Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
Phase: NA
Conditions: Exercise Therapy, Heart Rate Determination
Sponsor: Shirley Ryan AbilityLab

Assessing Feasibility, Efficacy, and Acceptability of visual feedback during HR monitoring in 
rehabilitation 
NCT05273801
February 11, 2022

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PROTOCOL TITLE:  Assessing Feasibility, Efficacy, and Acceptability of visual feedback during 
HR monitoring in rehabilitation 
PRINCIPAL INVESTIGATOR:
Miriam Rafferty PT, DPT, PhD
APTA Board Certified Neurologic Clinical Specialist
Shirley Ryan AbilityLab
312-238-7233
mrafferty@sralab.org
VERSION DATE: 2.11.2022
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
Heart Zones System
https://heartzones.com/heart-zones-system-
technical-documents/ 
IND / IDE / HDE # 
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
90
Funding Source
SRAlab/PMR Department 
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
OBJECTIVES:
The purpose of this investigation is to determine if knowledge of heart rate (HR) and target HR 
zones (HRzone), with visual feedback vs no feedback of HR or HRzone improves patient 
exercise intensity during rehabilitation. The central hypothesis for this study is with visual 
feedback of HR and target HR zones with instruction about exercise intensity and targets will 
increase patient HR intensity during sessions within a safe range set by their medical team. For 
purposes of this study, patients will be monitored in group and individual settings throughout the 
rehabilitation continuum of care sites including: inpatient rehabilitation, day rehabilitation, and 
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community fitness and will be inclusive of all individuals with chronic health conditions. Physical 
activity and exercise guidelines recommend everyone, including those with chronic health 
conditions, strive for 150 minutes of moderate intensity aerobic exercise per week.1 This study 
will contribute to the knowledge of how patients achieve recommended individual HR and 
moderate-high intensity zones during exercise. 
Aim 1: Measure the extent to which monitoring and education regarding intensity is 
provided (1) before HR monitoring intervention, (2) when providers know HR monitoring 
is occurring but without visual feedback, and (3) with visual feedback of HR monitoring.
We hypothesize providers will modify their behavior in the number of times they ask about 
intensity, adjust session intensity or provide education regarding intensity when visual feedback 
is provided compared to no feedback, which will be further increased from pre-study baseline 
levels. 
Aim 2: Determine the efficacy of using HR with visual feedback during rehabilitation to 
reach target intensity.   
We hypothesize participants will have higher mean HR and increased time in their individualized 
target HR zones when given visual feedback compared to no feedback during group sessions. 
Aim 3: Determine the safety of using Heart Zones technology in rehabilitation for 
increasing participant exercise intensity.
We hypothesize the technology will be safe without an increase in number of adverse events 
throughout their rehabilitation stay. 
Aim 4: Assess patient acceptability, exercise self-efficacy and confidence following use 
of Heart Zones technology in rehabilitation sessions. 
We hypothesize use of Heart Zones technology in group settings with feedback will increase 
participant self-efficacy and confidence in reaching higher exercise intensities, and will be well 
accepted.  Furthermore, we hypothesize the use of Heart Zones will be feasible in at least 75% 
of patient’s group sessions.
Aim 5: Explore the feasibility of submax exercise testing when completed 2 times to 
establish individualized training targets for individuals receiving inpatient rehabilitation. 
We hypothesize submax exercise testing will be feasible to perform, safe and informative to 
clinicians to establishing individualized heart rate zones. We believe there will be a change pre 
to post in submax testing indicating improvement in patient’s condition.  
Aim 6: Assess provider opinions regarding the feasibility, acceptability, and 
appropriateness of using Heart Zones technology in rehabilitation.   
We hypothesize providers will find the Heart Zones feasible, appropriate and easy to 
incorporate into therapy sessions. 
BACKGROUND:
One of the important components in regards to successful aerobic exercise is that it needs to be 
intensive. This has been described as one of the key active ingredients to improve walking 
function in those with chronic neurological diagnoses along with that the task is specific, and 
provided in high repetition.2, 3  Neurophysiologically, exercise performed in an intensive manner  
drives BDNF factors, increase brain blood flow and neuroplasticity for recovery post stroke as 
well as is thought to be one of the most important components with regard to safety and 
effectiveness of an aerobic endurance training program.4, 5 Exercise and intensity are thought to 
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play an integral role in quality of life, and reduced risk of secondary sequelae for individuals with 
cardiovascular, Parkinson’s and other chronic disease conditions.6, 7 
However, there is a misalignment in the application, selection, and actual execution of 
appropriate intensity exercise for aerobic endurance, both in rehabilitation and in the 
community.  Formulas such as Hunt and Karvonen that provide guidance for clinicians when 
determining target HR zones based on age, or age/resting HR, and suggested adjustments 
based on cardiotropic medications such as beta-blockers.8,9 Ratings of perceived exertion 
(RPE) such as the BORG 6-20 or modified BORG 1-10 scales are long accepted and validated 
scales used to help patients achieve appropriate intensities and should correlate with HR.  
Despite these measures, some studies have raised concerns for safety due to individual 
variability and inconsistencies between these measures of intensities in individuals in cardiac 
rehab as well as post stroke.10, 11 Furthermore, these concerns are heightened with the 
knowledge that often in rehabilitation, HR zones and RPE is utilized without performance of a 
submax exercise test due to cost containment challenges.12 Thus, the target range for patients 
may be inaccurate or inappropriate for the patient’s current condition. HR monitors commonly 
used in rehabilitation have allowed for instantaneous readings of HR, without a full log of 
session HR and are readable only by the therapist.  This presents several gaps: decreased 
ability to use standard formulas to establish accurate HR zones in complex medical populations 
in the rehabilitation setting, and unknown utilization/application of intensity recommendations in 
standard rehabilitation, in particular group therapy.  
Group exercise with HR monitoring has previously shown to be successful in healthy adults. 
These studies have found higher mean HRs, greater percent of time spent above 70% of HR 
max when individuals are given visual feedback in a group exercise setting compared to 
individual sessions with feedback or no feedback.13 Also the majority of subjects preferred the 
group condition with feedback.13 Another study found that subjects were able to maintain their 
time in higher intensity zone even after feedback was removed.14
Our previous pilot work in Parkinson’s Disease and others with chronic conditions confirmed 
similar results previously stated with healthy individuals as well as identified the need for 
individualized HR zoning. This work was completed in 14 individuals, 9 of whom had 
Parkinson’s Disease and 5 others with other chronic conditions in a community based fitness 
setting. In fitness class focused on large amplitude movements addressing 4 areas frequently 
affected by PD: antigravity extension, weight shifting, axial mobility, and transitional movements. 
Data was collected for a total of 7 sessions and visual feedback of HR was provided every other 
session while the exercise physiologist provided education about HR and zones.  We found that 
when visual feedback was provided it motivated participants to workout at a higher intensity and 
resulted in increased time spent in higher intensity zones, higher peak HR and average HR 
compared to the first class when feedback was not provided to participants. Average peak HR 
was 146 bpm with visual feedback compared to 101 when no feedback was provided. 
Participants reached higher intensity zones and were able to sustain the effort longer, as noted 
by longer duration in higher intensity zone in the class with feedback compare to the class 
without feedback. One limitation noted during this preliminary work was the difficulty of 
participant’s to reach targeted zones when calculated off percentage of age predicted max 
because some individuals never reach the target of 60% HR max, despite reporting higher RPE 
values. 
Provided this result in our preliminary data and prior evidence that chronic health conditions and 
comorbidities can affect an individual’s ability to reach target intensity, it is important to provide 
individualized HR zones based on submax exercise testing for this study.  Submax exercise 
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testing is a predictive test to estimate maximal aerobic capacity, however is consider safer, less 
labor intensive, and requires less patient motivation to complete compared to a maximal 
exercise test thus lending it to be more feasible and applicable in clinical settings.15
Clinical providers have many options for submaximal (submax) aerobic capacity testing, 
although they are rarely used outside of cardiac rehabilitation. The 6 minute walk test which 
have been studied in a range of populations including heart failure, end stage lunge disease, 
COPD, chronic renal failure, and older individuals.15 The recumbent stepper test has been 
shown to be able to predict VO2 peak in healthy adults.16 For individuals with limited ambulatory 
or lower extremity motor function, an alternative to determine aerobic capacity is to use the arm 
crank ergometer.17 
This study will facilitate the understanding of feasibility and safety of moderate to vigorous 
aerobic endurance exercise, based on individually set aerobic intensity zones carried out in a  
rehabilitation setting. It will also study if the behavior of the provider or participant changes when 
provided visual feedback of HR during sessions. 
STUDY ENDPOINTS:

To evaluate the safety of using Heart Zones technology in a rehabilitation model across 
the rehabilitation continuum by recording the incidence of adverse events. 

To demonstrate the feasibility of using Heart Zones during group sessions by measuring 
the incidence of session usage to missed sessions. 

To demonstrate the efficacy of using visual feedback of HR monitoring to achieve 
greater intensities during sessions compared to no visual feedback of HR. 

To analyze the effect of HR monitoring with visual feedback on therapist perception of 
acceptability, feasibility and appropriateness as well as participant exercise self-efficacy 
and confidence.

To assess feasibility of submax exercise testing in the inpatient setting to establish 
individualized target training intensities and assess the change in submax testing when 
completed at 2 times points.  
STUDY INTERVENTION(S)  / INVESTIGATIONAL AGENT(S):
Heart Zones is a commercially available software platform that integrates feedback from several 
different commercially available HR sensors. The software platform displays HR and provides 
continuous biofeedback with ability to provide individualized programs to maximize individual 
and multi-person sustained effort. It has the capability to record session data for later review 
and analysis. 
We are not evaluating safety or effectiveness of the Heart Zones software, rather assessing the 
effect of monitoring HR with visual feedback in a group setting. 
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We will be using commercially available non-invasive, wireless HR monitors, such as the 
Scosche forearm monitor or other monitors with Bluetooth capability to pair with the Heart 
Zones platform. Scosche has a sensor with Velcro strap armband that is able to be cleaned with 
standard hospital cleaning procedures (Cavicide) between patient uses, yet is affordable, 
accessible and easy to use.  Multiple heartrate monitors can be paired simultaneously and 
paired with a display such as an Apple IPad or other screen. Through visual display of multiple 
HRs in real time, it is feasible to use the Heart Zones application during a group rehabilitation 
session. The display monitors, HR monitors and Heart Zones platform will be stored in a locked 
cabinet accessible to research personnel for authorized use with this study.  
PROCEDURES INVOLVED:
AIM1: 
This will be conducted prior to enrollment of subjects into active phases of the study in order to 
understand baseline provider behavior regarding education to patients regarding intensity, 
monitoring of intensity and progression/modification of session intensity. 
Observation of 15 sessions of each of the following conditions (total of 1500 minutes/condition): 
1.
Condition 1: Baseline Provider Behavior (prior to study beginning) 
2.
Condition 2: HR monitor on, no visual feedback
3.
Condition 3: HR monitor on, visual feedback
Record number of instances in session the following occur: 
-Provider provides education regarding HR/RPE/intensity
-Provider monitors HR/vitals 
-Provider ask for RPE from patient
-Provider mentions target RPE/HR range
-Provider modifies task to reach target RPE/HR range
AIMS 2-5:
Screening Procedures & Consent 
1.
Potential subjects will be recruited from multiple settings across the continuum of 
rehabilitation as they are admitted. 
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2.
Once informed consent is obtained, screening will be performed to ensure inclusion 
criteria for study are met 
3.
Medical clearance for participation from supervising physician through online 
REDCap form. 
2.
Baseline
1.
Participants will complete submax exercise test with licensed physical therapist in 
order to establish individualized HR intensities and zones. 
i.
Based on participant capability and timing, we will perform one or more of the 
submax tests or HR zone calculation methods for the individual based on 
clinical presentation and functional capacity. 
1.
A formula using HR reserve: Based on individual factors and timing, 
target HRR may be calculated instead of using a formal submax 
exercise test.  40-60% HRR is considered moderate intensity and 60-
80% HRR is considered vigorous intensity.18 The appropriate range 
between moderate and vigorous will be used for each participant. 
2.
Clinical discretion to establish zones based on medical parameters: 
depending on recent medical procedures and precautions, 
occasionally patients will have strict guidelines to HR for exercise. The 
utilization of this is anticipated to be more of a rare occasion, however 
establishing zones for these patients will be based on set medical 
safety guidelines. 
3.
6 minute walk test: the participant is asked to walk as far as they can 
in 6 minutes with standard encouragement given every 1 minute. If a 
rest break is needed, it is permitted. Vitals including pre, during and 
post HR monitoring is performed. Peak VO2 can be estimated based 
on distance walked on 6MWT.19 
4.
Seated Stepper: this test is a progressive test using a seated stepper, 
called Nustep, in which the resistance is increased every 3 minutes 
until participant fatigues or until 85% HR max is achieved while 
maintaining a target stepping cadence of 100 steps/minute. HR is 
recorded at the end of the 2nd and 3rd minute of each stage, and if 
within 5 bpm of each other, participants progressed to the next stage.  
If the difference was greater than 5 bpm, an additional minute is 
performed to ensure a steady-state.  The amount of resistance added 
is measured through wattage output and is based on HR response in 
prior stage.  Upon completion of the exercise test, the individual 
continued to step at a comfortable self-selected speed for 2 minutes 
or until HR returned to near baseline levels.16
5.
Arm Crank Test: This test is performed in sitting for 6 minutes, up to 
10 minutes. It uses the upper extremities to cycle at a constant 
cadence of 55-65 revolutions/minute, and resistance starts at 25W 
and increases for the first 3 minutes by 5W. It is then is held constant 
for the remainder of the test until completion or a percentage of your 
max HR is reached. The aim is to reach a steady state of HR in 
minutes 5 and 6, with maximum fluctuation of 5 bpm between 60-85% 
HR max, if this was not achieved, the test is extended up to 10 
minutes to achieve steady state.17 
2.
Baseline measures and information will be collected from patient and medical record 
which include demographic information including gender, DOB, height, weight, co-
morbidities, prior level of function, medical complications or concerns (pressure 
injuries, falls etc), precautions, admission level of function based on QI mobility items 
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and outcomes measures in electronic medical record, reason for admission to 
rehabilitation. 
3.
Intervention:
1.
Group and individual physical or occupational therapy sessions that are focused on 
endurance training (using upper and/or lower limb activities) which is a part of 
standard care for appropriate patients. 
2.
The only addition to usual standard care is the addition of a HR monitor that syncs 
with the Heart Zones software platform with or without visual feedback. Subjects will 
wear the HR monitor on their less sensory/motor impaired upper extremity. 
3.
There will be a continuous rolling enrollment, so some participants will receive HR 
feedback first while others will receive it on their second week. 
4.
Timing
i.
Inpatient: 1 week of visual feedback of HR during group sessions and 1 week 
they will receive no feedback on their HR/zones. 
ii.
Day rehabilitation or community fitness: 2 weeks of visual feedback of HR 
and 2 weeks of no feedback due to fewer sessions per week.
5.
Session Monitoring and Feedback
i.
We will ask participants to rate their level of perceived exertion by using the 
Borg RPE Scale (6-20) at baseline, mid, and post each group session. 
ii.
Participants will answer 2 self-efficacy and confidence questions at the end of 
each session, rated from 0-100%. 
iii.
Subject’s HR data from each session will be transferred for storage on a 
password protected computer accessible by approved lab staff only in order 
to perform summative data analysis, including peak HR, time in target HR 
zone, and average HR for whole session and for endurance training portion 
of the session.
6.
We will monitor for occurrence of adverse events during sessions by assessing 
physiologic response to exercise, incidence of falls, etc. 
4.
Midpoint
1.
We will collect information from their electronic medical record including new medical 
complications or concerns, their current functional level based on QI mobility items 
and outcome measures completed. 
5.
Post 
1.
At the end of the study, we will ask participants to answer one summative quality 
improvement question regarding their participation in the study. 
i.
If discharged unexpectedly, we will attempt to reach out to participants via 
their preferred contact method (phone or email) in order to allow them to 
provide feedback.   
2.
We will collect information from their electronic medical record including new medical 
complications or concerns, their current functional level based on QI mobility items 
and outcome measures completed and ask the participant regarding discharge 
destination.
3.
If the submax exercise test was completed at baseline, we will complete the same 
test a second time at least 3 days later. 
AIM 6: 
a.
We will ask for provider feedback and perceptions at the end of the study by their 
completion of the Acceptability, Appropriateness and Feasibility Questionnaire. 
b.
Given the potential for covering providers, we will only ask participation from 
participating providers who are core staff/covering for a long term placement at each 
of the study locations. 
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SHARING RESULTS WITH PARTICIPANTS
Given the nature of the study design, participants will receive immediate continuous feedback of 
their heartrate for a portion of the study. Individual study results may be provided once the study 
is completed if the patient requests. Results will be shared in written or verbal means, 
depending on participant’s preference. 
STUDY TIMELINES
The participant will be in the study for up to the duration of their length of stay in inpatient 
rehabilitation or day rehabilitation. We anticipate that it will take up to 8 months to enroll all study 
participants and primary analyses will be completed by September 2022.
INCLUSION AND EXCLUSION CRITERIA
Participant Criteria: 
Inclusion:
-
Age 18-90 years 
-
Admitted to inpatient rehabilitation, day rehabilitation or participant in community fitness 
-
Qualifies for group therapy based on diagnosis and insurance reimbursement
-
Physician clearance for participation 
Exclusion: 
-
Unable to provide informed consent due to cognitive impairment 
-
Inability to communicate with investigators 
-
Sternal Precautions 
-
Individuals with LVADs 
-
Pregnant women
-
Uncontrolled Hypertension
-
Serious and unstable cardiac arrhythmias
-
Loss of bilateral upper extremity sensation
-
At high risk for skin breakdown due to poor skin integrity (open wound, fragile skin, etc)
-
Previous participation in this study while in another level of care in the last 6 months
Provider Criteria: 
-
Occupational therapist, physical therapist, assistant or exercise physiologist 
-
Core staff at locations of study or flex staff on long term placement (~3 months) 
-
Willing to participate in structured feedback via questionnaire
PARTICIPANT POPULATION(S)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
0
120
90
Local
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0
120
90
Study-wide
Total:
0
120
90
RECRUITMENT METHODS
Participant:
1.
Trained research staff who have access to medical records will review the data to 
identify all persons with recent admission to the strength and endurance (floors 19 and 
20) at Shirley Ryan AbilityLab who may be eligible to participate in this study during 
inpatient rehabilitation or during day rehabilitation at Streeterville. A research team 
member will approach in person potential participants and introduce the study. If the 
patient is interested in hearing more about the study, a team member will describe the 
project in detail. The team member will have recruitment flyers and a copy of the consent 
available for review. Per potential participants’ preference and continued availability, 
consenting procedures may occur at this time or a later time. If the patient agrees to 
participate in the study, the team member will obtain written documentation of informed 
consent from the patient. 
2.
Referrals from SRAlab healthcare providers involved in patient’s care who receive 
patient’s verbal permission to pass along their name to research staff regarding interest 
in the study.  
3.
In addition, we will update our website (www.sralab.org) to include this research project 
under current clinical trials and studies.
4.
We will distribute flyers to the community fitness center associated with Shirley Ryan 
AbilityLab to facilitate recruitment from this setting. 
Provider: 
1.
Will work with management to identify core and registry staff assigned provide group 
therapy in inpatient, day rehabilitation, and fitness center. 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Participants will receive a total of $50 via Clincard, $25 after medical clearance is received and 
and $25 following completion of final summative feedback question.d. 
WITHDRAWAL OF PARTICIPANTS
Participants may be withdrawn from the study without their consent if they are transferred to the 
MACU for higher level monitoring or discharged from rehabilitation care due to acute 
hospitalization for a change in medical status lasting greater than 72 hours or if they no longer 
meet inclusion criteria for the study. 
RISKS TO PARTICIPANTS
The possible adverse events or risks from the study procedures may include, but are not limited 
to: 

Discomfort or pressure caused by armband: temporary, minor risk associated with direct 
usage during the session.  Adjustment will be provided if patient provides feedback that 
it is too tight. 
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
Risk of skin breakdown due to armband pressure will be minimized by excluding people 
with sensory loss. Adjustments will be provided if the patient provides feedback 
regarding discomfort. If redness lasts greater 15 minutes after the session, patient may 
be placed on hold from further study participation at the discretion of the research PT 
and clinical teams.

Fatigue, or Muscle Soreness: these risks are associated with usual care and are 
associated with exercise.  We do not anticipate an increased incidence of these 
occurring due to participation in this study.  To minimize this risk, subjects will be closely 
monitored throughout sessions by their provider and given rest breaks as needed.

Chest Pain or Shortness of Breath: this is a potential risk of exercise, particularly for 
those with underlying medical conditions.  We do not anticipate an increased incidence 
of this occurring due to participation in this study. To minimize this risk, subjects will be 
closely monitored throughout the sessions by their provider and provided rest breaks as 
needed. 

Falls: this risk is associated with participation in exercise and is not increased by use of 
the heart monitor.  To minimize this risk, participants may be asked to wear a gait belt 
around the waist or a harness for safety or use an assistive device like a cane or walker 
per the discretion of the PT/OT/exercise physiologist. 

Loss of confidentiality of HR Intensity: because this study involves using HR in a group 
setting with feedback, the participants’ HRs and zones will be viewable to other 
participants of the group. Subjects will be able to self-identify/choose a nickname for the 
monitor during group training. 

Risk of loss of confidentiality will be minimized by not including personal identifying 
information on forms (participant will be assigned a research study number) and by 
conducting data collection in a private setting.
POTENTIAL BENEFITS TO PARTICIPANTS
There is likely no direct benefit to participants. Participation in this study will help researchers 
understanding if the use of visual feedback of HR in a group setting is feasible, efficacious and 
acceptable as care provided in a group model is a standard in rehabilitation.  
DATA MANAGEMENT AND CONFIDENTIALITY
The analytic plan follows from the aims and the hypotheses. Descriptive statistics will be used to 
describe the participants and the data. Statistical tests will be utilized to assess for differences in 
individual outcomes baseline, mid and post through paired t-tests or appropriate non-parametric 
tests in consultation with a statistician. Data regarding the aims below may be analyzed for 
group sessions, individual sessions, and combined.
Aim 1: The null hypothesis is that there is no different in therapist behaviors to monitor/progress 
intensity prior to study, without visual feedback, or with visual feedback of participant’s HR. 
Aim 2: The null hypothesis is that there will be no difference in participant’s ability to reach 
target intensity between sessions in which visual feedback of HR is provided and sessions 
where there is no visual feedback.  
Aim 3: The null hypothesis is that there will be no increase in number of adverse events related 
to the use of Heart Zones with and without visual feedback. 
Aim 4: The null hypothesis is that there will be no difference in participant exercise self-efficacy 
and confidence in reaching appropriate intensity when using visual feedback to no visual 
feedback during sessions. 
Aim 5: The null hypothesis is that there will be no difference between submax exercise tests 
completed at baseline compared to post. 
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Aim 6: The null hypothesis is that the providers will not feel the technology is appropriate, 
acceptable or feasible to use in a rehabilitation setting. 
Data will be transferred to and stored on Shirley Ryan AbilityLab’s REDCap system. 
All personal information (names, addresses, email or phone numbers, etc.) gathered for this 
study that can identify participants will be kept secure to protect their privacy and will never be 
shared at any time with any person or entity. Data collected during the study and shared with 
others will reference participants only by an alphanumeric code. The “master list” linking 
personal information to the alphanumeric code will not be shared, and will be kept by the study 
PI in a secure location. 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Every possible precaution will be taken to protect the privacy interests of subjects. To begin with 
participation in this study is completely voluntary. Trained research personnel will explain the 
purpose of the study and intended use of subject’s personal health information and precautions 
taken to keep the study information and data confidential.  Sessions will occur as a part of 
participant’s usual rehabilitation, it is important for the research team to know information about 
the care they received while in the rehabilitation, including things such number of sessions, 
progress, medical history and adverse events and thus access to their medical record is 
paramount. Participants will be asked on consent if they are ok with research personnel 
accessing their medical record as a part of this study.
Subjects have the right to refuse to answer to any questions they feel uncomfortable answering 
and the research team will mark these questions as unanswered. Furthermore, participants can 
refuse other objective tests in the protocol or during their care however if the participants refuse 
the majority of tests which affect the overall implementation of the study, the participants will be 
offered to withdraw from the study. 
COMPENSATION FOR RESEARCH-RELATED INJURY
The participant is required to promptly notify the PI of the study about the illness or injury. The 
hospital [Researchers, SRAL, Northwestern University and all affiliated clinical sites] will not pay 
for medical care required because of a bad outcome resulting from participation in this research 
study. However, this does not keep subject from seeking to be paid back for care required 
because of a bad outcome. 
ECONOMIC BURDEN TO PARTICIPANTS
There are no additional costs as a result to participation in this study as it occurs during their 
usual care.  Compensation is provided for their time to complete the additional brief surveys 
throughout the study with a terminal payment at the end of the study. 
CONSENT PROCESS
Before recruitment and enrollment onto this study, the patient will be given a full explanation of 
the study and will be given the opportunity to review the consent form. Each consent form must 
include all the relevant elements currently required by the FDA Regulations and local or state 
regulations. The consent process will take place at the Shirley Ryan AbilityLab in the patient’s 
room or in a private treatment space. Trained research personnel will guide the subject through 
consenting process. Subject will be given detailed explanation of the purpose, time line, 
commitment, procedures, data handling, privacy and confidentiality of information pertaining to 
the study. Participants will be allowed to ask as many questions as they have regarding the 
study and its procedures prior to proceeding. Once this essential information has been provided 
to the patient and the study team member is assured that the patient understands the 
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implications of participating in the study, the patient will be asked to give consent to participate 
in the study by signing an IRB approved consent form. The written informed consent form must 
be signed and personally dated by the patient and by the person who conducted the informed 
consent discussion.
Should there be amendment made to the consent form after the initial signature of the original, 
the subject will be required to sign a new consent form at their next visit. A researcher will 
review the changes and discuss the implications of the change. 
NON-ENGLISH SPEAKING PARTICIPANTS
For patient’s whose primary language is Spanish, an interpreter will be provided for their 
rehabilitation sessions through Shirley Ryan AbilityLab interpreter services.  Research consent 
and questionnaires will be translated to Spanish for utilization during the study. 
WAIVER OR ALTERATION OF CONSENT PROCESS – NA
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
Subjects records will be kept completely confidential: Every possible precaution will be taken to 
protect the privacy interests of subjects. Participation in this study is completely voluntary. 
Trained research personnel will explain the purpose of the study and intended use of a subject’s 
medical information and the precautions taken to keep the study information and data 
confidential. Data will be collected and kept confidential and compliant with HIPAA standards. 
Participants will be assigned an alphabetical or numerical study ID. Identifying data will be kept 
in locked cabinets and password protected servers completely separate from de-identified data. 
Research data will be de-identified and stored in locked cabinets in the lab accessible only by 
authorized research personnel. Electronic data will be de-identified and kept on secure, 
password protected servers at the Shirley Ryan Ability Lab. Only authorized research staff will 
be able to access any of the formerly mentioned data. De-identified data will be kept indefinitely. 
Study documentation will be collected and stored and kept confidential and compliant with 
HIPAA requirements. Identifying data will be held for 7 years after the study is completed and 
published. 
All personal information (names, addresses, email or phone numbers, etc.) gathered for this 
study that can identify participants will be kept secure to protect their privacy and will never be 
shared at any time with any person or entity. Data collected during the study and shared with 
others will reference participants only by an alphanumeric code. The “master list” linking 
personal information to the alphanumeric code will not be shared, and will be kept by the study 
PI in a secure location. All personal information linking participants to their data will be 
destroyed after 7 years following the completion of the study. 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
Shirley Ryan AbilityLab is a 226 bed rehabilitation hospital with up to 68 beds on the Strength 
and Endurance Floors, which is site of focus for recruitment for inpatient rehabilitation. 90% of 
patients would be eligible for participation in inpatient rehabilitation.  Streeterville Day 
rehabilitation at Shirley Ryan AbilityLab is a day rehabilitation site with appropriately 200,000 
patient units per year, approximately 80% of the patients at day rehab would be eligible for the 
study based on receiving group based rehabilitation as a part of their care. Because of the study 
design with rolling admission into the study, we anticipate being about to recruit the number of 
subjects needed from inpatient and day rehab with 2-3 months each. There will be medical 
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resources including a resident on call and nursing staff available 24 hours a day if needed in 
case of an emergency. All our treadmills have overhead harnesses for additional safety during 
training.
The PI of this study, Miriam Rafferty, is a research scientist at the Shirley Ryan AbilityLab. 
Adequate dedicated office space is available for private meetings with potential subjects, 
performing physical evaluations, explaining the study protocol and obtaining study consent, 
performing data analysis, and writing manuscripts. 
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doi:10.1177/1559827615625482
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improves heart rate moderation during moderate-intensity exercise. Medicine and science in 
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Interpretation. Physical Therapy. 2000;80(8):782-807. doi:10.1093/ptj/80.8.782
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IRB #: STU00216223-MOD0003 Approved by NU IRB for use on or after 3/3/2022