Adult Informed Consent Form
Title of Research Study:
The Effects of Exercise Duration on Salivary Levels of Immunoglobulin
Invitation to Participate
invited to participate in this research study.
The following information is provided in order to help you make an
informed decision whether or not to participate. If you have any questions, please do not
hesitate to ask.
Basis for Subject Selection
eligible to participate because you are a healthy male between the ages of 19
and 29, who exercises less than three times per week.
Purpose of the Study
purpose of this study is to determine the effects of exercise duration (the
length of time a person exercises) on salivary Immunoglobulin A (IgA)
concentration. IgA is a substance that
is found in the saliva that plays a role in preventing infection by viruses.
Explanation of Procedures
study will take two weeks to complete during which you will be scheduled for
four different exercise sessions in the University of Nebraska at Kearney Human
Performance Lab. The following are the
procedures you will undergo if you agree to participate in this study:
complete a Health History Questionnaire during your first visit to the Human
Performance Lab. The questionnaire,
which will take about 15 minutes, will provide your health history including
diagnoses of illness and/or medical problems, history of surgeries, use of over-the-counter and/or prescription
drugs, allergies, personal health and exercise habits, and your family health
history. Individuals who are potentially
at risk associated with the exercise required in this research should not
participate in this study, or they will be required to obtain a physician’s
clearance before participating.
your initial visit to the Human Performance Lab, the maximal treadmill test will
be conducted in order to determine your maximal ability to perform aerobic
exercise. This is based on the
maximum capacity of an individual's body to transport and use oxygenduring incremental exercise (VO2max). Before the text begins you will be asked to
sit quietly. Following several minutes of rest, your blood
pressure will be measured, and a mouthpiece will be placed in your mouth in
order to measure ventilation and the oxygen and carbon dioxide
concentration of the inhaled and exhaled air. VO2max is reached when
oxygen consumption remains at a steady state despite the increase in workload. Your heart rate responses will be
monitored by electrodes taped to your chest.
then begin walking on a motor driven treadmill.
At the start of the test the treadmill speed will be a slow (4 mph), and
you will walk on a level surface. Every
three minutes the speed will be increased 1 mph up to 9 mph. When you reach a speed of 9 mph, no further
increase in speed will occur. Instead,
the treadmill surface will be raised 2 degrees every three minutes until you
can no longer continue. You will be
encouraged to give your best effort at the end of the test. The test will take
about 60 minutes.
will be completed when you indicate that you do not wish to continue on to more
demanding exercise. If you do not give
such an indication, the test will be completed when your responses (heart
function, breathing rate, and/or physical appearance) indicate that either you
should not continue or that you have reached your peak effort. Following completion of this test, the speed
and incline of the treadmill will be decreased so that you may recover at a
slow jogging pace on a level surface for as long as you like.
after the maximal treadmill test and for two subsequent sessions at the Human
Performance Lab, you will return to the Human Performance Lab to complete a
series of three submaximal treadmill tests. You will perform these tests at an
intensity that is equal to 60 percent of your previously determined VO2max. Each of the tests will require about 60
minutes. The tests will be performed at
least 48 hours apart and as close to the same time of day as possible.
the submaximal treadmill test, you will be allowed a 5-10 minute warm-up at a
walking speed (4 mph). The speed will
then be increased so that you will be running at 60 percent of your VO2max
for 50 minutes.
samples will be taken at the time of each of the exercise sessions. The saliva sample will require that you
expectorate (spit) into a test tube. Two
saliva samples will be taken at the time of the maximal treadmill test, one
before the test and one following the test.
Two saliva samples will be taken at the time of each of the submaximal
tests. These samples will be taken
before the start of each run and five minutes after each run.
Potential Risks and Discomforts
following are the risks and discomforts you could potentially experience during
result of the maximal treadmill test you may experience, for a short time, some
breathing discomfort and/or muscle soreness similar to what you may have
experienced during or following intense running and/or exercise. The mouthpiece may be uncomfortable during
the test and may cause some soreness in the mouth. You should be aware that these tests involve
the possible risk of falls and/or muscle-joint injuries. Some muscle soreness may also be experienced
following the test. Sudden death is also
a possible risk. However, considering
your age and fitness level as determined by the Health History Questionnaire,
sudden death is unlikely.
submaximal treadmill tests should not cause any undue discomfort, except for
some muscle fatigue toward the end of the test. Other risks such as
muscle-joint injuries and sudden death are also possible risks, but are
considered highly unlikely.
risks are associated with the salivary analysis.
Protection Against Risks
certified in CPR will be present throughout all exercise procedures. Subjects also will be shown appropriate
stretching maneuvers in order to alleviate muscle soreness.
Potential Benefits to Subject
receive feedback about your aerobic fitness level. It also may be of interest
to you to see what changes, if any, in salivary IgA levels occur following a
bout of exercise of a particular duration and intensity.
Potential Benefits to Society
from this study may help to determine if exercise of a certain duration and
intensity affect susceptibility to upper respiratory infections.
Alternatives to Participation
alternative to participation is not to participate.
Assurance of Confidentiality
participation in this study is voluntary.
Any information obtained in this study that could identify you will be kept
strictly confidential. Your name will
not be associated in any way with the research findings. The information obtained in this study may be published in scientific journals and presented at professional meetings, but only as aggregated date. Your information will be identified only by a code number, and will be stored in a secure filing cabinet and computer database in the Human Performance Laboratory at UNK.
Compensation for Participation
no financial compensation for participating in this study.
In Case of Emergency Contact
event of a research-related injury, or if you experience an adverse reaction,
please immediately contact one of the investigators listed at the end of this
Emergency Care and Compensation
in Case of Injury
unlikely event that you should suffer an injury as a direct consequence of the
research procedures described
above, no additional compensation for physical care, hospitalization, loss of
income, pain, suffering,
or any other form of compensation will be provided. None of the above shall be construed as a
waiver of any legal rights or redress you may have.
Rights of Research Subjects
rights as a research subject have been explained to you. If you have any additional questions
concerning your rights as a research subject, you may contact the Institutional
Review Board (IRB) of the University of Nebraska at Kearney, phone (308)
Voluntary Participation and
free to decide not to participate in this study or to withdraw at any time
without adversely affecting your relationship with the investigators, or the
University of Nebraska at Kearney. Your
decision will not result in any loss of benefits to which you are otherwise
Documentation of Informed Consent
voluntarily making a decision whether or not to participate in this research
study. Your signature certifies that the
content and meaning of the information on this consent form have been fully
explained to you, and that you have decided to participate having read and
understood the information presented.
Your signature also certifies that you have had all your questions
answered to your satisfaction. If you
think of any questions during this study please contact the investigators. You will be given a copy of this consent
form to keep.
Name of Subject Date
of Subject Date
signature as a witness certifies that the subject signed this consent form in
my presences as his/her voluntary act and deed.
Name of Witness Date
of Witness Date
judgment the subject is voluntarily and knowingly giving informed consent and
possesses the legal capacity to give informed consent to participate in this
of Investigator Date
Identification of Investigators
Bill Wild, Ph.D. University of Nebraska at Kearney
Office : 865-1111 Home: 236-3337
Susan B. Ness, M.A. University of Nebraska at Kearney
Office: 865-2222 Home: 440-5638