Furman University IRB Form
Institutional Review Board for the Protection of Human Participants
FORM A
Project Description
USE OF HUMAN PARTICIPANTS
STATEMENT BY PRINCIPAL INVESTIGATOR OR ACTIVITY DIRECTOR
A. Principal Investigator/Activity Director:___Dr. Scott Murr and Dr. Randolph E. Hutchison______________
B. Activity Title: The effect of cycling intensity on subsequent running performance
C. Department: Health Sciences Telephone Ext: 864-294-3677 (Murr) and 864-294-3687 (Hutchison)
D. Student Investigators:, Morgan Kuhar, Olivia “Livi” Tant, Maggie Grisell
E. Sponsoring Agency (NIH, NSF, etc.):
Funds Awarded: No
none
Funds Applied For:
F. Date Submitted to Furman University IRB:
No
01/11/2013
G. Furman IRB registration number of Activity Director: 0150 (Murr) and 1035 (Hutchison)
----------------------------------------------------------------Furman University adheres to the Code of Federal Regulation, Title 45 (Public Welfare) concerning research
with human participants, Part 46 (Protection of Human Subjects).
1. TYPE OF SUBMISSION:
X_ New
Continuation (see section IX)
Renewal (See Section IX) Please include copy
of signed FUIRB approval from original
submission.
Modification (see section X & XIV-B1)
Previous approval date:
2. TYPE OF REVIEW:
Exempt – Form B (see section VIII-1)
__X
Expedited – Form C (see section VIII-2)
______ Full review – Form D (see section VIII-3)
3. DURATION OF INVESTIGATION: (Protocol must be reviewed annually or frequently if required by the
FUIRB)
Proposed Starting Date of Research Activity: January 2013
Expected Duration of Research Activity: _12 months Ending date:
12/31/2013________
1
4. PARTICIPANTS:
__X__Students
Minors (students under 18)
Patients as experimental subjects
Patients as controls English
Pregnant women or fetuses
Mentally disabled
Children/Infants (circle)
15
Prisoners, incarcerated subjects
__X __Normal adult volunteers
Persons whose first language is not
Geriatrics
Minority
Other (please specify)
TOTAL ANTICIPATED PARTICIPANTS
5.
PROCEDURES: (check all that apply; ATTACH relevant materials, such as questionnaires, interview
schedule, instruments, etc.)
Survey, questionnaire(s)
Drug trial/administration*
Interview: phone/in-person
Placebo
Medical or other personal records
X
Filming, taping, recording(only markers, no personal ID)
X
Observation
______Ionizing Radiation (attach CURRENT approval)
Participant observation
______Venipuncture, with IV
______Anthropological fieldwork
Surgery
Psychological Intervention
Payment of Subjects
Incomplete disclosure of purpose
(blood lactate) Other body fluids, excreta
_ Class project
Other procedure ______________________
*FDA approval certification required (include IND# or IDE#)______________
6. Location(s) where research will be conducted.
Molnar Human Performance Laboratory, Furman University, 3300 Poinsett Highway, Greenville, SC 29613
Principal Investigator or Activity Director’s Signature*
_________
Date
Faculty Advisor’s Signature (if other than above)*
Date
Department Chairperson’s Signature**
Date
* By signing this document, the investigator acknowledges that he or she has received IRB certification from
the FUIRB and has read and understood the Responsibilities of the Investigator Prior To and After Project
Approval (section XII of the FUIRB).
** By signing this document, the Chair indicates that he or she has considered the ethical and empirical nature
of the proposed investigation and can attest to its ethical and scientific merit.
2
FORM C
Expedited Review
(45 CFR 46.110)
USE OF HUMAN PARTICIPANTS
STATEMENT BY PRINCIPAL INVESTIGATOR OR ACTIVITY DIRECTOR
Research activities that (1) present no more risk to human subjects, and (2) involves only procedures listed in
one or more of the following categories, may be reviewed by the IRB through the expedited review process, as
authorized by 45 CFR 46.110 and 21 CFR 56.110. Please refer to Section X of the Furman University IRB
Guidebook to determine the criteria for expedited review prior to completing Form B.
1. Associate or Collaborating Investigator(s), excluding student assistants:
Name
Institution
Address
Tel.#
Fax #
Scott Murr
Furman University, 3300 Poinsett Hwy, Greenville, SC 20613 (864)294-3677_(864)-294-2942
Randolph Hutchison
Furman University, 3300 Poinsett Hwy, Greenville, SC 20613 (864)294-3687_(864)-294-2942
1.
Describe the Nature of the Research Activity (Please use language that can be understood by
reviewers outside of your discipline.). Provide enough detail to adequately and accurately represent the
proposed investigation. Include description of each of the following concerns:
A) The multidisciplinary sport of duathlon is composed of two different exercises in succession. It is
proposed that, throughout a duathlon, the residual effect of prior exercise creates physiological
responses that differ from performing the disciplines as individual events. Few multisport investigations
have considered the interaction between the two activities with a performance based objective. Previous
studies have not considered the effect that cycling effort may have on performance outcomes, thereby
limiting their application. No investigation has explored performance outcome by specifically
manipulating the cycling intensity before a run in female multisport athletes. The purpose of this study is
to examine the effects of cycling intensity on subsequent running time and overall duathlon
performance.
(a) Relevant background research with bibliography
No investigation has explored performance outcome by specifically manipulation the cycling intensity
before a run in female multisport athletes.
References
Beidleman, Rock, Muza, Fulco, Forte, and Cymerman. "Exercise V˙e and Physical Performance at
Altitude Are Not Affected by Menstrual Cycle Phase." Applied Physiology 86.5 (1998):
Bernard, Vercruyssen, Grego, Hausswirth, Lepers, Vallier, and Brisswalter. "Effect of Cycling Cadence
on Subsequent 3KM Running Performance in Well Trained Triathletes." Science and Medicine in Sport
(2003): 154-58.
Danner, and Plowman. "Running Economy Following an Intense Cycling Bout in Female Duathletes
and Triathletes." Women in Sport & Physical Activity 4.1 (1995): 29-39.
3
Hausswirth, Christophe, Didier Leh Naff, Patrick Dr. Ano, and Kai Savonen. "Effects of Cycling Alone
or in a Sheltered Position on Subsequent Running Performance during a Triathlon." Medicine & Science
in Sports & Exercise 31.4 (1999): 599-604.
Kishali, Necip, Osman Imamoglu, Dursun Katkat, Tulin Atan, and Pelin Akyol. "Effects Of Menstrual
Cycle On Sports Performance." International Journal of Neuroscience 116.12 (2006): 1549-563.
MacRae, Holden, Cindy Miller-Perrin, and Christine Tinberg. "Cycling with Video Feedback Improves
Performance in Untrained, but Not in Trained Women." Research in Sports Medicine 11.4 (2003): 26176.
Mauger, Jones, and Williams. "The Effect on Non-contingent and Accurate Performance Feedback on
Pacing and Time Trial Performance in 4-km Track Cycling."
Micklewright, Papadopoulou, Swart, and Noakes. "Previous Experience Influences Pacing during 20
Km Time Trial Cycling." 12 Apr. 2009.
Peeling, P. D. "Effect of Swimming Intensity on Subsequent Cycling and Overall Triathlon
Performance: Commentary." British Journal of Sports Medicine 39.12 (2005): 960-64. 17 May 2005.
Peveler, Will W., and Matt Green. "The Effect of Extrinsic Factors on Simulated 20-km Time Trial
Performance." Journal of Strength and Conditioning Research 24.12 (2010): 3265-269. 2010.
Phillips. "Menstraul Myth Busting." Sports Coach 28.2 (2005): 1-3.
Tew, Garra A. "The Effects of Cycling Cadence on Subsequent 10KM Running Performance in Welltrained Triathletes." Journal of Sports Science and Medicine (2005): 342-53. 01 Sept. 2005.
Vercruyssen, Fabrice, Jeanick Brisswalter, Christophe Hausswirth, Thierry Bernard, Olivier Bernard,
and Jean-Marc Vallier. "Influence of Cycling Cadence on Subsequent Running Performance in
Triathletes." Medicine & Science in Sports & Exercise 34.3 (2002).
(b) Purpose and methodology.
The purpose of this study is to examine the effects of cycling intensity on running time and overall sprint
distance duathlon performance.




Fifteen trained and experienced female multisport athletes will complete six separate laboratory sessions
comprising of a max cycling test, 20K cycling time trial, 5K run time trial, and three duathlons sessions.
The max cycling test will be performed on the participant’s own bicycle on a stationary CompuTrainer.
This testing session will be conducted in the Molnar Human Performance Laboratory.
The 20K cycling time trial will be performed on a participant’s own bicycle on a stationary
CompuTrainer. This testing session will be conducted in the Molnar Human Performance Laboratory.
The 5K run time trial will be performed on the Furman track.
4


The cycling velocities of the three duathlon sessions will be 89-91% (DU90), 94-96% (DU95), and 98100% (DU100) of the 20K cycling time trial. For the duathlon sessions, the cycling component will be
performed on the participant’s own bicycle on a stationary CompuTrainer. The subsequent running will
be performed on the Furman track at a perceived maximal intensity.
The max cycling test, RTT, and CTT will be completed first in randomized order.
(c) Requirements for the participant population.
Explain the rationale, if the population includes a special group such as prisoners, children, mentally
disabled, or those whose ability to give informed consent may be in question.
The sample population requirements will be females, age 18 to premenopausal, who have completed a
multisport event, with current training of 5 or more hours per week. The athletes’ current training must
include at least two (2) bike workouts and two (2) run workouts per week. The female participatns will
be tested at Furman University in Greenville, SC. Subjects will be required to be aerobically trained.
The study will include up to a maximum of 15 participants.
(d) Identify those procedures in which a human participant is used which depart from common and
established activities, or which increase the ordinary risks of daily life, including the recognized risks
inherent in a chosen occupation or field of service
Considering our sample population is predisposed to the physical strain that one experience with
physical activity, there are no procedures that divert from common activity.
(e) Describe and assess any potential risks--physical, psychological, social, legal, etc., and assess the
likelihood and seriousness of such risks.
Potential risks include personal discomfort during vigorous exercise, muscle pain due to high intensity
cycling and running, and in extremely rare situations cardiovascular complications. Investigators will
closely monitor the subject’s heart rate while cycling and running and the participant has the authority to
terminate the session at any point in the research process. In order to reduce the risks above, each
participant will complete a lifestyle and training questionnaire prior to participation. If any of these
risks are of concern to the participant, she can terminate her involvement at any time.
(f) Anticipated statistical analyses to be conducted on the obtained data.
Data will be analyzed upon completion of the study using SPSS statistical software.
2. Provide a copy of any and all Consent Forms to be used in this investigation.
Subject Informed Consent Form – see pages 6 – 7
Subject Lifestyle and Training Questionnaire – see pages 8 - 10
3. Provide copies of any instruments or other documents that will be used in this investigation.
CompuTrainer Testing Protocol – see page 11
Data Sheet – see page 12
For expedited review, submit the original plus Form A and other supporting materials to Ms. Pochard, Grants
Administration Office.
5
Effect of Cycling Intensities on Subsequent Running Performance
SUBJECT INFORMED CONSENT FORM
Department of Health Sciences
Molnar Human Performance Laboratory
1. Explanation of the Tests
You will be asked to participate in various tests for a total of approximately 6 hours over 6-10 days that will
enable the investigator (s) to assess your health status, cardio-respiratory fitness and maximal work capacity on
a stationary bike ergometer. The procedures for conducting the tests are as follows:
a. Standing Height - standing height will be measured as you stand erect, with shoes off, and
with your back against a stadiometer. After you inhale deeply, a square edge will be
brought in contact with the top of your head and your height will be recorded.
b.
Body Weight - body weight will be recorded as you stand on a weight scale, with your
shoes off and clad in shorts.
c.
Maximal Bike Test: You will be asked to perform one maximal bike test to fatigue. During the test,
workload will be progressed by 25-30 watts every 1 minute until you reach fatigue. The test should last
between 10-15 minutes. This test is important to establish your maximal workload. Heart rate will be
monitored during this test. The max cycling test will be performed on the participant’s own bicycle on a
stationary CompuTrainer. This testing session will be conducted in the Molnar Human Performance
Laboratory.
e.
Run Time Trial: You will be asked to perform one run time trial. During this test, you will run a 5K at
your race pace. During the run, your heart rate, time, and pacing will be recorded. This test will be
important in order to determine threshold running performance. The 5K run time trial will be performed
on the Furman track.
f.
Cycling Time Trial: You will be asked to complete one 20 kilometer cycling time trial. The 20K
cycling time trial will be performed on a participant’s own bicycle on a stationary CompuTrainer. This
will be to determine threshold cycling performance. This testing session will be conducted in the
Molnar Human Performance Laboratory.
g.
Duathlon Sessions: You will be asked to complete three sessions of a 20 kilometer bike followed by a
5K run. During each of these sessions you will be asked to cycle at a certain velocity (intensity), based
on your cycling time trial. For these sessions, the cycling component will be performed on the
participant’s own bicycle on a stationary CompuTrainer. The subsequent running will be performed on
the Furman track at a perceived maximal intensity.
h. Cardio-respiratory measures: A heart rate strap will be applied around your chest to record heart rates
during all sessions of this investigation.
6
2. Risks and Discomforts
The workouts during this study will be similar to the ones a multisport athletes completes as part of their
typical training. There exists the possibility of certain changes occurring during the bike and run
sessions. They include local muscle pain and fatigue. Potential risks include personal discomfort during
vigorous exercise, muscle pain due to high intensity cycling and running, and in extremely rare
situations cardiovascular complications. Investigators will closely monitor the subject’s heart rate while
cycling and running and the participant has the authority to terminate the session at any point in the
research process. In order to reduce the risks above, each participant will complete a complete a lifestyle
and training questionnaire prior to participation. If any of these risks are of a concern to the participant,
she can terminate her involvement at any time.
3. Responsibilities of the Participant
You are responsible for fully disclosing requested information regarding your health status, pertinent
lifestyle behaviors (usage of medications, caffeine, and tobacco, exercise habits) and psychological or
physical feelings/symptoms accompanying physical exertion.
4. Benefits to be Expected
The results from the exercise tests will be used to evaluate your physiological capacity and fitness.
5. Freedom of Consent
Please ask for further explanations if you have any doubts or concerns. Your permission to participate
in these exercise tests is entirely voluntary. You may freely choose to deny consent or to withdraw from
the testing at any time.
I __________________________________ acknowledge that I have thoroughly informed of and
understand the procedures to be administered in this study. I am fully aware of any possible risk or
discomfort that I may experience by participating in this study. My participation in this study is purely
voluntary and I understand that I may withdraw from the study at any time without incurring coercion or
prejudice. I acknowledge that I have no history of cardiovascular problems, especially diseases related
to hypertension. I understand that a copy of this consent form and my results will be available to me
upon request. I consent to participate in these tests.
____________________________________
Signature of Subject
___________________
Date
____________________________________
Signature of Witness
If any questions or problems arise related to your participation in this study, contact Dr. Scott Murr at PAC 4J
and 864.294.3677 or Randy Hutchison at PAC 4F and 864-884-7162.
7
Effects of Cycling Velocity in Duathlon Performance
Lifestyle and Training Questionnaire
Please complete the questionnaire to the best of your knowledge. Taking the time to provide as accurate
answers as possible will allow the staff to better evaluate your fitness. All responses will be held in the strictest
of confidence.
I. Personal Information
First Name
Middle
Preferred Name
Weight __________ lbs.
Last
Gender ______________ Age _______________yrs.
Height __________ inches
Technical Shirt Size
S
 M
 L  XL
Address
City
Telephone No.
State
Zip
E-mail address _______________________________________
Occupation: _______________________________________________________________________________
Approximately how many hours do you work a week? __________________________________________hrs.
Emergency Contact
Telephone No.
Physician Name
Telephone No.
II. Medical Background:

Are you currently under physician’s care?

Please list any medications you are presently taking:

Do you have diabetes?
Yes
No
______________

Have you ever had a stroke?
Yes
No
______________

Has your doctor ever said you have heart trouble?
Yes
No
______________

Do you take asthma medication?
Yes
No
______________

Are you, or do you have any reason to believe, you may be pregnant?
Yes
No
______________

Has your doctor ever told you that you have a heart murmur?
Yes
No
_____________

Is there any other physical reason that prevents you from participating
in an exercise program (e.g. cancer, osteoporosis, severe arthritis,
mental illness, thyroid, kidney, or liver disease)?
Yes
No
______________
Yes
No
______________
____________________________________________
8
III. Current Fitness
What do you consider to be your ideal running weight? ____________________________________________
If known, Maximal Heart Rate: _______________ bpm
Method: ________________________________
If known, VO2 MAX: ____________________ ml/kg/min
Method: ________________________________
If known, Lactate Threshold: ___________________
Method: ________________________________
If known, percent body fat: ____________________ %
Method: ________________________________
Do you monitor your morning heart rate?
Yes
No
if “yes,” please describe___________
Do you train with a heart rate monitor?
Yes
No
______________________________
Please indicate on the scale your perceived current level of fitness
|
|
|
|
|
|
|
Unfit
|
|
|
|
Average Fitness
|
|
|
|
|
|
Most Fit
Please describe your previous training and racing (years, races, etc.)
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
IV. Current Racing
If “Yes,” give most recent race, date and finish time.
No
______________________________________
Have you ever done a 5K race?
Yes
Have you ever done a 8K race?
Yes
No
______________________________________
Have you ever done a bike time trial?
Yes
No
______________________________________
Have you ever done a duathlon?
Yes
No
______________________________________
Have you ever done a triathlon?
Yes
No
______________________________________
Do you do any other exercise?
Yes
No
______________________________________
Do you have/use a heart rate monitor?
Yes
No
______________________________________
Do you have any current physical injuries?
Yes
No
______________________________________
9
V. Current Training
Please describe your current exercise/training program. Try to give an example of a typical current week (not
an ideal or best training week). Please provide as much detail as possible. Indicate time, distance, effort, etc.
Day
Activity
Distance
Time
Effort
Comments
Monday
Tuesday
Wed.
Thurs
Friday
Saturday
Sunday
Approximately how many hours a week do you exercise? ___________________________________________
How often do you take a day off from training? ___________________________________________________
10
CompuTrainer – Testing Protocol
Name_______________________________ Age __________________yrs
Body Weight ___________________kg
Average Days Bike Per Week  1 – 3
1.5W x body weight (kg) = __________
 Mount bike to CompuTrainer
4–7
3.0W x body weight (kg) = __________
□ inflate rear tire
□ check / adjust press-on force
 Ride 10 minutes to warm-up tire
 Complete rolling resistance calibration 3 times to set rolling resistance
Rider Warm-Up
Warm-Up
0:00 – 1:00
1:01 – 2:00
2:01 – 3:00
3:01 – 4:00
4:01 - 5:00
5:01 – 6:00
6:01 – 7:00
7:01 – 8:00
8:01 – 9:00
9:01 – 10:00
Duration:
10 minutes
Power Output: 1.5W x body weight (kg)
Other:
1 minute sprints at the 4th & 7th minutes; watts = 3.0W x body weight (kg)
Watts
1 minute sprint @ 3.0W x body weight (kg)
1 minute sprint @ 3.0W x body weight (kg)
Test Protocol Test cadence:
preferred cadence between 70 and 120 rpm
Test termination:
exhaustion; cadence drops below 70 rpm
 athlete bikes 1 – 3 days/week
 athlete bikes 4 – 7 days/week
output increases 25 Watts each minute
output increases 30 Watts each minute
Test Time
Watts
HR (bpm)
RPE
Test Time
Watts
HR (bpm)
RPE
0:00 – 1:00
50
0:00 – 1:00
50
1:01 – 2:00
75
1:01 – 2:00
80
2:01 – 3:00
100
2:01 – 3:00
110
3:01 – 4:00
125
3:01 – 4:00
140
4:01 - 5:00
150
4:01 - 5:00
170
5:01 – 6:00
175
5:01 – 6:00
200
6:01 – 7:00
200
6:01 – 7:00
230
7:01 – 8:00
225
7:01 – 8:00
260
8:01 – 9:00
250
8:01 – 9:00
290
9:01 – 10:00
275
9:01 – 10:00
320
10:01 – 11:00
300
10:01 – 11:00
350
11:01 – 12:00
325
11:01 – 12:00
380
12:01 – 13:00
350
12:01 – 13:00
410
13:01 – 14:00
375
13:01 – 14:00
440
14:01 – 15:00
400
14:01 – 15:00
470
11
Effect of Cycling Intensities on Subsequent Running Performance
Data Sheet
Name_______________________________________
Test / Session
Bike Max
20K Bike TT
5K Run
Duathlon #1
Duathlon #2
Duathlon #3
89 – 91%
94 – 96%
98 – 100%
Date
Time of day
Temperature
Humidity
Bike Intensity
maximum
Avatar wattage
20K Bike Time
Bike Heart Rate
5K Run Time
Run Heart Rate
Bike+Run Time
12