HIIT in Spinal Cord Injury

If the participant is eligible and would like to participate, the study team will send a
physician release form to be signed. 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 is easy to exercise in.

Visit 1: Baseline Visit

Eligible participants will be directed to come to the 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.

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. 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.

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) that will
later be used to set an individualized goal for the participant during the HIIT
protocol. Prior to starting the maximal exercise testing 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. Heart rate will be collected
using the same heart rate monitor that will be worn during the in home exercise portion
of the study. The heart rate monitors will be worn around the chest in area under the
heart. Participants will be able to use a private space to put the heart rate monitor on
prior to staring the study. A member of the study team will verify the heart rate
monitor is placed properly. Prior to beginning the maximal exercise test, the Borg and
Wheel Rating of Perceived Exertion (RPE) scales will be presented to participants. RPE
scales rate how hard a person feels their body is working and is an accepted
supplementary tool for prescribing exercise programs in both healthy and special
populations. Throughout the test, the participant will be asked to report their RPE by
pointing to the corresponding number on the scales. The exercise test will be
administered using an incremental modified Bruce protocol on an electronically-braked
cycle ergometer. The Bruce protocol outlines speeds and inclines to test cardiopulmonary
function and health. The protocol outlines specific time increments and the settings for
the treadmill to ensure a maximal aerobic capacity is achieved. This protocol will be
modified for an arm ergometer, where the resistance on the ergometer and the revolutions
per minute (RPMs) will be modified instead of incline and speed. The settings on the
ergometer will attempt to match the incremental changes outlined in the Bruce protocol.
Initially, resistance will be set at 25W, and then increased by 25W every 2 minutes
until the subject can no longer continue or until their respiratory exchange ratio
exceeds 1.15.

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 participant will initially crank on
the cycle with minimal resistance for about thirty seconds, then the resistance will be
increased to a maximal level. Participants will crank for as long and as hard as they
are able to for another thirty seconds. The participant will be asked to complete this
process up to three separate times, with a minimum of 30 seconds of rest in between.
After the test is completed, the resistance will return to zero and the participants
will cycle at a comfortable pace to cool down.

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.

6-Week HIIT Protocol: If participants already own a handcycle, investigators will make every
attempt to fit their handcycle to the roller system that will be used for the study. If
investigators 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
uncomfortable using a handcycle, or is unable to transfer into the handcycle, then the study
team will provide a tabletop ergometer to use for the duration of the study. At the end of
the study the handcycle or tabletop ergometer 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/ergometer 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. 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.

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. The Feeling Scale (-5
very bad to +5 very good) is commonly used to measure affective response during exercise.

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. 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. Investigators 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, 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). Finally, 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.

Inclusion Criteria:

1. SCI/D which occurred at least 6 months prior to the start of the study

2. uses a manual wheelchair as primary means of mobility (30+ hours per week)

3. is between 18 and 65 years of age

4. Weighs less than 250lbs

5. lives within one hour driving time from the research center

6. is able to perform a transfer independently to and from a wheelchair

7. has adequate strength and upper extremity function to operate a handcycle or arm
ergometer

8. has adequate space in a safe location (i.e., home, work) to accommodate a handcycle or
tabletop ergometer

9. Receipt of a signed physicians medical release form

Exclusion Criteria:

1. History of fractures or dislocations in the upper extremity from which the participant
has not fully recovered

2. Upper limb pain or injury that interferes with the ability to perform aerobic exercise

3. No current or recent (last 6 months) participation in a structured fitness program

4. Recent hospitalization for any reason (within the past three months)

5. Pregnant women

6. History of coronary artery disease, coronary bypass surgery or other cardiorespiratory
events or conditions

7. Likely to experience clinically significant autonomic dysreflexia and/ or orthostatic
hypotension in response to vigorous exercise

8. Any other conditions that the persons primary care physician deems is a
contraindication to participation in arm ergometry exercise stress testing or vigorous
exercise