Feasibility and Acceptability of Six-weeks of High Intensity Interval Training in Wheelchair Users With SCI
Phase: NA
Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Sponsor: University of Pittsburgh

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Feasibility and acceptability of six-weeks of high intensity 
interval training in wheelchair users with SCI 
 
 
Short Title:   
 
HIIT in Spinal Cord Injury (HIIT-SCI)   
 
 
Principal Investigator: 
Alicia Koontz, PhD, RET 
Human Engineering Research Laboratories 
VA Pittsburgh HealthCare System 
University of Pittsburgh 
6425 Penn Avenue, Suite 400 
Pittsburgh, PA 15206-4022 
Phone: 412-822-3700 
 
 
Funded By: 
 
 
University of Alabama – Birmingham 
1720 University Blvd 
Birmingham, AL 35294 
(205) 934-4011 
 
Eunice Kennedy Shriver National Institute of Child Health and 
Human Development (NICHD) 
NIH Clinical Center 
10 Center Dr 
Bethesda, MD 20814 
 
 
Study Protocol Number: 
NCT03152110  
(National Clinical Trials)  
PRO17020277  
(OSIRIS) 
 
 
 
 
STUDY19040142  
(University of Pittsburgh) 
 
 
 
 
 
 
 

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Overview 
An upper extremity form of high intensity interval training (HIIT) that is effective, safe, quick and 
has acceptable positive affect could be an attractive option for persons with SCI who are not 
presently exercising and have low fitness levels. The study will look at feasibility and acceptability 
of a 6-week HIIT program for persons with a spinal cord injury/dysfunction who are untrained. 
Additionally, the study will look at the effects of the training program on changes in activity levels. 
Participants will complete a 6-week HIIT training program in their homes, as well as two laboratory 
visits where aerobic and anaerobic fitness will be measured. 
 
Research Activities and Consent 
Potential subjects who contact the Human Engineering Research Laboratories (HERL) and express 
an interest in the study will undergo a brief telephone screening. The telephone screening will be 
used to provide the potential subject with more information and allow them to ask questions 
regarding the research study to help them determine their interest in participating. During the phone 
screening, we will ask them basic questions to see if they might qualify for the study. These 
questions will be based on the inclusion/exclusion criteria for the study, as well as questions about 
their current lifestyle. Prior to asking the participants these questions, we will make sure they 
understand why we are asking these questions and obtain their permission to do so. We will note the 
date and time of the permission obtained. We will use the Exercise Stages of Change Questionnaire, 
as well as questions about their current fitness activities to asses eligibility for the study. We want to 
make every effort to determine whether or not a participant would potentially qualify for the study 
prior to contacting their Primary Care Physician (PCP). 
Obtaining the approval of a physician is highly recommended for anyone starting an exercise 
program, regardless of disability. We will rely on the potential subject’s PCP in order to assess their 
readiness to participate in the research study. A participant’s PCP will know their medical history, 
and will be able to evaluate their overall health. The physician's release form will detail the study and 
list all contraindications. In addition, the PCP may contact the study team should he/she need 
additional information prior to signing the release form. The study team will not access any medical 
records. “ 
Location of testing: (1) two in-lab visits at University of Pittsburgh, Endocrinology and Metabolism 
Research Lab (Montefiore Hospital); (2) subjects’ homes or an agreed upon location where it's safe 
to store exercise equipment and for our research staff; (3) if necessary, there may be a visit at the 
Human Engineering Research Laboratories or a safe, agreed upon location for the purposes of 
retrofitting the add-on hand bike (this is detailed further below). 
A subject who contacts HERL over the phone will be asked for their verbal consent to the screening 
procedure. The screening procedure will include asking the participant the inclusion/exclusion 
criteria. The screening procedure will also determine which training options are available for them 
(i.e., handcycle and/or add-on hand bike). For example, if a person meets all the inclusion/exclusion 
criteria and they weigh less than 250 lbs, they will have the option to train using a handcycle or an 

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add-on hand bike. If a person meets all the inclusion/exclusion criteria and they weigh more than 250 
lbs, they will have the option to train using the add-on hand bike or not to participate. If the add-on 
hand bike option is selected, they will be asked to report the make/model of their wheelchair for 
retrofitting purposes. The study team feels that wheelchair make/model is sufficient information to 
determine whether the add-on hand bike can be retrofitted; however, an additional in-person visit 
may be scheduled for fitting purposes. 
If the participant is eligible and would like to participate, the study team will send a physician release 
form to be signed directly by the physician (please see “Cover Letter for Physician Release” and 
“PCP Release” under the “Supporting Documentation” section). After the study team receives the 
signed release form, the participant will be scheduled for their Visit 1, Baseline Visit. Participants 
will be given the following instructions prior to their first lab visit: 
1. Do not participate in any strenuous physical activity 24 hours prior to testing. 
2. Do not eat a large meal 4 hours prior to testing, however a light snack is okay. 
3. Do not drink alcohol or caffeine 4 hours prior to testing. 
4. No smoking 1 hour prior to testing. 
5. Wear comfortable, loose clothing that allows you to move your arms freely and that you can 
easily exercise in. 
 
Visit 1: Baseline Visit 
Eligible participants will be directed to come to the Endocrinology and Metabolism Research Lab to 
obtain written informed consent, complete study questionnaires, and perform baseline exercise tests. 
Participants will be considered enrolled in the study after they have signed the informed consent 
document.  
Participants will complete the following questionnaires regarding demographics, pain and health 
measures, general health and function, and physical activity: 
(1) Demographics questionnaire: May include information such as disability type, level of SCI, years 
with disability, age, gender, and information about their wheelchair (e.g. make, model, cushion, etc.). 
(2) Numerical Rating Scale (NRS): Participants will complete this scale once for each upper limb 
joint (wrist, elbow and shoulder). Participants will be asked to rate their average, most severe, and 
least severe wrist, elbow and shoulder pain during the last 24 hours using an 11 point scale (i.e. 0-10) 
anchored at the ends by "no pain" and "worst pain ever experienced." An 11 point NRS measure of 
intensity allows for comparison across clinical trials of pain treatment and is recommended as a core 
outcome measure for chronic pain clinical trials. NRS pain measures are widely used and have been 
shown to be valid and reliable assessments of pain. 
(3) Wheelchair Users Shoulder Pain Index (WUSPI): The WUSPI is a 15 item, self-report instrument 
that measures shoulder pain intensity, within the last week, in wheelchair users during various 
functional activities of daily living such as transfers, leading a wheelchair into a car, wheelchair 
mobility, dressing, bathing, overhead lifting, driving, performing household chores and sleeping. The 
WUSPI is a valid and reliable measure of shoulder pain. Test-retest reliability of the total index score 
was 0.99 and Cronbach's alpha (internal consistency) was 0.98. 

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(4) Short Form Health Survey Walk Wheel (SF-36 WW): A 36-item general health and function 
questionnaire that has been validated for persons with SCI/D. The SF-36 is a brief, multi-
dimensional, self-report health questionnaire that measures eight concepts: physical functioning, role 
limitation due to physical problems, bodily pain, general perception of health, vitality, social 
function, role limitation due to emotional problems and mental health. 
(5) Physical Activity Scale for Individuals with Physical Disabilities (PASIPD): The PASIPD is a 
13-item self-report instrument covering (1) leisure activities, (2) household activities, (3) 
occupational activities and (4) light, moderate, and strenuous sport and recreational activities. The 
scale asks individuals to report how many days and hours per week that they spend participating in 
these various physical activities and a total score is calculated that is expressed in a metabolic 
equivalent (MET). The maximum possible score on the PASIPD total score is 199.5 MET. 
(6) Physical Activity Stages of Change: This is a brief, 5-item, yes/no questionnaire that assesses an 
individual's readiness to exercise. 
(7) Exercise Participation Evaluation: This is a 4-item questionnaire developed by our study team 
that will be used to determine if the participant exercises, and if so, what type of exercise and how 
frequent. 
(8) Profile Of Mood States (POMS): This is a validated questionnaire that contains a series of 
descriptive words/statements that describes feelings. The participant will self-report on each of these 
areas using a 5-point Likert scale to assess total mood disturbance. 
Lastly, height and weight will be taken. Subjects will transfer to a mat table where they will lay on 
their backs. Once in this position we will measure their height with a measuring tape. Weight will be 
measured using a wheelchair scale. Participants will be weighed with their wheelchair and the 
wheelchair will be weighed without the subjects in them. The weight will be the difference between 
the two measurements. 
Following completion of all study questionnaires, participants will begin exercise testing. Both 
exercise tests will be administered by an exercise physiologist and directly supervised by a physician.  
Both tests have been widely used in previous research studies. The tests are outlined in further detail 
below: 
(1) Maximal aerobic exercise test: the purpose of this test is to evaluate cardiac function and fitness. 
Additionally, this test will determine peak power output (PPO) which will later be used to set an 
individualized goal for the participant during the HIIT protocol to be completed in the second, and 
possible third and fourth visits. Prior to starting the test, participants will be fitted with a mask that 
analyzes the air that is being inhaled and exhaled (also known as "open circuit spirometry"). 
Cardiorespiratory measures (i.e., heart rate, blood pressure, oxygen consumption, respiratory 
exchange ratio, pulmonary ventilation, carbon dioxide expiration, etc.) will be recorded throughout 
this test. A heart rate monitor will be worn around the chest. Participants will be able to use a private 
space to put on the heart rate monitor. A member of the study team will verify the heart rate monitor 
is placed properly. 
Prior to beginning the test, the Borg and Wheel scales will be explained to participants (please see 
“Borg Scale” and "Wheel Scale" under the “Supporting Documentation” section). Ratings of 

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Perceived Exertion (RPE) scales (such as the Borg and Wheel scales) rate how hard a person feels 
their body is working and is an accepted supplementary tool for exercise programs. Throughout the 
test, the participant will be asked to report their RPE by pointing to the corresponding number on the 
scale. The exercise test will be administered using an incremental, modified protocol on an 
electronically-braked arm ergometer. A study team member will choose one of two exercise 
protocols, depending on the answers to the questions on the demographics questionnaire. 
For one protocol, the resistance will initially be set at 10W and will increase by 10W every minute 
until the participant can no longer continue, or until their respiratory exchange ratio exceeds 1.15. 
For the second protocol, the resistance will initially be set at 35W and will increase by 10W every 
minute until the participant can no longer continue, or until their respiratory exchange ratio exceeds 
1.15. Both protocols will ask the participant to maintain an RPM of 55-65 revolutions per minute 
(RPM). If the RPMs drop below 55 for more than 20 seconds, the test will be completed. 
(2) Maximum power output test: the primary purpose of this test is to evaluate the highest amount of 
power that the participant can produce in a short period of time. Other measures include heart rate, 
blood pressure, relative peak power, anaerobic capacity and anaerobic fatigue. The same ergometer 
will be used for this study that was used for the maximal aerobic exercise test. Initially, the resistance 
will be set at zero and will then be increased over the duration of the test. The actual test will last one 
minute in duration. For the first 30 seconds, the participant will crank on the cycle with minimal 
resistance. Then, the resistance will be increased to a maximal level and participants will crank as 
hard and as fast as they are able to for the last 30 seconds. After that the test is completed, the 
resistance will then return to zero and the participants will cycle at a comfortable pace to cool down. 
Participants will rest a minimum of 20 minutes in between each assessment. 
Following completion of the exercise tests, the study team will introduce the participant to the type of 
exercises that will be performed for the study. They will be able to use the ergometer in the lab to try 
out a brief HIIT protocol. 
 
Activity Monitor Data Collection 
Activity monitors will be given to participants to address aim 5 as equipment is available. The 
following study procedures will not be performed if the monitors are not available. The following 
procedures will be followed when monitors are available and activity data is going to be collected. 
After the participants are introduced to the training, they will be given the two activities monitors that 
will be used to look at activity for the duration of the study. A SensorTag gyroscope will be secured 
to the participants wheelchair wheel in a position where it will not affect propulsion. This sensor will 
remain on the wheel for the duration of the study. Participants will also be given an ActiGraph GT9X 
accelerometer. This sensor will be worn on the wrist like a watch. The subject will be shown how to 
use the activity monitors (including donning/doffing, and operation), and provide ample time for 
practice. The subject will be asked to demonstrate how to use the devices to ensure compliance. 
Participants will be instructed to wear the activity monitor at all times as tolerated, including 
sleeping, or most of time, except for showering/bathing and swimming. Participants will be given 
instructions and details on how to use/wear the monitors. 

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At the regularly scheduled training visits, the trainer will monitor the function of the monitors. They 
will download data and replace sensor batteries as needed. 
The baseline period of activity collection will be the time after the first study visit at Montefiore 
hospital until the first in-home training session occurs. 
Visit 1 will take up to 3 hours to complete. 
 
6-Week HIIT Protocol: 
If the participant already owns a handcycle, we will make every attempt to fit their handcycle to the 
roller system that will be used for the study. If we are not able to retrofit their handcycle or if they do 
not own a handcycle, the study team will provide a handcycle for the duration of the program. If a 
participant is unable to transfer into the handcycle, then the study team will provide assistance and 
tips for how to get in and out. If a participant is still uncomfortable with transferring into the 
handcycle, then they may be provided with an add-on hand bike, or they have the option to not 
participate in the study. At the end of the study, the handcycle/hand bike and the roller system will be 
returned to the study team. Participants will be given a heart rate monitor, which they will be asked 
to wear and use for every exercise session for the duration of the study. They do not have to return 
the heart rate monitor at the end of the study. Participants will be provided with a bike computer that 
will be fit to the handcycle/hand bike and will be used solely for the purpose of recording power 
output and heart rate during the exercise sessions. Participants must return the bike computer at the 
end of the study. 
The first exercise visit will be tentatively scheduled within one week of the first study visit. Exercise 
sessions will be scheduled, ideally, 3 times per week (every other weekday), with the total training 
protocol lasting 6 weeks. Two of the sessions will be supervised by a trainer and one session will be 
completed on their own. The trainer may go to the third session if the participant requests assistance 
getting in and out of the handcycle or attaching the add-on hand bike, however, they will not provide 
any coaching or verbal cues during exercise. During the last week (week 6), subjects can opt to have 
their supervised sessions via FaceTime or Skype (if they have a smartphone or computer). The 
exercise goal for all participants is to achieve 10 sets of 60 second bouts of arm cycling at 90% of 
their PPO (as determined in baseline testing), separated by 60 seconds of active recovery. 
Further details regarding the supervised and unsupervised workouts are explained below. 
(A) Supervised exercise sessions: the trainer will meet the participant at their home for each 
supervised exercise session. Prior to exercise, the trainer will measure/record the participant’s heart 
rate and blood pressure. In addition, the trainer will make sure that there haven’t been any recent 
changes in health or medical status (please see “Exercise Training Intake Form” in the “Supporting 
Documentation” section). 
The trainer will guide the participant through a warm-up and stretching routine prior to exercising 
(approximately 10 minutes). The participant will be familiarized with the same Borg and Wheel RPE 
scales used during Visit 1, and the Feeling Scale (please see "Feeling Scale" in the "Supporting 
Documentation" section). The Feeling Scale (-5 very bad to +5 very good) is commonly used to 
measure affective response during exercise. 

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The trainer will prescribe individualized work and rest phases based on their PPO from their maximal 
aerobic test. In order to reach the HIIT goal mentioned above, the trainer will hold participants at 
90% PPO as a constant target intensity to start, shortening the work phase (e.g. 10-15 seconds), and if 
necessary, lengthening the recovery phase (e.g. 75-90 seconds). These ramping parameters will be 
progressed and documented by the trainer for each session. The trainer will determine when to 
change their work and rest parameters based off of heart rate and self-reported RPE. 
At the end of each session, the trainer will measure/record the participant’s heart rate and blood 
pressure again. Power output and heart rate data is automatically stored in the bike computer during 
each exercise session. After each session, the data will be transferred to a study iPad/laptop via USB 
and then deleted from the device. These measures are collected to evaluate adherence to the 
prescribed HIIT intensities. 
(B) Unsupervised exercise sessions: participants will be asked to repeat the same HIIT protocol they 
performed during the previous supervised session. The trainer will provide written directions for their 
convenience. Participants will be instructed to wear the heart rate monitor so that during the next 
supervised exercise session, the trainer will be able to retrieve/collect the data to store on one of our 
study devices for future analysis. The heart rate data as well as power output data will automatically 
be stored on the device in the same manner as during the supervised sessions. At the next supervised 
session, the trainer will retrieve the data from the device. 
 
Visit 2 
After completing the 6-week HIIT program, participants will be scheduled for a second/final lab 
visit. Visit 2 will be ideally scheduled within one week of finishing the 6-week HIIT program, but to 
provide scheduling flexibility, participants have up to two weeks to complete their second visit. We 
will try to schedule the follow-up exercise testing around the same time of day as Visit 1. Participants 
will complete the same exercise testing protocol that was completed in Visit 1. Participants will also 
complete the NRS, WUSPI, POMS and SF-36 WW questionnaires from Visit 1. Participants will be 
asked to complete a survey regarding their satisfaction of the HIIT program using the Physical 
Activity Enjoyment Scale (PACES). Participants will be provided with an open-ended questionnaire 
to discuss their feelings about HIIT, likelihood to continue, and what would be needed in terms of 
support to help them (or others like them) to keep doing HIIT. Activity monitors will be removed 
from the subject and wheelchair. 
 
*Please note: some participants take longer than others to finish questionnaires; to decrease burden, 
participants will be allowed to complete the questionnaires over the duration of the first lab visit and 
the first home visit (for baseline measures) and last home visit and second lab visit (for post-trial 
measures).