Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR): A Randomized Controlled Trial Using the activPAL3™ and activPAL3™ VT to Quantify Free-living Movement Patterns and Reducing Sedentary Time in Cardiac Rehabilitation Patients
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Ottawa Heart Institute Research Corporation

Measuring and reducing sedentary time in cardiac rehabilitation: The SIT-CR Study    Version 3 – July 25, 2016 
 
 
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Research Protocol 
 
Study title: Sedentary Intervention Trial in Cardiac Rehabilitation (SIT-CR): A randomized controlled 
trial using the activPAL3™ and activPAL3™ VT to quantify free-living movement patterns and 
reducing sedentary time in cardiac rehabilitation patients 
 
Principal Investigator:  
Dr. Bob Reid 
Deputy Chief, Division of Prevention and Rehabilitation 
University of Ottawa Heart Institute  
40 Ruskin Street 
Ottawa, ON, K1Y 4W7 
Canada 
 
Co-Investigators: 
Dr. Stephanie Prince Ware 
Post-Doctoral Fellow, Division of Prevention and Rehabilitation  
University of Ottawa Heart Institute  
 
Dr. Jennifer Reed 
Associate Scientist, Division of Prevention and Rehabilitation  
University of Ottawa Heart Institute  
 
Collaborators: 
Dr. Lisa Cotie 
Post-Doctoral Fellow, Division of Prevention and Rehabilitation  
University of Ottawa Heart Institute  
 
Dr. Andrew Pipe (Medical director of study) 
Chief, Division of Prevention and Rehabilitation 
University of Ottawa Heart Institute  
 
Staff: 
Evyanne Wooding 
Research Manager, Division of Prevention and Rehabilitation 
University of Ottawa Heart Institute  
 
 
VERSION 3 – JULY 25, 2016 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
BMI 
 
 
Body mass index 
C 
 
 
Control group 
CABG  
 
Coronary artery bypass graft (bypass surgery) 
CAD  
 
Coronary artery disease 
CI 
 
 
Confidence interval 
CR 
 
 
Cardiac rehabilitation 
I 
 
 
Intervention group 
MVPA  
 
Moderate-to-vigorous intensity physical activity 
PA 
 
 
Physical activity 
PCI 
 
 
Percutaneous coronary intervention 
RCT 
 
 
Randomized controlled trial 
SD 
 
 
Standard deviation 
SIT-CR 
 
Sedentary Intervention Trial in Cardiac Rehabilitation 
UOHI  
 
University of Ottawa Heart Institute 
VTAP  
 
activPAL3™ VT 
 
 
 
 
 
 
 
 
 

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1.  
INTRODUCTION 
Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of total and 
cardiovascular-related mortality and morbidity [1, 2].  Cardiac rehabilitation is often prescribed for 
those who have experienced a cardiac event and follows Canadian guidelines to achieve a minimum of  
30 minutes of moderate-to-vigorous intensity physical activity (MVPA) on at least five days per week 
[3].  Although current CR guidelines focus on MVPA, sedentary behaviours have gained recent 
attention as strong and modifiable risk factors for heart disease.  Specifically, they have an effect on 
cardio-metabolic functioning and are strongly associated with several markers of cardio-metabolic risk 
[4].  Recent data from the University of Ottawa Heart Institute (UOHI) shows that CR graduates spend 
the majority of their wakeful time sedentary and this time is negatively associated with body mass 
index (BMI) and measured cardiorespiratory fitness [5].   
 
UOHI offers a supervised on-site 8-week CR program.  The program consists of twice-weekly sessions 
(1 hour each) with a focus on aerobic and resistance exercise.  There is currently no intervention 
component or outcome measure focusing on sedentary behaviours.  This is unfavorable given the 
knowledge of the impact of sedentary behaviours on cardio-metabolic health.  It is important to assess 
sedentary behaviours in this population to assess whether current programming affects sedentary 
behaviours or if more is needed to target these behaviours.  This is important to note given that physical 
activity (PA)-focused interventions do not generally result in clinically meaningful reductions in 
sedentary behaviours [6].   Therefore, it is important to also investigate the feasibility of adding 
sedentary behaviour interventions to CR programming and whether these interventions can 
consequently further improve cardio-metabolic health.  Using cues and prompting from wearable 
technology may provide a feasible way to reduce sedentary behaviours.  A recent systematic review 
noted that interventions using education and prompts/cues were promising for reducing sedentary 
behaviours [7].  To date, most research using direct measures of PA and sedentary time have used 
research-grade accelerometers (e.g. ActiGraph®, Actical®, etc.).  Research has shown that these 
monitors are not as valid for measuring sedentary time and postural changes as the activPAL3™ 
monitor which is more precise and sensitive to changes in sedentary time [8]. 
 
The activPAL3™ monitors have the capability to discern between standing and sitting which can 
increase our knowledge of movement patterns among CR participants.  Additionally, the development 
of the activPAL3™ VT (VTAP) with vibrotactile feedback (VT), offers direct feedback to the wearer 
regarding time spent being sedentary.  The prompts provided by these monitors have the capacity to 
reduce sedentary time and increase breaks from prolonged sitting by promoting individual awareness 
around movement patterns.  
 
 
2.0  
PURPOSE 
 
This research is timely given recent interest in the role of sedentary behaviours in both the primary and 
secondary prevention of cardiovascular disease.  Sedentary behaviours have been shown to be high in 
patients with cardiovascular disease [5] and it is not yet known if current CR programming results in 
significant reductions of these behaviours, or whether a targeted component is warranted.  It is also 
unclear if self-reported sedentary time measures can provide valid and reliable information for 
monitoring these behaviours in a CR setting, or whether more objective measures such as the 
activPAL3™ are needed.  This study has multiple purposes:  

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1. To inform the development of a larger randomize controlled trial; 
2. to assess the feasibility and usability of the activPAL3™ devices for measuring sedentary 
time in a CR setting and identify how it compares to self-report methods.  
3. to describe changes in sedentary time that occur over standard CR with the use of prompting 
cues from the VTAP; and  
4. to assess whether the addition of prompting cues can result in further decreases in sedentary 
behaviour and improvements in clinical outcomes, health-related quality of life (HRQoL), 
symptoms of anxiety and depression, self-efficacy, aortic stiffness, and aerobic capacity.   
 
Results from this study will inform current gaps in the literature and help to generate recommendations 
for whether targeting sedentary behaviours in the CR setting is warranted.   
 
 
3.0  
KEY TERMS AND DEFINITIONS 
 
3.1 
Sedentary time  
 
Sedentary time refers to the amount of time spent engaged in sedentary behaviours. Sedentary 
behaviour refers to an energy expenditure of 1.5 metabolic equivalents (METS; measure of energy 
expenditure) or less while in a sitting or reclining posture during waking hours and not simply the 
absence of PA [4]. This study will collect both self-reported and objectively measured sedentary time. 
 
3.2 
Physical activity (PA) 
PA refers to “any bodily movement produced by the skeletal muscle that results in energy expenditure” 
[9].  This study will employ the use of both self-reported and objectively measured PA, specifically of 
moderate-to-vigorous intensity (MVPA). 
 
 
4.0 
OBJECTIVES 
 
4.1 
Primary objective 
 
The primary objective of this study is to evaluate the feasibility and usability of the VTAP to reduce 
sedentary time and the activPAL3™ monitors to quantify changes in free-living time spent sitting, 
standing and lying in CR patients in the UOHI on-site cardiac rehabilitation program (SIT-CR Study).    
 
4.2 
Secondary objectives 
 
Secondary objectives include: 
1. quantifying sedentary time (including time spent sitting, standing and lying) in CR patients 
(control arm); 
2. assessing the possible effect of an on-site CR program on reducing time spent being sedentary 
(control arm); 
3. evaluating whether the addition of sedentary prompts (Intervention group [I]) leads to further 
reductions in sedentary time, beyond those achieved through regular CR (Control group [C]); 

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4. validating a CR-specific PA and sedentary time log; and 
5. evaluating the impact of the Intervention on: clinical outcomes (e.g., blood pressure, resting 
heart rate, blood lipids, blood sugar, body weight, body mass index [BMI], waist 
circumference, aortic stiffness); health-related quality of life [HRQoL]; self-efficacy; 
symptoms of anxiety and depression); MVPA; and maximal aerobic power (VO2max). 
4.3 
Hypotheses 
 
In adults with a diagnosis of coronary artery disease (CAD) (including heart attack, angina (chest pain), 
stent, percutaneous coronary intervention (PCI), and/or bypass surgery (CABG), providing sedentary 
prompts using a thigh-worn activity monitor (VTAP) will be superior to standard 8-week on-site CR 
programming in:  
 
1. decreasing sedentary time;  
2. increasing breaks from sedentary time;  
3. increasing MVPA; 
4. improving clinical outcomes (e.g. blood pressure, resting heart rate, blood lipids, HbA1c, body 
weight, BMI, waist circumference) 
5. improving HRQoL, self-efficacy, symptoms of anxiety and depression;  
6. improving measures of aortic stiffness; and  
7. increasing maximal aerobic power (VO2max). 
 
 
5.0 
METHODS 
 
5.1 
Study design 
 
This is a single-centre, two-armed randomized controlled trial (RCT) to evaluate the feasibility and 
usability of the activPAL3™ in measuring sedentary time and the VTAP in providing sedentary 
prompts to reduce sedentary time in a CR setting (SIT-CR Study).  The RCT (see Figure 1 for study 
flow) will randomly allocate 32 individuals (16 males and 16 females) in a 1:1 ratio entering the CR 
program to either the Control Group (CR program) or to the Intervention Group (CR program + 
sedentary prompts from VTAP).   
 
A week prior to their first class, participants will be asked to come to the UOHI to complete informed 
consent, a short questionnaire to assess employment patterns, self-efficacy to reduce sedentary 
behaviour and increase light and moderate PA, and HRQoL (see SIT-CR Study Baseline and Follow-
up Questionnaires).  Participants will also have their aortic stiffness, blood pressure and resting heart 
rate measured.  In order to test for aortic stiffness participants will be asked to fast if possible, the study 
will provide a package of nuts and a glass of water at this first meeting.  After the measurements, 
participants will then be asked to wear an activPAL3™ during waking time for 7 days to collect 
baseline measures of sedentary time over one week prior to their first CR class.   
 
On the day of their first CR class, participants will be asked to come in 30 minutes early to complete a 
Modified Bruce Ramp Treadmill Test to estimate maximal aerobic power.  Once the test is complete, 
participants will be randomized in a 1:1 ratio (stratified by sex) to the Intervention or Control Groups.  
At this visit, participants in the Intervention Group will receive a wear time log sheet and a VTAP 

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monitor that will provide sedentary prompts to break up prolonged periods of sedentary time (prompts 
after 30 minutes of sedentary time).  Participants in the Intervention Group receive a full-charged 
VTAP monitor each week when they attend their on-site CR class. Participants in the Control Group 
will continue with their regular CR class schedule. 
 
Follow-up sedentary time measures will be taken at the end of CR (during Week 8 of CR/Week 9 of 
the RCT), participants will be asked to once again wear an activPAL3™ during waking time for 7 
days.  Participants will be asked once again to complete a short questionnaire to assess employment 
patterns, self-efficacy to reduce sedentary behaviour and increase light and moderate PA, and HRQoL 
(see SIT-CR Study Follow-up Questionnaires).  They will also have their arterial stiffness, blood 
pressure and resting heart rate measured and will once again be asked to complete a Modified Bruce 
Ramp Treadmill Test during this last week.   
 
As part of the regular CR program standard of care, clinical measures will be taken (e.g. blood lipids, 
HbA1c, body weight, BMI, waist circumference) and depression and anxiety will be self-reported (see 
CR Questionnaire) at both baseline and follow-up. 
 
The 8 week intervention time period was chosen to align with current CR programming to allow for 
comparisons between the intervention and standard CR programming (control group).  As sedentary 
behaviour intervention research is currently in its infancy, it is unknown how long an intervention is 
required; therefore, this investigation will provide pilot-level information to inform whether 7 weeks of 
intervention is adequate and whether it is feasible to add to the pre-existing CR programming.  
Previous studies have shown significant reductions in sedentary time following 4 to 24 weeks of 
intervention [10-14].  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1. Study schema 
 
 
5.2 
Study setting 
 
This trial will be conducted at the UOHI in the Minto Prevention and Rehabilitation Centre.  
Specifically, all intake sessions and appointments with participants will be on the Cardiac 
Rehabilitation Track on the 2nd floor of the UOHI. 
   
5.3 
Study population 
 
A total of 32 participants will be included in this study.  The study population will be drawn from 
patients currently enrolled in on-site CR at the UOHI.  The sample size calculation is provided in 
Section 5.6.1.  Eligibility criteria are outlined below. 
Patients entering UOHI 
on-site cardiac 
rehabilitation program 
N = 32 
Patients consenting to 
SIT-CR RCT 
N = 16 
Intervention Group (I) 
 
(CR + prompts) 
N = 16 
Control Group (C)  
 
(CR only) 
Eligibility criteria: 
• 
CR patient 
• 
Willing to provide written 
informed consent 
• 
Willing and able to wear 
activPAL for 9 weeks 
• 
Willing to perform sub-max 
exercise test 
Baseline Week – all wear activPAL3™ micro, blood work, questionnaire, aortic stiffness with 
a sub-maximal exercise test prior to first class (C, I) 
Study end (Week 8) – all wear activPAL3™ micro (C, I) 
Weeks 1-7 – I group wears 
VTAP + CR classes 
Weeks 1-7 – C group attends 
regular CR classes 

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5.3.1 Inclusion and exclusion criteria 
 
Inclusion criteria include:  
 
1. Patient is attending on-site (2 x weekly for 8 weeks) CR at the Minto Prevention and Rehabilitation 
Centre at the UOHI;  
2. Patient is ≥18 years;  
3. Patient has confirmed diagnosis of coronary artery disease (CAD);  
4. Patient understands English or French; 
5. Patient is willing and able to provide informed consent.  
 
 
Exclusion criteria include: 
 
1. Patient is unwilling to wear activity monitors; 
2. Patient is already using a commercial activity monitor with sedentary prompts (e.g., Jump Up, 
Garmin); 
3. Patient is unable to attend follow-up visits;  
4. Patient is not participating in a CR program at the UOHI; 
5. Patient has cognitive impairment (unable to comprehend or participate in the intervention); 
6. Patient has a history of postural hypotension; 
7. Patient is unable, in the opinion of the Medical Director, to participate in the study. 
 
5.4 
Data collection procedures 
 
If a patient expresses interest in participating in research to a heath care professional within their circle 
of care, this will be acknowledged as permission to contact the prospective participant, in order to 
provide them with study information and determine interest and eligibility. The PI and/or RC and/or 
study staff may also screen incoming cardiac rehabilitation patients using vOACIS for eligibility in the 
study. The PI and/or RC and/or study staff will only contact patients who have given permission to be 
contacted by research to provide them with information about the study and determine if they are 
interested in participating. Interested individuals will be contacted by the PI and/or RC and/or study 
staff who will prescreen patients for eligibility and arrange a visit to confirm eligibility and obtain 
written, informed consent.   
 
Each participant will be asked to complete the following study-related visits: 1) baseline (1 week prior 
to first CR class), 2) exercise test prior to the first class of CR, 3) 8 weeks of a UOHI CR on-site 
program, and 4) an 8-week follow-up with post measures.  The duration of participation will be 9 
weeks.  Each component of the study is described in more detail below.  
 
5.4.1 Baseline assessment 
 
Participants will be asked to meet with the research staff 1-week prior to their first CR session.  Prior to 
data collection, written informed consent will be obtained.  The research staff will then measure aortic 
stiffness, blood pressure and resting heart rate using a Mobil-O-Graph device.  Participants will be 
provided with a brief study questionnaire to assess self-efficacy to reduce sedentary behaviour and 
increase light and moderate PA and HRQoL (SF-36).  Participants will be provided with a parking pass 
for this visit. During the baseline phase, participants will also self-report demographics (e.g., age, sex, 

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income), exercise (using the modified Godin Leisure-Time Exercise Questionnaire [15]), as well as 
symptoms of anxiety and depression (Hospital Anxiety and Depression Scale [16]) as part of the CR 
intake questionnaire which is the usual standard of care.  In addition, the study staff will extract several 
cardiovascular risk factor measurements obtained by CR staff at the participant’s Intake Session, 
including: measured height (cm) and weight (kg) to compute BMI (kg/m2), waist circumference (cm), 
total cholesterol, high density lipoprotein (HDL), low density lipoprotein (HDL), triglycerides, and 
fasting HbA1c.  Participants will then be provided with an activPAL3™ activity monitor, to be worn 
for seven days on the right thigh under clothing (see product description of the activPAL3™ device).  
The activPAL3™ is worn directly on the skin using a hypoallergenic, hair-friendly adhesive sticker.  
Participants will also be provided with Hypafix tape to use if they feel more support is needed to secure 
the device. Participants will also complete a daily log (FITS log) over this period of time to assist with 
the verification of the data collected while the monitor was worn and for validation of self-reported 
sedentary time.  The research assistant will demonstrate how to properly wear the monitors and answer 
any questions and the participants will be provided with written instructions (see SIT-CR Baseline 
Questionnaire).   
 
One week following the baseline measures, participants will be asked to meet approximately 30 
minutes before their first session begins to complete the sub-maximal exercise test (Modified Bruce 
Ramp Treadmill Test) to estimate maximal aerobic power (VO2max) [17].   
 
5.4.2 Intervention  
 
Following the baseline phase and the sub-maximal exercise test, participants will be randomized in a 
1:1 ratio to: 1) usual care (C), 2) usual care + sedentary prompts from the VTAP monitor (I) using a 
computer-generated, stratified by sex, random sequence.  Treatment assignments will be generated and 
placed in sealed, numbered envelopes to ensure concealment until baseline data is collected.     
 
Both groups will complete a combination of supervised and home-based exercise sessions over an 8-
week period (as per standard CR programming).  Supervised exercise sessions will take place at the 
Minto Prevention and Rehabilitation Centre at the UOHI.   
 
Intervention Group participants will also be provided with a VTAP monitor to wear directly on the skin 
of the front of their right thigh during waking hours for weeks 1 through 7.  The monitor will provide 
participants with real-time feedback on their sedentary behaviour.  The VTAP is the world’s first 
commercially available device for free-living sedentary behaviour modification.  The VTAP alerts 
wearers to the fact they have been sitting for a period of time and ought to move.  The alerts are 
delivered by way of gentle vibrotactile feedback (buzzing).  The monitors will be programmed to 
provide feedback once the wearer has been sedentary for 30 consecutive minutes.  The monitors will 
also be able to log the duration and intensity of the primary movements including: sedentary, upright 
and ambulatory activities of the intervention participants.  Due to the battery life of the monitors, each 
week participants will be provided with a newly charged VTAP and sticker applications at the first CR 
session of the week.  See the product information sheet for the activPAL3™ VTAP Specifications. 
 
5.4.3 Intervention assessments 
 
Participants in the Intervention Group will be asked to return their weekly wear time journals each 
week by dropping off into a study mail box on the Track in the Minto Prevention and Rehabilitation 

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Centre at the UOHI.  They will also exchange their VTAP for a newly charged device and be provided 
with a new wear time log. 
 
5.4.3 Follow-up assessments 
 
After 8 weeks of the study (end-of-intervention), participants will return to the UOHI for their last 
week of CR and all participants will once again be ask to wear an activPAL3™ to monitor movement 
patterns.  A research staff member who will be blinded to the participants' allocation will once again 
collect measures of aortic stiffness, blood pressure and resting heart rate and conduct a Modified Bruce 
Ramp Treadmill Test to estimate maximal aerobic power (VO2max). Participants will be provided with 
a parking pass for aortic stiffness measurement visit. 
 
Once again clinical measures (collected as part of standard of CR care) will be abstracted from the 
participant's chart (e.g. measured height (cm) and weight (kg) to compute BMI (kg/m2), waist 
circumference (cm), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (HDL), 
triglycerides, and fasting HbA1c) and participant responses from the CR questionnaire will also be 
abstracted (e.g. self-reported exercise, HADS).   
 
Participants in both groups will also be asked to complete a brief intervention satisfaction survey to 
assess satisfaction associated with wearing both the activPAL3™ and VTAP monitors (see Evaluation 
Surveys). 
 
Upon completion of the study, both groups will receive a fact sheet about sedentary behaviours 
including the hazards associated with sedentary time and 'Tips and Tricks' for reducing sedentary time 
(see Sedentary Fact Sheet).   
 
5.5 
Measures 
 
The primary objective of this study is to assess the feasibility and usability of the activPAL3™ and the 
VTAP in a CR setting to inform the development of a larger RCT.  This will be assessed by examining: 
 
• Recruitment rates; 
• acceptability of intervention and wearing the  activPAL3™ and the VTAP using an evaluation 
survey (see Evaluation Surveys); 
• completion and drop-out rates; and 
• intervention adherence using wear time logs.   
 
The primary outcome of the intervention focuses on changes in sedentary time measured by self-report 
and the activPAL3™ over the 8-week intervention period.   These outcomes will provide standard 
deviations to estimate an effect size for a future RCT.  Secondary outcome measures will include:  
 
• changes in MVPA (self-reported and objectively measured);  
• changes in clinical outcomes (e.g., body weight, BMI, waist circumference, blood pressure, 
total cholesterol, HDL, LDL, triglycerides, and fasting plasma glucose);  
• changes in measures of anxiety and depression (HADS);  
• changes in self-efficacy to reduce sedentary time and increase PA;  

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• changes in HRQoL (SF-36);  
• changes in aortic stiffness (PWV); and  
• changes in maximal aerobic power (Modified Bruce Ramp Treadmill Test).   
 
Measures and study time-line are provided in Table 1. 
 
5.5.1 Sedentary time  
 
The primary objective of this study is to evaluate the feasibility and usability of the activPAL3™ in 
collecting time spent sitting, standing and lying in an on-site CR program. From this, the primary 
outcome of the RCT will be changes in sedentary time as measured both by self-report (sitting time 
from the International Physical Activity Questionnaire [see SIT-CR Baseline and Follow-up 
Questionnaires], sitting time from a FITS log [see SIT-CR Baseline and Follow-up Questionnaires], a 
sitting time question from the CR intake questionnaire), and objectively measured by the activPAL3™ 
over 7-days.  See the provided PAL Technologies Ltd. End User Licence Agreement.  
 
5.5.2 Moderate-to-vigorous intensity physical activity (MVPA) 
 
MVPA will be measured by both self-report (using the modified Godin Leisure-Time Exercise 
Questionnaire [15] [see the CR Questionnaire] and FITS log [see the SIT-CR Baseline and Follow-up 
Questionnaires]) and objectively measured using the activPAL3™ over 7-days.  Minutes of MVPA per 
week will be summed and used to assess goals and meeting guidelines.  The device will also provide 
time spent in sedentary and light movement, as well as steps/day.   
 
5.5.3 Body composition 
 
Height (in cm), weight (in kg) and waist circumference (in cm) are measured as part of the regularly 
scheduled CR intake and final sessions by a nurse or physiotherapist using a standardized procedure.  
BMI will be computed from measured height and weight (kg/m2).  For the purpose of this study BMI 
will analyzed both continuously and using adult categories of underweight (<18.5 kg/m2), normal 
weight (18.50-24.99 kg/m2), overweight (25.0-29.99 kg/m2)  and obese (≥30.0 kg/m2) [18].  Waist 
circumference will be analyzed both continuously and using adult cut-offs of ≥ 102 cm (40 in.) for men  
and ≥88 cm (35 in.) for women at increased risk of diabetes, heart disease and high blood pressure [19]. 
 
5.5.4 Lipid profile 
 
Total cholesterol, HDL, LDL, and trigylcerides will be extracted from the participant's CR file.  These 
will be measured as part of CR evaluation practice at intake and upon completion. 
 
5.5.5 Fasting HbA1c  
 
Fasting HbA1c will also be extracted from the participant's CR file.  This is also measured as part of 
CR evaluation practice at intake and upon completion. 
 
5.5.6 Aortic stiffness 

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Aortic stiffness will be measured using the Mobil-O-Graph device (see Case Report Form).  This 
device uses an algorithm based on blood pressure measurement taken at the upper arm to estimate the 
participants’ aortic pulse wave velocity (PWV).  The Mobil-O-Graph is a valid and reliable tool to 
measure PWV in clinical populations.  Our lab has successfully used this device before in individuals 
with CVD.  Participants are asked to sit at rest for five minutes prior to the measurement being 
obtained.  A blood pressure cuff is placed on the individuals arm and four readings are taken.  The test 
should take 5 to 10 minutes to complete.  While measures are being taken the participant is asked to sit 
in a comfortable seated position, not to talk, to stay still and to keep their legs uncrossed.  The Mobil-
O-Graph will also supply resting heart rate and blood pressure values.  These are both secondary 
outcome measures.  Participants will be asked to follow the pretesting guidelines for PWV: 
 
o 
No eating or drinking within 4 hours of the test 
o 
No moderate or vigorous exercise within 12 hours of the test 
o 
Void urine completely within 30 minutes of the test 
o 
Abstain from alcohol consumption within 48 hours of the test 
o 
Do not ingest diuretics, including caffeine before the assessment unless they are prescribed by a 
physician  
o 
If you are in a stage of your menstrual cycle during which you perceive you are retaining water, 
postpone testing (female participants only) 
 
5.5.7  Blood pressure 
 
Resting blood pressure will be measured by the research coordinator or assistant using a. Blood 
pressure will be measured in a seated position after a five-minute rest period using a Mobil-O-Graph 
device (see aortic stiffness for further detail) that performs three measurements.  An average of three 
measurements will be used for statistical analyses (see Case Report Form).   
 
5.5.8 Resting heart rate 
 
Resting heart rate will be measured by the research coordinator or assistant using a. Blood pressure will 
be measured in a seated position after a five-minute rest period using a Mobil-O-Graph device (see 
aortic stiffness for further detail) that performs three measurements.  An average of the three 
measurements will be used for statistical analyses (see Case Report Form).  
 
5.5.9 Anxiety and depression 
 
Screening for anxiety and depression is carried out at baseline and follow-up CR visits using the 
Hospital Anxiety and Depression Scale (HADS) [16].  The HADS is a 14-item scale; seven of the items 
relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 with 
a final score between 0 and 21 for either anxiety or depression, with higher scores indicating greater 
anxiety and depression symptoms. See the CR intake questionnaire for the HADS. 
5.5.10 Self-efficacy  
 
Self-efficacy to reduce sedentary behaviour and increase light and moderate PA will be measured using 
a reliable questionnaire developed and validated by Adams [20].  The questionnaire includes twelve 
confidence scales (4 for each measure). Each item is a likert-type scale, ranging from 1 to 5.  

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Participants are asked to rate their level of confidence (not at all confident to completely confident) for 
specific sitting and PA behaviors. The average of the four items will produce the score for each 
particular sub-scale.  See the SIT-CR Baseline and Follow-up Questionnaires for the self-efficacy 
questions. 
5.5.11 Health-related quality of life (HRQoL) 
 
Health-related quality of life (HRQoL) will be measured using the Medical Outcomes Study short form 
(SF-36) [21].  The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-
scale profile of functional health and well-being scores as well as psychometrically-based physical and 
mental health summary measures and a preference-based health utility index. See the SIT-CR Baseline 
and Follow-up Questionnaires for the SF-36. 
 
5.5.12 Maximal aerobic power (VO2max)  
 
Maximal aerobic power (VO2max) will be estimated using a Modified Bruce Ramp Treadmill Test 
[22].  The Modified Bruce Ramp Treadmill Test is a sub-maximal multistage test for the prediction of 
aerobic capacity.  Participants will be asked to walk on the treadmill with the incline and speed 
increasing every 3 minutes.  During the test participants' heart rates (HRs) will be measured at the end 
of each 3 minute stage.  The test is stopped once participants reach 85% of their estimated maximum 
HR (207-(0.7*age)). The test will be instructed by a research assistant and should take 10-15 minutes to 
complete.  The HR values will be extrapolated to measure HRmax, and VO2max estimated from the 
highest speed and grade that would have been achieved if the participant had worked to maximum (see 
SIT-CR Case Report Form). 
 
5.5.13 Covariates 
 
The following are possible confounders that will be used in the analysis.  
 
Age:  Each participant’s age will be extracted from the CR patient file.  
 
 Sex:  Participant’s sex will be extracted from the CR patient file. 
 
Education: Participant education is self-reported as part of the CR intake questionnaire and is defined 
as the highest education level attained from Grade 6 or less, up to 4+ years of college/university. 
 
Marital status: Participant marital status is self-reported as part of the CR intake questionnaire, it is 
categorized as: “single", "married/common law",  
"divorced/separated”, or “widowed”.          
 
Occupational status: Participants' current occupational status is self-reported as part of the CR intake 
questionnaire and is categorized as: "Full time, working for pay (35 hrs or more/wk)", "retired", "part 
time, working for pay", "unemployed (looking for work)", "not working, but have a job to return to 
(e.g. sick leave)", "unemployed", "not/never employed outside the home", or "presently on disability 
leave". 
 
Occupation activity: Participants that are currently working, will be asked to rate their current 
occupation activity using the following categories: "mostly sedentary (e.g., desk-based job)", 

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"moderately active (e.g., mix of desk-based job and walking about)", "active and on your feet most of 
the time (e.g., teacher, nurse)", or "very active and physical (e.g., mail carrier, manual labour)" 
 
 
Number of people in the household: Participants will be asked for the number of people in their 
household. 
 
Season: The season/time of year the participant completed the majority of the intervention will be 
collected. 
 
 
5.6 
Statistical considerations 
 
5.6.1 Sample size calculation 
 
Pilot/feasibility studies are generally not designed with the power to detect intervention effects, which 
is the intention of future definitive trials.  Pilot/feasibility studies are often carried out to be able to 
estimate an effect size for a larger trial.  However, to provide guidance, we have estimated a sample 
size based on previous study effect sizes to detect differences in sedentary time.  G*Power Version 
3.1.9.2 power analysis and sample size software was used to calculate the sample size [23].  A minimal 
clinically important difference (MCID) for reductions in sedentary time (i.e. substituting sedentary time 
for light or moderate+ intensity PA) associated with improvements in cardiometabolic health, health-
related quality of life and reduced mortality, has been estimated to be 30-60 minutes/day [24-26], with 
a cumulative effect (i.e. more is better).  Unfortunately, as this study is a pilot-level RCT, there are not 
adequate resources to accommodate a large enough sample size to detect differences in 30 minute/day.  
Rather, there will be adequate power to detect a difference of 91 minutes/day, which was the average 
reduction in sedentary time from sedentary interventions found by the authors in a recent systematic 
review [6].  A total sample size of 32 participants, 16 per arm, is needed to detect a 91 minute/day 
difference in sedentary time at a 0.05 significance level with 80% power, an addition of 10% for those 
who do not complete the trial, and 5% for data missing at random, assuming a standard deviation of 94 
minutes/day as found in a recent evaluation of sedentary time among CR graduates from the UOHI [5].  
This sample size is sufficient to test the research hypothesis using t-tests to measure the difference in 
sedentary time between the intervention and control groups.   
 
When the study is close to completion a sample size recalculation will be undertaken by the Research 
Methods Centre at the UOHI. 
 
5.6.2 Analysis strategies 
  
Baseline clinical and socio-demographic characteristics will be compared between groups to identify 
any chance differences that may have occurred despite random assignment.  Outcome variables will be 
screened to determine whether they meet assumptions of normally distributed random variables with 
equal variances, and a descriptive examination will be performed, including plotting of relationships by 
condition. Retention rate will be computed by condition.   
For the primary analyses, group differences in objectively measured and self-reported sedentary time 
(using the average of seven days) over the two time points (baseline and 8 weeks) will be examined 
using independent t-tests for parametric variables and Wilcoxon Mann Whitney test for nonparametric 

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variables.  Similar analysis techniques will be used for secondary outcomes of interest (i.e., activPAL-
measured and self-reported weekly MVPA; BMI, waist circumference, total cholesterol, HDL, LDL, 
triglycerides, fasting blood glucose, blood pressure, resting heart rate, aortic stiffness, HRQoL scores, 
self-efficacy scores, HADS scores, and maximum aerobic capacity).   
 

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Table 1. Study measurement timeline. 
 
 
 
 
Cardiac rehabilitation 
Visit 
Screen 
Baseline 
week 
Week 1 
Week 
2 
Week 
3 
Week 
4 
Week 
5 
Week 
6 
Week 
7 
Week 8/ 
follow-up 
Length of time needed 
30 min 
1-2 hours 
45 min 
30 min 
30 min 
30 min 
30 min 
30 min 
30 min 
1-2 hours 
Informed consent  
C, I 
 
 
 
 
 
 
 
 
 
Diagnosis 
C, I 
 
 
 
 
 
 
 
 
 
Age 
C, I 
 
 
 
 
 
 
 
 
 
Sex (male/female) 
C, I 
 
 
 
 
 
 
 
 
 
Height  
 
C, I 
 
 
 
 
 
 
 
 
Weight 
 
C, I 
 
 
 
 
 
 
 
C, I 
Waist circumference  
 
C, I 
 
 
 
 
 
 
 
C, I 
Blood pressure (Mobil-O-Graph) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Resting heart rate (Mobil-O-Graph) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Blood work (cholesterol, HDL, LDL, 
triglycerides, HbA1c) 
 
C, I 
 
 
 
 
 
 
 
C, I 
MVPA (CR questionnaire + 
activPAL3) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Questionnaires (self-efficacy, HRQoL, 
anxiety/depression) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Aortic stiffness (Mobil-O-Graph) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Aerobic power (Bruce Treadmill Test)   
 
 
C, I 
 
 
 
 
 
 
C, I 
Sedentary time (activPAL3™, IPAQ, 
CR Questionnaire) 
 
C, I 
 
 
 
 
 
 
 
C, I 
7-day activity journal (FITS) 
 
C, I 
 
 
 
 
 
 
 
C, I 
Wear-time log  
 
 
I 
I 
I 
I 
I 
I 
I 
 
Sedentary feedback (VTAP) 
 
 
I 
I 
I 
I 
I 
I 
I 
 
Feedback survey 
 
 
 
 
 
 
 
 
 
C, I 
 
C - Control group, HDL - high-density lipoprotein, HRQoL - health-related quality of life, I - Intervention group, IPAQ - International 
Physical Activity Questionnaire, LDL - low density lipoprotein, MVPA - moderate-to-vigorous intensity physical activity

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6.0 
RESEARCH PLAN AND FEASIBILITY 
 
6.1 
Clinical relevance 
 
Results from this study will provide important missing information regarding movement patterns 
and sedentary time in patients undergoing CR.  Results of the trial will be useful for the design of 
a larger intervention trial to reduce sedentary time in CR patients and further improve patient-
related clinical and behavioural outcomes.  Additionally, results of this study will identify 
whether using the activPAL3™ as a means of measuring sedentary time in a CR population is 
feasible, and whether the use of prompting devices are acceptable to patients. 
 
6.2 
Risks, benefits and usual standard of care 
 
No changes will occur to the usual standard of care for patients enrolled in CR. 
 
Participation in this study requires that participants wear an activPAL3™ monitor taped (using 
stickers) to the front of the right thigh during waking hours for a minimum of 7 consecutive days 
(baseline and follow-up) and the VTAP monitor continuously during waking hours for weeks 1-7 
in the intervention group.  The PALstickies used to apply the activPAL devices are 
hypoallergenic and consist of a dual layer hydrogel that does not pull at skin or hair.  They are 
used for waking day recordings and are removed when going to bed, showering or bathing and 
will therefore, be reapplied each morning.  In order to reduce possible skin irritations, 
participants in the intervention group will be instructed to alternate the location and leg used over 
weeks 1-7.  The monitors are not an intentional emitter or radiator of electric or magnetic fields 
and poses no risk to a person fitted with a pacemaker.  Important to note however that there are 
some limitations to when the monitor can be worn during scans and testing.  The table below 
outlines when it should be removed and will be provided in the information sheet to participants: 
 
  
Scan/test Affects activPAL activPAL affects scan Comment/action 
MRI scan YES 
YES 
Remove from test 
CT scan 
YES 
YES 
Remove from test 
X-ray 
NO 
Yes if in imaged area 
Remove if in imaged area 
EMG 
NO 
MAYBE if in test area 
Remove if thigh is tested 
ECG 
NO 
NO 
ECG electrodes are on chest 
EEG 
NO 
NO 
EEG electrodes are on chest 
 
 
Participation in this study requires that participants perform an exercise test (Modified Bruce 
Treatment Test) and training sessions.  The risk of cardiovascular events during exercise testing 
varies directly with the incidence of cardiovascular disease.  The risk of exercise testing is low, 
with approximately 6 cardiac events per 10,000 tests (0.06%).  This is comparable to the usual 
care that patients in cardiovascular rehabilitation programs would receive.  Recent studies have 
reported a rate of 1 cardiac arrest per 116,906 patient-hours, 1 myocardial infarction per 219,970 
patient-hours, 1 fatality per 752,365 patient-hours, and 1 major complication per 81,670 patient-
hours in a cardiovascular rehabilitation setting.  It should be noted that these rates are low and 

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likely due to the fact that patients in these studies were screened and exercised in a medically 
supervised setting equipped to handle emergencies.  This is the case of the UOHI, Division of 
Prevention and Rehabilitation.  
 
The commonly reported side effects that may result from exercise testing and training sessions 
may include palpitation, chest pain, shortness of breath, headache, nausea and/or fatigue. 
 
Participants may find the questionnaires regarding HRQoL (Short Form 36) and anxiety and 
depression (HADS) distressing. 
 
Mild discomfort is sometimes associated with blood draws, however, the procedure is quick, 
completed by a trained professional in a sterile environment and is associated with minimal 
discomfort. 
 
6.3 
Monitoring and reporting of adverse events/serious adverse events 
 
The following definitions have been approved as part of Good Clinical Practice in Research: 
 
Unanticipated problem 
An unanticipated problem is defined as any incident, experience, or outcome that meets all of the 
following criteria:  
 
Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the REB-approved research protocol and 
informed consent document, or the Investigator Brochure (IB) or product monograph (PM); and 
(b) the characteristics of the research participant population being studied; and  
 
Related or possibly related to participation in the research (possibly related means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
[investigational product(s)] or procedures involved in the research); and  
 
Suggests that the research places research participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known or 
recognized.  
 
Adverse event 
An adverse event is defined as any untoward medical occurrence in a research participant 
administered an investigational product and which does not necessarily have a causal 
relationship with this product. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding, for example), symptom, or disease temporally 
associated with the use of an investigational product, whether or not related to the investigational 
product. 
 
Serious adverse event 
To ensure no confusion or misunderstanding of the difference between the terms "serious" and 
"severe," which are not synonymous, the following note of clarification is provided:  

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The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, 
moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor 
medical significance (such as severe headache).  
 
This is not the same as "serious," which is based on patient/event outcome or action criteria 
usually associated with events that pose a threat to a patient's life or functioning.  
 
 
Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. 
After reviewing the various regulatory and other definitions in use or under discussion 
elsewhere, the following definition is believed to encompass the spirit and meaning of them all: 
 
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any 
dose: 
o results in death; 
o is life-threatening; 
o requires inpatient hospitalization or prolongation of existing hospitalization; 
o results in persistent or significant disability/incapacity; or 
o is a congenital anomaly/birth defect. 
 
The term "life-threatening" in the definition of "serious" refers to an event in which the patient 
was at risk of death at the time of the event; it does not refer to an event which hypothetically 
might have caused death if it were more severe. 
 
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may require 
intervention to prevent one of the other outcomes listed in the definition above. These should 
also usually be considered serious. 
 
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or 
development of drug dependency or drug abuse. 
 
All unanticipated problems/adverse events/serious adverse events will be recorded on the case 
report form (CRF) and in the source documents at the site of testing. A log for all unanticipated 
problems/adverse events/serious adverse events occurring in the study will be kept. The details 
of any unanticipated problems/adverse events/serious adverse events at each study visit, using 
the protocol-defined terminology, will be recorded.  
 
The principal investigator and or study staff will educate the participants about unanticipated 
problems/adverse events/serious adverse events as well as the importance of reporting them to 
the study coordinator at study visits. 
 

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Anyone within the research team who becomes aware of unanticipated problems/adverse 
events/serious adverse events will report this to the principal investigator.  The principal 
investigator will assess the unanticipated problems/adverse events/serious adverse event and 
provide the research participant with appropriate medical care as applicable.  The principal 
investigator will report to the REB within 7 days only the local adverse events/serious adverse 
events that are deemed to be unanticipated problems.      
 
The monitoring of these unanticipated problems/adverse events/serious adverse will be made in 
accordance with SOP C3-007.1 Safety Reporting Requirements. 
 
6.4 
Benefits of participant participation 
 
Participants may not receive any direct benefit from their participation in this study.  Upon 
completion of the study, participants will receive a summary of their sedentary and health 
measurements.  
 
6.5 
Withdrawal criteria 
 
Participants have the right to withdraw from the study at any point in time. Personnel conducting 
the study have the right to withdraw participants from this study for any of the following reasons:  
 
o The investigator feels it is in the participant's best interest.  
o Participant needs medication/treatment that would interfere with the study. 
o Participant does not follow the study staff’s instructions. 
 
6.6 
Confidentiality/privacy 
 
All Personal Health Information (PHI) and Personal Identifying Information (PII) will be kept 
confidential, unless release is required by law. Release of PHI/PII information will only be 
allowed if it is legally required by law.  For audit purposes only, representatives of the Ottawa 
Health Sciences Network Research Ethics Board (OHSN-REB) and the University of Ottawa 
Heart Institute may review participants’ records under the supervision of Dr. Stephanie Prince 
Ware.  
 
Results of research studies should be shared, to ensure participants are always provided with the 
best possible care. Therefore, results from this study may be presented at scientific conferences 
and/or published in journals but participants’ will not be identifiable in any publications or 
presentations.  
 
All participants will be assigned a study ID number once informed consent in obtained.  The 
study ID will serve as the only identifier used on all study related documents.  Informed consent 
will occur at the time of recruitment once verification of eligibility has been completed.  The 
master list will be maintained by study staff and stored in a separate file from the coded study 
dataset on a password protected computer.  The master list will be in a password protected file 
stored separately from all other study files; the master file will be password protected and only 
individuals directly involved with the study (e.g., principal investigator or designate) will have 

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access to this file.  The participant identifiers to be stored in the master list include full name and 
contact information (e.g., phone number, email, address).  The UOHI and the Health Sciences 
Network Research Ethics Board (OHSN-REB) will have access to the records for audit purposes. 
 
A separate database will be kept that contains study ID numbers along with personal identifiers.  
The database containing descriptive information (e.g., height, weight, etc.) will only have study 
ID numbers as identifiers.  Case Report forms will only have study ID numbers used as 
identifiers, all other personal information (e.g., name) will not be collected on these forms. 
Participants will be reminded not to write their name on any forms. Please refer to the Case 
Report Form (CRF) for personal health information to be collected.  
 
No identifying information will leave the UOHI. All information that leaves the UOHI will be 
coded with an independent study number that will be used throughout the study on all of the 
study records. The Master List which links participants’ name and the independent study number 
will only be accessible by Dr. Stephanie Prince Ware and/or her staff. The link and study files 
will be stored separately and securely.  
 
6.7 
Record keeping/document management  
 
Dr. Prince Ware and research assistants will perform all data collection and entry.  Data quality 
will be maintained via validation checks at the time of data entry and will be reviewed and 
cleaned on an on-going basis by a Research Assistant. 
 
Both paper and electronic records will be kept by Dr. Prince Ware and her staff.  All paper 
records will be stored in a locked filing cabinet and office.  All electronic records, including the 
Master List, will be stored on a secure internal hospital server and password protected, only 
accessible by Dr. Prince Ware and/or her staff.  No identifiable information will be stored on any 
mobile devices (laptops, USB keys, CDs, DVDs, etc.).  Research files will be kept for a period of 
10 years after the study has been completed, as required by law.  At the end of the retention 
period, all paper records will be disposed of in confidential waste for shredding and all electronic 
records will be securely deleted. 
 
6.8 
Data handling  
 
All data will only be accessible by the Principal Investigator, Co-Investigators or Research Staff. 
 
6.9 
Proposed timeline 
Submission to the Ottawa Health Science Network Research Ethics Board – May 2016  
Registration with ClinicalTrials.gov – June 2016  
Acquire activPAL devices – June 2016  
Start date for recruitment and enrollment – July 2016  
End of recruitment – December 2016  
End of data collection – February 2017  
Data analysis – March 2017  
Final Report generation – April 2017  

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Publication of results – June 2017 
 
6.10 
Assembled research team 
 
Robert Reid (PhD, MBA), is Deputy Chief of the Division of Prevention and Rehabilitation 
Centre at UOHI, and a Full Professor in the Faculty of Medicine at the University of Ottawa.  He 
has extensive experience conducting RCTs of rehabilitation interventions in patients with heart 
disease [27-32].  Dr. Reid will have overall responsibility for the conduct of the trial.  Stephanie 
Prince Ware (PhD) is a post-doctoral fellow in the Division of Prevention and Rehabilitation at 
UOHI.  Her post-doctoral work is focuses on sedentary behaviours in cardiac populations and 
their effects on health. She has expertise in the use of activity monitors in research and clinical 
settings.  Dr. Prince Ware will be responsible for the final analysis of the study results.  Dr. 
Prince Ware will also be overseeing the trial.  Jennifer Reed (PhD, MEd CS) is an Associate 
Scientist in the Division of Prevention and Rehabilitation at the UOHI and a Part-Time Professor 
at the University of Ottawa in the Faculty of Health Sciences.  She led a RCT examining the role 
of feedback from a motion sensor with a web application on nurses’ physical activity levels.  Dr. 
Reed will provide guidance on the project and its design and will contribute to the final analysis 
and interpretation of the study results.  
 
6.11 
Funding 
 
This trial is made possible through the provision of an equipment award (PI: Dr. Prince Ware) to 
provide the activPAL3™ and VTAP devices from PAL Technologies Ltd.  Dr. Prince Ware is 
the recipient of their "Show Us the Numbers" competition which provides up to £12000 in 
equipment.  For further information please see: http://www.paltechnologies.com/blog/university-
of-ottawa-heart-institute-submission-wins-pal-competition-prize/  
 
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