Promoting Optimal Physical Exercise for Life (PROPEL) - Aerobic Exercise and Self-management Early After Stroke to Increase Daily Physical Activity: a Randomized Trial
Phase: NA
Conditions: Stroke
Sponsor: Toronto Rehabilitation Institute

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Promoting Optimal Physical Exercise for Life (PROPEL) – aerobic exercise and self-
management early after stroke to increase daily physical activity: a randomized trial 
 
Site Principal Investigators 
Avril Mansfield, PhD 
Site PI – SRI and TRI 
Scientist, Toronto Rehabilitation Institute 
Affiliate Scientist, Sunnybrook Research Institute 
550 University Ave, Toronto, ON, M5G 2A2 
Tel: 416-597-3422 ext 7831 
e-mail: avril.mansfield@uhn.ca  
 
Dina Brooks, PhD 
Site PI – West Park 
Professor, University of Toronto 
Senior Scientist, West Park Healthcare Centre 
500 University Ave, Toronto, ON, M5G 1V7 
Tel: 416-978-1739 
e-mail: dina.brooks@utoronto.ca  
Ada Tang, PhD 
Site PI – Hamilton Health Sciences 
Assistant Professor, McMaster University 
1400 Main St W, Hamilton, ON, L8S 1C7 
Tel: 905-525-9140 ext 27818 
e-mail: atang@mcmaster.ca  
 
Denise Taylor, MPH, BScPT 
Site PI – St Joseph’s Care Group 
Box 3251 Thunder Bay, P7B 5G7 
Tel: 807-343-2431 ext 2562 
e-mail: taylord@tbh.net  
 
Co-investigators 
Elizabeth Inness, PhD, BScPT 
Leader, Balance Mobility and Falls Clinic, 
Toronto Rehabilitation Institute 
550 University Ave, Toronto, ON, M5G 2A2 
Tel: 416-597-3422 ext 7816 
e-mail: liz.inness@uhn.ca  
 
Alex Kiss, PhD 
Scientist, Sunnybrook Research Institute 
2071 Bayview Ave, Toronto, ON, M4N 3M5 
Tel: 416-480-6100 ext 7509 
e-mail: alex.kiss@ices.on.ca  
Laura Middleton, PhD 
Assistant Professor, University of Waterloo 
200 University Ave West, Waterloo, ON, N2L 
3G1 
Tel: 519-888-4567 ext 33045 
e-mail: lmiddlet@uwaterloo.ca  
 
 
Collaborators 
Louis Biasin, BScPT 
Clinical Resource Specialist, Toronto 
Rehabilitation Institute 
550 University Ave, Toronto, ON, M5G 2A2 
Tel: 416-597-3422 ext 3111 
e-mail: louis.biasin@uhn.ca 
 
Mila Bishev, 
Patient Care Manager A-3, St. John’s Rehab – 
Sunnybrook Health Sciences Centre 
285 Cummer Ave, Toronto, ON, M2M 1G1 
Tel: 416-226-6780 ext 7029 
e-mail: mila.bishev@sunnybrook.ca 
 
 

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Rebecca Fleck, MSc, BHSc (OT) 
Clinical Manager, Regional Rehabilitation Centre, 
Regional Rehabilitation Outpatient Services, SCI 
Rehab (B2 South) & Hand Clinic 
Hamilton Health Sciences, 237 Barton St East, 
Hamilton, ON, L8L 2X2 
Tel: 905-524-4322 ext 44833 
e-mail: fleckr@hhsc.ca  
 
Esmé French 
Regional Stroke Rehabilitation Specialist, 
Northwestern Ontario Regional Stroke Network 
Medical Centre, 201 – 984 Oliver Road, Thunder 
Bay, ON, P7B 7C7 
Tel: 807-684-6498 
e-mail: frenche@tbh.net 
Gina Lam 
A3 Physiotherapist, St. Johns’ Rehab – 
Sunnybrook Health Sciences Centre 
285 Cummer Ave, Toronto, ON, M2M 1G1 
Tel: 416-226-6780 ext 6218 
e-mail: gina.lam@sunnybrook.ca  
Kathryn LeBlanc 
Director, Regional Rehabilitation Program, 
Hamilton Health Sciences 
300 Wellington St North, Hamilton, ON, L8L 
0A4 
Tel: 905-527-4322 ext 40821 
e-mail: leblanck@hhsc.ca  
 
Vivien Poon, MScPT 
Clinical Resource Specialist, Toronto 
Rehabilitation Institute 
550 University Ave, Toronto, ON, M5G 2A2 
Tel: 416-597-3422 ext 3111 
e-mail: vivien.poon@uhn.ca 
 
Cathy Pupo 
Manager, St John’s Rehab – Sunnybrook Health 
Sciences Centre 
285 Cummer Ave, Toronto, ON, M2M 1G1 
Tel: 416-226-6780  
e-mail: cathy.pupo@sunnybrook.ca  
Shannon Reid, MScPT 
Physiotherapist, Neurological Rehabilitation and 
Spasticity Clinic, West Park Healthcare Centre 
82 Buttonwood Ave, Toronto, ON, M6M 2J5 
Tel: 416-243-3600 ext 2284 
e-mail: shannon.reid@westpark.org 
 
Lynn Sutter, MSc, BScPT 
Clinical Practice Leader – Physiotherapy, 
Neurological Rehabilitation, West Park 
Healthcare Centre 
82 Buttonwood Ave, Toronto, ON, M6M 2J5 
Tel: 416-243-3600 ext 2378 
e-mail: lynn.suter@westpark.org  
 
Krista Trow 
Clinical manager, Integrated Stroke Program, 
Hamilton Health Sciences 
237 Barton St East, Hamilton, ON, L8L 2X2 
Tel: 905-521-2100 ext 41187 
e-mail: trow@hhsc.ca  
 
 
Study Personnel 
Kay-Ann Allen, BSc 
Research Assistant 
Sunnybrook Research Institute 
285 Cummer Ave, Toronto, ON, M2M 2G1 
Tel: 416-226-6780 ext 7614 
e-mail: kay-ann.allen@sunnybrook.ca  
  
 
 

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1. ABBREVIATIONS 
BBAQ – Barriers to Being Active Quiz 
CMSA – Chedoke-McMaster Stroke Assessment 
GAE – Group Aerobic Exercise 
MOCA – Montreal Cognitive Assessment 
NIH-SS – National Institutes of Health Stroke Scale 
PASIPD – Physical Activity Scale for Individuals with Physical Disabilities 
PROPEL – Promoting Optimal Physical Exercise for Life 
SOEE – Short Self-Efficacy for Exercise scale 
SSEE – Short Outcome Expectations for Exercise scale 
SWT – Stepped Wedge Trial 
 
2. INTRODUCTION 
People often have low aerobic capacity after stroke,1,2  which makes even light physical activity 
effortful and can limit activities of daily living.1,3,4 Aerobic exercise is beneficial post-stroke for 
improving aerobic capacity,5-7 maintaining or promoting recovery8 and for general health, including 
reducing risk of another stroke or other cardiovascular events.9 Importantly, aerobic exercise is 
beneficial even early after stroke,6 and can be feasibly implemented during routine rehabilitation.10 
However, length of stay in stroke rehabilitation is relatively short, so ongoing self-directed exercise 
post-discharge is necessary to maintain these benefits. 
People with stroke do not maintain adequate levels of long-term exercise. Community-living 
people with stroke walk, on average, 70-5800 steps/day;11 less than the 6000 steps/day recommended 
for people with physical disabilities.12 Data from heart rate monitors reveal that, even when individuals 
with stroke are active, the activity is not of sufficient intensity.13 Chronic inactivity within this group 
means that any gains in aerobic fitness made during rehabilitation are quickly lost post-discharge.14 A 
vicious cycle can ensue: limited activity results in de-conditioning, functional decline and greater 
difficulty being active.4 
There is a need to establish strategies to promote long-term uptake of exercise after stroke.15 
Most studies aiming to increase self-directed exercise post-stroke have been implemented in the 
community after formal rehabilitation is complete.16,17  While some community-based programs have 
reported increased physical activity after the program,18-20 many people have difficulty accessing 
community programs16 and consequently attendance can be low.21 The early recovery period during 
rehabilitation may be an optimal time to not only deliver fitness programming to increase exercise 
capacity,  but also to shape long-term self-directed exercise behaviour.14 To our knowledge only one 
group has studied such a program during stroke rehabilitation.22 This study found that 67% of those 
who completed the intervention met exercise recommendations, compared to 55% in the control group. 
However, this study is limited by a non-randomized design, high rates of withdrawal in the intervention 
group compared to the control group (28% versus 12%), and low rates of compliance with the 
intervention (<67%). Furthermore, this study included individuals receiving rehabilitation for various 
conditions and was not focused solely on people with stroke, who have unique challenges to 
participating in exercise.23  
We developed Promoting Optimal Physical Exercise for Life (PROPEL) – an exercise and self-
management program that aims to facilitate the transition to the community. Our pilot non-randomized 
study suggests that those who complete PROPEL are more physically active after discharge from 
rehabilitation than those who do not.24 The primary aim of this study is to evaluate the effect of 
PROPEL delivered during stroke rehabilitation on participation in self-directed exercise after 
rehabilitation. Our secondary aims are to evaluate the effect of PROPEL on self-efficacy and outcome 
expectations for exercise, and barriers to exercise. We hypothesize that, compared to those who 

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complete group aerobic exercise only,  those who complete PROPEL will: 1) be more likely to meet 
the recommended intensity and duration of self-directed physical activity in the community (i.e., 
≥150mins/week of moderate intensity exercise25); and 2) report higher self-efficacy and outcome 
expectations for exercise, and fewer barriers to community activity. 
 
3. METHODOLOGY 
3.1.Design overview 
This study involves a single-blind, continuous recruitment short exposure, stepped-wedge cluster 
randomized controlled trial (SWT).26 Participants will be recruited from one of 6 sites in Ontario. 
Collectively, these 6 sites have approximately 710 admissions to out-patient stroke rehabilitation 
annually (St. John’s – Sunnybrook: 150; Toronto Rehab – University Centre: 160; Toronto Rehab – 
Rumsey: 130; West Park: 150; St. Joseph’s Care Group: 60; Hamilton Health Sciences: 60). At a 
randomly-determined time within the study period (see Figure 1), each site will transition from the 
control intervention (group aerobic exercise only; GAE) to the experimental intervention (PROPEL). 
New participants will be recruited continuously throughout the study period and will either complete 
the GAE or PROPEL intervention, depending on which program that site is administering at the time at 
which they are admitted to rehabilitation. 
 
Each site will be staffed by a research assistant (RA) and a physiotherapist (PT). The RA will 
be responsible for recruiting participants and collecting data. The PT will administer the interventions. 
 
  
Figure 1: Intervention allocation schedule. G1, G2 etc. are the 6-week long group aerobic exercise (GAE) or PROPEL 
groups. Each site should be able to complete 8 groups per year; however, only 7 groups will be completed in 2017 to allow 
for additional time at the start of the year to obtain research ethics approval, inter-institutional agreements, and pilot 
implementation at all sites (see also Figure 3). ‘0’ indicates that the site will complete GAE in that time period, whereas ‘1’ 
indicates that they will complete PROPEL. A simple randomization procedure will be used to determine the time at which 
each site transitions from GAE to PROPEL. Sites will be allocated in order by drawing names from a hat; e.g., the 1st site to 
be drawn will be Site A, the 2nd will be Site B, etc.  
 
3.2.Rationale for SWT design 
The group format is essential to PROPEL (see below). We experienced from our pilot study24 that there 
was often a delay to start the group until there were ≥3 people referred. Therefore, a study design 
whereby individual participants are randomly allocated to either GAE or PROPEL would be 
problematic as there would be even greater delays in starting the groups. Likewise, a traditional cluster 
randomized controlled trial, where sites are randomly assigned to either complete GAE or PROPEL, 
would not be ideal due to the relatively low number of sites (6), and thus, reduced statistical power.27 
Therefore, the SWT is a pragmatic trial design that is suitable for evaluating interventions that are 
implemented routinely at the level of cluster.26,27 It balances the need for robust evaluation with logistic 
constraints in program evaluation, particularly in cases of inter-site variability.28 Indeed, previous 
authors have argued that well-designed and executed SWTs can be as rigorous as traditional cluster 
randomized trials.26 
 
G1
G2
G3
G4
G5
G6
G7
G8
G9
G10
G11
G12
G13
G14
G15
Site A
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
SIte B
0
0
0
1
1
1
1
1
1
1
1
1
1
1
1
Site C
0
0
0
0
0
0
1
1
1
1
1
1
1
1
1
Site D
0
0
0
0
0
0
0
0
0
1
1
1
1
1
1
Site E
0
0
0
0
0
0
0
0
0
0
0
0
1
1
1
Site F
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2017
2018

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3.3.Interventions 
The interventions will be implemented as part of routine care at all sites according to the schedule 
outlined in Figure 1 (e.g., Site B is expected to implement GAE in mid-February 2017, and PROPEL in 
around mid-May 2017). The interventions will supplement, rather than replace, current practice; that is, 
patients will still complete their regularly-scheduled physiotherapy, occupational therapy, and speech 
and language pathology sessions, as required. However, for patients who are enrolled in the GAE or 
PROPEL interventions, physiotherapists might choose to not complete individualized aerobic exercise 
during patients’ regularly scheduled physiotherapy sessions as this will be completed as part of 
GAE/PROPEL, and to spend this time instead focusing on other rehabilitation goals (e.g., balance or 
gait retraining).  
Both interventions involve supervised, individualized, group aerobic exercise up to 3 days/week 
for 6 weeks. Patients will be referred by their treating physiotherapist. The interventions will be 
implemented as part of routine care in out-patient rehabilitation at each site, and will be delivered in a 
‘closed group’ format. That is, participants referred to the program will be placed on a waiting list until 
there are a sufficient number of participants to form a group (≥3), and all participants in the group will 
start the program at the same time. This will ensure that the mean time post-stroke at study enrolment 
does not differ between the two phases of intervention. Prior to starting the group, participants may 
complete individualized or open-group aerobic exercise as part of their regular in- or out-patient 
rehabilitation. 
 
3.3.1. Control intervention – GAE 
The control intervention will involve group aerobic exercise only (GAE). The intensity and duration of 
exercise within a session will be determined from a sub-maximal aerobic capacity test conducted prior 
to entry into the program using a protocol developed by our team.10 The choice of exercise modality for 
the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be 
individually prescribed based on patients’ sensori-motor recovery, postural control, functional abilities, 
and safety. Group exercise will be supervised by the PT. A typical exercise session will involve a 3-5 
minute ‘warm-up’, 20-30 minutes of aerobic exercise at a target heart rate determined from the sub-
maximal test, and a 3-5 minute ‘cool-down’ of low-intensity exercise, which we have shown to be 
feasible for this target population.10 Heart rate, blood pressure, rate of perceived exertion, workload, 
and duration of training will be documented for each session. These data will be reviewed by the PT 
with appropriate progression of the intensity and/or duration of exercise as necessary.  
 
Patients in the GAE program may receive general advice to keep physically active after 
discharge, and may receive an individualized home exercise program, as is currently routine care at all 
sites. 
 
 
3.3.2. Experimental intervention – PROPEL 
The PROPEL program,24 involves both group aerobic exercise and group discussion aimed at enabling 
participation in exercise after discharge. Components of the PROPEL program were developed 
according to the Transtheoretical Model of health behaviour change29 and Social Cognitive Theory.30 
Participants will complete group exercise up to 3 days/week (described above for GAE). Participants 
will also attend 1-hour small group discussion sessions once weekly to learn self-management skills for 
exercise in preparation for discharge from rehabilitation. These group sessions include discussions to: 
identify and problem-solve around barriers to exercise; understand personal and general benefits of 
exercise; explore appropriate community resources for exercise; and find individualized and realistic 
strategies for incorporating exercise in a regular routine. The group format allows vicarious 
experiences; seeing others’ achievements, especially for those uncertain of their own capabilities, may 
improve beliefs in the individuals’ own capabilities.31 The group can also act as a motivator for 

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continued engagement in exercise to achieve personal goals,32 offering encouragement to attempt new 
exercises and challenge negative perceptions of ability (social persuasions).33 Exercise self-efficacy 
predicts exercise behaviour post-stroke;32,34,35 to facilitate self-efficacy for exercise, patients will learn 
how to monitor their own heart rate and rate of perceived exertion. Patients will also become 
comfortable with progressing their aerobic exercise and will set short- and long-term exercise goals. 
Access to a health care professional (PT) leading the group can increase an individual’s belief about 
personal skill,31 and support in teaching stroke survivors how to exercise independently, promoting 
feelings of safety and confidence.33,34 Supportive planning and problem-solving to achieve long-term 
goals of continued exercise in the community would be fostered as patients transition from the fitness 
group to independent community programming or exercise. 
 
3.4.Participants & recruiting 
Individuals who complete either GAE or PROPEL as part of routine care at one of the 6 sites will be 
invited to participate in the study.  To be eligible for referral to GAE or PROPEL, patients must be 
admitted to the facility for rehabilitation after a diagnosed stroke, and must be able to understand 
instructions. Patients will be excluded from GAE or PROPEL if they have conditions that limit their 
ability to exercise, including uncontrolled hypertension, uncontrolled diabetes, other cardiovascular 
morbidity that limits exercise tolerance (e.g., heart failure, abnormal blood pressure responses or ST-
segment depression >2mm, symptomatic aortic stenosis, or complex arrhythmias), unstable angina, 
orthostatic blood pressure decrease of >20mmHg, or musculoskeletal impairments or pain. 
Additionally, participants will be withdrawn from GAE or PROPEL if significant cardiovascular 
abnormalities are observed during the sub-maximal exercise test. We have used these criteria to 
successfully enrol patients with stroke in aerobic exercise during in-patient rehabilitation with no 
serious adverse events.10 Referral to the group will be made by the patients’ primary treating 
physiotherapists, who will document the patients’ verbal consent for treatment, as is usual practice. 
Participants will be considered for inclusion in the study if they are referred to the GAE or 
PROPEL program as part of their stroke rehabilitation. Participants will be excluded from the study if: 
• They have a language or communication barrier that prevents completion of 
questionnaires (e.g., severe receptive or global aphasia or non-English speaking);  
• They have cognitive impairment that would prevent participation in unsupervised 
exercise; 
• They attend less than 50% of GAE/PROPEL sessions; and/or  
• They attend less than 4 of the 6 group discussion sessions (for individuals referred to the 
PROPEL program). 
Communication and cognitive capacity to participate in the study will be determined via consultation 
with participants’ healthcare team.  
Potential participants will be assessed for eligibility by the study PT within the final two weeks 
of the patients’ participation in the GAE/PROPEL programs. The study PT, who is in the patients’ 
circle of care, will ask eligible patients if they are interested in speaking with the RA about 
participating in the study. The RA will discuss the study at a time that is convenient for interested 
individuals. She will describe the study, as outlined in the consent form (Appendix A) and will answer 
any questions the patient may have about the study. The patient will be provided with a copy of the 
consent form and will be invited to discuss the study with friends or family members, and/or to take 
some time to think about being involved in the study. If a patient indicates that s/he would like to 
participate in the study, s/he will be asked to sign the consent form. At that time, the RA will arrange a 
time that is convenient for the participant to collect baseline data (see Section 3.6.3.). We will assume 
that patients who do not provide consent to the study within two weeks after they finish the 
GAE/PROPEL program are not interested in participating in the study. 

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In order to keep track of participants, we will request contact information of a friend or family 
member (‘alternative contact’; Appendix B); this form will be completed by the alternative contact. 
Participants who provide consent for us to contact their friends or family members will be provided 
with this form at the time when written consent is obtained, and will be asked to return the form at the 
next visit or by mail (a stamped self-addressed envelope will be provided). This information will only 
be used to obtain information about the whereabouts of a research participant if we are unable to 
contact them after multiple attempts. Participants will primarily be contacted by telephone throughout 
the study, unless otherwise requested. Each time they are contacted, participants will be told when they 
should next expect to hear from the RA and will be asked to inform the RA of upcoming limited 
availability (e.g. due to vacation or scheduled surgery). A letter will be mailed to participants 
(Appendix L) who are unable to be reached: 1) because his/her telephone number is out of service; or 
2) five attempts have been made to telephone the participant over the course of two weeks (with at least 
two voicemail messages for participants who have voicemail and have provided consent for us to leave 
voicemail). In the latter case, telephone calls will be placed at varying times of the day in an attempt to 
reach participants who are unavailable at the same time each day due to regular appointments. The 
letter will request that participants contact the RA. If the RA does not hear from the participant two 
weeks after the letter was mailed, the RA will contact the alternative contact. 
In order to generate a CONSORT flow-diagram for participant recruiting,36 RA will count the 
number of individuals who are admitted to the out-patient stroke program and, of these, the number 
who are referred to the GAE or PROPEL program (Appendix C). The RA will also maintain 
documentation related to screening and enrolment of potential participants (Appendix D). Note that any 
identifying or health-related information will not be documented for individuals who do not consent to 
participate in the study. 
 
3.5.Blinding 
Participants cannot be blinded to intervention allocation. Assessors (RA at each site) who collect data, 
including administering questionnaires, will be unaware of the time at which the site transitions from 
GAE to PROPEL. While it is more likely that a given site will be allocated to GAE at the start of the 
study period, and to PROPEL at the end of the study, inclusion of two sites that always complete either 
GAE or PROPEL will create uncertainty in intervention allocation at all time points. Furthermore, 
using objective methods to collect data pertaining to the primary outcome (i.e., heart rate and activity 
monitor) helps to protect against bias if assessors inadvertently become unblinded. 
 
3.6.Outcomes 
3.6.1. Primary outcomes – physical activity 
Physical activity will be assessed using a step counter, heart rate monitor, and questionnaires for 7 
continuous days at three time points: 1) one month, 2) four months, and 3) six months post-intervention 
(Figure 2). Because of the limitations of relying on a single method of data collection for physical 
activity data, combining data from these three sources is recommended.13,23,24,35 Participants will be 
supplied with a commercial wrist-worn step counter and heart rate monitor (FitBit Charge HR). Our 
pilot data suggests that this device provides reasonably accurate measures of walking activity and heart 
rate among individuals with stroke (unpublished data). Individuals who typically use a rollator for 
ambulation may also be provided with an activity monitor to be worn at the ankle (FitBit One), which 
would be more accurate for measuring walking activity than a wrist-worn device for these 
individuals.37 The devices will be configured to not provide participants with information regarding 
step counts and heart rate. While participants will not have access to activity data to reduce 
measurement bias, they may choose to purchase their own activity-monitoring device to augment self-
management strategies. The devices will be mailed to participants with a postage-paid return envelope. 

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Participants will be instructed to wear the device at all times (except when bathing) for 7 days 
continuously (Appendix E).  
The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)38 will be 
conducted by telephone with a blinded RA at the end of the 7-day monitoring period. The PASIPD is a 
13-item questionnaire in which participants are asked to indicate the frequency and duration of 
recreational, household and occupational physical activities completed in the previous 7 days. The 
PASID has been validated within a group of individuals with various physical disabilities, including 
individuals with stroke, showing good test-retest reliability (=0.77) and criterion validity when 
compared to accelerometer-based activity monitoring (=0.30).39   
We will use the step activity, heart rate, and questionnaire data to determine if participants meet 
the recommended intensity and duration of physical activity in the community; that is, at least 150 
minutes per week of moderate-vigorous intensity exercise.25 Participants will be deemed to meet the 
recommendations within a given week if they meet at least two of three criteria: 1) record at least 150 
‘active minutes’ (from the step activity monitor); 2) record at least 150 minutes of heart rate between 
55-80% of age-predicted maximum;9 and/or 3) report at least 150 minutes of moderate and/or vigorous 
intensity activity on the PASIPD.  
 
 
Figure 2: Hypothetical timeline for one participant. The exact timing of in- and out-patient rehabilitation will vary for 
each participant. The sub-maximal aerobic capacity test is completed during in-patient rehabilitation. After this point the 
participant could participate in individual or open-group aerobic exercise during in- and out-patient rehabilitation (while 
waiting to be enrolled in the study intervention). The closed-group study intervention (group aerobic exercise (GAE) only or 
PROPEL) will likely start during out-patient rehabilitation, though some patients may start during in-patient rehabilitation. 
The participant will be enrolled in the study at the end of the study intervention, at which point cohort descriptors, the Short 
Self-Efficacy for Exercise (SSEE) scale, and the Short Outcome Expectations for Exercise (SOEE) scale will be collected. 
Activity monitoring will be conducted for 7 days continuously at three time points: 1) one month; 2) 4 months; 3) and 6 
months after the end of the study intervention. The Barriers to Being Active Quiz (BBAQ) will be conducted at the 1-month 
post-intervention time point. 
 
3.6.2. Secondary outcomes - self-efficacy and outcome expectations for exercise, and barriers to 
activity 
Exercise self-efficacy will be assessed using the Short Self-Efficacy for Exercise (SSEE) scale.40 The 
SSEE is a four-item questionnaire where participants are required to rate their confidence exercising 
through pain and fatigue, and when alone and depressed on a five-point scale. The Short Outcome 
Expectation for Exercise (SOEE) scale40 will be used to assess beliefs and attitudes related to exercise. 
The SOEE is a five-item questionnaire where participants are asked to rate their beliefs regarding the 
benefits of exercise on a five-point scale. The SSEE and SOEE will be assessed at enrolment into the 
study. The SSEE and SOEE have been shown to be valid and reliable among individuals with chronic 
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Perceived barriers to physical activity will be assessed 1-month post-intervention with the 
Barriers to Being Active Quiz (BBAQ).23,41 The BBAQ has previous been used to evaluate barriers to 
exercise among individuals with stroke.23 The BBAQ is a  21-item scale where individuals are required 
to indicate how likely they are to make specific statements regarding barriers to exercise, for example 
“I’m getting older so exercise can be risky”.41 Items on seven categories of barriers are included in the 
questionnaire: lack of time, social influence, lack of energy, lack of willpower, fear of injury, lack of 
skill, and lack of resources. Each individual item is scored from 0-3 and scores for each barrier 
category are the sum of the scores for the three items in that category. Participants are considered to 
have a ‘significant’ barrier to being active if the score for a category is 5 or higher.23 The average 
number of significant barriers per participant will be calculated.  
 
3.6.3. Cohort descriptors 
The following information will be obtained from chart review in order to characterize individuals who 
participate in the study: age, sex, time post-stroke (at enrolment into the study), lesion location, and 
medical conditions/history (Appendix F). The National Institutes of Health Stroke Scale (NIH-SS),42 
the Chedoke-McMaster Stroke Assessment (CMSA)43 foot and leg scores, and the Montreal Cognitive 
Assessment44 will be administered at enrolment into the study by the RA or study PT; however, if these 
measures were conducted as part of clinical care within 1-week of study enrolment, the scores will be 
extracted from the hospital charts to minimize participant burden. The NIH-SS is an 11-item scale that 
provides a gross measure of the effects and severity of stroke. The NIH-SS has good intra-rater 
(ICCs=0.93) and inter-rater (ICCs=0.95) reliability.45 The CMSA assigns a score according to the level 
of motor recovery in the foot and leg and is frequently used to evaluate level of motor recovery post-
stroke in clinical settings. The CMSA foot and leg scores have good intra-rater (ICCs=0.94-0.98) and 
inter-rater (ICCs=0.85-0.96) reliability.43 The MOCA44 is a paper-based test that can be used to screen 
for mild cognitive impairment; patients are scored on visuospatial and executive function, naming, 
memory, attention, language, abstraction, delayed recall, and orientation.  
We will document the frequency and intensity of exercise during in- and out-patient 
rehabilitation by chart review (Appendix F). Participants will complete a questionnaire at baseline that 
asks about their social supports, employment, familial responsibilities, living situation etc (Appendix 
G), which are factors that could influence participation in physical activity. Many of these questions 
have been adapted from the Canadian Longitudinal Study on Aging.46 Some questions will be repeated 
at the 6-month post-discharge time-point (Appendix H) to account for lifestyle changes since discharge 
from rehabilitation. Pre-morbid exercise behaviour will be evaluated with the Schmidt retrospective 
physical activity scale.47 This scale shows good agreement with previously-completed questionnaires 
regarding physical activity.47 We will use this scale to estimate participants’ average amount of time 
(hours/day) prior to their strokes spent in sedentary activities (e.g., watching television, sedentary 
occupational activity) and in physical recreational activity or exercise. 
 
3.7.Intervention allocation 
The time at which each site transitions from GAE to PROPEL will be determined by drawing site 
names at random (see Figure 1 for full details). One site will implement PROPEL at the start of the 
study period, whereas one site will never transition to PROPEL; this will help to ensure blinding of 
assessors (see next section). The site that does not transition to PROPEL during the study period will be 
offered training in PROPEL at the end of the study period. Intervention allocation will be performed at 
the start of the study period by the principal investigator, who will not be directly involved in recruiting 
or data collection.  
 
 
 

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3.8.Statistical analysis  
We will compare cohort descriptors between the two phases (GAE and PROPEL) using t-tests, Mann-
Whitney U tests, or chi-square tests, as appropriate. If phases significantly differ at baseline on cohort 
descriptors these measures may be used as covariates in the analysis. To test our primary hypothesis, 
we will compare the proportion of active and inactive individuals at the final assessment point (6 
months post-intervention) using mixed-model logistic regression, with fixed effects of time and phase 
and random effect of cluster (site).48 We will also examine between-phase differences in physical 
activity at the 1-month and 4-month time points, which could reveal short-term benefits of PROPEL, 
even if there are no differences at 6-months. A similar mixed-model ANOVA will be used to compare 
SSEE, SOEE, and BBAQ scores between programs to test the secondary hypothesis. 
 
3.9.Sample size 
We expect that approximately 25% of people who complete GAE49 and 50% of individuals who 
complete PROPEL24 will be classified as ‘active’. A sample of 96 per phase will provide 80% power to 
detect a 25% to 50% difference at alpha of 0.05 for the 6 sites taking into account an intracluster 
correlation of 0.05.50 The sample size calculation was run using PASS Version 12 (Hintze, J, 2014, 
NCSS, LLC. Kaysville, Utah). We will aim to recruit 120 participants total per phase to account for a 
conservative 20% drop-out rate; note that in our previous studies where participants were recruited at 
discharge from rehabilitation and followed for up to 6 months, the rate of withdrawal was much lower 
(<12%24,51,52). There are 710 admissions annually to out-patient stroke rehabilitation at all sites 
combined. We conservatively estimate that approximately 40% of these individuals will be eligible for 
the study and, of these, 50% will consent to participate. Thus, we expect to recruit ~140 participants 
annually to meet the target sample size with ~2 years of recruiting (see timelines and milestones: 
Figure 3). Target sample sizes for each site are: St John’s – 60, West Park – 60, Toronto Rehabilitation 
Institute (both sites) – 116, St Joseph’s Care Group – 24, Hamilton Health Sciences – 24. 
 
3.10. 
Timelines 
This project is expected to take 3.5 years to complete (Figure 3). The first 6-7 months will be spent 
obtaining research ethics approval at all sites, establishing inter-institutional agreements, and hiring and 
training study staff. We will also pilot implement at least one GAE group at each site prior to the start 
of the study period. Interventions will begin around mid-February 2017 and will continue until the end 
of 2018. Data collection will continue for 6 months beyond the end of the interventions, and will be 
complete by June 2019. Clinical staff training in PROPEL will be ‘rolled out’ at each site according to 
the allocation schedule (see also Figure 1). Data analysis and writing will occur in the final 6 months. 
 

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Figure 3: Gantt chart showing anticipated timelines for the study.  
 
4. ROLE OF TEAM MEMBERS 
Avril Mansfield will oversee the study, lead regular team meetings, and serve as site lead for St John’s 
Rehab – Sunnybrook and the Toronto Rehab sites. Dina Brooks will be the site lead at West Park, Ada 
Tang will be the site lead at Hamilton Health Sciences, and Denise Taylor will be the site lead at St 
Joseph’s Care Group. All site leads have prior experience leading clinical trials. Elizabeth Inness will 
lead knowledge translation activities and will coordinate training of sites in GAE or PROPEL. Alex 
Kiss will perform statistical analysis. Collaborators will facilitate implementing the interventions at 
each site. All team members will participate in dissemination activities (e.g., preparation of 
manuscripts and conference abstracts).  
 
5. RISK MANAGEMENT 
5.1.Patient safety and burden 
Sites will implement two interventions as part of routine care (GAE or PROPEL). Some aerobic 
exercise is currently conducted at all sites, but might not be implemented in the systematic manner 
required for this study. However, aerobic exercise is recommended as part of stroke rehabilitation 
within the Canadian Stroke Best Practice Recommendations.53 Furthermore, with appropriate screening 
and prescription, aerobic exercise is safe and feasible early after stroke.10 Treating physiotherapists will 
screen patients, with appropriate consultation with the inter-professional team, and provide the exercise 
prescription following established guidelines for aerobic exercise after stroke,54 prior to referring them 
to GAE or PROPEL. The interventions will be supervised by a trained registered physiotherapist, who 
will continue to monitor patients’ response to exercise and may choose to adjust the intensity or 
duration of exercise to minimize risk to participants.  
Heart rate and blood pressure will be measured at rest at the start of each intervention session to 
obtain a baseline measure of cardiovascular function. If measured blood pressure or heart rate is outside 
of an acceptable range (systolic blood pressure: 90-140 mmHg; diastolic blood pressure: 60-90 mmHg; 
heart rate: 60-100 bpm) a second measure will be obtained. If the 2nd measurement reveals elevated 
heart rate and/or blood pressure, the participant will be allowed to rest seated for 5 minutes, after which 
measurements will be retaken. If the 2nd measurement reveals low heart rate and/or blood pressure, the 
participant will be offered a glass of water and measurements will be retaken after 5 minutes. 
Q3 Q4
Register trial
*
Hire staff at all sites
Prepare & submitt research ethics applications
Research ethics approval in place
*
Prepare inter-institutional agreements
Inter-institutional agreements in place
*
Pilot implementation of GAE at all sites
Study interventions
Data collection
Training in PROPEL - Site A
Training in PROPEL - SIte B
Training in PROPEL - SIte C
Training in PROPEL - SIte D
Training in PROPEL - Site E
Data collection complete
*
Data analysis & writing
Q1
Q4
Q3 Q4
2019
2016
Q1 Q2 Q3
Q2
2017
2018
Q1 Q2 Q3 Q4

PROPEL randomized trial 
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Participants with heart rate/blood pressure measurements outside the acceptable range will also be 
questioned regarding recent medications (what they have taken and when, or if they have not taken 
their usual medications), when they last had something to eat and drink, and if they recently took 
caffeine or exercised. The decision to continue or terminate the session will be made by the PT 
considering factors such as the participants’ usual resting heart rate/blood pressure, how far the 
measured values are outside of the acceptable range, the participants’ usual medications (e.g., beta-
blockers), and the participants’ perception of how they are feeling. If the session is terminated, the PT 
may consult with the patients’ physiatrist or other physician.  
 
The Canadian Stroke Best Practice Recommendations also recommend including a plan to 
enable patients to continue to exercise post-discharge, including addressing barriers to physical 
activity.53 However, the specific education, self-management, and problem-solving components of the 
PROPEL program are not part of routine care at all sites. The additional risk to participants in 
completing this component of the PROPEL program is minimal. Participants can opt out of any part of 
the discussion if they feel uncomfortable. 
 
The additional measures conducted as part of the study pose minimal risk to participants. The 
CMSA, NIH-SS, and MOCA are frequently conducted as part of clinical care in stroke rehabilitation. 
Other measures are questionnaires which ask routine questions about physical activity behaviour and 
lifestyle. Despite the minimal risk involved in these measures, participants will be reminded that they 
can opt out of any testing and/or decline to answer any of the questions in the questionnaires. The 
activity monitoring also poses minimal risk to participants; the devices are available commercially and 
are worn daily by millions of individuals around the world. Participants may develop skin irritation 
from wearing the device daily; they will be instructed to remove the device if this occurs. Participants 
may feel burdened by donning and doffing the activity monitors each day. 
The study PT will document any adverse events that occur during the interventions; the RA will 
document adverse events for participants who enrol in the study during the follow-up period (Appendix 
I). 
 
5.2.Confidentiality 
The study PT will run the GAE and PROPEL interventions as part of routine care at each site. Patients 
who are referred to GAE or PROPEL may decline participation in the study. Therefore, individuals 
who do not consent to the study may participate in GAE or PROPEL. The study PT will be an 
individual who also has a role in clinical care on the stroke program at the site and, therefore, will 
already be part of the circle of care. The study PT will not have a role in recruiting participants into the 
study, other than to introduce the RA to potential participants.  
A number of steps will be taken to ensure protection of personal health information. Data will 
be initially stored at each site. Each activity monitor will be linked to an anonymous account, and 
activity monitor data will be stored on the manufacturer’s servers linked to these anonymous accounts. 
We will document internally which participants’ data are associated with which accounts; therefore, 
there will be no information about study participants (e.g., name, age, study ID number) stored on the 
manufacturer’s servers. Activity data will be downloaded from the manufacturer’s servers as soon as 
possible after collection. All other electronic data will be stored on secure institutional servers. Files 
containing patient names and contact information will be password protected. Hard copies of files 
containing de-identified data will be stored in locked cabinets and/or in offices that are locked when not 
occupied. Consent forms will be stored in locked cabinets/offices separately from other data. Only 
those individuals who require access to the data for the purpose of this study will be provided with the 
password to the file containing identifiers and/or the keys to the locked cabinet/office. Each site will 
use secure/encrypted methods approved by their institution to transfer data to the main site 
(Sunnybrook Research Institute).  

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6. IMPACT 
This work addresses methodological limitations of studies aiming to increase exercise participation 
post-stroke16,17 by: 1) basing the intervention on principles of behaviour modification; 2) using 
objective measures of exercise participation; and 3) evaluating long-term self-directed exercise (e.g., at 
least 6 months post-intervention). We expect that this study will find that a simple intervention 
delivered during stroke rehabilitation can encourage participation in exercise post-discharge. 
Ultimately, translation of this program into practice has the potential to reduce healthcare costs (by 
reducing risk of cardiovascular events) and increase independence for stroke survivors. 
 
7. LIST OF APPENDICES 
 
A. Consent form 
B. Alternative contact form 
C. Screening log 
D. Enrolment log 
E. Participant FitBit instructions 
F. Chart review form 
G. Baseline questionnaire 
H. 6-month follow-up questionnaire 
I. Adverse event reporting form 
J. Overall study budget 
K. Site budget 
L. Follow-up letter draft 
 
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