Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
Phase: NA
Conditions: Congenital Heart Defect, Hypoplastic Left Heart Syndrome, Physical Activity
Sponsor: University of Alberta

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 1 of 8 
iStudy Tittle: Physical activity promotion in children and adolescents with single ventricle physiology 
 
Protocol Number: Pro00057730 
 
Protocol Version Date: 24 Feb 2017  
 
Principal Investigator:  
 
Dr. Nee Khoo MBChB, FRACP 
Cardiology/Pediatrics | University of Alberta 
4C2.36 Stollery Children’s Hospital 
Edmonton, AB T6G 2C8 
Email: khoo@ualberta.ca 
Phone: 780-407-3964 
 
Collaborators: 
 
Dr. Andrew Mackie 
Dr. Michael Stickland 
Dr. Pierre Boulanger 
Dr. Gwen Rempel 
Dr. Jennifer Conway 
Mr. Peter Wood 
Dr. Michael Khoury 
 
Research Coordinator:  
 
Rae Foshaug 
 
 
 
 
 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 2 of 8 
List of Abbreviations 
 
BP  
 
Blood pressure  
CHD   
Congenital Heart Disease 
CPET   
Cardio Pulmonary Exercise Testing 
ECG   
Electrocardiograph  
SV 
 
Single Ventricle 
 
 
 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 3 of 8 
Background 
Children with single ventricular (SV) heart were a uniformly fatal condition prior to descriptions of 
surgical palliation in 1980 that results in a Fontan circulation with single ventricle physiology.  In the 
present era, 5-year survival is 75% in multicenter studies, with some centers including the Stollery 
Children’s Hospital reporting higher survival. Although mortality remains a challenge for this population, 
the research focus has shifted towards optimizing management of late complications as well as improving 
patient physical and mental health-related quality of life issues. Children with SV have decreased exercise 
tolerance and the reduction is progressive through adolescence and into adulthood.  Physical factors 
contributing to decreased exercise tolerance in the Fontan patient include cardiovascular inefficiencies 
and the loss of peripheral lean muscle mass and efficiency from deconditioning. Recently, Cordina et al. 
has shown that an intensive exercise regiment can improve muscle strength and mass, cardiac output and 
exercise capacity in adults with Fontan circulation. The majority of published outcomes from exercise 
training in patients with congenital heart disease (CHD) have resulted in increased measured exercise 
capacity with no apparent negative effect. Although the link between improved exercise capacity and 
improved patient quality of life remains controversial, participation in an aerobic exercise regimen leads 
to improved health-related quality of life. 
Aside from physical limitations to their exercise capacity, Fontan patient self-confidence toward physical 
activity is low, as is exercise participation. Studies indicate that amongst youth with CHD, low self-
confidence may be a more important predictor of participation than the severity of the disease. Parental 
overprotection is a common finding in children with CHD with a lasting impact on patient self-confidence 
and anxieties toward physical activity well into adulthood. Alteration of patient and parental perception 
and anxieties toward participation in physical activity may improve compliance to exercise training and 
encourage more positive patient perceptions toward healthy lifestyle habits, including frequent physical 
activity participation. 
Recent technological advances in remote health assessment capabilities and telehealth systems have 
allowed the development of medically supervised home graduated physical training for adult cardiac 
patient rehabilitation.  The application of such technologies to pediatric congenital heart patients has not 
been tested.  In collaboration with Prof. Boulanger at the Advanced Man Machine Interface Laboratory at 
the University of Alberta, a custom pediatric remote bike ergometer (MedBike) was developed.  This 
technology provides the medical supervisor with a live-feed of patient video/audio, electrocardiograph 
(ECG), blood pressure (BP) and blood oximetry signals while enabling remote determination of patient 
work load through the bike ergometer. The long-term goal is to use this technology to improve patient 
exercise capacity and to positively influence patient and parental perceptions of the patient’s physical 
ability.  
Study Design: Prospective Cohort Study 
Study Procedures: 
Dr. Michael Khoury is a member of potential participants clinical care team. He has been added to the 
study team. Whenever he is available, he will perform early contact by telephone just as the clinic nurse 
would as described in this section. However, since he is a member of both the study team and the clinical 
care team there is no need for an early contact letter or permission to contact letter. This process is in 
adherence with section 55 (section 34) of the Health Information Act. This role will be documented on the 
delegation log. 
 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 4 of 8 
A clinic nurse will be put on the delegation log to cover Dr. Khoury during any absence. For that reason 
the early contact letter and permission to contact letter will be maintained on this ethics approval. 
Whenever the clinic nurse covers for Dr. Khoury’s early contact role, the early contact letter and 
permission to contact letter will be used to adhere with section 55 (section 34) of the Health Information 
Act. This role will be documented on the delegation log. Potential participants will be identified by clinic 
nurses/physician who will be made aware of the inclusion criteria. Clinic nurses will ask potential 
participants if they would be willing to be approached by a study investigator. If so, a clinic nurse will 
contact a member of the study team. Recruitment will be achieved by approaching eligible patients in the 
clinic by a member of the study team that is not the most responsible physician (research coordinator) to 
prevent undue pressure.   
 
Given that 10 healthy adult participants will be recruited from the study team for stage 1, we will take 
additional steps to prevent undue pressure. The study team will be been made aware eligibility. Interested 
persons have been asked to contact the study coordinator. The study coordinator will complete the 
consenting process. The study PI/team will be available for further discussion. It will be clearly stated that 
participation is completely voluntary and that the participant may withdraw consent at any point without 
it impacting their role/credit in this study, their employment or future medical care. 
 
Study will be performed in two stages. 
Stage 1 (pre study): To calibrate Medbike with reference standard cardiopulmonary exercise test (CPET), 
and to determine patient tolerance to maintenance of exercise intensity to varying workload in children 
with Fontan for planning of optimal exercise regimen. 
Stage 1A: The program has two retrospective calibration samples already that will be used. Consent will 
not be obtained given that the data is anonymized and medical records/other identifying information will 
not be obtained. We will also recruit 10 healthy adult participants prospectively to calibrate the MedBike. 
VO2 and CPET will be set at a constant workload between 25W and 125W. Exercise will be repeated 
after 2 hours of rest on the Medbike with the same setting and VO2 measures. This visit will take 3 hours 
to complete. 
Stage 1B: We will recruit 10 patients with Fontan physiology to undergo a baseline standard CPET. 
Consistent with standard guidelines (ATS/ACCP statement on cardiopulmonary exercise testing, Am J 
Respir Crit Care med 2003; 167:211-277), exercise workload will be increased progressively such that 
peak oxygen consumption is achieved in 8-12 minutes. Oxygen consumption, CO2 production, 
ventilation, arterial saturation (SpO2) and blood pressure will be monitored throughout each exercise test.  
Stage 1B will be completed in two visits. 
 
Visit 1: Participants will perform a standard CPET and VO2 will be measured. This visit will take 
1 hour to complete. From the results of this baseline CPET, a high-intensity interval training 
(HIIT) program will be designed for the subjects (described below).  
 
Visit 2: Participants will perform the designed HIIT program using the MedBike. This will 
consist of a 5-minute warm up at 30% of the subject’s peak power output (based on results of the 
baseline CPET study). There will then be 7 bouts of high-intensity interval bursts. Each burst will 
consist of 2-minutes at 70-90% of peak power output and a 1-minute rest at 40-50% of peak 
power output. The subjects will then end with a 5-minute cool down at 30% peak power output. 
An exercise physiologist will be present and will make changes to the interval bursts based on the 
subject’s perceived difficulty and workload. The program is 30-minutes in total. We anticipate 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 5 of 8 
that Visit 2 will take approximately 1-hour to complete with set-up, orientation, and sizing of the 
MedBike to the subject. In the room with the subject will be an exercise physiologist/technician 
capable of troubleshooting issues with the MedBike and associated devices for data collection. 
There will also always be a supervising physician with training in Pediatric Advanced Life 
Support (PALS), who will continuously monitor the subject’s vital signs and the subject’s overall 
clinical status.  A 5-10 minute questionnaire will be administered. The purpose of this short 
questionnaire is to learn a bit more about the participants experience using our video-game tele-
medicine exercise bike, the MedBike. 
Stage 1B will provide insights as to the feasibility and logistics regarding HIIT programs in the 
pediatric Fontan patients. This will provide critical information for the invesitgators as they 
transition to Stage 2.  
Stage 2 (HIIT exercise program): We will evaluate the safety and efficacy of an 8-week, 3 times per week 
supervised HIIT exercise program in patients with SV physiology.  
We aim to recruit 15 subjects with Fontan physiology for Stage 2. Fontan subjects who participated in 
Stage 1B will invited to continue to Stage 2. If they choose to continue with the HIIT exercise program, 
Visit 2 of Stage 1B will serve as their first session. Two MedBike exercise ergometers (one pediatric size 
and one adult size bike) will be housed in the University of Alberta Hospital Rehabilitation Unit with tele-
health links to a remote workstation in a separate room.  The patients will exercise in a room adjacent to 
the supervisor workstation with no direct visual or audio contact except for the video/audio feed. This is 
to help simulate the real-world applicability of having the MedBike at a remote location (such as the 
subject’s home). The HIIT program described above will be applied. The exercise physiologist will again 
have the ability to modify the program based on the perceived difficulty or ease of it, noting changes that 
were made. Again, a medical personnel with training in Pediatric Advanced Life Support certification will 
be present supervising the sessions.  
All eligible patients will undergo full cardio pulmonary exercise testing (CPET) and anthropometry 
assessment of lean muscle mass prior to exercise training and at the end of the training period. For 
subjects who participated in Stage 1 of the study, their Stage 1 CPET will serve as their initial study. We 
will document any adverse effects from the 240 training sessions during the study.  
Exercise sessions will be based on standardized guidelines for aerobic exercise (ACSM's guidelines for 
exercise testing and prescription 2013). Heart rate, blood pressure, oxygen saturation and rating of 
perceived exertion will be monitored during each session. 
Any adverse events such as profound desaturation (oxygen saturations fall of > 10% points for greater 
than 1 min, chest pain and ECG changes consistent with ischemia (ST depression or elevation in 2 
consecutive leads), reducing blood pressure during exercise >20mmHg, development of tachyarrhythmia 
(atrial or ventricular) and any bike injury, will result in immediate stoppage of exercise regimen and 
evaluation by the onsite medical personal, if necessary pediatric cardiology consultation.  
The impact of the exercise program on patient and parental perceptions of the patient’s physical capacity 
will be evaluated using qualitative methods, as well as health related quality of life questionnaires. Patient 
and parents will be interviewed prior to, and at the end of, the exercise training as to their perceptions of 
the influence of physical activity in the presence of complex CHD. 
Primary outcome: Exercise capacity assessed as the change in max VO2 pre- vs. post- completion of the 
HIIT exercise program. Hypothesis- we will observe an increased in VO2 max of 15%.  

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 6 of 8 
Secondary outcomes: a)Patient and parental perception of a CHD patient’s safety and limitations while 
performing physical activity through a successful physical rehabilitation program; b) adverse events 
(safety profile of exercise program). 
Inclusion Criteria: 
Stage 1A – Retrospective calibration records, prospectively recruited healthy adults 18+  
Stage 1B: SV patients with Fontan circulation age 10 - 18 years. 
Stage 2 - SV patients with Fontan circulation age 10 - 18 
Exclusion Criteria: Patients with cardiac arrhythmias, persistent low resting oxygen saturation of < 85%, 
severe ventricular dysfunction on the most recent clinical echocardiogram, patients with reports of chest 
pain on exertion, and those in whom their cardiologist has restricted their exercise for any reason. 
Statistical Plan  
Sample Size  
Stage 1A:  
Two retrospective samples will be included. Ten healthy adults will be recruited prospectively.  
Stage 1B:  
10 patients with Fontan physiology. 
Stage 2:  
To detect a clinically relevant change of 15% in max VO2 with power of 0.8, alpha of 0.05 and effect size 
of 1.08 with the an anticipated mean peak VO2 28.2 ml/kg/min +/- 6.1, the calculated sample size is 
9.  We will recruit 15 Fontan patients in anticipation of up to 30% failure to complete study exercise 
regimen. 
Statistical Methods:  
All data will be reported as median with ranges. Comparison between pre and post exercise training data 
will be tested using paired Wilcoxon signed rank sum. Significance is present when p<0.05. 
The Research Team: 
 
This research will be lead by Dr. Khoo, who is a proven investigator with 25 peer- reviewed publications 
in the last 5 years.  The co-investigators include Dr. Conway, a heart failure specialist and Dr. Mackie, the 
team lead of the Division's Single Ventricle Outcomes Team that is supported by a WCHRI- funded 
fulltime research coordinator. This team is also supported by the Department of Pediatrics and AHS, with 
3 funded Clinical Research Fellows attached to the Division.  Our collaborators Prof. Boulanger, Dr. 
Stickland and Dr. Rempel are recognized experts in their respective fields of computing science, exercise 
physiology and qualitative research of family outcomes related to SV, all with extensive success in their 
research endeavor.  
     
Anticipated Outcomes and Impact: 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 7 of 8 
 
We anticipate improved patient CPET performance and a potential increase in measured total lean muscle 
mass after completing the exercise regimen. We do not anticipate any significant adverse effect from 
participation in the training sessions thus confirming its safety profile. As we have already performed 
prototype testing of the custom remote ergometer bike during design and assembly, we do not anticipate 
any major equipment performance issue or failure. The qualitative research findings will help explain our 
quantitative findings as we will elicit detailed descriptions of experiences, attitudes, and emotions related 
to physical activity in children and adolescents with life-limiting/complex CHD. We expect improved 
health-related quality of life scores in both patient and parental report post exercise training.  The impact 
of a successful exercise training program in pediatrics has immediate benefits in promoting physical 
activities in children with SV which is currently reduced and likely to continue to decline with increasing 
age.  Exercise training promotes self-confidence and perceived improvement in quality of life. It has the 
potential to promote a lifetime habit of regular physical activities that is likely to positively impact on a 
child’s long-term cardiovascular and mental health.  
 
Future direction and Knowledge Translation: 
 
We will disseminate our findings through national and international presentations and publications in peer 
reviewed scientific journals.  We will use our findings to support and guide the formation of a Pediatric 
Cardiac Exercise Rehabilitation Program in Alberta through establishing a guiding committee to engage 
stakeholders in the Western Canadian Children’s Heart Network, nurses, cardiologists, general 
pediatricians, and organizations such as the Canadian Pediatric Cardiology Association, the Canadian 
Pediatric Society, and the Canadian Nurses Association, health care administrators and program and 
policy development personnel at the local and provincial levels. At a local level, we will use the results of 
the study to lobby charitable foundations, Alberta Health Services, other local funding agencies and 
government to support the establishment of an Edmonton Pediatric Cardiac Exercise Rehabilitation 
Program for immediate implementation.  We will link with The Children’s Heart Society to disseminate 
our results through their social media outlets and newsletter. In addition to the immediate clinical impact 
for patients with SV, the findings from the study will spawn subsequent research initiatives for promotion 
and improvement of physical fitness in other pediatric congenital heart lesions and non-cardiac pediatric 
conditions with an increased life-time burden of cardiovascular risk such as patients with diabetes, obesity 
and other chronic disease. 
 
 
 

PI: Nee S. Khoo, MD 
CONFIDENTIAL 
This material is the property of individual.  No part of it may be transmitted, reproduced, published, or used by other persons without written 
authorization. 
Version No & Date: 7 | Feb 24, 2017  
 
Page 8 of 8 
References: 
 
1) Atallah J, Dinu IA, Joffe AR, Robertson CM, Sauve RS, Dyck JD, Ross DB, Rebeyka IM, Western 
Canadian Complex Pediatric Therapies Follow-Up group. Two-Year survival and mental and 
psychomotor outcomes after the Norwood procedure: an analysis of the modified Blalock-Taussig 
shunt and right ventricular-to-pulmonary artery shunt surgical eras. Circulation 2008; 118:1410-8   
2) Möller P, Weitz M, Jensen KO, Dubowy KO, Furck AK, Scheewe J, Kramer HH, Uebing A. 
Exercise capacity of a contemporary cohort of children with hypoplastic left heart syndrome after 
staged palliation. Eur J Cardio-thoracic Surg 2009; 36: 980-985 
3) Giardini A, Hager A, Pace Napoleone C, Pichhio FM, Natural history of exercise capacity after 
Fontan operation: a longitudinal study. Ann Thorac Surg 2008; 85: 818-821 
4) Jenkins PC, Chinnock RE, Jenkins KJ, Mahle WT, Mulla N, Sharkey AM, Flanagan MF 
Decreased exercise performance with age in children with hypoplastic left heart syndrome. J 
Pediatr. 2008 Apr; 152: 507-12. 
5) Goldberg DJ, Avitabile CM, McBride MG, Paridon SM. Exercise capacity in the Fontan circulation. 
Cardiol Young. 2013 Dec;23(6):824-30 
6) Cordina RL, O'Meagher S, Karmali A, Rae CL, Liess C, Kemp GJ, Puranik R, Singh N, Celermajer 
DS. Resistance training improves cardiac output, exercise capacity and tolerance to positive airway 
pressure in Fontan physiology. Int J Cardiol. 2013 Sep 30;168(2):780-8 
7) Duppen N, Takken T, Hopman MTE, ten Harkel ADJ, Dulfer K, Utens EMWJ, Helbing WA. 
Systematic review of the effects pf physical exercise training programmes in children and young 
adults with congenital heart disease. Int J Cardiol 2013; 168:1779-1787 
8) Idorn L, Jensen AS, Juul K, Overgaard D, Nielsen NP, Sorensen K, Reimers JI, Sondergaard L. 
Quality of life and cognitive function in Fontan patients, a population-based study. Int J Cardiol 2013; 
168: 3230-5 
9) Dulfer K, Duppen N, Kuipers IM, Schokking M, van Domburg RT, Verhulst FC, Helbing WA, Utens 
EM. Aerobic exercise influences quality of life of children and youngsters with 
congenital heart disease: a randomized controlled trial. J Adolesc Health. 2014;55(1):65-72 
10) Bar-Mor, G., Bar-Tal, Y., Krulik, T., & Zeevi, B. (2000). Self- efficacy and physical activity in 
adolescents with trivial, mild, or moderate congenital cardiac malformations. Cardiol Young 2000; 
10: 561-566 
11) Rebrouck Y, Mertens L. Physical performance and physical activity in grown-up congenital heart 
disease. Eur J Cardiovasc Prev Rehabil 2005; 12: 498-502 
12) Moola F, Fusco C, Kirsh JA. The perceptions of caregivers towards physical activity and health in 
youth with congenital heart disease. Qual Health Res 2011;21:278 
13) Ong L, Nolan RP, Irvine J, Kovacs AH. Parental overprotection and heart-focused anxiety in adults 
with congenital heart disease. Int J Behav Med 2011;18:260-267  
14) Kraal JJ, Peek N, Marle MEvdA, Kemps HMC. Effects and cost of homebase training with 
telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: The 
FIT@Home study. BMC Cardiovacular Disorders 2013; 13: 82 
15) Hebert A, Mikkelsen UR, Thilen U, Idorn L, Jensen AS, Nagy E, Hanseus K, Sorensen KE, 
Sondergaard L. Bosentan improves exercise capacity in adolescents and adults after Fontan 
Operation: the TEMPO (Treatment with Endotheline Receptor Antagonist in Fontan Patients, a 
Randomized, Placebo-Controlled, Double Blind Study measuring Peak Oxygen Consumption) study. 
Circulation 2014; 130(23): 2021-2030 
 
ii  
                                               

 
 
 
 
           
 
 
Stage 1B and Stage 2 Adult  
Consent Version: 30 Aug 2018 
Page 1 of 4 
ADULT CONSENT FORM 
 
Title of Study:  Physical Activity Promotion in Children and Adolescents with Single Ventricle Physiology 
 
Principal Investigator:  
 
Dr. Nee Khoo, 780-407-3355 
 
Research/Study Coordinator:  
Rae Foshaug, 780-407-7499 
 
 
 
 
 
 
Why am I being asked to take part in this research study?  
 
You and your child are being asked to participate in this research study because we would like to learn more 
about a group of heart conditions called single ventricle physiology (SV). We will be asking children with SV to 
participate. We will be including about 35 patients in this study.  
 
Before you make a decision one of the researchers will go over this form with you. You are encouraged to ask 
questions if you feel anything needs to be made clearer. You will be given a copy of this form for your records.   
 
What is the reason for doing the study? 
  
We found that children with SV have lower exercise ability. But the way children and their parents feel about 
exercise might be a better predictor of the child’s exercise ability rather than their physical limitations.   
 
We have developed a graduated exercise program for children with SV. The purpose of this study is to test this 
exercise program and measure the feelings of the child and their parent toward exercise before and after this 
exercise program.  
 
What will I be asked to do?   
 
If you join this study you and your child will be asked to: 
 
Your child has already participated in Stage 1B of the study which involved determining patient tolerance to 
varying exercise intensities and workloads. We are now inviting your child to participate in Stage 2. Stage 2 
involves completing the graduated exercise program.  
 
Stage 2:  
 
Your child will complete a standard test for heart and lung function called a CPET while exercising on a bike 
once before they participate in the graduated exercise program and once after they complete the program. 
Each visit will take 1 hour to complete. 
 
Only children with SV heart conditions will participate in a graduated exercise program on the MedBike. The 
MedBike is equipped with telehealth links to a remote and portable workstation in the University of Alberta 
Hospital. The MedBike will be installed in your home before your child begins the graduated exercise program. 
Members of the MedBike team at the University of Alberta will be responsible for installation, set-up, and 
training with regards to participant use of the MedBike. Installation, set-up, and training will occur at a time that 
is most convenient for you. 
 
Your child will complete the graduated exercise program in the convenience of their home with tele-health link 
that includes a live video and audio feed to the supervisor workstation at the University of Alberta. Each 
If you are the patient, please note that where it states ‘child’ it is referring to you rather than your 
parent/guardian or legal representative. 

 
 
 
 
           
 
 
Stage 1B and Stage 2 Adult  
Consent Version: 30 Aug 2018 
Page 2 of 4 
session will take 1 hour and your child will complete 3 sessions each week for 8 weeks. We ask that you be 
available to supervise your child while they are exercising on the MedBike. 
You and your child will complete a quality of life questionnaire before and after the 8 week exercise program. 
This will take about 20 minutes to complete. 
 
You and child will participate in an interview before and after the 8 week exercise program. These interviews 
will be voice recorded. This will take about 30 minutes of your time. 
  
Give us permission to review your child’s cardiology records for information about his/her heart. This includes 
the name of your child’s heart condition, cardiac operations or procedures, cardiac medications, cardiology 
clinic notes, and inpatient notes for cardiac problems. We will NOT review medical records that are not related 
to your child’s heart condition. All information will be kept strictly confidential. 
 
What are the risks and discomforts? 
 
The risks and discomforts for this study are minimal. Your child may feel tired from the exercise. Each exercise 
session will be supervised remotely by a member of the MedBike team, and exercise physiologist, and by 
medical personnel capable of reading ECG data to minimize the risk or injury. If you or your family has any 
concerns during this study, please feel free to contact the principal investigator, Dr. Nee Khoo, or the study 
coordinator, Rae Foshaug. 
 
It is not possible to know all of the risks that may happen in a study, but the researchers have taken all 
reasonable safeguards to minimize any known risks to a study participant. If we find out anything new during 
the course of this research which may change your willingness to be in the study, we will tell you about these 
findings. 
 
What are the benefits to me?   
 
There are no direct benefits to you or your child from participating in this research study. However, your child’s 
exercise capacity may improve. Also, you and your child’s feelings towards exercise may improve. However, 
you may not get any benefit from being in this research study. 
 
Do I have to take part in the study?   
 
Being in this study is your choice. If you decide to be in the study, you can change your mind and stop being in 
the study at any time, and it will in no way affect the care or treatment that you are entitled to. If you decide to 
quit before the study is over, we will keep the data collected about you and your child up until that time unless 
you ask us not to, but we will not collect any further data. 
 
Will I be paid to be in the research?   
 
You will be provided with parking passes in order to attend both CPET testing sessions. Your child will receive 
a $25 gift card of his/her choice to Walmart, Chapters Indigo, or iTunes at the end of Stage 2 to acknowledge 
the time and commitment to participating in the exercise sessions. 
 
Will my information be kept private?   
 
During the study we will be collecting data about you and your child. We will do everything we can to make 
sure that this data is kept private. No data relating to this study that includes you or your child’s name will be 
released outside of the researcher’s office or published by the researchers. Sometimes, by law, we may have 
to release your information with your name so we cannot guarantee absolute privacy. However, we will make 
every legal effort to make sure that your information is kept private 

 
 
 
 
           
 
 
Stage 1B and Stage 2 Adult  
Consent Version: 30 Aug 2018 
Page 3 of 4 
The investigator or their study staff may need to look at your child’s personal health records or at those kept by 
other health care providers that you may have seen in the past (i.e., your cardiologist). Any personal health 
information that we get from these records will be only what is needed for the study.  
 
During research studies it is important that the data we get is accurate. For this reason your child’s health data, 
including your name, may be looked at by people from: 
 
the University of Alberta, HREB, and Health Canada. 
 
By signing this Consent Form you are saying it is okay for the study team to collect, use and disclose 
information about your child from your personal health records as described above. 
 
After the study is done, we will still need to securely store your child’s health data that was collected as part of 
the study. At the University of Alberta, we keep data stored for a minimum of 5 years after the end of the study.   
 
If you leave the study, we will not collect new health information about you, but we will need to keep the data 
that we have collected if it is already included in our analysis of the results of the study. 
 
What if I have questions? 
 
If you have any questions about the research now or later, please contact Dr. Nee Khoo at 780-407-3355 or 
the study coordinator at 780-407-7499.  
 
If you have any questions regarding your rights as a research participant, you may contact the Health 
Research Ethics Board at 780-492-2615. This office has no affiliation with the study investigators. 
 
 

 
 
 
 
           
 
 
Stage 1B and Stage 2 Adult  
Consent Version: 30 Aug 2018 
Page 4 of 4 
ADULT CONSENT 
 
Title of Study: Physical activity promotion in children and adolescents with single ventricle 
physiology 
 
Principal Investigator(s):  
Dr. Nee Khoo 
Phone Number(s): 780-407-3355 
Study Coordinator:  
Rae Foshaug 
Phone Number(s): 780-407-7499 
 
1. Do you understand that your child has been asked to be in a research study?  
□ Yes   □ No 
 
 
2. Have you read and received a copy of the attached Information Sheet?  
 
□ Yes   □ No 
 
3. Do you understand the benefits and risks involved in your child  taking part in this      □ Yes   □ No 
     research study?  
 
4. Have you had an opportunity to ask questions and discuss this study?  
 
□ Yes   □ No 
 
 
5. Do you understand that you and/or your child are free to leave the study at any time, □ Yes   □ No 
without having to give a reason and without affecting your future medical care? 
 
 
 
 
6. Has the issue of confidentiality been explained to you? 
 
 
 
 
□ Yes   □ No 
 
7. Do you understand who will have access to your child’s study records, (including  
□ Yes   □ No 
     personally identifiable health information? 
 
 
Stage 2: 
8. I agree for my child ______________________________to take part in this study. □ Yes  □ No 
9. Do you understand that YOU have been asked to be in a research study? 
 
□ Yes  □ No 
 
10. I ______________________________agree to take part in this study.  
 
□ Yes  □ No 
 
 
 
 
__________________________________ 
____________________________ 
________________________ 
Signature  
 
 
 
 
Printed Name 
 
 
Date 
 
I believe that the person signing this form understands what is involved in the study and voluntarily 
agrees to participate.  
 
__________________________________ 
____________________________ 
________________________ 
Signature of Designee 
 
 
Printed Name of Designee  
Date 
 
THE INFORMATION SHEET MUST BE ATTACHED TO THIS CONSENT FORM AND A COPY 
GIVEN TO THE RESEARCH PARTICIPANT 

 
 
 
 
 
 
           
 
 
Stage 1B and Stage 2 Child Assent  
 
Version Date: 30 Aug 2018 
 
Page 1 of 2 
 
CHILD ASSENT FORM 
 
Physical Activity Promotion in Children and Adolescents with Single Ventricle 
Physiology 
 
Principal Investigator: 
Dr. Nee Khoo, 780-407-1103 
Research Coordinator: 
Rae Foshaug, 780-407-7499 
  
You and your parent(s) are being asked to take part in a research study because we 
would like your help to understand a heart condition. We are asking children with this 
heart condition to be part of this study.  
 
The treatment for this heart condition has gotten a lot better. But children with this heart 
condition still have a lower ability to exercise. Also, the feelings of children and their 
parents about exercise needs to be better.  
 
We have created an exercise program for children with this heart condition. We want to 
learn if this program can help children’s ability to exercise. Also we want to understand 
the feelings of children and parents about exercise before and after the program.  
 
What will you have to do?  If you and your parent(s) agree then you will do the following: 
 
You will come to the hospital for several visits.  
 
Stage 1: 
- 
You’ve already completed this stage of the study.  
 
Stage 2:  
- 
Only children with the heart condition will be asked to do stage 2. 
- 
You’ll visit the hospital twice so we can test your heart and lungs before and 
after you do the exercise program. 
- 
In your home, you will exercise 3 times a week for one hour. This will happen 
for a total of 8 weeks.  
- 
You and your parent will answer a questionnaire. This will take about 20 
minutes to finish. 
- 
You and your parent will be asked questions before and after the exercise 
program. We will take voice recordings of this visit. This will take about 30 
minutes to finish. 
- 
We will look at your chart for information about your heart. 
 
Will it hurt?  Some kids might feel tired from exercise but we will be there the whole time 
to make sure you are exercising safely to lower the risk of getting hurt. If you or your 
parents have any concerns you can contact Dr. Khoo at 780-407-1103 or Rae Foshaug 
at 780-407-7499. 
 
Will it help? There is no direct benefit to you but you might get better at exercising and it 
may make you and your parents feel better about your exercise ability. Also, your help in 
this study might teach doctors, nurses and other children with your heart condition. 
 
 

 
 
 
 
 
 
           
 
 
Stage 1B and Stage 2 Child Assent  
 
Version Date: 30 Aug 2018 
 
Page 2 of 2 
 
What will you get for being in the study? 
If you decide to be in this study, we would like to thank you for your time with a $25 gift 
card of your choice to Walmart, Chapters Indigo, or iTunes at the end of Stage 2. Even if 
you choose to withdraw before the study is finished, you will still get a portion of this gift 
card.  
 
Can you quit? You are allowed to say no if you don’t want to take part in this study. If you 
say yes and then change your mind later, you can quit. No one will be frustrated with you 
if you decide you don’t want to do this, or if you decide to stop part way through. You 
should tell your mom or dad, or the doctor or nurse that you want to quit. 
 
Who will know? No one except your parents and the doctor will know you’re taking part 
in the study unless you want to tell them. Your name and your chart won’t be seen by 
anyone except the doctors and study staff during the study. 
 
Your signature: We would like you to sign this form to show that you agree to take part. 
Your mom or dad will be asked to sign another form agreeing for you to take part in the 
study.  
 
Do you have more questions? You can ask your mom or dad about anything you don’t 
understand. You can also talk to Dr. Khoo. His phone number is 780-407-1103. Or you 
can talk to Rae Foshaug. Her phone number is 780-407-7499. 
 
I agree to take part in this study.  
 
 
 
________________________________________          ________________________ 
<signature of research participant>  
<date and time> 
 
________________________________________           ________________________ 
<signature of investigator/designee>   
<date and time>