The Effect of Cardiovascular Fatigue on Performance of the Forward-Step-Down Test
Phase: NA
Conditions: Fatigue
Sponsor: Louisiana State University Health Sciences Center Shreveport

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Cardiovascular Fatigue on Performance of the 
Forward-Step-Down Test 
 
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PROTOCOL TITLE: 
The Effect of Cardiovascular Fatigue on Performance of the Forward-Step-Down Test 
 
PRINCIPAL INVESTIGATOR: 
Erin McCallister 
Department of Physical Therapy 
School of Allied Health Professions 
LSUHSC-Shreveport 
(860)218-5494 or (318)813-3502 
emadar@lsuhsc.edu 
 
VERSION NUMBER: 
2 
DATE: 
3/6/2018 
 

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Table of Contents 
1.0 
Objectives* ........................................................................................................... 3 
2.0 
Background* ........................................................................................................ 3 
3.0 
Inclusion and Exclusion Criteria* ......................................................................... 4 
4.0 
Study-Wide Number of Subjects* ......................................................................... 5 
5.0 
Study-Wide Recruitment Methods* ...................................................................... 5 
6.0 
Multi-Site Research* ............................................................................................ 5 
7.0 
Study Timelines* .................................................................................................. 5 
8.0 
Study Endpoints* .................................................................................................. 6 
9.0 
Procedures Involved* ........................................................................................... 6 
10.0 
Data and Specimen Banking* ............................................................................... 8 
11.0 
Data Management* ............................................................................................... 8 
12.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects* ......................... 9 
13.0 
Withdrawal of Subjects* ....................................................................................... 9 
14.0 
Risks to Subjects* ............................................................................................... 10 
15.0 
Potential Benefits to Subjects* ............................................................................ 11 
16.0 
Vulnerable Populations* ..................................................................................... 11 
17.0 
Community-Based Participatory Research* ........................................................ 11 
18.0 
Sharing of Results with Subjects* ....................................................................... 11 
19.0 
Setting ................................................................................................................ 11 
20.0 
Resources Available ........................................................................................... 12 
21.0 
Prior Approvals .................................................................................................. 13 
22.0 
Recruitment Methods .......................................................................................... 13 
23.0 
Local Number of Subjects ................................................................................... 13 
24.0 
Confidentiality ...................................................... Error! Bookmark not defined. 
25.0 
Provisions to Protect the Privacy Interests of Subjects ........................................ 13 
26.0 
Compensation for Research-Related Injury ......................................................... 14 
27.0 
Economic Burden to Subjects ............................................................................. 14 
28.0 
Consent Process .................................................................................................. 14 
29.0 
Process to Document Consent in Writing ............................................................ 15 
30.0 
Drugs or Devices ................................................................................................ 15 
 

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1.0 
Objectives* 
1.1 The purpose of this study is to investigate the effects that a volitional 
maximal cardiovascular exertion test (the Bruce Treadmill Protocol) has on 
performance of the Forward-Step-Down (FSD) test, and to investigate how 
performance on the FSD test changes at multiple time points following the 
fatigue test. 
1.2 Our hypotheses for this study are as follows: 
 Null (H0): Participants will not demonstrate a change in score on 
the FSD test after performance of the Bruce test at any time point.  
 Alternate (H1): Participants will demonstrate a change in score on 
the FSD test after performance of the Bruce test at one or multiple 
of the repeated measurements.  
2.0 
Background* 
2.1 The FSD test has been shown to correlate with movement quality. Deficits 
in strength and flexibility that result in movement impairments are 
associated with scores on the test delineating “moderate” movement 
quality.1 Fatigue may play a role in increased injury risk, with fatigued 
participants in numerous studies showing compromised movement patterns 
that increase risk of injury.2-7 At this time, many of the screening tools used 
to determine the impact of fatigue on a player’s ability to continue to 
play/practice involved dynamic or explosive movements,2,8-10 and rely on 
indicators such as femoral internal rotation or hip adduction angles at initial 
contact to grade movement patterns. These biomechanical indicators may be 
difficult for non-professional personnel to observe, limiting their use outside 
a clinic. There is currently no research on the role of the FSD test in 
assessing for changes in movement pattern that result from fatigue.  
2.2 N/A 
2.3 The literature currently acknowledges that fatigue results in altered 
movement patterns. Several studies have investigated the impact that fatigue 
has on performing challenging movements, such as plyometric drop jumps,8 
cutting,2 jumping and running,3 and landing.7 However, with higher level 
assessments such as these, there is an increased risk for injury if performed 
while fatigued.8 Therefore, a lower level test, such as the FSD test, would be 
ideal as a safe and effective screening tool to look at the impact of fatigue 
stimulus (game play) on a person’s movement quality. As stated above, the 
FSD test has been validated as a measure of movement quality,1 with 
acceptable interrater reliability.11 In addition, poor movement quality during 
the FSD test has been shown to correlate with several impairments such as 
hip abductor strength and poor flexibility.1 Existing literature discusses the 
impact of the hip abductors on knee position and risk for knee injury.2,3,5 
Therefore, a functional test that assesses not only movement quality but 

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identifies possible causes of poor movement would be ideal for preventing 
injury. Research has shown difference in postural balance following aerobic 
fatigue depending on the time since fatigue,12 with poor performance 
immediately following but improved performance 10 minutes after the 
fatigue stimulus was stopped. Therefore, this study will examine the FSD 
test at one, five, and ten minutes following the cardiovascular fatigue 
protocol in order to discern performance differences in movement quality 
related to time/recovery. These differences may be important because if the 
FSD test can be used as a screening tool to examine a person’s fatigue level, 
it is important to also know the appropriate time to use the test in order to 
get accurate results.   
In this study, the Bruce test is used to achieve cardiovascular fatigue. 
Clinically it is a “VO2max” (maximum volume of oxygen consumption) 
prediction test and is intended to continue to the point of failure (maximum 
test). In a true VO2max test, the participant performs the cardiovascular test 
until respiratory spirometry measures a plateau of the VO2, or oxygen 
consumption, between two workloads. This is indicative of that participant’s 
maximum cardiovascular physiological limits. During a true VO2max test, 
respiratory gases are analyzed as well as heartrate, blood pressure, and 
sometimes blood lactate samples are obtained. Together these values 
determine the success in reaching a true VO2max test, demonstrate 
cardiovascular fatigue, and ensure safety of the participant. Often, this point 
is not reached in untrained or unhealthy individuals.13  
Performing a true VO2max test is more expensive and time-consuming for the 
participant than performing a maximal or submaximal graded exercise test. 
Therefore, the Bruce protocol uses mathematical derivation to predict 
VO2max from the participant’s performance on the Bruce. To estimate an 
accurate prediction of the VO2max and ensure cardiovascular fatigue, the 
target heart rate is often set at 10bpm of the age-predicted maximum heart 
rate when using a lower error formula such as the Tanaka formula.14 
Therefore, in this study participants’ age-predicted maximum heart rate will 
be calculated using the formula derived by Tanaka15 with an acceptable 
variability of 10bpm at the maximum heart rate measured during the 
Bruce. The Tanaka formula is accurate for a population of healthy men and 
women. In this study, “healthy” is defined as being in the “low risk” 
category for exercise as stated by the American College of Sports 
Medicine,16 and is one of the inclusion criteria for this study. 
3.0 
Inclusion and Exclusion Criteria* 
3.1 Participants will be recruited from current physical therapy students in the 
class of 2020 who are enrolled in PHTH 7565. During the consent process, 
the participants will be screened using the American College of Sports 
Medicine’s guidelines for safe participation in vigorous exercise.13,16 By 
meeting the ACSM criteria, the participant is considered low risk for 
adverse events while participating in vigorous activity. Finally, in order for 

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the student to participate, they must achieve 10bpm of their predicted 
maximum heartrate, as calculated by the Tanaka15 formula as stated above. 
3.2 Exclusion criteria are pre-existing cardiovascular conditions or diseases that 
prevent participation in a maximal effort test without physician clearance 
per the ACSM guidelines.16 Participants who do not reach their calculated 
target heart rate  by the end of the Bruce protocol will be withdrawn from 
the study and will not complete post-fatigue testing.  
3.3 The investigators plan to include the special population of students in this 
study. To mitigate potential risk of coercion, participation in the study will 
be voluntary. While the Bruce protocol testing is part of one of the 
mandatory laboratory activities for the exercise physiology class (PHTH 
7565), participation in the study is not mandatory and it will be explained 
that participation in the study will not impact the students’ grades in any 
class in any way. The testing will be performed as an adjunct to exercise 
testing performed in the regularly scheduled exercise physiology class, and 
the researchers are not responsible for grading in the exercise physiology 
class.  
4.0 
Study-Wide Number of Subjects* 
N/A 
5.0 
Study-Wide Recruitment Methods* 
N/A 
6.0 
Multi-Site Research* 
N/A 
7.0 
Study Timelines* 
7.1 Describe: 
 
Prior to performing the testing, participants will be consented and 
screened for inclusion and exclusion criteria at the end of an exercise 
physiology class during the summer 2018 semester. This will occur 
before the students begin their exercise testing labs in which the Bruce 
protocol is performed. Following consenting, participants will proceed 
to the testing during the four-week data collection period during the 
summer 2018 semester.  
 
Each participant will perform the pre-and post-testing in the same day. 
The pre-fatigue FSD test occurs just prior to the fatigue (Bruce) 
protocol, and the post-testing will occur at one, five, and ten minutes 
after completion of the fatigue protocol. Initial resting heart rate will 
be measured, as will heart rate at 0, 30, and 60 seconds following 
completion of the Bruce to ensure appropriate heart rate responses to 
exercise for a healthy young adult as per the inclusion criteria of 

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participants being “low risk” for adverse events during vigorous 
exercise.  
 
The expected duration to obtain all necessary participants is up to 4 
weeks. 
 
The estimated time for the researches to perform the primary analysis 
is 3 months 
 
The estimated time to prepare the manuscript for publication is 1 year. 
8.0 
Study Endpoints* 
8.1 The primary endpoint will be collection of the FSD test scores and 
maximum heartrate on the Bruce protocol. The secondary endpoint will be 
submission for publication. 
8.2 During the fatigue (Bruce) protocol, the student will be monitored each 
minute for heartrate and rating of perceived exertion (RPE). Should either 
exceed safe values, or should the participant demonstrate adverse heart rate 
reaction to the exercise as stated in the ACSM termination criteria,13 the test 
will be terminated. The participant also has control over the treadmill and 
can halt testing at any time should adverse events occur, or should the 
participant wish to stop the protocol. FSD testing will be halted if adverse 
events or injury occurs prior to or during the testing process. RPE has been 
established as a subjective correlation to physiological fatigue,17 and is 
accepted as a non-invasive measure of physiological fatigue that will be 
used as a reinforcement of heartrate monitoring. There are no secondary 
safety end points.  
9.0 
Procedures Involved* 
9.1 This study will be a repeated-measures design, with all participants 
undergoing both pre- and post-fatigue FSD test assessments. Two 
orthopaedic specialist physical therapists will perform the FSD assessments. 
The investigators will review scoring guidelines per the Park article,1 and 
will practice scoring the test prior to data collection to ensure good interrater 
reliability. Scores on the FSD test from each assessor will be averaged after 
data collection and prior to data analysis, with each assessor blinded to the 
other’s score prior to averaging the scores. Participants will be healthy 
physical therapy students. Fatigue will be induced via the Bruce protocol 
used in assessment of maximum cardiovascular capacity. The treadmill used 
is an HP Cosmos Quasar (HP Cosmos, Germany). The heart rate monitors 
used are Polar monitors (Polar Electro Inc, Bethpage, NY) 
9.2 The FSD test grades the participant on movement quality during a repeated 
step down from a 20 cm step. The weight bearing leg will be the dominant 
leg (the leg the participant would use to kick a ball) as used in the Park et al1 
experiment. The FSD test consists of five repeated movements of the 
forward step down, with one score given for the whole set of five 
repetitions. For each set of five movements, the rater observes and produces 

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one score for that set of five movements. For data analysis, the investigators 
will use the average of each score for each FSD test. For example, on the 
pre-test for a participant, if one investigator scored the pre-test FSD a 2/6, 
and the second investigator scored the pre-test a 1/6, the “averaged” score 
for the participant’s pre-test is a 1.5/6. This same procedure would be 
repeated for the three post-test FSD tests. 
The Bruce protocol is self-limited with participants stopping at maximal 
exertion. Maximal exertion will be defined as 10bpm of the participants 
predicted maximum heartrate as calculated by the formula “208-(0.7 x age)” 
derived by Tanaka from a population of healthy men and women.15 The 
10bpm heart rate cutoff has been used as a benchmark of achieving 
maximal exertion in a maximal exercise test based off the calculated 
maximum heart rate using the Tanaka formula.14 The participants’ Borg 
Rating of Perceived Exertion (RPE) will also be recorded as part of the 
Bruce protocol; however, since the participants know they will have to 
perform the FSD test following the Bruce protocol, the investigators will use 
heartrate instead of RPE as a metric for exertion due to its more objective 
nature and to avoid a possible threat to validity of the fatigue protocol. 
During the Bruce protocol, treadmill speed and incline are increased every 
three minutes until the subject volitionally stops the test at maximal 
exertion. Heartrate and RPE are monitored each minute during the Bruce 
protocol, with assessment of blood pressure prior and following the 
treadmill test as part of the Exercise Physiology class.  
9.3 Table of events and tests to occur: 
Events/Procedure 
Frequency 
Informed Consent 
1 
FSD test 
4 
Bruce test 
1 
Notification of results 
1 
 
9.4 Describe: 
 
Participants will be screened for health contraindications to performing 
the testing by use of the ACSM’s screen for participation in vigorous 
activity (see flow chart on Informed Consent document). No other data 
will be collected from the participant’s health record. They will be 
informed of their right to stop testing and withdraw from the study at 
any point. Heart rate will be monitored each minute during the 
maximal testing to ensure appropriate responses occur; testing will be 

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halted by the investigators if heartrate fails to respond appropriately, 
the patient shows signs of hypoxia, or other injury/adverse events 
occur.  
 
N/A 
 
No source records will be required for the purposes of this study 
9.5 The study will collect pre- and post-fatigue FSD test scores. Heartrate will 
be monitored and the maximum heart rate during the Bruce will be recorded 
to ensure the participant meets the 10bpm cutoff, but will not be stored for 
further use.  
9.6 N/A 
10.0 Data and Specimen Banking* 
N/A 
11.0 Data Management* and Confidentiality 
11.1 Since this study involves multiple repeated-measures over time, dealing 
with an ordinal level dependent variable, a Friedman’s ANOVA would 
typically be used for data analysis. However, at least one previous study has 
analyzed this measure via parametric statistics, so we could potentially also 
pursue a Repeated Measures ANOVA if our data meets all parametric 
assumptions. Since our alternate hypothesis is two-tailed, our p-value will 
be divided by two for accurate significance assessment 
11.2 To the investigators’ knowledge, there is no previous literature examining 
the effects of an activity/intervention on a within-subjects change in 
performance on the FSD test. As a result, no within-subjects effects sizes 
were available for an a priori power-analysis for required sample size. In 
previous work examining the inter-rater reliability of the FSD test, Park, et 
al. used an effect size of 1.26, based upon the work of Rabin and Kozol, in 
which they measured the amount of ankle dorsiflexion and compared groups 
scoring differently on the FSD test in this anthropometric measure.17 We 
therefore, used 0.5 as our effect size because the current study design differs 
from the Rabin and Kozol study design, and given their large effect size the 
investigators felt justified in setting a moderate effect size for the power 
analysis. The power analysis used an alpha of .05 and power of .80 for a 
two-tailed hypothesis via a repeated measures, within factors ANOVA 
analysis. This power analysis determined the need for nine participants. 
With 37 students in the class, we have more potential participants than 
needed to ensure the required power to observe a statistical result if it exists. 
11.3 The Excel sheet will be kept in in a password protected file on password 
locked computers in the PI and co-investigator’s offices. Consent forms will 
be secured in a locked file cabinet in the PI’s office.  
11.4 N/A 

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11.5 Each investigator will track scores independently during the testing 
procedures, with a random number assigned to each participant recorded on 
the consent form and matched to the Excel data collection document. The 
results will be combined into a locked spreadsheet that will be stored on the 
PI’s and co-investigator’s laptops, which are both password protected. The 
only information collected that will be stored will be the patient’s health 
screening and consent information which will be secured in a locked file 
cabinet in the PI’s office, and the scores from the FSD test secured as stated. 
Following publication of the data, the informed consent documents will be 
retained for the requisite six years per HIPAA and LSUHSC-S IRB 
regulations. At this time, the records will be shredded. Both the PI and the 
co-investigator will have access to the data since the co-investigator will be 
responsible for statistical analysis of the data.  
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
The Bruce protocol is utilized in the many clinical exercise stress tests, and 
therefore is considered minimal risk because it is not greater than normal 
risk/discomfort expected during routine physical examination. In addition, the 
participants must all meet ACSM criteria that determine them to be low risk to 
participate in vigorous exercise. Therefore, the Bruce and FSD tests are not 
considered greater than normal activity for the participants of the study. However, 
the potential adverse events of exercise do include cardiovascular events such as 
myocardial infarction and death.18,19 Therefore, these risks will be minimized as 
follows: 
 
Prior to consenting the participants, either investigator will give 
potential participants a health screen that will determine if they require 
a physician’s clearance to undertake vigorous physical activity such as 
the Bruce protocol. Those who do need a referral will not be consented 
to participate until cleared by their physician if they still wish to 
participate. The screen is detailed by the American College of Sports 
Medicine (see Appendix A for the screening flow chart).16 
 
Participants will wear a heart rate monitor that will ensure the 
investigators are able to confirm appropriate cardiovascular response 
to exercise. Heart rate will be measured prior to and during testing 
each minute during the Bruce protocol. An adverse reaction to a 
maximal exertion test such as the Bruce protocol is a decrease in heart 
rate with the same or increased work load.  
13.0 Withdrawal of Subjects* 
13.1 Participants will be withdrawn without their permission if they demonstrate 
adverse reaction during the Bruce protocol that necessitates termination of 
the protocol prior to volitional maximum effort, as well as if they experience 
musculoskeletal injury during any portion of the test. Participants will be 
withdrawn if pre-testing blood pressure/heartrate monitoring reveals 

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abnormalities that contraindicate Bruce Protocol testing. Participants will 
also be withdrawn if they do not meet the heart rate threshold during the 
Bruce protocol.  
13.2 If the test must be terminated during the Bruce, the treadmill will be stopped 
and the participant monitored for normalization of hemodynamics, or 
appropriate medical procedures will be followed if necessary. Should 
participants be withdrawn before completion of the post-test FSD test, their 
data set will be removed from the analysis.  
13.3 Data from participants who do not complete the final FSD test will be 
removed. Since testing is complete after the final FSD test, no further 
collection will need to be completed and participants do not need to return to 
the clinic. 
14.0 Risks to Subjects* 
14.1 Risks from performing the Bruce Protocol include muscle soreness and 
musculoskeletal injury, both of which are temporary and non-life 
threatening. Musculoskeletal discomfort is reversible with discomfort 
expected to pass within days. Since the participants are students who would 
be performing the Bruce Protocol tests for classroom experience, there is 
minimal economic or time burden. 
More serious risks are possible, with a less than one percent risk for 
myocardial infarction and death due to over-exertion. Historically, this risk 
has been shown to be acceptable while performing cardiovascular stress 
tests with an estimate of 3.58 infarcts per 10000 tests and 4.78 serious 
arrhythmias per 10000 tests. The risk of death was 0.5 per 10000 tests.8 19 
However, cardiovascular stress tests are not performed in young, healthy 
populations because they are not deemed medically necessary for sports or 
activity participation. Therefore, these numbers represent adverse events 
that occur in the population that is recommended by a physician to undergo 
the cardiovascular stress tests. In this study, if a participant falls into a 
category that requires physician clearance before participating in exercise, 
they do not meet the inclusion criteria for this study. 
In general the risk of death from sudden cardiovascular infarct during 
vigorous exercise remains low. The ACSM estimates one death per 1.5 
million vigorous exercise training sessions in men, and one per 36.5 million 
hours of moderate-to-vigorous exercise in women. These numbers were 
drawn from participation in community gyms, where screening for exercise-
risk does not always occur; therefore, the risk for these serious side effects is 
predicted to be lower due to the pre-test screening performed. Again, the 
risk noted above in the general population is most likely higher due to the 
careful medical screening that will occur as part of the inclusion criteria. 

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14.2 There is no data regarding risks other than possible musculoskeletal 
discomfort from performing the FSD test. It is possible that injury may 
result from performing this test in a fatigued state but this is an unlikely risk. 
14.3 N/A 
14.4 N/A 
15.0 Potential Benefits to Subjects* 
15.1 Participants will be able to calculate their predicted VO2max from the Bruce 
protocol data, which is useful for training purposes should the participants 
be aerobic athletes. Participants will also gain knowledge of their movement 
quality during the FSD test, which can be used to improve their deficits and 
potentially decrease injury risk. After data collection is complete, 
participants can contact the investigators to obtain their FSD test scores. 
15.2 N/A 
16.0 Vulnerable Populations* 
The study does involve students of the university at which the investigators 
are instructors. The risk of coercion has been minimized by ensuring the 
participants give voluntary informed consent. In addition, the students 
participate in the Bruce protocol testing for one of their classes. Care was 
taken to select investigators who are not involved with grading of that class 
to ensure students do not perceive they are being coerced into participation 
in the study.  
17.0 Community-Based Participatory Research* 
Not applicable at this time; the goal of the investigators is to ultimately 
determine if the FSD test can be used as a screening tool for injury risk 
based on current fatigue levels. Should the study progress to that level, 
involvement with members of the community, such as coaches, will be 
included to determine if this is a feasible screening tool.  
18.0 Sharing of Results with Subjects* 
18.1 Should cardiovascular abnormalities be discovered in the heartrate and 
blood pressure screenings prior, during, or after the testing, the participant 
will be informed of the importance of following up with the appropriate 
medical professional. If desired, the investigators will provide the 
participant with a letter detailing the findings.  
19.0 Setting 
19.1 Describe the sites or locations where your research team will conduct the 
research. 
 
Participants will be identified by the cohort who will be enrolled in 
Exercise Physiology (PHTH 7565) in the summer of 2018. 

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 
Research will be conducted at the School of Allied Health Professions 
Faculty Practice Clinic.  
 
N/A 
o 
N/A 
20.0 Resources Available 
20.1 Both investigators have completed orthopaedic residencies and hold current 
licenses to practice physical therapy in the state of Louisiana. The co-
investigator is an Orthopaedic Clinical Specialist, and the PI has recently 
taken the Orthopaedic Clinical Specialist exam and is awaiting results. PT 
licensure includes indications and contraindications for maximal exercise 
testing and prescription for various healthy and unhealthy populations. In 
addition, the PI has experience working with exercise testing at the 
Pennington Biomedical Research Center in Baton Rouge, LA. The co-
investigator is currently completing his PhD work in Physical Therapy.  
20.2 Describe other resources available to conduct the research: For example, as 
appropriate: 
 
The class of 2020 that will be enrolled in Exercise Physiology has a 
total of 37 students. With nine participants needed per the power 
analysis, there should be no difficulty recruiting the necessary number 
of participants. 
 
Both investigators are instructors in the School of Allied Health 
Professions in the Department of Physical Therapy, and have 30% of 
their time set aside for research purposes. This time will include 
recruitment and consenting of participants, testing, data analysis, and 
writing results for publication. 
 
The Faculty Practice Clinic in the School of Allied Health Professions 
is a functioning outpatient physical and occupational therapy clinic. It 
includes treadmills for aerobic testing, and the appropriate equipment 
to perform the FSD test. It also includes the emergency equipment 
necessary to be a functional clinic within regulation.  
 
The School of Allied Health Professions is part of the larger Health 
Sciences Center campus. Emergency transportation is available to the 
hospital, which is adjacent to the Medical School portion of campus. 
In addition, students have mental health services available for free 
through the School should this be necessary if a participant has an 
adverse psychological event to the testing procedures.  
 
All participants will give voluntary informed consent, by which they 
will be educated on what tests they will be expected to perform. Both 
investigators will be able to consent participants into the study. Both 
investigators will review the protocol prior to the testing sessions, and 
will keep independent records of FSD test. Prior to each testing 
sessions, the investigators will clarify any questions regarding 

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procedure to ensure the same progression of tests are performed on 
each participant.  
21.0 Prior Approvals 
21.1 Permission will be obtained from the Exercise Physiology Course 
Coordinator to add the FSD test pre- and post-testing to the Bruce protocol 
laboratory experience.  
22.0 Recruitment Methods 
22.1 Participants will be recruited from the physical therapy students enrolled in 
PHTH 7565 Exercise Physiology at the School of Allied Health Professions 
in the summer of 2018.  
22.2 The participants will be from the DPT Class of 2020. 
22.3 All students in the above class who do not meet the exemption criteria will 
be eligible.  
22.4 N/A: an announcement will be delivered to the Exercise Physiology class 
regarding the experiment and consenting process. 
22.5 N/A 
23.0 Local Number of Subjects 
23.1 One hundred percent of the subjects will be recruited locally. As stated in 
the inclusion/exclusion criteria, participants will be included for post-testing 
only if they achieve 10bpm of their predicted maximum heartrate on the 
Bruce protocol. Participants will be informed of the study, screened, and 
consented to participate at one time. During testing, participants will be 
gathered until adequate power is reached. 
23.2 The physical therapy class the participants will be drawn from has 37 
students total. All willing participants will be screened and consented for 
inclusion, and data will be gathered until adequate power is reached.  
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 Due to the nature of the Bruce Protocol testing for the Exercise Physiology 
class, students will be visible to their classmates during testing. However, 
participants will have the ability to request screens be placed around the area 
where the FSD test occurs to ensure privacy.  
24.2 Participants will be educated on the nature of the tests that they will be 
performing, as well as the risks and benefits associated with research 
participation. They will be allowed three minutes of familiarization prior to 
the pre-testing portion of the FSD test. 
24.3 The investigators will inquire about past medical history in order to ensure 
the participant meets the inclusion criteria. Access to medical records is not 
otherwise required.  

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25.0 Compensation for Research-Related Injury 
25.1 N/A 
25.2 N/A 
26.0 Economic Burden to Subjects 
N/A 
27.0 Consent Process 
27.1 Indicate whether you will you be obtaining consent, and if so describe: 
 
Consent will take place in the classroom with all students present. 
Those wanting to participate will be screened with the ACSM medical 
screen, and there will be time for questions regarding the testing both 
as a group during the information and consent session, and 
individually by appointment with the PI or co-investigator within the 
one week following the informational session.  
 
Participants will be informed that they have up to one week to consent 
for the study after the general information is given. They will be given 
the contact information for both investigators, and both investigators 
will be able to consent a participant in the study. 
 
Participants will be reminded that they are able to withdraw at any 
time. 
 
The study will be following “SOP: Informed Consent Process for 
Research (HRP-090).”  
Non-English Speaking Subjects 
 
N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
 
N/A 
Subjects who are not yet adults (infants, children, teenagers) 
 
N/A 
Cognitively Impaired Adults 
 
N/A 
Adults Unable to Consent 

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 
N/A 
Adults Unable to Consent 
 
N/A 
28.0 Process to Document Consent in Writing 
28.1 The study will follow “SOP: Written Documentation of Consent (HRP-
091).”  
28.2 Given the special population of students in this study, the investigators 
decided to obtain written informed consent.  
28.3 Consent Document attached with ACSM medical screening to be performed 
at the time of informed consent.  
29.0 Drugs or Devices 
 
N/A 
 
N/A 
 
 
 

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Appendix A: ACSM Exercise Screening Flow Chart 
 
Participants must fall in the “Medical Clearance Not Necessary” column for moderate or 
vigorous exercise to be included in the study per the inclusion criteria. 
 

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Forward-Step-Down Test 
 
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