Full 20irb 20revised 2010 24 16
Full 20irb 20revised 2010 24 16
University of Mary
INSTITUTIONAL REVIEW FOR HUMAN SUBJECTS RESEARCH
Project Title: Glucose Depletion and Lactic Levels as a Response to the WAnT, Test
Until Failure, and Test Retest in Trained vs Untrained Male Individuals.
Type Of Project:
My signature below certifies that I have reviewed the institutions policies and procedures on
research involving human subjects. I understand my responsibilities and agree to abide by the
provisions of these policies and procedures.
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For University Faculty and Staff and for Outside Agent Projects:
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Please forward two (2) copies: A signed original and one (1) photocopy and, if applicable, two
(2) copies of the proposed consent form and two (2) copies of supporting documentation
(surveys, protocols, for example) to:
Background:
The Wingate Test is an all-out anaerobic test, which is used to measure peak
anaerobic peak power, as well as anaerobic capacity, mean anaerobic power,
and fatigue index. Anaerobic peak power represents the highest mechanical
power generated during any 3-5 second interval of the test. Anaerobic capacity
in the Wingate test is the total amount of work accomplished over a 30-second
bout. Anaerobic fatigue is the percentage decline in power compared with the
peak power output. A blood glucose test (mg/dL) measures the amount of
glucose in the blood. Glucose is a type of sugar derived from carbohydrates
consumed through food and is the main source of energy used by the body
during anaerobic exercises. A normal fasting (no food for eight hours) blood
sugar level is between 70 and 99 mg/dL. A lactic acid test is a blood test that
measures the level of lactic acid (mmol/L) produced in the body, mainly by
muscle tissue, the nervous system and red blood cells. Normal lactic acid
levels in the venous blood range from 0.5-2.2 mmol/L at rest. Heart rate (bpm)
is the number of contractions of the heart per minute. A maximum heart rate
can be estimated according to the formula (220 - age). Blood pressure (mmHg)
is the measure of the force of blood pushing against blood vessel walls. A non-
pathological resting BP is 120/80 (systolic and diastolic accordingly) and lower.
Finally, the RPE Scale (rate of perceived exertion) is a subjective measure of
overall exercise intensity using a chart of numbers from 6-20, with 6 described
as at rest and 20 described as maximal exertion.
Study Design:
Included in this study will be 2 groups of subjects; all males aged 18-25. All
participants will undergo 3 tests that include a classic Wingate Anaerobic Test,
a test until failure and a test retest. Group No. 1 will consist of 10 healthy
active individuals (n=10) and group No. 2 will consist of 10 healthy untrained
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individuals (n=10). Sample size will include those who have successfully
completed all 3 tests. All subjects will likely be students at the University of
Mary, but may be individuals from the general community as well. Blood
glucose (mg/dL), lactate (mmol/L) and blood pressure (BP, mmHg) will be
obtained at rest; immediately after warm up; immediate post; 5 minutes into
recovery; 10 minutes into recovery; and 15 minutes into recovery after the
participants Wingate Anaerobic Test. The mechanical work will be measured
and calculated. See protocol below.
Protocol:
Pre-first Visit to the Lab (enrollment):
Untrained and trained individuals will be recruited via direct approach, word
of mouth and/or posters approved by the IRB that will be posted on campus.
Subjects do not have to be students at the University of Mary.
Upon interest, an email will be sent to the candidate with the informed
consent form and contact information, or an informational meeting with the
subject will be set.
Visit No. 1: Data Collection, Risk Stratification and Familiarity with the Wingate
Protocol:
The subject will lie in a supine position for five minutes, then resting
measures such as plasma Glucose (mg/dL) will be taken by utilizing the True-
result glucometer, blood pressure (BP, mmHg) via an Omron
sphygmomanometer, heart rate (HR, bpm) via Polar Heart Rate Monitor and
strap, and lactate (mmol/L) via fingertip Point of Care (POC) lactate meter will
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be obtained. Finally, cycle seat height will be measured utilizing the Monark
E804 Cycle Ergometer; it will be measured by notches on the bike.
Pre-Second Visit:
A member of the research team will call the subjects one day before testing
to remind the individuals of their testing time, behavioral instructions prior to
the test, ensure that they have the self-report sheet and to remind them to
bring it completed to the lab the day of testing. They will be reminded to fast
from caffeine for at least 8 hours, get a good night sleep (7-8 hours), inform
us if they are sick/injured, and to inform the team if prescribed with
medications. The subjects will inform the team of any medications they are
currently taking during the risk stratification. This will be done before each
test.
The researchers will come before testing and ensure that equipment is fully
functional and calibrated. This will be checked before each test.
The research team will ensure that an AED is present and working or within 3
minutes of reach according to emergency procedures. This will be done
before every test.
When the subject arrives, the team will ensure nothing has changed with the
subjects physical condition. The subjects BP needs to be within 5 mmHg, no
injuries have occurred, he has followed the behavioral instructions, and HR
should be within 10 bpm compared to their baseline measurements. If these
requirements are not met, the subject will be put in the supine position for 5-
10 minutes until vitals are at baseline values. If vitals are not back to
baseline values the subject will be rescheduled to another day for testing. If
the vitals are at baseline level the subject will complete the test. This process
will be done at the beginning of each test.
The cycle will be adjusted for the subject according to the recorded height
from the first visit. The cycle will be adjusted for each participant every time
before the begin cycling for each test done.
The video camera will be prepped to record the RPM (repetitions per minute)
screen. The video camera will be used and prepared for every test
completed.
The subject will be instructed to keep their rear end fully on the seat of the
ergometer cycle. In addition, the subject should keep upper body motion to a
minimum, avoiding an exaggerated side to side motion and hold on to the
cycles handles at all times. These instructions will be given to the subject
before every test.
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During the warm-up for all tests, the subject will cycle with no resistance for
55 seconds at a warm-up pace and then he will cycle as fast as he can for 5
seconds. The subject will repeat this 3 times in total as the warm-up before
the actual test.
Then, the subject will sit on the cycle for 2 minutes, doing nothing at all. As
they sit on the cycle we will take BP, HR, glucose, and lactate levels. This will
be recorded as warm-up post values.
After 2 minutes, the subject will get to maximal cadence within 3-5 seconds.
Immediately following the test, glucose (mg/DL), lactate (mmol/L), heart rate
(bpm) and BP (mmHg) measurements will be obtained. These will be
considered as the immediate post measurements of the study.
The subject will step off of the bike and continue to hold the handle bars on
the cycle for about 5 seconds to become accustomed to being off of the bike.
Then the subject will lie down in order to cool down and recover.
After 5 minutes post-test glucose (mg/DL), heart rate (bpm), BP (mmHg), and
lactate (mmol/L) measurements will be taken again. These will be considered
as the post 5 measurements of the study.
In case the subjects heart rate is <100 beats per minute and blood pressure
is within 5 millimeters of mercury of resting blood pressure, with no other
clinical indication (vomiting, nausea, light headiness, dizziness, syncope) the
subject will be allowed to leave with the instructions to avoid driving
immediately and to avoid exercise for the rest of the day. If the subject does
not meet the criteria mentioned above, he will stay under the supervision of
the research team until all criteria are met. If our subject becomes
unconscious the researchers will lay him on a plinth and check for his
responsiveness. If the subject is unresponsive the first responder will perform
CPR as another responder will grab an AED and call 911. If the subject
develops a psychological disorder, we will refer him to see a psychologist.
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This cool down and recovery period will be monitored the same way at the
end of each test.
During the test-retest protocol, after the first Wingate testm the subject is
given 3 minutes to recover. After three minutes of recovery via cycling, the
subjects glucose (mg/DL), lactate (mmol/L), heart rate (bpm), and blood
pressure (mmHg) will be measured.
Immediately following the test, glucose (mg/DL), lactate (mmol/L), heart rate
(bpm) and BP (mmHg) measurements will be obtained. These will be
considered as the immediate post 2 measurements of the study.
During the test until failure protocol, the subject will warm-up as in the
classic test, then cycle until he is unable to cycle any more. This duration
must be at least 30 seconds long.
The subject will cool down as described above in the classic Wingate test.
Usage of Data:
SPSS 22.0 for Windows will be used to analyze all data of the study. A 3 way
ANOVA with repeated measures will be used to analyze the data, calculate
averages, standard deviations and correlations between variables. Variables
will be presented as mean SD, significance (p 0.05) and F value when
appropriate. Students plan to present the study and results at the University
of Mary, School of Health Sciences Scholarship Colloquium, a forum open to
the public, in the spring of 2017. Additional plans to disseminate the
information may include submitting an article for publication in a peer
reviewed professional journal.
This study will provide important information pertaining to the influences that
different versions of the Wingate Anaerobic Test (Classic version; Test until
failure; Test retest) have on blood Glucose and lactate. This study will allow
us to learn how the mechanical output (peak power) produced during these
tests causes the skeletal muscle to deplete glucose, produce lactate, and
influences the fatigue index (FI, %. Representing the overall power loss from
the start of the test to its end) calculated after the tests, all signs of muscle
fatigue as a result of these testing modes.
Statistical correlations between the power produced, FI, blood glucose, and
lactate accumulated will be used to present the connection between these
variables in healthy trained and untrained male young adults, as the
hypothesis is that a higher power mechanical output will result in greater
skeletal muscle fatigue (increased glucose depletion, increased lactate
accumulation, and a higher FI).
The three modes of maximal anaerobic testing may be used to simulate actual
situations in an anaerobic athletes practice schedule and competitions.
Through these tests, the athlete, as well as her/his coach can learn of the
athletes maximal anaerobic abilities and the influences that maximal
muscular work of three different modes has on the athletes skeletal muscles.
This information may use both athlete and coach to improve ones training
regime and performance.
Risks:
Due to maximal effort, there are a few risks associated with the study. These
risks may include possible light headedness, nausea, and loss of appetite,
musculoskeletal injury, and muscle soreness. These risks will be minimized by
proper warm up and cool down, as well as administration of the tests according
to protocol. There is also a risk of an allergic reaction due to sterilization
products and/or latex. Risks involved with blood sampling and analysis will be
minimized via following precautions for blood borne pathogens. Participants
may also have psychological effects such as depression, lowered confidence,
lowered self-esteem, and fear of admonishment due to possible undesirable
test results. These psychological risks will be minimized by proper education of
the test results for the participants. If an above risk is realized, proper first aid
procedures will be used and the patient will be referred for treatment if
necessary.
References:
1. Driss, T., & Vandewalle, H. (2013). The Measurement of Maximal (Anaerobic)
Power Output on a Cycle Ergometer: A Critical Review. BioMed Research
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3. Quistorff, B., Secher, N. H., & Lieshout, J. J. (2008). Lactate fuels the human
brain during exercise. The FASEB Journal, 22(10), 3443-3449. Retrieved
March 9, 2016, from http://www.fasebj.org/content/22/10/3443.long
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University of Mary
Institutional Review Board
Part 3: Informed Consent
Program in Exercise Science/Department of Exercise Physiology/School of Health
Sciences
Glucose Depletion and Lactic Levels as a Response to the WAnT, Test Until Failure,
and Test Retest in Trained vs Untrained Male Individuals
Purpose: The purpose of this study is to better understand how male trained and untrained
individuals 18-25 years of age differ in the extent of blood glucose depletion, blood pressure
and lactate levels produced as a response to the WAnT, test until Failure, and Test
Retest.
I understand that participation in this study is completely voluntary. I acknowledge that the
Wingate anaerobic test will demand a physical anaerobic effort equal to 100%
intensity within 30 seconds of all-out cycling against 8% of my total body weight. I
acknowledge that the Wingate anaerobic test will demand a physical anaerobic
effort equal to 100% intensity within a Wingate test until failure as an all-out
cycling against 8% of my total body weight. I acknowledge that the Wingate
anaerobic test will demand a physical anaerobic effort equal to 100% intensity twice
in a row with a recovery period in between as an all-out cycling against 8% of my
total body weight. In addition, I will attend an informational and familiarization session prior
to the testing, as well as stay in the lab for purpose of supervision for at approximately 15
minutes after the test ends. The length of time will be determined by the researchers or a
medical team in case of emergency.
I understand I will have my blood pressure assessed via mercury sphygmomanometer taken
with a blood pressure cuff on my arm, my lactate levels measured as a finger-stick blood
sample analyzed with Lactate Plus blood lactate analyzer, my glucose levels measured as a
finger-stick blood sample. These measures will happen up to seven times (at rest before the
cycle test, after warm-up recovery, immediate post cycle test, 5 minutes post cycle test, and
10 minutes post cycle test and 15 minutes post cycle test).
I agree to avoid participation in any other form of exercise for the remainder of the day of the
Wingate Anaerobic Test and to avoid any maximal or fatigue-inducing physical effort before the
test (max testing or vigorous workout involving lower or upper body, etc...).
I agree to abstain from caffeinated and alcoholic beverages on the day of the test from when I
wake up, until the test (at least 8 hours prior to the test). I agree to get a full 7-8 hours of sleep
the night prior to the test. I acknowledge that I do not have a history of heart disease, lung
disease, metabolic disease, or hypertension, and that I must complete a health history
questionnaire.
Risks: I acknowledge by participating in this study, that risks may include nausea, dizziness,
lack of appetite for a few hours, high blood pressure, possible drop in blood glucose, delayed
onset muscle soreness, musculoskeletal injury, and possible psychological risks due to
underperforming. Efforts to minimize these risks will be made by including warm-up, cool-
down, instruction on proper form, prior familiarization to the equipment and protocol,
supervised sessions, and use of verbal encouragement utilizing only positive language
according to standards of the American College of Sports Medicine (ACSM).
Benefits: The benefits of my participation in this study include obtaining new information on
power and fatigue (personal results will be shared with me) and assisting in research of
glucose depletion and the relationship with different groups, which has not been published yet.
The results of the research may provide new information to the field of Exercise Physiology,
and may serve as a baseline for future comparisons. This information may further benefit
athletes, by better understanding the stress mechanisms influencing athletic anaerobic
performance.
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Confidentiality: My participation in this study will not result in my name being published in any
way without my consent. My test measurements will be documented and recorded during the
study under a generic identification number or code. My records will not be issued to anyone
other than myself and the research members without my approval or an IRB committee if
needed and according to HIPPA privacy information rules. All data will be kept in the office of
the supervising faculty member, Dr. Moran Saghiv for seven years.
In the event that I have a question or concern I have been provided with these contacts to help
solve the issue:
Conductor (1) Victoria Brucker (701) 202-6655
My involvement in this study is completely voluntary. At any time during the study I am free to
stop, refuse to take part or terminate the protocol for any reason I see fit. I will not be forced in
any way to explain the reasons for my termination of participation, but might be asked kindly
to volunteer the information in order to perfect future research. Stopping the study will not
result in any penalty or other loss of benefits that I was otherwise entitled. This will not prevent
me from participating in other activities of the university (research or other). I acknowledge
that if for any reason, the test will not be completed as needed, I might be asked to retake the
test within a weeks time. The participation in the additional test will be completely voluntarily
and according to the same informed consent I am signing at present.
_____________________________ ____________________
Signature Date
____________________________ ____________________
Witness Signature Date
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______
________________________
Signature
______________________________
Name
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University of Mary
Health History Questionnaire
Department of Exercise Physiology/Program in Exercise Science/ School of Health Sciences
Medications: Are you currently taking any prescription or nonprescription medications / supplements?
Yes No
If yes, please list:
Medication/Supplement Purpose Dosage For how long
(months/years)
Describe your currently level of physical activity. (How many days per week are you physically active or exercise?
What level of intensity do you work out at? How long are each of your exercise sessions?)
_______________________________________________________________________________________________
_______________________________________________________________________________________________
____________________________________________________________________
Please list any other medical problems / concerns that have not been identified above and that might have an effect on
blood lipids, body weight, or blood pressure:
_______________________________________________________________________________________________
_____________________________________________________________________________
Height_______________________ Weight________________________
Resting BP__________________
Resting HR__________________
Glucose______________________
Risk Category__________________
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6 21
7 22
8 23
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10 25
11 26
12 27
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b. Peak Power (Anaerobic Power) = the highest work completed in 5 seconds; usually occurs
within the 1st 5 seconds.
a. Peak Power = _________ Watts
c. Average or Mean Power (Anaerobic Capacity) = an average of the power produced in each
of the 6, 5-second periods.
a. Average Power = _______1st 5 seconds + _____2nd 5 seconds + _____3rd 5 seconds +
_____4th 5 seconds + _____ 5th 5 seconds + _____6th 5 seconds = __________
b. ________Total of 6, 5 second average powers 6 = ________Ave. Power or Anaerobic
Capacity
d. Power Decline (Fatigue Index) = Power decline is an indication of the fatigue rate and is
calculated as a percentage of peak power according to:
a. Peak Power Lowest Power x 100 = __________% decline
Peak Power
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University of
Mary
INSTITUTIONAL REVIEW
BOARD
Human Subjects
Review
Part 4: Institutional Review
Board Action
Additional Comments:
Recommendation:
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IRB Member Approved
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