ProACTIVE SCI Physical Activity Coaching Intervention
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: University of British Columbia

 
 
 
Intervention Protocol  
 
Version 2.0, 04/01/2017 
 
 
 
Study Title: 
ProACTIVE SCI Physical Activity Coaching Intervention 
 
Primary Investigator:  
Dr. Christopher West (ICORD) 
 
Co-investigators:  
Dr. Kathleen Martin Ginis (University of British Columbia, 
ICORD) 
Jasmin Ma (University of British Columbia) 
 
 
Study Sites: 
1. International Collaboration on Repair Discoveries  
    (ICORD), Vancouver, BC, Canada 
2. University of British Columbia, Kelowna, BC, Canada 
 
Sponsors:  
 
 
Ontario Neurotrama Foundation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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SUMMARY 
 
Purpose: To address the low levels of physical activity reported in the SCI population by 
providing individualized physical activity sessions and evaluating their impact on 
physical activity behaviour and health outcomes.  
 
Hypothesis i: Physical activity levels will be higher in the experimental than the wait-list 
control group. 
 
Hypothesis ii: Self-reported HAPA model constructs (e.g. action planning, self-efficacy) 
will be improved in the experimental group compared to the wait-list control group. 
 
Hypothesis iii: Participants who report higher levels of PA will have greater 
improvements on arterial stiffness and secondary health outcomes (cardiovascular, 
fitness). 
 
Justification: Given the number of barriers individuals with SCI face, it is not surprising 
that PA levels in this population are remarkably low. These low levels of PA can lead to 
increased risk for chronic disease and other dangerous health conditions.  In particular, 
cardiovascular disease (CVD) is a leading cause of morbidity and mortality in the SCI 
population, and risk of developing CVD is increased in those who are physically inactive. 
Strategies tailored to individuals with SCI are needed to increase levels of PA and 
ultimately reduce risk for the development of such chronic diseases as CVD. Results 
from a recent meta-analysis of PA interventions in people with disability support that 
interventions that are guided by theory are more effective than those that do not use 
theory for increasing PA levels in this population. More specifically, an examination of 
over 200 people with SCI showed that the Health Action Process Approach model is 
well-suited to predict PA levels in this population. Further, previously successful studies 
have supported the use of behaviour change techniques that target specific constructs of 
the HAPA model (e.g. self-efficacy and planning). However, to date, interventions 
designed to use the HAPA model in its entirety have yet to be tested in individuals with 
SCI. Thus, this study will employ a comprehensive, tailored intervention using 
techniques to target all constructs outlined by the Health Action Process Approach model 
(i.e. risk perceptions, outcome expectancies, barriers, resources, self-efficacy, planning, 
action control) to improve levels of PA in individuals with SCI.  Improvements in PA 
will then be examined for effects on fitness and cardiovascular function and health.     
 
Objectives: Primary objective: To determine whether brief physical activity (PA) 
coaching sessions guided by the Health Action Process Approach model can change PA 
behaviour and psychosocial factors in individuals with chronic (>1 year post-injury) 

 
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spinal cord injury (SCI) 
 
Secondary objective: To determine whether improvements in PA have beneficial effects 
on arterial stiffness (aortic pulse wave velocity; aPWV) and secondary health outcomes 
(cardiovascular and fitness indices) in individuals with chronic (≥ 1 year post-injury) 
SCI. 
 
Research Design: This study will employ a multi-centre, randomized, wait-list 
controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 
18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. Physical 
activity measures will be taken using wrist-based accelerometers and the Physical 
Activity Recall Assessment for Persons with SCI. Psychosocial factors will be evaluated 
through questionnaires. The primary health outcome measure (aPWV), and secondary 
cardiovascular parameters will be assessed using a combination of echocardiography and 
ultrasound. Fitness will be determined using a peak oxygen consumption test on an arm-
cycle ergometer. All measurement will be taken at baseline and after 9 weeks following 
intervention commencement. Physical activity will also be sampled mid-intervention at 4 
and 7 weeks.  For the wait-list control group, an additional measurement time point will 
be added after they have received the intervention upon completion of the control period. 
Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All pre- and 
post-assessments will take place at the Blusson Spinal Cord Centre at ICORD or the 
University of British Columbia Okanagan. Intervention content will be delivered over 
Skype or phone, and the wrist- worn accelerometers will be delivered and picked up from 
the participant’s home during the intervention.  
 
Statistical Analyses: Analyses will be conducted to determine the training (time), group 
(control vs experimental) and interaction (time x group) of all indices. 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
SUMMARY .............................................................................................................. 2 
Preamble ................................................................................................................... 5 
1. 
BACKGROUND AND PROGRAM RATIONALE ........................................... 5 
1.1 Physical inactivity and spinal cord injury (SCI) ............................................................... 5 
1.2 Physical inactivity and cardiovascular disease (CVD) in spinal cord injury (SCI) ......... 5 
1.3 The Health Action Process Approach and physical activity interventions in spinal cord 
injury........................................................................................................................................ 6 
2. 
PURPOSE & HYPOTHESES ........................................................................... 6 
3. 
RESEARCH DESIGN/ PROTOCOL ................................................................ 7 
4. 
RECRUITMENT .............................................................................................. 9 
5. 
OUTCOME MEASURES................................................................................ 10 
Primary Outcome Measure: Physical activity ................................................................. 10 
6.1.1: Physical Activity Recall Assessment for People with Spinal Cord Injury (PARA-
SCI): ...................................................................................................................................... 10 
6.1.2: 6-day Physical Activity Monitoring Period................................................................. 10 
Measurement of energy expenditure during different sub-maximal wheeling speeds for 
calculation of moderate-vigorous physical activity during the 6-day physical activity 
monitoring period .................................................................................................................. 11 
Secondary Outcome Measure: Psychosocial factors influencing PA participation .......... 11 
6.2.1 Health Action Process Approach Model Measure ....................................................... 11 
6.2.2 Semi-Structured Interview: .......................................................................................... 11 
Tertiary Outcome Measure: Arterial stiffness ................................................................ 12 
6.3.1 Pulse Wave Velocity .................................................................................................... 12 
Quaternary Outcome Measure: Cardiovascular and Fitness Parameters ....................... 12 
6.4.1 Arterial structure: Wall thickness and lumen diameter ................................................ 12 
6.4.2 Flow mediated dilation ................................................................................................. 12 
6.4.3 Cardiac structure and function...................................................................................... 12 
6.4.4 Aerobic Fitness Evaluation: Peak oxygen uptake test (VO2peak) ............................... 13 
6. 
ADVERSE EVENTS ....................................................................................... 13 
7. 
ADHERENCE ................................................................................................. 15 
8. 
DATA ANALYSIS .......................................................................................... 15 
9. 
CONFIDENTIALITY ..................................................................................... 16 
10. 
REFERENCES ............................................................................................ 16 
 
 
 
 

 
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Preamble 
Increased morbidity and mortality in chronic SCI appear to be caused by inactivity-
related illnesses; for example, cardiovascular disease (CVD) is the primary cause of 
illness and death in this population.1 People with SCI develop CVD at younger ages and 
at greater rates than the able-bodied population.2–5 Given that a sedentary lifestyle is one 
of the most important modifiable risk factors for CVD.6 a logical course of action would 
be to increase physical activity (PA) in individuals with chronic SCI.  
 
Despite the benefits of PA, people with SCI report some of the lowest rates of PA 
participation when compared to abled bodied samples and samples of other chronic 
diseases.7 Given the number of barriers people with SCI face to participating in PA, 
strategies that are specifically tailored to promote PA to people with SCI are needed.8,9 
Previous studies have supported that the Health Action Process Approach (HAPA) model 
may be an appropriate guide for designing physical activity interventions for people with 
SCI.10–12 To date, no intervention has explicitly tested the HAPA model and its potential 
use of all constructs to guide intervention content for delivery to people with SCI. 
 
1. BACKGROUND AND PROGRAM RATIONALE 
1.1 Physical inactivity and spinal cord injury (SCI) 
Adults living with SCI not only exhibit lower PA levels than able bodied 
samples, but also show some of the lowest rates of PA participation among samples 
with chronic disease and disability.7 In an epidemiological study of nearly 700 
Ontarians with spinal cord injury, 50% reported engaging in no leisure time PA 
whatsoever.13 These low levels of PA can significantly impact the long-term health of 
people with SCI. 
1.2 Physical inactivity and cardiovascular disease (CVD) in spinal cord injury (SCI) 
Increasing PA may have potent effects on decreasing cardiovascular disease 
risk, the primary cause of illness and death in people with SCI.1 Able-bodied 
individuals who participate in regular PA experience a 40-50% reduction in risk of 
CVD compared to sedentary counterparts.14 In addition, PA reduces CVD risk in 
obese individuals independent of any effect on weight.15 Interestingly, modifications 
in traditional risk factors with exercise training do not fully account for the 
observed reduction in risk in people with SCI. For example, a literature review 
suggested that contrary to the able-bodied population, body mass index is not an 
accurate predictor of obesity and coronary heart disease in people with SCI.16 Thus, 
examining the effects of exercise on other parameters that may act as surrogate 
measures of health status (e.g. cardiac, vascular, and fitness) are warranted. In 

 
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combining the evidence for low PA rates and the potential effectiveness of PA to 
improve health in people with SCI, strategies to improve the current state of 
physical inactivity and ultimately the health of Canadians living with an SCI are 
needed. 
1.3 The Health Action Process Approach and physical activity interventions in spinal 
cord injury 
The Health Action Process Approach (HAPA) model may be an effective model 
to guide PA intervention development for people with SCI. A large-scale cross-sectional 
examination has previously shown that the HAPA model can be used to predict levels of 
PA based on their level of motivation (i.e. pre-intender, intender, actor) 12. Further, 
experimental studies have supported that targeting specific constructs of the HAPA 
model (e.g. self-efficacy and planning) can improve PA behaviour (Arbour-Nicitopoulos 
et al., 2013; Latimer-cheung et al., 2013). Thus, the evidence is building in support of the 
use of the HAPA model for changing PA behaviour in this population. 
A limitation of these interventions is no study to date has examined the effects of an 
intervention that incorporates all constructs of the HAPA model. The Health Action 
Process Approach (HAPA) is a hybrid stage/ continuum theory 19,20. Specifically, risk 
perceptions are proposed to stimulate cognitive processing to consider outcome 
expectations, which work reciprocally with task self-efficacy (SE) to form intentions. 
Planning (action planning/ coping planning) mediates the intention- action 
relationship 21. Action is sustained through ongoing processes of action control. 
Task SE, maintenance SE, and recovery SE are implicated to play a role in intention 
formation, planning, and action, respectively, with task-self efficacy also important 
for planning, and maintenance SE also supporting action. Lastly, barriers, resources, 
and social supports are proposed to influence intentions, planning, and action. As 
previously demonstrated, planning and self-efficacy are very important constructs 
in the HAPA model, however, given the number of barriers people with SCI face in 
participating in PA it is likely that more complex interventions are needed to 
overcomes these barriers and facilitate sustained behaviour change. Thus, an 
examination of other constructs (e.g. resources, outcome expectancies, action 
control) that may be tailored to the participants (e.g. based on stage of motivation, 
identified barriers) should be examined for their role in changing PA behaviour in 
this population. 
2. PURPOSE & HYPOTHESES 
Primary objective: To determine whether brief PA coaching sessions guided by the 
HAPA model can change PA behaviour and psychosocial factors in individuals with 
chronic (>1 years post-injury) spinal cord injury (SCI) 

 
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Secondary objective: To determine whether improvements in PA have beneficial effects 
on arterial stiffness (aortic pulse wave velocity, aPWV) and secondary health outcomes 
(cardiovascular, fitness) in individuals with chronic (≥ 1 years post-injury) SCI. 
 
Hypothesis i: Physical activity levels will be higher in the experimental than the wait-list 
control group. 
 
Hypothesis ii: Self-reported HAPA model constructs (e.g. action planning, self-efficacy) 
will be improved in the experimental group compared to the wait-list control group. 
 
Hypothesis iii: Participants who report higher levels of PA will have greater 
improvements on arterial stiffness and secondary health outcomes (cardiovascular, 
fitness). 
3. RESEARCH DESIGN/ PROTOCOL 
A multi-centre, randomized, wait-list controlled trial will be used to compare the 
effects of tailored PA coaching sessions versus no coaching on PA behaviour, 
psychosocial factors, and health outcomes. Eligible individuals will be randomly assigned 
(1:1) to either the experimental (PA coaching sessions) or wait-list control condition. 
Groups will be stratified by injury level, age, and site. The randomization sequence will 
be generated by a research assistant independent of the trial. For an overview of the 
protocol see Figure 1.  
 
Figure 1. Study Overview 
 
 
Day 1 testing measures include vascular measures (arterial pulse wave velocity, 
arterial structure, and flow mediated dilation; 30 minutes), cardiac structure and function 
measures (30 minutes), administration of the demographics and Health Action Process 
Approach model questionnaire (25 minutes), and a measurement of energy expenditure at 
different sub-maximal wheeling speeds to calibrate MVPA cut-points (35 minutes) for a 
total duration of 2 hours. Participants will be given an accelerometer to wear for the 6-
day monitoring period (6.1.2) after which they will return for Day 2 testing. 
 
Day 2 testing measures include administration of the PARA-SCI (45 minutes), a peak 
oxygen uptake test (45 minutes), and at baseline, the first PA coaching session will be 

 
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administered (30 minutes) whereas at post-test a semi-structured interview will be 
administered (30 minutes). Total duration of day 2 testing will be 2 hours. The 
intervention protocol is described below. During the intervention, physical activity will 
be sampled at two time points; accelerometer and PARA SCI data will be taken during 
week 4 and week 7. Following the intervention, follow-up assessments of physical 
activity will be sampled monthly for 12 months in the intervention group only using the 
Leisure Time Physical Activity Questionnaire. 
 
INTERVENTION 
Intervention Protocol: 
Experimental participants will receive weekly PA coaching sessions. Each session 
will be 10-15 minutes in duration and delivered either face to face, over Skype, or when 
the former modes are unavailable, over the phone. These sessions will be recorded using 
a portable audio recorder. Additionally, supplemental resources may be emailed to the 
participants based on need throughout the intervention. 
Participants’ motivation to exercise will first be determined according to stages of the 
HAPA model. Those who identify as pre-intenders (no intention to exercise) will receive 
intervention strategies that focus on changing motivation to be physically active. Those 
identified as intenders (willing to exercise but have not started) will focus on providing 
resources and behavioural strategies to commence physical activity. Lastly, those 
identified as actors (already exercising) will receive intervention strategies that help 
participants maintain or improve PA behaviour.  
For those in the intender or actor stage, the intervention aims to promote the 
international SCI PA guidelines to promote fitness (at least 20 minutes of moderate 
vigorous aerobic activity twice/week and strength training twice/week). For those 
exceeding the fitness guidelines, the international SCI PA guidelines to promote health 
are promoted (at least 30 minutes of moderate to vigorous aerobic activity three 
times/week and strength training twice/week). However, these aims will be modified 
based on the individual’s baseline PA. During the first visit, participants’ baseline PA 
levels will be reviewed and an appropriate PA goal to achieve in the following month 
will be formed. In line with small changes PA goal setting, no pre-set goal grading 
strategies are established.22 In general, the goal of increasing daily PA by ten minutes on 
at least two days/week is provided as a guideline for grading the increase in goals. 
However, ultimately, the goal is the decision of the participant.  
Following goal setting, barriers to participating in PA will be identified. The 
interventionist will select intervention strategies based on the identified barriers. A pre-
formed chart of corresponding intervention strategies (e.g. use of behaviour change 
techniques, referral to facilities or peers, suggesting at-home exercises) was developed to 
aid this pairing process (Appendix A). These intervention strategies are accompanied by 

 
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a comprehensive toolkit based from the HAPA model (Appendix B). In brief, the toolkit 
advises on three key strategies for promoting PA to people with SCI: i) education, ii) 
referral, iii) tailored PA prescription.  
Remaining weekly coaching sessions will review participants’ progress and barriers 
to discuss new goals and strategies as outlined above.  
 
Control Participants:  
Control participants will complete baseline and post-testing only. Following 
completion of post-test measures they will be administered the same PA coaching session 
as the intervention group, with post-test measures being repeated upon intervention 
completion.  
 
Standardization across sites 
The intervention will take place in Vancouver for the months of April to July and in 
Kelowna from August to October. The same equipment brand and model will be used 
between sites where available. All intervention content, psychological, and fitness 
measures will be delivered by the same researcher. Although vascular and cardiac 
measures will be administered by different researchers in Vancouver and Kelowna, all 
technicians are experienced in their respective techniques, decreasing the likelihood of 
human error.  
4. RECRUITMENT 
A total of 30 participants with a chronic (>1 year post injury) spinal cord injury 
between 18-65 years of age will be recruited. Individuals must be competent to give 
informed consent, and be able to propel an arm ergometer.  
 
Exclusion Criteria: 
• History and/or symptoms of CVD or cardiopulmonary problems/disease. 
• Major trauma or surgery within the last 6 months. 
• Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory 
Panel classification) 
• Recent (within 1 year) history of lower-extremity or non-union fracture 
• Any unstable medical/psychiatric condition or substance abuse disorder that is 
likely to affect their ability to complete this study. 
• Individuals with active medical issues such as pressure sores, urinary tract 
infections, hypertension, or heart disorders. 
• Any cognitive dysfunction or language barrier that would prevent subjects from 
following English instructions. 
• Subjects may be excluded at the discretion of the principal investigator due to 
other, unforeseen, safety issues. 

 
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Sample size calculation: Our study is powered to detect a significant condition X time 
effect for our primary outcome measure, min/wk of PA. A previous single-group study of 
adults with SCI tested the effects of a PA-enhancing intervention delivered by a peer and 
a fitness trainer (Latimer-Cheung et al., 2013). That study found very large, significant 
effects for change in min/wk of PA (d = .96). Given our two-group design, we are 
powering for a more modest interaction effect (d = .75). Twelve participants/condition (N 
= 24) are needed to yield a significant effect of this magnitude in a repeated measures 
ANOVA, with β = .80 and α = .05. To account for study dropouts, we are budgeting for 
an N of 30. 
 
Potential participants will be identified through a variety of recruitment strategies 
including: posters which will be distributed among hospital locations and local 
community venues (e.g. local sports venues, community program centres); social media 
advertising (i.e., website, Facebook, Twitter); email; and at the individual’s request (some 
participants have previously provided consent to be contacted for future studies).  
5. OUTCOME MEASURES 
All measurements will be collected at the International Collaboration on Repair 
Discoveries (ICORD) in the Blusson Spinal Cord Centre or the University of British 
Columbia Okanagan.  
Primary Outcome Measure: Physical activity 
6.1.1: Physical Activity Recall Assessment for People with Spinal Cord Injury 
(PARA-SCI): 
Participants will be asked to complete a 3-day PA recall (PARA-SCI) guided by the co-
investigator (Jasmin Ma). The recall assessment will take approximately 30 minutes to 
complete.  
6.1.2: 6-day Physical Activity Monitoring Period 
Participants will be fitted with a wrist-based tri-axial accelerometer to be worn 24 hours a 
day for 6 days in order to determine intensity and amount of PA. They will keep a 
detailed PA diary recording all leisure time PA performed during the day. The primary 
outcome will be minutes of PA per day equivalent to moderate intensity or higher (≥ 3 
SCI METs determined from individual calibrations, see 2.14) from a tri-axial wrist-worn 
accelerometer (GT9X, ActiGraph LLC, FL). During the intervention, the accelerometer 
will be picked up and dropped off to the participant’s home to decrease burden. Text or 
email reminders (i.e. “Please don’t forget to wear your accelerometer today”) will be 
used to promote adherence to accelerometer wear. 

 
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Measurement of energy expenditure during different sub-maximal wheeling speeds for 
calculation of moderate-vigorous physical activity during the 6-day physical activity 
monitoring period  
We will assess energy expenditure during different sub-maximal wheeling speeds on 
a treadmill (self-selected slow, medium, fast) to establish cut points relating wrist-based 
accelerometer counts to intensity of PA in SCI. Participants will be required to push at 
each of the 3 speeds for 5 min/stage to ensure steady state is reached. 
Resting heart rate (Polar T31 heart rate monitor, Polar Electro Inc., Woodbury, NY, US), 
brachial artery blood pressure (Carescape™ V100; GE Healthcare, 
Buckinghamshire, UK) will be measured two minutes prior to wheeling.  Heart rate will 
be measured continuously throughout the test and blood pressure will be measured again 
at the end of each stage. Breath-by-breath gas exchange indices will be assessed using an 
online system (sensorMedics V Max).  We will then relate activity counts from the 
accelerometer to energy expenditure in SCI METs (1 SCI MET = 2.7ml/kg/min)23 to 
determine individualized cut-points for habitual PA monitoring and the subsequent 
determination of the amount of moderate-to-vigorous PA (≥ 3 SCI METs).  Individuals 
classified as ASIA D (have preserved muscle function below the level of injury) who do 
not use a wheelchair will not complete the treadmill cut-point evaluation for safety 
reasons (e.g. tripping while walking). Instead, able-bodied cut-points will be applied. In 
addition to the wrist accelerometer, a hip accelerometer and a pedometer will be worn to 
validate the wrist-based values for participants classified as ASIA D. 
6.1.3: Leisure Time Physical Activity Questionnaire 
Participants will be asked to complete a 7-day PA recall (LTPAQ) guided by the co-
investigator (Jasmin Ma). The recall assessment will take approximately 5 minutes to 
complete and will be done either in-person or over the phone.  
Secondary Outcome Measure: Psychosocial factors influencing PA participation 
6.2.1 Health Action Process Approach Model Measure 
This survey will examine psychological factors that may affect PA participation. The 
survey will be recorded either electronically or with pen and paper depending on the 
respondent’s preference. Survey will take approximately 25 minutes to complete, and 
will assess constructs related to exercise such as perceived risks, self- efficacy, planning, 
and social support. The demographics questionnaire will also be administered with this 
measure. 
6.2.2 Semi-Structured Interview: 
A semi-structured interview will be conducted at the end of the intervention to 
understand what components were and were not effective. Data will not be recorded. This 
feedback will be used to improve future iterations of the intervention. 

 
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Tertiary Outcome Measure: Arterial stiffness 
6.3.1 Pulse Wave Velocity 
aPWV (m/s) is calculated by dividing the distance between measurement sites, by 
the pulse transit time. Distance between the carotid and femoral arteries will be measured 
using measuring tape along the surface of the body, held parallel to the testing table. The 
pulse transit is determined from the arterial blood pressure waves, which are collected at 
each arterial site. A pen-like device (model SPT-301; Millar Instruments Inc., Houston, 
TX) will be applied to the carotid and femoral arterial sites using a light pressure to 
obtain arterial pressure waves. Heart rate will be recorded using a single-lead (lead I) 
electrocardiogram (ECG) (model ML 123, ADInstruments Inc., Colorado Springs, CO).  
Quaternary Outcome Measure: Cardiovascular and Fitness Parameters 
6.4.1 Arterial structure: Wall thickness and lumen diameter 
Carotid arterial images will be collected using B-mode ultrasound (INFO) for 10 
cardiac cycles. Images will be analyzed using internal ultrasound software to determine 
lumen diameter and intima-media thickness. 
 
6.4.2 Flow mediated dilation 
 
A tight cuff will be placed on the upper 1/3 of the forearm and will be inflated to 
200mmHg for 5min to occlude blood flow. The brachial artery diameter and blood 
velocity will be measured 1-minute prior to cuff inflation, 30 seconds before cuff 
deflation, and for the subsequent 3 minutes following cuff deflation.24 The vasodilatory 
response will be assessed using wall-tracking software capable of continuously assessing 
vessel diameter and blood flow velocity. 
 
6.4.3 Cardiac structure and function 
Cardiac images will be collected non-invasively using Doppler ultrasound (Vivid 
q, GE Healthcare, Buckinghamshire, UK). Briefly, apical four and two-chamber views, 
and parasternal short and long-axis views will be collected and stored on the ultrasound 
for offline analysis. Indices of interest will include volumes (end systolic (ESV), end 
diastolic (EDV)), diameters (intraventricular septum systole (IVSs) and diastole (IVSd), 
left ventricular internal diameter systole (LVIDs)), systolic function (left ventricular 
posterior wall systole (LVIDd) and diastole (LVPWd), ejection fraction (EF), cardiac 
output (CO), fractional shortening, mitral regurgitation (dP/dT)) and diastolic function 
(E/A, E/e’ ratio, IVRT, DT).  

 
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6.4.4 Aerobic Fitness Evaluation: Peak oxygen uptake test (VO2peak)  
Participants will perform a graded arm ergometer test on an electronically braked arm 
ergometer (Angio Rehab arm ergometer, Lode, Groningen, the Netherlands), height 
adjusted so that the shoulder joint is aligned with the crank axis of the ergometer. Blood 
pressure (Dinamap Carescape V100; GE Healthcare, Buckinghamshire, UK) and 
respiratory measures (Quark CPET, Cosmed, Rome, Italy) will be collected two minutes 
prior to exercise. Heart rate will be recorded at one-second intervals via a chest strap 
heart rate monitor (Garmin, Schaffhausen, Switzerland). For participants with tetraplegia 
who have limited handgrip function, gloves (Active Hands, Solihull, Great Britain) will 
be used to secure hands to the ergometer handles. Participants will be instructed to 
maintain a cycling rate of 50 revolutions per minute (rpm) for the duration of the test. 
After an initial warm-up at 0W, power output will be increased each minute at a rate of 2-
5 W/min for participants with tetraplegia, or 10 W/min for participants with paraplegia, 
until volitional exhaustion (i.e. dropping below 30 rpm). Ratings of perceived exertion 
(Borg 6-20 scale)25 will be collected in the final 10-seconds of each stage. Oxygen 
consumption will be recorded on a breath-by-breath basis for the duration of the test and 
reported as rolling 30-second averages sampled at 5-second intervals as per consensus 
recommendations26. This test is used to determine participants’ peak oxygen uptake, 
ventilatory threshold and maximum heart rate. 
 
6. ADVERSE EVENTS 
Exercise will not be supervised by the interventionist, but physical activity 
recommendations will be made by a personal trainer.  Participants will be advised that for 
up to 48 hours after exercise, the participant may experience delayed-onset muscle 
soreness as a result of performing strength training exercises. To minimize physical risks, 
the personal trainer will provide clear exercise instructions and training tips to ensure that 
proper technique and form are used.  Participant feedback on the exercise perceived 
physical effort (mild, moderate or heavy) will be monitored weekly and the personal 
trainer will adapt the exercise plan as necessary to accommodate for this feedback.   
 
A systematic review of adverse events reported in exercise interventions involving 
people with SCI was recently conducted. The limited adverse event data for upper-body 
training (aerobic or resistance) suggested that adverse events were rare, except for the 
occasional occurrence of musculoskeletal complaints.27 Thus, it appears safe for adults 
with chronic SCI to exercise. 
 
To minimize psychological and social risks in general, participants will be advised 
that their participation is completely voluntary, their data are completely anonymous, and 
that they may withdraw from the study at any time without penalty.  In addition, to 

 
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minimize mental strain, the research assistant will attempt to keep the physical activity 
coaching sessions to less than 15 minutes, allow participants to take breaks as needed 
and/or discontinue participation at any time during the session.   
 
8. ADVERSE EVENTS  
The study will be overseen and monitored by Dr. Christopher West (ICORD, 
Vancouver, BC Canada) and Dr. Kathleen Martin Ginis (UBC, Kelowna, BC Canada), 
who will visit their respective sites to examine trial procedures, ensure data quality, and 
monitor compliance with the study protocol.  
Should an adverse event occur during exercise at the Vancouver or Kelowna site, subjects 
will be assisted by staff trained in emergency procedures. At the Vancouver site, 
defibrillators and resuscitation equipment will be in the training room at all times and if 
required physicians are within the building to provide emergency response. All exercise 
sessions in Vancouver are implemented on a hospital site where the VGH Emergency 
Department is nearby (920 W 10th Ave). At the Kelowna site, defibrillators and 
resuscitation equipment are located in the adjacent lab (ARTS 183), 911 will be dialed in 
case of on an emergency, and if needed will be transported to Kelowna General Hospital 
(2268 Pandosy St- 15-20 minutes via ambulance). There is also on-campus advanced life 
support team who have a fast (<5 minute) response time. Their phone number (250-807-
8111) is located in the lab if needed. The researcher is certified in CPR C. 
Autonomic Dysreflexia (AD)  
AD is a common complication with SCI at or above the sixth thoracic level (T6) and is 
caused by loss of cardiovascular control. AD can be a life-threatening condition if not 
recognized and treated properly. Symptoms include: pronounced hypertension (rapid 20- 
40 mm Hg systolic rise); bradycardia or tachycardia; pounding headaches; anxiety; 
changes in vision; nasal congestion; sweating; goose bumps; and flushed skin. When 
reporting cases of AD, severity will be classified into mild, moderate and severe cases, 
based on observed symptoms. In the event that moderate to severe AD is suspected 
during testing sessions, the investigator will follow the steps outlined below:  
I. Have the participant sit upright or raise their head 90 degrees   
II. Take off or loosen any tight or restrictive clothing   
III. Monitor blood pressure every 2-3 minutes if hypertensive   
IV. Empty bladder and check for kinks and blockages if using an indwelling catheter  

 
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V. Check skin for new wounds, pressure ulcers, burns, cuts, insect bites etc.   
VI. Check for any other negative stimulus below the lesion level   
VII. If no stimulus is found and blood pressure does not change in 2 minutes, call for 
 medical assistance and ambulance (Dial 88 for emergency response in 
Vancouver General Hospital, 911 in Kelowna).   
 
Orthostatic Hypotension (OH)  
OH is a common complication of SCI where the individual is unable to maintain 
homeostatic blood pressure during a change in body position. Symptoms include: 
lightheadedness and loss of consciousness. In the event OH is suspected during testing 
sessions, the investigator will follow the steps outlined below:  
i. Have the participant lie down in the supine position and monitor blood pressure every 
2 minutes   
ii. If consciousness does not return within 5 minutes, call for medical assistance (Dial 88 
for emergency response in Vancouver General Hospital, 911 in Kelowna)   
 
 
7. ADHERENCE 
With a total of 9 physical activity coaching intervention sessions, a minimum of 6 
sessions must be attended to be included for data analysis. Accelerometer wear time must 
exceed 600 min/day over 4 days to be included as a measure of physical activity for any 
given time point.  
8. DATA ANALYSIS 
To test hypothesis i, differences in physical activity levels will be examined using 
repeated measures analyses of covariance with baseline physical activity as the covariate. 
Where significant intervention x time interactions are found, post-hoc analyses will be 
conducted to determine the specific time point at which differences in physical activity 
between groups are found. 
 
To test hypothesis ii, independent samples t-tests will compare post-intervention HAPA 
model constructs between groups. 
 
To test hypothesis iii, we will use separate hierarchical regressions with change in 
physical activity entered as the predictor of change in arterial stiffness and secondary 

 
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health outcomes (cardiovascular, fitness). 
 
9. CONFIDENTIALITY 
 
The investigator will ensure that the anonymity of each participant is maintained and 
identity is protected from unauthorized parties. A unique identification number will be 
assigned to each participant upon study entry, which will be used to identify them for the 
duration of the study. 
Any reports or publications about the study or any other research will not include the 
participant’s name or any other personal identification information. If the participant 
desires, the investigator will provide access to the published results of the study. 
Participant names will not be placed on any mailing lists or sold to anyone for marketing 
purposes. The Research Ethics Board may have access to information about participants 
and data regarding the performance of the treatments on a confidential basis.  
All data collected (electronic or hardcopy documents) will be coded with the unique 
identification numbers and stored on a password-protected computer or in a locked filing 
cabinet in a secure laboratory space only accessible to the study investigators. This 
includes data from the accelerometers and audio recordings. When data is needed to be 
transferred, data will be transferred via password protected zipfolder to an encrypted, 
password-protected USB until it is downloaded onto the password-protected computer at 
UBCO. The online questionnaire is administered by the UBC-hosted version of 
FluidSurveys. All data will be stored and backed up in Canada. All data will be kept for 5 
years after publication, after which it will be destroyed. 
Contact information will be used to organize testing/ training sessions and for payment 
only unless you have indicated that you would like to be contacted for future studies. This 
research is part of a PhD thesis. Results will become publically available on cIRcle 
(http://circle.ubc.ca). 
 
10. REFERENCES 
 
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