3 months.   
Justification
Inguinal hernia repair is one of the most common surgeries performed
globally, with more than 20 million performed each year.[1] Not only does
this huge number of surgeries have a substantial direct economic burden on
healthcare systems, there is also indirect impact from time off work and
decreased productivity due ongoing post-surgical pain requiring extended
time spent on modified duties. It is estimated that approximately 15% of
patients undergoing inguinal hernia repair will experience persistent post-
surgical pain that could last months to years.[2, 3] Furthermore, current
clinical guidelines for return to work and activity after inguinal hernia repair
are inconsistently informed by evidence, highly variable, and outdated.

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[4] Forbes et al (2012) found that the average patient undergoing inguinal
hernia repair experiences more than 40 days of short-term disability despite
indications that earlier return to activity is safe (i.e. will not lead to repair
failure) and likely beneficial for reducing chronic pain and disability.[4]
Evidence from related procedures indicates that better surgical preparation
through pre-operative exercise and education (i.e. Prehabilitation) followed
by ongoing post-surgical rehabilitation leads to more rapid recovery, return
to activities and lower likelihood of persistent post-surgical pain.
[5]  Prehabilitation was first described in the 1940’s when the British Army
developed a prehabilitation program as part of an experiment to increase
the quality of recruits.[6]The concept of prehabilitation gained traction within
the medical community when Topp et. al.[7] and Ditmyer et. al.[8]promoted a
theoretical model of prehabilitation, positing that patients who participate in
presurgical exercise with the goal of improving functional capacity may
experience more rapid postoperative recovery than patients who remain
physically inactive through the preoperative period.[6] Prehab has also been
shown to increase self-efficacy,[9] a moderator of pain catastrophizing and
fear avoidance beliefs, that are important factors linked to the pain
experience of those with persistent pain. We propose that this theoretical
model can be extrapolated to inguinal hernia repair and theorize that
prehabilitation will increase patients’ preoperative self-efficacy, allowing
them to more rapidly regain abilities, subsequently shortening duration of
modified duties and decreasing likelihood of persistent post-surgical pain. 
Little information is available regarding the use of prehabilitation in the
context of inguinal hernia repair. There have been numerous studies looking
at prehabilitation in orthopedics, cardiovascular surgery, and prior to major
abdominal surgeries, but limited studies for inguinal hernia repair.[5]  A
randomized control study by Liang et. al. examined the impact of
prehabilitation on ventral hernia recurrence and post-operative
complications.[10] They concluded that patients undergoing prehabilitation
have a higher likelihood of being hernia-free and complication-free 30 days
postoperatively. Notably, this study is limited in that only obese patients
were included, and outcomes only included recurrence and complications.
We were unable to find studies examining the impact of prehabilitation on
recovery time, post-surgical pain, and return to activity after inguinal hernia
repair. However psychosocial factors such as pain catastrophizing appear to
be important predictors.[11] Typical practice guidelines often recommend
limiting activity for at least 3 months to avoid re-rupture.[4] However, these
guidelines are based on expert opinion due to a lack of quality research and
can pose a risk in building unhelpful beliefs about pain, fear of movement
and poor coping strategies.[12] Research is needed to inform practice
guidelines and return-to-activity recommendations.
Objectives
We will determine if our program and the study protocol are feasible for
use on a group of patients with inguinal hernia undergoing surgical repair.
Research Methods/Procedures
Design - We will conduct a pilot randomized controlled trial. Specifically, this
project will inform the development and testing of a specific exercise and
education program, tailored to each patient's individual needs and
conducted before and after hernia repair surgery, aimed at reducing
likelihood of chronic post-surgical pain while doing minimal harm. 

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Sample - We will recruit patients referred to general surgery for an elective
inguinal hernia repair within Alberta Health Services – Fort Saskatchewan
Community Hospital (Dr. Farooq's clinic). Patients meeting the inclusion
criteria will be randomized 1:1 to either undergo 6 weeks of prehabilitation
exercises + post-surgical follow-up or else usual care. Inclusion criteria
include: 1) scheduled to undergo first-time inguinal hernia repair surgery
after a physical examination identified signs and symptoms consistent with
inguinal hernia (direct or indirect hernia); 2) willingness to participate in a
targeted perioperative exercise program; 3) 18+ years of age; 4) no medical
contraindications to participation in exercise; and 5) employed full-time and
required to lift at least 10kg at work. Specific contra-indications that will be
screened for include associated medical conditions that preclude exercise.
This includes uncontrolled medical conditions including diabetes,
hypertension, vertigo, congestive heart failure, chronic obstructive
pulmonary disease, intra-abdominal ascites, or pre-existing malnutrition. We
will also screen for previous recurrence of hernia, use of narcotics, bone
and joint conditions of the spine or extremities, or history of other abdominal
surgeries, which will be exclusionary criteria for the study. Exclusion criteria
include: 1) previous inguinal hernia; and 2) Body Mass Index >35 since
morbidly obese patients experience more surgical complications.[13]
Sample Size - Since this is a pilot study evaluating feasibility of our
intervention and evaluation protocols, we will aim to enrol 30 patients. We
will randomize 15 to both the intervention and control groups. Thirty
participants has been deemed acceptable to yield confidence intervals
whose lower limits can help define the range of plausible values for a
subsequent power analysis.[14] This will also provide adequate estimates of
enrolment, follow-up rates, information on timing, and variance in our
measurement protocol to inform a subsequent randomized controlled trial of
the intervention.
Data Collection Procedures – Activities and timing of data collection are
outlined in the attached document entitled 'Perioperative Rehabilitation
Activity and Data Collection Protocol for Inguinal Hernia ' We will
enrol patients undergoing inguinal hernia repair surgery.  Participation will
be voluntary, and patients will be informed of the study 8 weeks before
their scheduled surgery. Once scheduled and enrolled, patients will be
randomized by a research team member using Redcap. Schedule will be
developed by a statistician not involved in the randomization. Participants in
the intervention group will be referred to the University of Alberta’s Student
Physical Therapy clinic where they will undertake the pre-operative exercise
and education program. The education program will include self-
management, expectations about the surgical and recovery process as well
as guidelines for post-operative exercises. After surgery, participants in the
intervention group will undergo a clinical evaluation after surgery, with the
physiotherapists who will guide post-operative exercises and modify as
needed. The exercises will avoid all contraindications in the acute post-
surgical period, including no lifting >10kg for the first 4 weeks. The study will
not impact scheduling of surgery or typical procedures. Participants in the
intervention group will be booked for a short assessment with the general
surgeon, remotely, to evaluate progress. 
COVID-19 Implications - Since inguinal hernia repair operations have
continued to be conducted despite the pandemic and physiotherapy clinics
are operating following public health recommendations, unless these
interventions are out on hold we will conduct this study within the typical
clinical care pathway. After an initial in-person evaluation where masks will

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be worn and all exercise and testing equipment is sterilized after use, all
interventions will be conducted in accordance with the COVID-19 specific
requirements from Public Health authorities. Telehealth options for the
interventions will be available.  
Intervention Description - The perioperative rehabilitation program will
include an established set of structured exercises aimed at core
strengthening and individualized activity-based functional training in pre-
and post- operative stages. We will follow a traditional occupational
rehabilitation approach, focusing exercise training on activities that the
patient is experiencing difficulty with due to the hernia. The exercise
program is described in more detail in the attached 'hernia exercise
protocol' document. The program will be delivered by a physiotherapist and
a trained exercise therapist.  This includes the sessions that will be done in
person as well as those that will be done virtually.  Education that will be
provided includes basic information about inguinal hernia and the surgical
repair technique, what to expect in the days and weeks following surgery,
advice for post-operative recovery, importance of activity and exercise to
recovery, pain coping strategies and techniques for reducing risk of hernia
recurrence. Education will be provided in person by the surgeon and study
team, as well as through YouTube videos that provide more standardized
information. Education that will be provided includes basic information about
inguinal hernia and the surgical repair technique, what to expect in the days
and weeks following surgery, advice for post-operative recovery, importance
of activity and exercise to recovery, pain coping strategies and techniques
for reducing risk of hernia recurrence.
Measures – In additional to demographic and occupational information, we
will collect feasibility and clinical outcomes.Feasibility outcomes are: 1)
recruitment rate expressed as the average number of patients referred to
the study per week and the number of participants enrolled in the program;
2) patient adherence to the program; 3) acceptability of program content; 4);
acceptability and compliance with study questionnaires; 5) follow-up rates;
and 6) serious adverse events. A priori criteria for the feasibility outcomes
are presented in the Appendix. 
Clinical outcomes will be collected at baseline, before surgery, and following
the post-surgical intervention by a researcher not involved in the delivery of
the intervention. Persistent post-surgical will be defined as pain lasting
longer than 3 months post-surgery as per the IASP definition.[15]  We will
measure pain intensity ratings on a 0-10 Numeric Pain Scale. We will also
measure pain-related disability using the Pain Disability Index and SF-12
measures.  Lastly, after the operation we will administer the hernia-
specific Carolinas Comfort Scale (CCS).[16] The CCS is a widely used
hernia-specific patient reported outcome measure that focuses on mesh-
related symptoms.[17] We will also measure quality of life and factors linked
to chronic pain such as coping strategies, catastrophizing and
Kinesiophobia.
Safety and adverse effects – At the weekly sessions, we will as about both
exercise completion as well as any symptoms or adverse events
experienced. These will be documented. Any post-surgical complications
severe enough to warrant referral to the surgeon or ultrasound imaging will
also be tracked. Since the ultrasounds are only being done to rule out
hernia recurrence as part of routine clinical care, this will be done and
interpreted by a radiologist. All patients will also undergo a consult with the
surgeon at 1-week, 1-month, and 3-month follow-up as per usual practice.

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2.2  Research Methods and Procedures
Some research methods prompt specific ethical issues. The methods listed below have
additional questions associated with them in this application. If your research does not
involve any of the methods listed below, ensure that your proposed research is adequately
described in Section 2.1: Study Objectives and Design or attach documents
in the Documentation Section if necessary.
Plan for Data Analysis
A sample size of 30 participants will yield confidence intervals whose lower
limits can help define the range of plausible values for a subsequent power
analysis program. This will guarantee the timely and on-budget completion
of the study. All analyses will be conducted using STATA 14.2. Descriptive
analysis will be used to report feasibility outcomes (e.g. recruitment rates,
adherence, etc.) and identify trends of clinical outcomes. Feasibility targets
will be evaluated as per the Appendix.
See Attached Study Protocol for the full list of references.
3.0
Describe procedures, treatment, or activities that are above or in
addition to standard practices in this study area (eg. extra medical or
health-related procedures, curriculum enhancements, extra follow-up, etc):
The Prehab program discussed above that we are studying is in addition to
the standard surgical practices in this study area.
4.0
If the proposed research is above minimal risk and is not funded via a
competitive peer review grant or industry-sponsored clinical trial, the
REB will require evidence of scientific review. Provide information
about the review process and its results if appropriate.
This project is under review for a Michael G. DeGroote Institute for Pain
Research and Care Seed Grants
5.0
For clinical trials, describe any sub-studies associated with this
Protocol.
Not applicable.
1.0
* This study will involve the following(select all that apply)
Surveys and Questionnaires (including internet surveys)
 
NOTE 1: Select this ONLY if your application SOLELY involves a review of
paper charts/electronic health records/administrative health data to answer
the research question.  If you are enrolling people into a study and need to
collect data from their health records in addition to other interventions, then
you SHOULD NOT select this box.
NOTE 2: Select this option if this research ONLY involves analysis of
blood/tissue/specimens originally collected for another purpose but now
being used to answer your research question. If you are enrolling people
into the study to prospectively collect specimens to analyze you SHOULD
NOT select this box.

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2.9  Surveys and Questionnaires (including Online)
 
3.1  Risk Assessment
 
 
 
 
1.0
How will the survey/questionnaire data be collected (i.e. collected in
person, or if collected online, what survey program/software will be
used etc.)?
If participants are unable to complete study questionnaires on REDCAP, we
will provide paper copies. But this will not be based on preference. We will
complete as much as possible using REDCAP to minimize contact due to
COVID-19.
2.0
Where will the data be stored once it's collected (i.e. will it be stored
on the survey software provider servers, will it be downloaded to the
PI's computer, other)?
Data will be downloaded and stored on the Co-Principal Investigators'
computers.
3.0
Who will have access to the data?
The Co-Principal investigators and any graduate students supervised by the
Co-PIS working on this project will have access to the data.
4.0
If you are using a third party research tool, website survey software,
transaction log tools, screen capturing software, or masked survey
sites, how will you ensure the security of data gathered at that site?
1.0
* Provide your assessment of the risks that may be associated with
this research:
Minimal Risk - research in which the probability and magnitude of possible
harms implied by participation is no greater than those encountered by
participants in those aspects of their everyday life that relate to the research
(TCPS2)
2.0
* Select all that might apply:
Description of Possible Physical Risks and Discomforts
Yes Participants might feel physical fatigue, e.g. sleep deprivation
Yes Participants might feel physical stress, e.g. cardiovascular stress tests
Yes Participants might sustain injury, infection, and intervention side-effects or
complications
Yes The physical risks will be greater than those encountered by the

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participants in everyday life
Possible Psychological, Emotional, Social and Other Risks and
Discomforts
Possibly
Participants might feel psychologically or emotionally stressed,
demeaned, embarrassed, worried, anxious, scared or distressed, e.g.
description of painful or traumatic events
Possibly Participants might feel psychological or mental fatigue, e.g intense
concentration required
Possibly Participants might experience cultural or social risk, e.g. loss of
privacy or status or damage to reputation
No
Participants might be exposed to economic or legal risk, for instance
non-anonymized workplace surveys
Possibly The risks will be greater than those encountered by the participants in
everyday life
3.0
* Provide details of all the risks and discomforts associated with the
research for which you indicated YES or POSSIBLY above.
Since the Prehab program involves physical exercise by the participants,
there is an inherent element of physical risk. This may involve fatigue,
tiredness, physical stress or injury, or other related complications. The
Prehab program is in addition to usual care and typically patients with
inguinal hernia do not participate in physical exercise prior to undertaking
surgery. However, the program comes with several potential benefits that
will be discussed. 
Specific physical complications could arise before the operation is
performed or after surgery. Prior to surgery, the patient may experience
more pain in the hernia site as well as normal pain associated with exercise,
they may notice worsening of the size of the hernia, and there is a very
small chance of hernia incarceration (i.e. herniated tissue becomes trapped
and cannot easily be moved back into place – typically occurs in less than
1% (0.18% to 0.79%) of hernia cases). Increased symptoms or size of the
hernia will be monitored, and exercises will be modified if the symptoms
become intolerable to the participant. Hernia incarceration is an acute
painful episode that will require a visit with the surgeon. 
In the post-operative phase, patients may experience postoperative pain,
opening of the superficial wound from potential hazards associated with
exercising (i.e. falling, etc.). However, studies on the force required to cause
hernia rupture indicate the force is quite high and beyond those generated
during the exercises prescribed. If a participant experiences pain associated
with our exercise intervention, we will modify or stop the aggravating
exercises after consultation with the surgeon.
Exercise prior to surgery requires mental concentration and participants
may feel psychologically or emotionally stressed or fatigue. Since they are
in a research study, there is always some risk of social risk through loss of
privacy. 
4.0
* Describe how you will manage and minimize risks and discomforts,
as well as mitigate harm:

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3.2  Benefits Analysis
 
The exercise programs will be monitored by experienced physical therapists
and kinesiologists who will track patient progress. Since the exercise
program is overall low intensity exercise, we do not anticipate many injuries
or adverse events. However, if patients begin experiencing problems, the
therapists will advise on alterations to make the exercises less intensive or
recommend that the program be stopped. The therapists will also be
available should more serious adverse events occur such as injury or other
related complication. If this occurs, the therapists will advise on self-
management strategies for the injury or initiate follow-up with the surgeon.
5.0
Is there a possibility that your research procedures will lead to
unexpected findings, adverse reactions, or similar results that may
require follow-up (i.e. individuals disclose that they are upset or distressed
during an interview/questionnaire, unanticipated findings on MRI, etc.)?
  " Yes ! No
Describe the arrangements or referral the researcher will make.
Explain if no arrangements have been made. 
As mentioned above, the participants will be monitored by experienced
physical therapists and kinesiologists that can provide advice or take
immediate action. The general surgeon on our team who are helping to
recruit patients will also be available to consult on any serious adverse
reactions.
6.0
If you are using any tests in this study diagnostically, indicate the
member(s) of the study team who will administer the
measures/instruments:
 Test
Name
Test
Administrator
OrganizationAdministrator's
Qualification
There are no items to display
7.0
If any research related procedures/tests could be interpreted
diagnostically, will these be reported back to the participants and if so,
how and by whom?
Not applicable as the measures we are using track patient progress only.
They are not interpreted diagnostically. 
If the surgeon believes an ultrasound imaging scan is needed to detect re-
of the hernia, this will be done in the context of usual care and results will be
reported to the patients.
1.0
* Describe any potential benefits of the proposed research to the
participants. If there are no benefits, state this explicitly:
The patient centred evidence-based perioperative program that participants
will be undertaking has the potential to: 1) improve post-surgical pain; 2)
increase post-surgical functional and patient oriented outcomes; 3)
decrease post-surgical opioid use; and 4) decrease short- and long-term

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4.1 Participant Information
 
4.2 Additional Participant Information
 
healthcare costs by reducing readmissions, and post-operative health
utilization.
2.0
* Describe the scientific and/or scholarly benefits of the proposed
research:
This study is novel and timely given the current healthcare focus on
improving prevention strategies, and improving access to, delivery and
outcomes of surgical interventions. This will be the first perioperative
program specifically developed for patients undergoing surgery for inguinal
hernia. The obvious potential benefits for patients undergoing inguinal
hernia repair is the development of a program that has the potential to
improve post-surgical outcomes, increase quality of life, while addressing
healthcare and individual costs, minimizing the impact of the condition on
the individual and society.
3.0
If this research involves risk to participants explain how the benefits
outweigh the risks.
While the perioperative program comes with some inherent risks due to
participation in exercise, this exercise also comes will several potential
benefits for participants. Since the risk of adverse events are quite small, we
believe the potential benefits outweigh the risks.
1.0
* Will you be recruiting human participants (i.e. enrolling people into the
study, sending people online surveys to complete)?
  " Yes ! No
1.1 Will participants be recruited or their data be collected from Alberta
Health Services or Covenant Health or data custodian as defined in the
Alberta Health Information Act?
  " Yes ! No
1.2 Would you like to include information about this study on the Be
The Cure searchable database?
  ! Yes " No
1.0
Describe the participants that will be included in this study. Outline
ALL participants (i.e. if you are enrolling healthy controls as well): 
We will recruit 30 participants with inguinal hernia who are scheduled for
surgery by a general surgeon in Fort Saskatchewan (Dr. Omar Farooq). We
will recruit 30 participants in total and randomize 15 participants to each of
the intervention and control groups.

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2.0
* Describe and justify the inclusion criteria for participants (e.g. age
range, health status, gender, etc.):
Inclusion criteria include:
1) scheduled to undergo first-time inguinal hernia repair surgery after a
physical examination identified signs and symptoms consistent with inguinal
hernia (direct or indirect hernia);
2) willingness to participate in a 6-week targeted exercise program;
3) 18+ years of age;
4) no medical contraindications to participation in exercise. Contra-
indications that will be screened for include associated medical conditions
that preclude exercise. This includes uncontrolled medical conditions
including diabetes, hypertension, vertigo, congestive heart failure, chronic
obstructive pulmonary disease, intra-abdominal ascites, or pre-existing
malnutrition.
and
5) employed full-time and required to lift at least 10kg at work. 
3.0
Describe and justify the exclusion criteria for participants:
Exclusion criteria include: 1) previous inguinal hernia;
2) Body Mass Index >35 since morbidly obese patients experience more
surgical complications
3) use of narcotics
4) bone and joint conditions of the spine or extremities
5) history of other abdominal surgeries
4.0
Participants
4.1 How many participants do you hope to recruit (including controls, if
applicable?)
30
4.2 Of these, how many are controls, if applicable?
0
4.3 If this is a multi-site study, how many participants do you
anticipate will be enrolled in the entire study?
30
5.0
Justification for sample size:
Since this is a pilot study evaluating feasibility of our intervention and
evaluation protocols, we will aim to enrol 30 patients. We will randomize 15
participants to each group. Thirty participants has been deemed acceptable
to yield confidence intervals whose lower limits can help define the range of

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4.3  Recruitment of Participants (Health)
 
plausible values for a subsequent power analysis. This will also provide
adequate estimates of enrolment, follow-up rates, information on timing, and
variance in our measurement protocol to inform a subsequent randomized
controlled trial of the intervention.
 
1.0
Recruitment
* 1.1 How you will identify potential participants? Please be
specific. (i.e. Will you be screening clinical lists, accessing electronic health
records (e-clinician), asking staff from a particular area to let you know when
a patient meets criteria, will you be sitting in the emergency department
waiting room, etc?)
Recruitment will take place at the general surgical practice of Dr. Farooq at
the Fort Saskatchewan Community Hospital. Patients on the wait list for
inguinal hernia repair surgery will be contacted by Dr. Farooq's
administrative support staff. They will ask the participant if they are
interested in participating in this study. If so, their contact information will be
taken and provided to the study team who will then contact the individual to
provide further study information and obtain informed consent.
1.2 If you are using patient/clinical records to identify potential
participants for research purposes, will someone from the data
custodian/clinical care team seek prior consent of the participant to
allow the researcher to look at their records?
  " Yes ! No
1.3 Once you have identified a list of potentially eligible participants,
indicate how the potential participants’ names will be passed on to the
researchers AND how will the potential participants be approached
about the research.
The names and contact details of potentially eligible participants will be
provided to the investigative team by the surgeon's research coordinators
using a 'Consent to Contact' form that will be completed either at time of
their examination by the surgeon or after they are on the wait list and
contacted by the administrative support staff. If contacted over the phone,
the consent to contact form will be emailed for signing. The investigators will
then arrange a meeting (telephone or Zoom videoconference) with the
potential participant to explain the study and provide an information sheet.
Final consent to participate will be done over REDcap.
1.4 Outline any other means by which participants could be
identified(e.g. response to advertising such as flyers, posters, ads in
newspapers, websites, email, list serves, physicial or community
organization referrals): 
Not applicable since we require patients who have been scheduled for
inguinal repair surgery.

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4.5  Informed Consent Determination
 
2.0
Pre-Existing Relationships
2.1 Will potential participants be recruited through pre-existing
relationships with researchers (e.g. Will an instructor recruit students
from his classes, or a physician recruit patients from her practice? Other
examples may be employees, acquaintances, own children or family
members, etc)?
  " Yes ! No
2.2 If YES, identify the relationship between the researchers and
participants that could compromise the freedom to decline (e.g.
clinician/patient, professor/student):
If it is acceptable to the ethics board, Dr, Farooq will recruit directly.
However, we will have a research assistant make first contact with patients
on Dr. Farooq’s surgical wait list so that patients feel no obligation or
coercion to participate in the study.
 2.3 How will you ensure that there is no undue pressure on the
potential participants to agree to the study?
Initial contact will be made by an administrative staff member to determine if
the potential participants are interested.
3.0
Will your study involve any of the following (select all that apply)?
None of the above
1.0
Describe who will provide informed consent for this study(i.e. the
participant, parent of child participant, substitute decision maker, no one will
give consent – requesting a waiver)
Each participant will provide informed consent for this study. Since the first
session is in-person, we will complete the consent process and
documentation in person. Although the participants may also be asked to
complete the study demographic form and questionnaires via REDCap prior
to that session (consent implied through completion).
1.1 Waiver of Consent Requested
If you are asking for a waiver of participant consent, please justify the
waiver or alteration and explain how the study meets all of the criteria
for the waiver. Refer to Article 3.7 of TCPS2 and provide justification for
requesting a Waiver of Consent for ALL criteria (a-e)
Not applicable.
 
1.2 Waiver of Consent in Individual Medical Emergency
If you are asking for a waiver or alteration of participant consent in
individual medical emergencies, please justify the waiver or alteration
and explain how the study meets ALL of the criteria outlined in Article
3.8 of TCPS2 (a-f).

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5.1  Data Collection
 
Not applicable.
2.0
How will consent be obtained/documented? Select all that apply
Signed consent form
 
If you are not using a signed consent form, explain how the study
information will be provided to the participant and how consent will be
obtained/documented. Provide details for EACH of the options
selected above:
3.0
 Will every participant have the capacity to give fully informed consent
on his/her own behalf?
  " Yes ! No
4.0
What assistance will be provided to participants or those consenting
on their behalf, who may require additional assistance? (e.g. non-
English speakers, visually impaired, etc.)
The study team will meet with the participants to provide any assistance
needed. However, due to the nature of this study any participants
experiencing difficulty with the consent process will not be enrolled.
5.0
* If at any time a PARTICIPANT wishes to withdraw from the study or
from certain parts of the study, describe when and how this can be
done.
Participants can withdraw at any time during the study. If requested, all
electronic data will be deleted for those withdrawing.
6.0
Describe the circumstances and limitations of DATA withdrawal from
the study, including the last point at which participant DATA can be
withdrawn (i.e. 2 weeks after transcription of interview notes)
Participants can withdraw from the study up to the point where analysis has
been completed and results presented.
7.0
Will this study involve any group(s) where non-participants are
present? For example, classroom research might involve groups
which include participants and non-participants.
  ! Yes " No
 
 
1.0
* Will the researcher or study team be able to identify any of the
participants at any stage of the study?

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5.2  Data Identifiers
 
  " Yes ! No
2.0
Primary/raw data collected will be (check all that apply):
All personal identifying information removed (anonymized)
3.0
If this study involves secondary use of data, list all original sources:
Not applicable.
4.0
In research where total anonymity and confidentiality is sought but
cannot be guaranteed (eg. where participants talk in a group) how will
confidentiality be achieved?
Not applicable.
1.0
* Personal Identifiers: will you be collecting - at any time during the study,
including recruitment - any of the following (check all that apply):
Surname and First Name
Address
Full Postal Code
Telephone Number
Email Address
Age at time of data collection
2.0
Will you be collecting - at any time of the study, including recruitment
of participants - any of the following (check all that apply):
There are no items to display
3.0
* If you are collecting any of the above, provide a comprehensive
rationale to explain why it is necessary to collect this information:
Name and contact information will be used to recruit participants.
Age at time of data collection is being collected to describe our sample.
Address and postal code will be used to contact patients at follow-up.
4.0
If identifying information will be removed at some point, when and how
will this be done?
Personal identifying information will not be removed, since we will need it to
contact participants at follow-up.
5.0
* Specify what identifiable information will be RETAINED once data
collection is complete, and explain why retention is necessary. Include
the retention of master lists that link participant identifiers with de-
identified data:
All patient names and contact information will be retrained in case we need
to follow-up with patients about the study.
6.0
If applicable, describe your plans to link the data in this study with

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5.3  Data Confidentiality and Privacy
 
5.4  Data Storage, Retention, and Disposal
 
data associated with other studies (e.g within a data repository) or
with data belonging to another organization:
Not applicable.
1.0
* How will confidentiality of the data be maintained?  Describe how the
identity of participants will be protected both during and after
research.
All investigators and graduate students working on this project will be
trained in research ethics (CORE certification) and confidentiality issues. All
data will be stored on password-protected and encrypted secure computers
at the University of Alberta and McMaster University campuses. 
During presentations, we present group-level data and avoid providing
individual identifiers.
2.0
How will the principal investigator ensure that all study personnel are
aware of their responsibilities concerning participants' privacy and the
confidentiality of their information? 
All investigators and graduate students working on this project will be
trained in research ethics (CORE certification) and confidentiality issues.
3.0
External Data Access
* 3.1  Will identifiable data be transferred or made available to persons
or agencies outside the research team?
  ! Yes " No
 
 
 
1.0
* Describe how research data will be stored, e.g. digital files, hard
copies, audio recordings, other. Specify the physical location and how
it will be secured to protect confidentiality and privacy. (For example,
study documents must be kept in a locked filing cabinet and computer files
are encrypted, etc. Write N/A if not applicable to your research)
All electronic data will be saved in a password protected, secure University
of Alberta computer and network within a password protected Excel file. All
physical documents will be stored in the Rehabilitation Research Centre
(Room 3-62 Corbett Hall) at the University of Alberta. Only the Co-PIs and
their graduate students will have access to study data.
2.0
* University policy requires that you keep your data for a minimum of 5

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Documentation
Add documents in this section according to the headers. Use Item 11.0 "Other Documents"
for any material not specifically mentioned below.
Sample templates are available by clicking HERE.
years following completion of the study but there is no limit on data
retention. Specify any plans for future use of the data. If the data will
become part of a data repository or if this study involves the creation
of a research database or registry for future research use, please
provide details. (Write N/A if not applicable to your research)
We have no plans for future use of the data, but will keep all records and
data for a period of 5 years at least.
3.0
If you plan to destroy your data, describe when and how this will be
done? Indicate your plans for the destruction of the identifiers at the
earliest opportunity consistent with the conduct of the research and/or
clinical needs:
We have no plans for destroying our data.
1.0
Recruitment Materials:
Document Name
VersionDate
Description
 #  $ Consent to Contact form
V2
0.03
2021-03-02
4:43 PM
 
 #  $ CLEAN Consent to
Contact form V2
0.02
2021-03-03
9:01 AM
 
2.0
Letter of Initial Contact:
Document Name
Version
Date
Description
There are no items to display
3.0
Informed Consent / Information Document(s):
3.1  What is the reading level of the Informed Consent Form(s):
9
3.2  Informed Consent Form(s)/Information Document(s):
Document Name
VersionDate
Description
 #  $ Letter of Information and
Consent V2
0.05
2021-03-
02 4:43
PM
 
CLEAN Letter of
2021-03-

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 #  
Information and Consent
V2
0.01
03 7:47
AM
 
4.0
Assent Forms:
Document Name
Version
Date
Description
There are no items to display
5.0
Questionnaires, Cover Letters, Surveys, Tests, Interview Scripts, etc.:
Document Name
VersionDate
Description
 #  $ Assessment booklet
V4.docx
0.03
2021-03-02
4:44 PM
 
 #  
Feedback Survey
0.01
2021-03-02
4:44 PM
 
 #  
Functional Testing Form
0.01
2021-03-02
4:45 PM
 
 #  
Adherence and Adverse
Events Form
0.01
2021-03-02
4:46 PM
 
 #  
CLEAN Assessment
booklet V4.docx
0.01
2021-03-03
7:48 AM
 
6.0
Protocol/Research Proposal:
Document Name
VersionDate
Description
 #  $ Full proposal
0.04
2021-01-13
12:57 PM
 
 #  
Data Collection Timeline
and Protocol
0.01
2021-03-02
4:45 PM
 
 #  
Exercise Protocol
0.01
2021-03-02
4:46 PM
 
7.0
Investigator Brochures/Product Monographs:
Document Name
Version
Date
Description
There are no items to display
8.0
Health Canada No Objection Letter (NOL):
Document Name
Version
Date
Description
There are no items to display
9.0
Confidentiality Agreement:
Document Name
Version
Date
Description

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Final Page
 
There are no items to display
10.0
Conflict of Interest:
Document Name
Version
Date
Description
There are no items to display
11.0
Other Documents:
For example, Study Budget, Course Outline, or other documents not
mentioned above
Document Name
VersionDate
Description
 #  Appendix with Feasibility
Criteria
0.02
2021-01-13
12:25 PM
 
 
You have completed your ethics application! Click "Continue" to go to your
workspace.
This action will NOT SUBMIT the application for review. 
 
Only the Study Investigator can submit an application to the REB by
selecting the "SUBMIT STUDY" under My Activities after you click
CONTINUE.
 
 

 
DEPARTMENT OF PHYSICAL THERAPY  
FACULTY OF REHABILITATION MEDICINE 
___________________________________________________________________________________ 
 
 
Ethics Certification Number: Pro00106451 
Dr. Douglas Gross – Letter of Information/Consent Form (February 12, 2021)  
Page 1 of 4 
 
LETTER OF INFORMATION / CONSENT 
 
Title of Study: A Study Evaluating the Feasibility of a Peri-Operative Rehabilitation 
Program for Inguinal Hernia Repair Surgery to Reduce Risk of Post-Surgical Pain 
INVESTIGATORS:  Douglas Gross, Omar Farooq, Luciana Macedo, Geoff Bostick, 
Quentin Durand-Moreau, Anna Shologan, Chad Piper 
 
PRIMARY STUDY CONTACT: Dr. Douglas Gross   Email: doug.gross@ualberta.ca 
 
 
 
 
 
Phone number: 780-492-2690 
Funding Source: Not applicable
Why are you being asked to be part of this research study? 
You are being invited to participate in a research study because you are scheduled for 
inguinal repair surgery.  
 
To decide whether or not you want to be a part of this study, you should understand 
what is involved and the potential risks and benefits. This letter gives detailed 
information about the study that will be discussed with you. Once you understand the 
study, we will ask you to sign a consent form if you wish to participate.  Please take your 
time to make your decision. Feel free to discuss it with your friends and family, or your 
family physician. 
  
What are we trying to discover? 
You are invited to take part in this study on the feasibility of a program to help people 
undergoing inguinal hernia repair surgery. The program includes exercise and education 
to help people prepare for their surgery and recover faster after the operation. We hope 
the program will improve your chance of a successful surgery and lead to faster 
recovery. We will study levels of pain, disability, work status, and quality of life before 
and after our program. We will also test things like whether you are satisfied with the 
program and how long it takes to complete study questionnaires. We will use results to 
make changes to the program. We will then test if the program works in a larger study.  
 
What will happen during the study? 
During this study you will be asked to participate in a program to help you get ready for 
your surgery. The program will take place over 6 weeks before your surgery and 12 
weeks after the operation.  
 
Before Surgery (Approximately 12-hour commitment over 6 weeks) 
You will have one in-person assessment session at the beginning for testing. If you feel 
comfortable, we will ask you to disclose some personal information like your age, mailing 
address and education. You will also fill out questionnaires related to your job and levels 
of pain, disability, and quality of life. These questions should last 15 to 20 minutes.  
 
You will then undergo work ability testing. We will ask you to do activities you usually 
perform at work (lifting, standing, crouching, bending and twisting). At the end of the 
assessment and after you formally agree to participate in the study, the therapists will 
use an automated computer service to randomize you into a treatment group.  

 
DEPARTMENT OF PHYSICAL THERAPY  
FACULTY OF REHABILITATION MEDICINE 
___________________________________________________________________________________ 
 
 
Ethics Certification Number: Pro00106451 
Dr. Douglas Gross – Letter of Information/Consent Form (February 12, 2021)  
Page 2 of 4 
You will then either be taught exercises and receive pain-related education or else only 
receive pain-related education. The sessions will be in person for the first session and 
then over videoconference for weekly follow-ups. The exercises (strengthening and 
stretching) and education will be delivered by a physiotherapist and a trained exercise 
therapist. You will be asked to exercise at home 15-20 minutes per day before the 
operation. The therapists will also teach you about inguinal hernia and how best to 
prepare for your surgery. You will also watch educational videos prepared by a surgeon.  
 
After Surgery (Approximately 18-hour commitment over 12 weeks) 
After your operation you will recuperate for 3 weeks. One week after the operation we 
will ask you to complete surveys related to pain and disability. After being cleared by the 
surgeon to participate in exercise you will again begin exercising under the supervision 
of an exercise therapist. You will have 1 in-person session with the therapist and then 
exercise on your own for 6 weeks. You will have weekly virtual check-ins with the 
therapist.  
 
There will be one last in-person assessment session with a therapist about 12 weeks 
after your operation. We will repeat the same surveys and tests you did on the first day. 
 
All the activities in this study should take about 30 hours in total including assessments 
and therapy sessions. Two hours will be for testing and completing surveys while the 
treatment activities will take approximately 28 hours in total. 
 
Are there any risks to doing this study? 
Before surgery - You may experience temporary muscle soreness following exercise. 
This is a normal response to exercise if you’re not used to it. It should feel better within a 
day or two. People also sometimes have a temporary increase in their inguinal hernia 
symptoms following exercise. If this happens, you should tell the therapist. They will help 
you decide whether to modify or stop your exercises. There is also a very small risk that 
the hernia tissue will become trapped and cannot be easily moved back into place. The 
risk is not much greater than during your usual activity. But if this happens you will 
immediately visit the surgeon.  
 
After surgery - There is a small risk of hernia re-rupture but not much higher than 
during your usual activity. You will be in regular contact with the surgeon. If the surgeon 
thinks a re-rupture has occurred, you will be sent for an ultrasound scan. If the scan 
shows a repeat hernia you will have repeat surgery. 
 
You do not need to answer questions that you do not want to answer or that make you 
feel uncomfortable. You can withdraw (stop taking part) at any time during the study. We 
will describe below the steps we are taking to protect your privacy. 
 
What are the possible benefits for me and/or for society? 
If you decide to participate in this study, you may benefit from the exercise and 
education sessions. We also hope that what is learned will help us improve the pre-
surgical program for people with inguinal hernia.  The end goal is to help people have 
successful surgeries. This includes lower pain, higher function, and shorter length of 
hospital stay after surgery. However, we cannot guarantee that you will experience these 
potential benefits. 

 
DEPARTMENT OF PHYSICAL THERAPY  
FACULTY OF REHABILITATION MEDICINE 
___________________________________________________________________________________ 
 
 
Ethics Certification Number: Pro00106451 
Dr. Douglas Gross – Letter of Information/Consent Form (February 12, 2021)  
Page 3 of 4 
 
 
Who will know what I said or did in the study?  
Every effort will be made to protect your confidentiality and privacy. A member of the 
research team will contact you to discuss participating in the study. We will not use your 
name or any information that would allow you to be identified.  The information you 
provide will be kept in a secure computer where only we will have access to it. 
Information kept on a computer will be protected by a password. The research data will 
be kept for at least 5 years to allow for the publication of findings.  
 
What information will be kept private? 
The health information collected in this study will be kept confidential unless release is 
required by law. All information will be used only for the research study. The researchers 
and the University of Alberta Health Research Ethics Board may access your study 
records to monitor the research and verify the accuracy of study information. 
 
In Canada, study information is required to be kept on file for five years. Even if you 
withdraw from the study, the information and data that is obtained for study purposes will 
not be destroyed. You have the right to check your health records and request changes 
if personal information is incorrect. 
 
What if I change my mind about being in the study? 
If you volunteer to be in this study, you may withdraw at any time. You have the option of 
removing your data from the study. You may also refuse to answer any questions you 
don’t want to answer and remain in the study. Not following the study protocol will not be 
a reason for excluding you from the study. The investigator may withdraw you from this 
research if circumstances arise which warrant doing so. This could include things like 
cancellation of your surgery or major delays due to COVID-19. 
 
How do I find out what was learned in this study?  
We expect to have this study completed by approximately December 2021. If you would 
like a brief summary of the results, please let us know how you would like it sent to you.   
 
What do I do if I have questions about the study? 
If you have questions or need more information about the study itself, please contact Dr. 
Doug Gross at email: doug.gross@ualberta.ca or phone: 780-492-2690. 
 
This study has been reviewed by the University of Alberta Research Ethics Board (REB). 
The REB is responsible for ensuring that participants are informed of the risks 
associated with the research, and that participants are free to decide if participation is 
right for them. If you have any questions about your rights as a research participant, 
please call the REB at (780) 492-2615. 
 
 
 

 
DEPARTMENT OF PHYSICAL THERAPY  
FACULTY OF REHABILITATION MEDICINE 
___________________________________________________________________________________ 
 
 
Ethics Certification Number: Pro00106451 
Dr. Douglas Gross – Letter of Information/Consent Form (February 12, 2021)  
Page 4 of 4 
Part 2  
Title of Project: A Study Evaluating the Feasibility of a Peri-Operative Rehabilitation 
Program for Inguinal Hernia Repair Surgery to Reduce Risk of Post-Surgical Pain 
INVESTIGATORS:  Douglas Gross, Omar Farooq, Luciana Macedo, Geoff Bostick, 
Quentin Durand-Moreau, Anna Shologan, Chad Piper 
 
PRIMARY STUDY CONTACT: Dr. Douglas Gross   Email: doug.gross@ualberta.ca 
 
 
 
 
 
Phone number: 780-492-2690 
 
 
 
Yes 
 
No 
Do you understand that you have been asked to participate in a research 
study? 
¨ 
¨ 
Have you read and received a copy of the Information Letter? 
¨ 
¨ 
Do you understand the benefits and risks of being involved in this research 
study? 
¨ 
¨ 
Have you had an opportunity to ask questions and discuss this study with 
a representative thereof? 
¨ 
¨ 
Do you understand that you are free to withdraw from the study at any time 
without having to give a reason and without affecting your future medical 
care? 
¨ 
¨ 
Has the issue of confidentiality been explained to you? 
¨ 
¨ 
Do you understand who will have access to the information you provide? 
¨ 
¨ 
I agree to take part in this study: 
¨ 
¨ 
 
------------------------------------------------------------------------------------------------------------------ 
Participant’s Name______________________ Date___________________________ 
 
Contact Information for Future Follow-up 
 
Phone Number: 
 
Address: 
 
 
Email: 
 
 
 

Medtronic External Research Program 2021 
Gross, Douglas P. 
 
9 
APPENDIX 2 
 
 
FEASIBILITY AND ACCEPTABILITY CRITERIA 
 
 
 
Proceed 
 
Proceed with Protocol 
Amendments 
 
Significant Amendments 
Required 
 
 
Recruitment 
 
n=30 within 4 months 
n > 15 within 8 months 
n < 10 within 8 months 
50% of eligible participants 
consent to participate 
40% of eligible participants 
consent to participate 
25% of eligible participants 
consent to participate 
 
Exercise program 
 
60% of participants report 
exercise at least 3 times a 
week 
40% of participants report 
exercise at least 3 times a 
week 
25% of participants report 
exercise at least 3 times a 
week 
 
Content Acceptability 
 
50% found treatment useful 
(Likert ≥ 4/5) 
25% found treatment useful 
(Likert ≥ 4/5) 
< 25% found treatment useful 
(Likert ≥ 4/5) 
50% found treatment helpful 
(Likert ≥ 4/5) 
25% found treatment helpful 
(Likert ≥ 4/5) 
< 25% found treatment 
helpful (Likert ≥ 4/5) 
 
Format Acceptability 
 
50% found treatment delivery 
(in-person and home) 
acceptable (Likert ≥ 4/5) 
25% found treatment delivery 
acceptable (Likert ≥ 4/5) 
< 25% found treatment 
delivery acceptable (Likert ≥ 
4/5) 
50% reported being likely to 
recommend this treatment 
25% reported being likely to 
recommend this treatment 
< 25% reported being likely to 
recommend this treatment 
50% reported being likely to 
use this treatment again 
25% reported being likely to 
use this treatment again 
< 25% reported being likely to 
use this treatment again 
 
 
 

Medtronic External Research Program 2021 
Gross, Douglas P. 
 
10 
Follow Up 
 
90% of participants followed 
up at the end of Prehab 
50% of participants followed 
up at the end of Prehab 
25% of participants followed 
up at the end of Prehab 
80% of participants followed 
up at 3 months 
50% of participants followed 
up at 3 months 
25% of participants followed 
up at 3 months 
 
Treatment 
 
70% of participants attended 
all treatment sessions 
50% of participants attended 
all treatment sessions 
25% of participants attended 
all treatment sessions 
70% of sessions were 
compatible with participant’s 
work/activity schedule 
50% of sessions were 
compatible with participant’s 
work/activity schedule 
25% of sessions were 
compatible with participant’s 
work/activity schedule 
 
Burden 
 
75% of participants found the 
burden of completing 
questionnaires Likert <3/10 (0 
= no burden, 10 = most 
burden) 
50% of participants found the 
burden of completing 
questionnaires Likert <3/10 (0 
= no burden, 10 = most 
burden) 
25% of participants found the 
burden of completing 
questionnaires Likert <3/10 (0 
= no burden, 10 = most 
burden) 
 
Adverse Events 
 
No adverse event 
1 adverse event related to re-
injury 
2 or more adverse events