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CONSENT
FOR EXPERIMENTAL
PROCEDURE / RESEARCH STUDY
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1. Title of research
project
Acute exercise effects on heart-rate and blood-pressure variability
in post-menopausal women
2. Name of the researcher(s)
Katarina T. Borer, Ph.D., Professor
3. Why is this study
being done? Describe purpose of the research
The purpose of this research is to determine the effects of acute
exercise on blood pressure (BP) and heart rate (HR) variability
in post-menopausal women. High daily BP variability and low HR variability
are associated with increased risk of coronary heart disease (CHD).
Endurance exercise lowers BP and resting HR and raises HR variability
more consistently in hypertensive than in normotensive subjects.
In hypertensive subjects, BP changes last for several hours after
exercise. Both systolic BP and HR increase (and HR variability decreases)
in proportion to exercise intensity during acute exercise, but it
is not clear whether and how exercise intensity affects these variables
during recovery from exercise and how long any such changes last.
This study examines how exercise intensity affects the time course
of changes in BP and HR and their variabilities in normotensive
post-menopausal women immediately following an exercise bout both
at low intensity and at high intensity, and compares it to a control
day when no special exercise is carried out.
4. What is involved
in the study.
First we will measure your height, weight and several body dimensions
(circumferences and skin-fold thickness) that will allow us to estimate
your body fat level. Next, you will wear a BP and HR monitors for
24 hours to record the fluctuations in your blood pressure and heart
rate over one day. You will undergo a walking treadmill test to
establish your ventilatory threshold (VT). That is the speed at
which you become winded. You will walk on the treadmill two other
times, once at a low intensity and once at a high intensity. The
low intensity walk will consist of three 15-minute walks at 95%
of your VT with 4 minutes of standing rest in between. The high
intensity walk will consist of three 10-minute walks at 115% of
your VT with 4 minutes of slow-walking rest inbetween. After walking
tests, you will wear HR and BP monitors for 48 hours to record how
exercise has affected your blood pressure during the immediate post-exercise
period. After each bout of HR and BP monitoring, you will need to
come back to the lab so that we can remove the monitors and record
the data.
5. How long will the
subjects participate in the study.
The entire study can be completed in 9 days although it may take
a few days longer depending on particular scheduling needs. The
initial treadmill test to determine your aerobic fitness, along
with body composition measurements and orientation to monitoring
equipment, require between 30 minutes and one hour. The exercise
tests each require approximately one hour. Seven days have to separate
high-intensity and low intensity tests. The two monitors need to
be returned after 48 hours of use before they can be used again.
6. What are the risks
and/or discomforts of participating in this study.
| a. Risks
and discomforts of this study |
| |
Wearing a HR-BP
cuff for one to two days at a time may be slightly inconvenient
in that it may affect the type of clothing you may wear over
the cuff on the arm. Inflation of the blood pressure cuff will
cut off circulation to your forearm for a few minutes every
half an hour while you will wear ambulatory HR-BP monitor, and
this may produce some discomfort or pain. A small chance of
muscle soreness is possible from the walking. As in everyday
locomotion, injuries of the ankle, and knee could occur but
are unlikely. Risk of cardiovascular accidents (heart attacks
and stroke) increases with intensity of acute exercise bouts
but diminishes with regular submaximal exercise. The probability
of experiencing a cardiovascular accident during submaximal
exercise in this study is very low. Overall, the risks of participating
in this study are minimal. |
| b. Additional
risks of participating in multiple studies |
| |
Taking part in more
than one research study may be harmful to you. If you are already
taking part in another study, please let us know. You should
not take part in more than one study at the same time, unless
you and the investigators agree that you are not likely to be
harmed, and the outcome of this study will not be disturbed.
This is particularly important if you are receiving in another
research study any investigational or non-investigational drugs.
If taken at the same time, some drugs may change each other's
effects on the body, so that one drug may become harmful because
of another drug. |
7. Measures to be taken to minimize risks and discomforts:
Risks of joint injuries will be prevented or minimized by inclusion
of a warm-up and cool-down, recommendations to wear appropriate
walking shoes and by walking on a level surface. You should be given
clearance from your personal physician attesting that no conditions
exist that would make exercise potentially hazardous to your health.
Healthy people should experience no cardiac distress with any level
of walking in this study. Your answers in Physical Activity Readiness
Questionnaire also will help us identify conditions that would make
exercise potentially hazardous. If at any time any subject develops
chest pains or shortness of breath, exercise will be discontinued
and a physician consulted. As an additional risk management measure,
at least one person at each walking session will have minimal training
in American Red Cross Adult CPR and Standard First Aid.
8. Are there expected benefits to subjects or to others.
You will gain information about your risk of developing cardiovascular
morbidity based on the information about your level of body fat
and changes in HR-BP variability in response to exercise. You also
will learn how the intensity of acute bouts of exercise influence
HR and BP variability. This study will define exercise intensity
range that causes most beneficial changes in HR and BP variability
so that you and other postmenopausal women will be able to use exercise
to improve your cardiovascular health.
9. Costs to subject resulting from participation in the study
There will be no costs to you or your insurance carrier for participation
in this study.
10. Payments to subject
for participating in the study
There will be no financial remuneration for participation in this
study.
11. How will confidentiality
of information collected be kept.
We shall put the information collected about you during the study
into a research record. This research record will not show your
name, but will have codes entered in it that will allow the information
to be linked to you. However, we shall keep your research record
confidential, to the extent provided by federal, state and local
law. We shall not allow anyone to see your record other than people
who have a right to see it . You will not be identified in any reports
on this study.
12. Do you plan to audio/video tape your subjects? No.
13. Management of
Physical Injury (where applicable)
In the unlikely event of physical injury resulting from research
procedures, the University will provide first-aid medical treatment.
Additional medical treatment will be provided in accordance with
the determination by the University of its responsibility to provide
such treatment. However, the University does not provide compensation
to a person who is injured while participating as a subject in research.
14. Availability of
further information
If significant new knowledge is obtained during the course of this
research which may relate to your willingness to continue participation,
you will be informed of this knowledge.
15. Whom does the
subject call if they have questions or problems?
If you have any additional questions or problems with this study,
please contact study director, Dr. Katarina Borer, 3060G CCRB, Division
of Kinesiology, 401 Washtenaw Ave, The University of Michigan, Ann
Arbor, MI. 48109-2214, phone : (734) 647-2703, FAX: 936-1925, e-mail:
[email protected]
If you have have any
questions about the study's approval or the research subject's rights,
please contact the Institutional Review Board Administrator Kate
M. Keever, Human Subjects Protection Office, UM Office of the Vice
President for Research, Fleming Administration Building, Room 1040,
phone (734) 936-0933, FAX: 647-9084 or e-mail [email protected]
.
16. Voluntary nature
of participation
Your becoming a subject in this study is entirely by your own free
choice. You may refuse to enroll in the study, or drop out of the
study at any time without any penalty even after having agreed to
become a subject. By doing so, you will not lose any benefits that
you may be entitled to up to that point in the study.
In case you withdraw
from the study, you will not be harmed in any way. The investigators
of this study may have to end your taking part in this study as
a subject, if any of the following conditions came up:
| 1. |
you
do not comply with the agreed-upon walking routine; |
| 2. |
you
do not cooperate in agreed-upon measurements; |
| 3. |
you
start taking medication that could interfere with physiologic
responses to exercise; 4. you start smoking or dieting. |
17. Documentation
of the consent
One copy of this document will be kept together with the investigators'
research records on this study. A second copy will be given to you
to keep.
18. Consent of the
subject
I have read the information given above. The investigator personally
discussed with me and told me more about the study, and answered
my questions. I understand the meaning of this information. I am
aware that, like in any research, the investigators cannot always
predict what may happen or possibly go wrong. I have been given
sufficient time to consider if I should join this study. I hereby
consent by my own free choice to take part in the study as a research
subject.
ADULT SUBJECT OF RESEARCH
____________________________________________________________
Printed Name
____________________________________________________________
Consenting signature
____________________________________________________________
Date
H:\Grantrpro\IRB\MilesConSPHMay01.rtf
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