The Feasibility of Low-Volume High Intensity Interval Training on Inpatient Stroke Rehab
Phase: EARLY_PHASE1
Conditions: Stroke, High Intensity Interval Training, Aerobic Fitness, Physical Therapy
Sponsor: University of Kansas Medical Center

 
 
  
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University of Kansas Medical Center  
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
TEMPLATE WITH GUIDANCE 
 
Version date: 08.15.2024 
Principal Investigator: Dr. Alexandria Arickx, MD 
Study Title: Low-Volume High Intensity Interval Training during Inpatient Stroke Rehabilitation: A 
Feasibility Trial.  
Co- Investigator(s): Bria Bartsch OT. OTR/L., Dr. Sandra Billinger, PT. PhD., Dr. Ann Wingard, DO. 
 
 
I. 
Purpose, Background and Rationale 
A. Aim and Hypotheses  
The objective of this study is to explore the safety and feasibility of conducting low-volume, high-
intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in 
an inpatient rehabilitation setting. HIIT has emerged as a promising exercise therapy for patients with 
stroke, with work from the REACH laboratory and others, showing that HIIT leads to improvement in 
overall walking capacity and endurance.[1-5] Furthermore, in people with stroke, HIIT has been reported to 
improve aerobic fitness, increase muscle strength, and improve neuroplasticity, which are vital for functional 
recovery after stroke.[4, 6-9]  Previous studies exploring HIIT in stroke have primarily used treadmills, 
focused on outcomes in functional gait, and included participants with higher walking abilities.[1, 5, 10, 11] 
Given that many individuals post-stroke, however, experience significant motor deficits, balance impairment, 
and reduced cardiovascular fitness, HIIT may be more accessible when conducted on a TBRS. The TBRS 
minimizes upright balance demand, offers adaptations for hemiparesis, and allows for exercise to be 
prescribed using peak power output, which accounts for motor ability [12]. Previous research conducted by 
Dr. Billinger has demonstrated that a single bout of low-volume, short-interval HIIT, performed on a TBRS 
is safe and feasible in individuals with chronic stroke. Research is required, however, to determine the safety 
and feasibility of low-volume, short-interval HIIT, performed on a TBRS, in inpatient rehabilitation. Given 
the nature of increased neuroplasticity during the subacute phase of stroke, compared to the chronic 
phase[13], implementing an accessible HIIT paradigm during inpatient rehabilitation may prove beneficial 
for optimizing stroke recovery. Determining the safety and feasibility of a low-volume, short-interval 
HIIT program, conducted on the TBRS, is a logical and critical next step in investigating ways to 
optimize stroke recovery. 
 
This proposed study will explore the safety and feasibility of HIIT using a recumbent stepper during 
inpatient stroke rehabilitation. We hypothesize that a single bout of low-volume, short-interval TBRS 
HIIT will be safe and feasible in patients with subacute stroke admitted to inpatient rehabilitation. 
 
We will recruit up to 25 patients admitted to The University of Kansas Acute Inpatient Rehabilitation Unit 
with subacute stroke, age 18-85 years, to perform a single bout of short-interval (60 seconds), low-volume 
(10 minutes) HIIT on the TBRS, in line with the protocol used in STUDY00146161 (NCT04673994). 
 
Aim 1: Explore the safety of short-interval; low volume HIIT in stroke. Safety will be defined as the 
presence of no study-related cardiac or serious adverse events.[14] We hypothesize that low-volume, short-

 
 
  
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interval, TBRS HIIT will be safe in individuals with subacute stroke while admitted to inpatient 
rehabilitation during HIIT (H1a) and within the 30 minutes following HIIT cessation (H1b). 
 
Aim 2: Explore the feasibility of short-interval, low-volume HIIT in stroke. Feasibility will be assessed 
by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. At 
least 75% of participants will complete the entire 10-minute HIIT bout, (H2a) and ≥75% of participants will 
reach target heart rates (75%-85% max HR) during ≥75% of the high-intensity intervals (H2b). To examine 
acceptability, the valid and reliable 8-item Physical Activity Enjoyment Scale (PACES-8) will be used, 
where higher scores indicate greater exercise enjoyment (H2c)[15-19]. 
 
B. Background and Significance 
Globally, stroke is the second leading cause of death, and third leading cause of death and disability 
combined, often resulting in significant impairments in physical function and quality of life.[20] Multiple 
randomized controlled trials have shown that exercise performed before and after stroke decrease the 
likelihood of having an initial stroke and subsequent strokes, respectively,[21, 22] and exercise-based 
rehabilitation is crucial for optimizing functional recovery and cardiovascular health post-stroke [4, 6, 10]. 
However, traditional approaches, such as treadmill training and overground walking at low and moderate 
intensities, may not effectively stimulate improvements in cardiovascular fitness and may not be inclusive of 
individuals with a wide range of cognitive and motor abilities post-stroke. Evidence by Billinger et al.,[23] 
has demonstrated that cardiorespiratory fitness is significantly reduced in individuals with stroke compared 
to age- and sex-matched peers, and reduced cardiorespiratory fitness is associated with an increased risk for 
overall mortality[24] and poor functional recovery.[25, 26] This is likely due to the fact that individuals with 
low cardiorespiratory fitness expend more energy during tasks performed at submaximal effort (i.e., 
activities of daily living, walking and community activities) when compared to age-matched peers.[27] This 
results in greater engagement of sedentary behaviors, further exacerbating deconditioning and functional 
decline. [27, 28] As such, a critical need exists for exercise protocols to be implemented which target 
cardiorespiratory fitness and recovery post-stroke. 
 
More recently, two randomized controlled trials[5, 29] and a superiority trial [30] sought to compare 
treadmill-based HIIT to treadmill-based moderate-intensity continuous training[5, 30] or standard of care 
[29] in participants with late subacute to chronic stroke. Findings indicated that HIIT facilitated the greatest 
improvements in gait function and cardiorespiratory fitness, and no study-related serious adverse events 
occurred.[5, 29, 30] Given the promising findings observed with treadmill-based HIIT, implementing more 
accessible HIIT paradigms for individuals post-stroke may prove beneficial for improving cardiorespiratory 
fitness and functional recovery. 
 
Recent (NCT04673994) and ongoing (NCT05936008) work from Dr. Billinger’s laboratory has been 
focused on exploring the feasibility of HIIT, using the TBRS, in chronic stroke to provide a more accessible 
modality for HIIT training. We have previously demonstrated that a single bout of low-volume, short-
interval, TBRS HIIT is safe and feasible in individuals with chronic stroke.[14] However, research is 
required to explore the safety and feasibility of TBRS HIIT in subacute stroke. As neuroplasticity is 
increased during the subacute phase of stroke recovery, and evidence suggests that HIIT may upregulate 
neurotrophic factors and corticospinal activity in stroke, [31, 32] HIIT performed during the subacute phase 

 
 
  
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may further optimize neuroplasticity and recovery while improving cardiorespiratory fitness. This study will 
provide critical insight into the safety and feasibility of a single session of recumbent stepper HIIT, laying 
the groundwork for potential future studies seeking to optimize inpatient rehabilitation outcomes for stroke 
recovery. 
 
Preliminary Data from Dr. Billinger’s Laboratory: Exercise post-stroke is complex and requires a well-
coordinated, experienced, multi-disciplinary team. Our team has developed the essential infrastructure and 
processes required to perform rigorous exercise trials in adults with stroke. Dr. Billinger has built a stroke 
recovery trial unit, fully integrated with KU Medical Center’s physician partners, and has published on the 
role of physician engagement in successful stroke recovery trials.[33] 
Dr. Billinger has successfully filled and completed enrollment in: 
-    Two acute stroke studies (n = 38; and n = 15) under 1.5 years as part of her career development 
award, K01 HD067318 (2011-2016). Dr. Billinger’s career development award supported her work 
in 39 publications. 
- 
An internally funded pilot study in subacute stroke using an 8-week moderate intensity exercise 
intervention (n = 10) that demonstrated a significant improvement in aerobic fitness with no adverse 
events.  
- 
Two stroke studies (n = 69; and n = 12) that were conducted on The University of Kansas Inpatient 
Rehabilitation Unit. Dr. Billinger has great rapport with the Medical Director of KU’s Inpatient unit 
as well as the chair of the Physical Medicine and Rehabilitation department.  
- 
A trial on the KUMC inpatient rehabilitation unit, which included 20 participants with stroke. 
Participants were tested after conducting their therapies on the Inpatient Rehabilitation Unit (similar 
to as proposed in this study). 
 
II. 
Research Plan and Design 
 
A. Study Objectives: The objective of this study is to explore the safety and feasibility of 
conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper 
(TBRS) in persons with stroke in an inpatient rehabilitation setting. The study aims are as 
follows: 
Aim 1: Explore the safety of short-interval; low volume HIIT in stroke. Safety will be 
defined as the presence of no study-related cardiac or serious adverse events.[14] We hypothesize 
that low-volume, short-interval, TBRS HIIT will be safe in individuals with subacute stroke 
admitted inpatient rehabilitation during HIIT (H1a) and within the 30 minutes following HIIT 
cessation (H1b). 
 
Aim 2: Explore the feasibility of short-interval, low-volume HIIT in stroke. Feasibility will 
be assessed by adherence to the exercise session, attainment of target heart rates, and 
acceptability of the exercise. At least 75% of participants will complete the entire 10-minute HIIT 
bout, (H2a) and ≥75% of participants will reach target heart rates (75%-85% max HR) during 
≥75% of the high-intensity intervals (H2b). To examine acceptability, the valid and reliable 8-
item Physical Activity Enjoyment Scale (PACES-8) will be used, where higher scores indicate 
greater exercise enjoyment (H2c)[15-19]. 
 

 
 
  
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B. Study Type and Design: We propose a feasibility study with up to 25 participants with subacute 
stroke (18-85 years of age) admitted to The University of Kansas Acute Inpatient Rehabilitation 
Unit. Participants will be asked to engage in two visits, both located on the acute inpatient 
rehabilitation unit. 
 
Visit 1 
Visit 1 will take approximately 1 hour to complete. The Total Body Recumbent Stepper (TBRS) 
Submaximal Exercise Test, which is valid and reliable in persons with stroke, will be used to 
assess cardiorespiratory fitness. Following completion of the TBRS Submaximal Exercise Test, 
participants will complete a HIIT familiarization bout. Details on visit 1 procedures can be found 
in Section E. 
 
Visit 2 
Visit 2 will take approximately 1 hour to complete. Participants will complete the single bout of 
low-volume, short-interval HIIT on the TBRS. Vitals will be monitored throughout the HIIT 
bout. Details on visit 2 can be found in Section E. 
 
C. Sample size, statistical methods, and power calculation 
1. We plan to recruit a sample of up to 25 participants. This sample size aligns with other 
feasibility trials examining HIIT in stroke.[14, 34] 
2. Blinding: No blinding will be used. 
3. Analytic and statistical methods to be used: Descriptive statistics will be used to report 
adverse events, participants who completed the entire HIIT bout, target heart rates achieved, 
and PACES-8 scores. 
 
D. Subject Criteria (See Vulnerable Populations appendix, if applicable): 
We intend to enroll up to 25 participants (18-85 years of age) with subacute stroke admitted to 
The University of Kansas Acute Inpatient Rehabilitation Unit. Inclusion and exclusion criteria are 
outlined in the table below. 
 
Inclusion 
criteria 
-Both sexes between the age of 18-85 years at time of consent 
-Ischemic or hemorrhagic stroke at consent. People with stroke and newly 
diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 
5 years.[35] Index stroke or recurrent stroke on same side as index stroke will be 
allowed.  
-Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent 
stepper to demonstrate ability to perform the exercise test or therapist 
confirmation/documentation of participant’s ability to use the recumbent stepper.[36] 
-No aerobic exercise contraindications[37] or other safety/physical concerns during 
the submaximal exercise test determined by the therapy team or inpatient physicians. 
-Able to communicate with investigators, follow 2-step command & correctly 
answer consent comprehension questions 

 
 
  
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Withdrawal/Termination of exercise criteria: A participant may withdraw from the study at any time 
or be withdrawn from the study at the principal investigator’s discretion if exercise is deemed unsafe 
for continuation. 
 
E. Specific Methods and Techniques used throughout Study: 
All data collected during the study will be stored on a secure university server database (i.e., 
REDCap®). 
 
Participant Recruitment and Screening 
Potential participants will be identified for the study by the following methods: 1) University of 
Kansas Health System healthcare practitioners notify the study team of a potentially eligible 
participant, and/or 2) Electronic Medical Record (EMR) screening by the study team. A screening of 
the EMR will be conducted to determine if participants meet preliminary criteria, as outlined in the 
inclusion/exclusion criteria (i.e., no additional neurologic disease, oxygen-dependent chronic 
obstructive pulmonary disease, etc.). Potential participants who meet the preliminary criteria will then 
be approached for interest in participation. 
 
For individuals who wish to participate, a study team member will review the consent form and 
complete the consent comprehension questions with this individual. If the individual chooses to 
participate and provides written informed consent, consent will be documented in EPIC O2, 
physician clearance for participation will be obtained from a KU Physical Medicine and 
Rehabilitation physician, and the following will occur: 
 
Basic demographic information such as date of birth, age, sex, gender, height, weight, and 
race/ethnicity will be collected and stored in REDCap®. We will also collect: participant address, 
contact methods (phone and/or email), and stroke information (i.e., date of stroke, type of stroke, 
location of stroke, etc.). 
Exclusion 
criteria 
  - Implanted pacemaker or defibrillator limiting exercise performance 
-Reported pain that limits or interferes with activities of daily living and physical 
activity/exercise 
-Acute MI in the last 2 days  
  -Ongoing unstable Angina  
  -Active Endocarditis  
  -Symptomatic Severe Aortic Stenosis  
  -Decompensated HF  
  -Acute PE, PI, or DVT  
  -Acute Myocarditis or Pericarditis  
   -Other significant neurologic, orthopedic, or peripheral vascular conditions that 
would limit exercise participation 
-Oxygen-dependent chronic obstructive pulmonary disease 
-Neurological disease (Multiple Sclerosis, Alzheimer’s disease, Parkinson’s disease)  
-Pregnancy 

 
 
  
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Visits 1 and 2 will be performed by trained personnel with experience administering exercise in 
stroke. Visits will occur ≥2 hours after meals, and participants will be asked to avoid caffeine for 4-6 
hours prior. 
 
Visit 1: 
1. The American College of Sports Medicine cardiac risk screen will be completed, as done in 
STUDY00147598 to provide increased insight into cardiovascular health. 
 
2. Participants will be fitted with a Polar heart rate monitor to continuously monitor heart rate 
throughout exercise, and a resting blood pressure will be taken. 
- 
Substep: As shown in the inclusion/exclusion criteria, participants must be able to exercise 
at 30 watts for 3 minutes on the TBRS to demonstrate their ability to perform the Total 
Body Recumbent Stepper (TBRS) Submaximal Exercise Test. If inpatient therapists have 
not previously confirmed or documented the participant’s ability to use the TBRS, the 
participant will be asked to demonstrate an ability to step at 30 watts for 3 minutes on the 
TBRS. Following successful completion of this task, participants will be asked to rest to 
allow their heart rate to return to near resting values. If a participant is unable to complete 
this task, they will be deemed ineligible for the study. 
 
3. Participants will complete the TBRS Submaximal Exercise Test[38] with oversight from a 
trained study team member, and as performed in protocols STUDY00146161 and 
STUDY00147598. Participants will be asked to step at a step rate of ~90-100 steps per minute 
until one of the following occurs: 1) 85% of age-predicted heart rate maximum (HRmax) is 
reached, 2) All four stages of the test are completed, or 3) Participant requests to stop. Each 
stage of the test is approximately 3 minutes in duration and consists of increasing resistance. We 
have previously employed the TBRS Submaximal Exercise Test in subacute stroke with 
success.[39] 
- 
As done in STUDY00147598, American College of Sports Medicine Guidelines will be 
used to guide test termination indications for submaximal exercise testing: 
- 
Absolute Indications: 
o Drop in systolic blood pressure of >10 mmHg, despite an increase in workload, 
o Moderate to severe angina 
o Central nervous system symptoms (i.e., ataxia, dizziness, or near syncope) 
o Signs of poor perfusion (cyanosis or pallor) 
o Any arrhythmia that interferes with normal maintenance of cardiac output during e
xercise 
o Technical difficulties with equipment that interferes with testing or participant safe
ty 
o The individual requests to stop  
- 
Relative Indications: 
o Increasing chest pain 
o Fatigue, shortness of breath, wheezing, leg cramps, or claudication 

 
 
  
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o Exaggerate hypertensive response (systolic blood pressure >250 mmHg or diastoli
c blood pressure >115 mmHg) 
 
4. Blood pressure will be taken immediately following completion of the TBRS Submaximal 
Exercise Test, as done in STUDY00147598, and participants will be asked to subjectively 
evaluate exercise intensity using the Rating of Perceived Exertion. 
 
5. The participant will rest to allow heart rate and blood pressure to return to near resting values. 
 
6. A HIIT familiarization bout will be performed, as done in STUDY00146161. 
- 
The familiarization will last for no more than 10-minutes. Participants will perform 1-
minute high-intensity intervals at ~70% peak power output (range: 65-95% peak power 
output), interspersed with 1-minute active recovery intervals at ~10% peak power output. 
An upper heart rate limit of 85% HRmax will be used to align with the upper heart rate 
limit used in our TBRS Submaximal Exercise Test. 
 
7. Blood pressure will be obtained. To complete the session, the participant’s blood pressure must 
be <180/100 mmHg, and heart rate must be below <100 beats per minute. As such, blood 
pressure recordings may be repeated as necessary. 
 
8. The heart rate monitor will be removed from the participant. 
 
Visit 2 
1. Participants will be fitted with a Polar heart rate monitor, and resting vitals (heart rate and blood 
pressure) will be obtained. 
 
2. Participants will perform a 1-minute warm-up at ~30% peak power output. 
 
3. Participants will perform the HIIT bout: 
- 
1-minute high-intensity intervals will be interspersed with 1-minute active recovery 
intervals for a total of 10 minutes. As used in STUDY00147598, high-intensity intervals 
will be prescribed at ~70% peak power output (range: 65-95% peak power output) with a 
target heart rate range of 75-85% HRmax or 60-89% heart rate reserve. The upper heart rate 
limit of 85% HRmax aligns with the upper heart rate limit used in the TBRS Submaximal 
Exercise Test. Active recovery intervals will be performed at ~10% peak power output. 
 
4. Blood pressure will be taken immediately post-HIIT, and participants will perform a ~1-minute 
cool-down at ~20% peak power output. Participants will also be asked to subjectively evaluate 
the HIIT bout using the Rating of Perceived Exertion. 
 
5. Heart rate will be monitored 30minutes to one hour following HIIT completion and blood 
pressure will be recorded within one hour of conclusion of the study. 

 
 
  
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6. During the monitoring period, the PACES-8 will be administered to assess exercise acceptability. 
 
7. The heart rate monitor will be removed from the participant. 
 
F. Risk/benefit assessment:  
Potential Benefits of Proposed Research 
The participant may or may not benefit from this study. Researchers hope that the information gained 
from this study may be useful in developing increased insight into accessible HIIT modalities for 
stroke recovery during inpatient rehabilitation. 
 
Potential Risks of Proposed Research 
Exercise: There are certain risks and discomforts that may be associated with exercise such as 
temporary shortness of breath, muscle fatigue, sweating, and physical discomfort. It is extremely 
unlikely, but there is always the risk of having a serious heart problem, such as developing an 
abnormal rhythm, heart attack, or having another stroke during exercise. To protect and minimize 
risks during exercises, the study team will monitor heart rate and blood pressure during all exercise 
procedures and obtain physician clearance prior to exercise engagement. If a participant would report 
chest discomfort, dizziness or any other problems, exercise will be discontinued. We have 
successfully studied individuals with stroke during the TBRS submaximal exercise test (HSC#2173) 
during inpatient stroke rehabilitation without serious adverse events. We have also successfully 
implemented a single bout of low-volume, short-interval HIIT in chronic stroke (STUDY00146161). 
Our laboratory team is well equipped and trained to execute this study. 
 
Blood pressure: A participant may experience mild discomfort in the upper extremity when assessing 
blood pressure due to cuff inflation. Should this occur, the cuff can be deflated. 
 
Possibility of unknown risks: There may be other side effects or risks that are not yet known. The 
study team will work to minimize any discomfort associated with the aforementioned procedures. 
 
G. Location where study will be performed: This study will take place at Kansas University 
Medical Center Inpatient Rehabilitation. Address:  The Second Floor of 3910 Rainbow Blvd, 
Kansas City, KS 66103 
 
H. Personnel who will conduct the study, including: 
Members of the study team added to the IRB will be involved in determining participant 
eligibility, obtaining informed consent, providing ongoing information updates to the IRB, 
conducting study visits, and managing study data. Team members who are involved in the study 
will be trained on their respective duties and tested for competency prior to performing any tasks 
with participants. The principal investigator, Dr. Arickx, will oversee all study procedures to 
ensure compliance. 
 
I. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
The REDCap® web-based system will be used for data entry, data monitoring, and linking 
participant ID to participant name. The consent forms and all paper copies will be kept in a 
locked filing cabinet in the REACH Lab in accordance with professional standards of privileged 

 
 
  
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information. Confidentiality is strictly safeguarded by HIPAA-compliant standards. Data from 
testing may also be stored on a spreadsheet using the unique subject code and stored on a secure 
network drive (P drive) with access only provided to the study team. 
Adverse events will be assessed during each visit. Adverse event inquiries will end at the 
completion of the second visit. Any adverse event that occurs will be immediately reported to the 
PI(s) and then to the Human Subjects Committee per KUMC Human Subject Committee 
reporting policies. Dr. Arickx will be notified immediately of all grade 3 adverse events and any 
grade 2 or above cardiac adverse events. Should a participant experience an adverse event in any 
category rated 4 or greater according to CTCAE v5.0, that individual will be removed from the 
study. If more than 6 participants experience an adverse event in any category rated 3 or greater 
according to CTCAE v5.0, the study will be reviewed in conjunction with the Human Subjects 
Committee for possible termination. 
Dr. McCasey Smith will serve as the internal safety monitor and receive quarterly reports on any 
adverse events. 
 
III. 
Subject Participation 
 
A. Recruitment and Informed consent process and timing of obtaining of consent: 
Potential participants admitted to the University of Kansas Acute Inpatient Rehabilitation Unit 
will be identified for the study by the following methods: 1) University of Kansas Health System 
healthcare practitioners notify the study team of a potentially eligible participant, and/or 2) 
Electronic Medical Record (EMR) screening by the study team. A screening of the EMR will be 
conducted to determine if participants meet preliminary criteria, as outlined in the 
inclusion/exclusion criteria (i.e., no additional neurologic disease, oxygen-dependent chronic 
obstructive pulmonary disease, etc.). 
 
Potential participants who meet the preliminary criteria will then be approached for interest in 
participation. For individuals who wish to participate, a study team member, trained on the 
informed consent process, will review the consent form, and complete the consent comprehension 
questions with this individual. Potential participants will be reminded that research is voluntary, 
and all questions asked will be answered by the trained study team member. We will make clear 
that their participation or lack thereof will not influence any care that may be received at KU 
Medical Center. Participants will be provided with a copy of their signed informed consent form, 
and we will electronically document that the participant consented to be in the study in EPIC O2. 
 
Should a team member have any concern about a potential participant’s ability to provide 
informed consent, they will refer to the principal investigator before obtaining informed consent. 
 
B. Screening Interview/questionnaire: As outlined in Section E, preliminary screening will be 
performed using the EMR. Following EMR screening, and as necessary, a study team member 
will confirm inclusion/exclusion criteria verbally with the participant. Questions regarding 
eligibility may be directed to the participant’s physician as well, as necessary. 

 
 
  
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C. Alternatives to Participation: The alternative to participating is not participating. Participants 
will be informed that this has no effect on the care that they receive at KU Medical Center, and 
participation is completely voluntary. 
 
D. Costs to Subjects: This will be no monetary cost to the participant.  
E. How new information will be conveyed to the study subject and how it will be documented: 
Aside from any new information that arises regarding risks associated with the study, no new 
information will be conveyed to the participant. If this occurs, they may be asked to sign a new 
consent form. 
F. Payment to participants: Participants will receive $50 upon completion of the study. 
G. Payment for a research-related injury: The following text will be included in the consent form: 
“Despite all safety measures, you might develop medical problems from participating in this 
study. You must report any suspected illness or injury to the study team immediately. If such 
problems occur, you will be provided with emergency medical treatment and the investigator will 
assist you in getting proper follow-up medical treatment. The investigator will not provide 
compensation for research-related injuries. Payment of lost wages, disability or discomfort is not 
available. You do not give up any of your rights by signing this form.” 
H. Photo and Video Consent: Participants may be photographed and or recorded during the two 
visits. These images and or videos may be used for presentation purposes.  
IV. 
Data Collection and Protection 
A. Data Management and Security/Procedures to protect subject confidentiality: As mentioned 
previously and as used in STUDY00146161 and STUDY00147598, the REDCap® web-based 
system will be used for data entry and data monitoring. Each participant will be assigned a unique 
participant ID, and REDCap® will be used to link participant ID to participant name. The 
informed consent forms will be kept in a locked filing cabinet in the REACH Lab in accordance 
with professional standards of privileged information. Confidentiality is strictly safeguarded by 
HIPAA-compliant standards. Data may also be stored on a spreadsheet using the unique subject 
code and stored on a secure network drive (P drive) with roll-based access only provided to the 
study team.  
B. Sample/Specimen Collection: N/A 
C. Tissue Banking Collection: N/A 
D. Procedures to protect subject confidentiality: Study procedures to protect participant 
confidentiality are outlined above in sections II.I. and IV.A. 

 
 
  
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E. Quality Assurance / Monitoring: Study team members involved in the data collection process 
will be trained on their respective duties and tested for competency prior to performing any of these 
tasks with participants. Dr. Arickx will review the obtained data and collect self-audits as necessary 
to ensure quality of data collection. 
 
V. 
Data Analysis and Reporting 
A. Statistical and Data Analysis:  Descriptive statistics will be used to report adverse events, 
participants who completed the entire HIIT bout, target heart rates achieved, and PACES-8 scores. 
B. Outcome: We expect that a single bout of low-volume, short-interval HIIT will be safe and 
feasible in individuals with subacute stroke admitted to inpatient rehabilitation. 
C. Publication Plan: We plan to publish findings from this study in a peer-reviewed journal. 
Findings may also be presented at conferences. 
 
Bibliography 
 
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