University of Waterloo
Date
Title of Project: (Insert Title)
Principal Investigator: (Insert Name of Principal Investigators)
University of Waterloo, Department of (Insert Dept Name)
519-884-4567 Ext. (Insert extension)
Student Investigator: (Insert Name of Student Researcher, if applicable)
University of Waterloo, Department (Insert Dept Name)
519-884-4567 Ext. (Insert extension)
Purpose of Study:
You have been asked to take part in a research study designed to evaluate
submaximal exercise tests that might be used in future studies of astronauts who
will spend 3-6 months on the International Space Station. Development of these
tests is necessary because NASA has directed that astronauts cannot take part
in physical activities that would cause their heart rate to increase above 85% of
their maximum value. The tests might also provide a safer means of evaluating
physical fitness in older individuals and in patients with heart disease.
Procedures Involved in this Study:
As a participant in this study, you will be asked to complete the following:
1. Incremental exercise tests with legs or with arms to determine the upper
limit of your exercise performance.
2. Four different intensities of two submaximal exercise protocols. The tests
will be completed with each of the arms and the legs. You will do several
repetitions of the tests so that we can average the responses across the
different tests to reduce the normal physiological variability that occurs
within a single test session.
Further information about each of these tests is presented on the following
sheets.
Time Commitment:
The maximum time requirement for these tests will be about 12 hours in the
laboratory on different test days.
Personal Benefits of Participation:
Our major purpose in doing this research is to determine whether a simple
submaximal exercise test will provide similar information to that obtained during
incremental exercise tests to exhaustion. These latter tests are often applied to
healthy and to people with heart disease. The results of these studies will provide
the basis for proposing to the Canadian Space Agency and to NASA that fitness
of astronauts can be evaluated from this type of submaximal exercise test. When
we finish the studies, we will provide feedback to let you know how your
responses compare to the group results.
Explanation of Procedures and Risks:
The risks of doing incremental exercise to your functional limit are very similar to
the risks of doing heavy voluntary exercise. There is a very slight chance that
an apparently healthy individual will have a cardiovascular complication that
has not been previously detected during normal medical examinations. There is
no way to predict this potential complication.
Heart Rate – Heart rate is continuously monitored by an electrocardiograph
(ECG) by placing 3 spot electrodes on the skin surface. The electrodes are
normally placed in the lower portion of the chest. This procedure is entirely safe.
In a very small group of individuals, a skin rash might occur due to the
adhesive on the electrodes. There is no way of knowing this ahead of time. The
rash, if it develops, will resolve itself within a day or so. However, you are asked
to avoid scratching any rash and to keep it clean.
Oxygen Uptake – We measure the amount of oxygen you take from the air you
are breathing by having you breathe through a mouthpiece or face mask.
Attached to the mouthpiece will be a sensor to determine the volume of air that
moves into and out of your lungs, and a sample line that takes a small quantity of
the air to a gas analyzer system. The mouthpiece or facemask and the volume
measurement device are sterilized before each person’s use to eliminate any risk
of spread of infection. If you are allergic to rubbing alcohol, then you should
not participate in this study.
Incremental Exercise – These tests will begin with a four-minute accommodation
period in which you will pedal against a very low resistance. After this, the work
rate will increase progressively until you are unable to continue to do the exercise
due to sensations of fatigue. The total test duration will be approximately 10-20
minutes. We ask that you push yourself to the point where you feel that it is
impossible to continue at the required rate. This maximal effort is necessary
because we need to be able to compare our results with a very large database of
previous research in which the participants have pushed themselves to their limit.
Incremental exercise does have some risk. We will not include individuals
who have high blood pressure (resting diastolic pressure over 90 mmHg
during a measurement in our lab) or who have been told by their doctor
that they have some form of cardiovascular disease. It is impossible to
predict whether apparently healthy individuals might have some previously
undetected cardiovascular disease that might cause a heart attack or
arrhythmia (irregular heart beat) during strenuous exercise. The sensation of
fatigue that you experience during incremental exercise will probably be similar to
that experienced previously during some voluntary activities. The sensation of
fatigue should quickly disappear after the test.
Submaximal Exercise – These tests will place less stress on your body than the
incremental exercise because the upper limit for work rate will be maintained at
85% or less of your maximum measured in the incremental tests. At the 85%
work rate, you might experience some sensations of fatigue because you will be
asked to maintain this intensity for up to six minutes. All submaximal exercise
tests will start with a warm-up period of four minutes before the work rate is
increased to the required level.
Stopping the Session:
If you experience any sensation that appears to be unusual to you (i.e. not what
you would expect during voluntary maximal exertion), then you can stop the
exercise and inform the researchers of this.
Special Instructions:
Participants are asked to refrain from drinking alcohol in the 24-hour period
immediately prior to testing. Participants should eat a normal mixed diet prior to
the tests. Dietary manipulation might affect the way in which muscle units fatigue
and this could influence the experimental results.
Health Status Screening Form:
This questionnaire asks some questions about your health status. This
information is used to guide us with your entry into the study. Contraindications to
participation in this study include any injury that makes exercise uncomfortable,
any kidney problems, or any cardiovascular diseases including bleeding
disorders, or any respiratory diseases.
Changing Your Mind about Participation:
You may withdraw from this study at any time without penalty. To do so, indicate
this to the researcher or one of the research assistants by saying, "I no longer
wish to participate in this study".
Confidentiality:
To ensure the confidentiality of individuals’ data, each participant will be identified
by a participant identification code known only to the principal investigator and
his research assistants.
Participant Feedback:
After the study is completed, you will be provided with a feedback sheet that will
include summary graphs of your performance.
Contact Information:
If you have any questions about the study at any time, please contact either
Professor (insert faculty name) at his/her office 519-888-4567 ext. XXXX, or
(insert student investigator name) at extension (insert extension), or the Lab
Assistants at ext. (insert extension).
Concerns about Your Participation
I would like to assure you that this study has been reviewed and received ethics
clearance through a University of Waterloo Research Ethics Committee.
However, the final decision about participation is yours. If you have any
comments or concerns resulting from your participation in this study, you may
contact Dr. Maureen Nummelin, the Director, Office of Research Ethics, at 1-519888-4567, Ext. 36005 or maureen.nummelin@uwaterloo.ca.
CONSENT FORM
By signing this consent form, you are not waiving your legal rights or releasing
the investigator(s) or involved institution(s) from their legal and professional
responsibilities.
______________________________________________________________________
I agree to take part in a research study being conducted by Dr. (Insert
researcher name) and (Insert student researcher name) of the Department of
(Insert Dept Name), University of Waterloo.
I have made this decision based on the information I have read in the Information
letter. All the procedures, any risks and benefits have been explained to me. I
have had the opportunity to ask any questions and to receive any additional
details I wanted about the study. If I have questions later about the study, I can
ask one of the researchers (list names, departments, telephone numbers of
investigators).
I understand that I may withdraw from the study at any time without penalty by
telling the researcher.
This project has been reviewed by, and received ethics clearance through a
University of Waterloo Research Ethics Committee. I am aware that I may
contact this office (519-888-4567, ext. 36005) if I have any concerns or questions
resulting from my involvement in this study.
_____________________________
Printed Name of Participant
___________________________
Signature of Participant
_______________________________
Dated at Waterloo, Ontario
_________________________
Witnessed
HEALTH SCREENING FORM
STUDY: (Insert title)
Name:
________________________________________________________________
______________
Local Address:
________________________________________________________________
________
Phone #: ________________________ Birth Date: _________________
Course at UW: ____________
SELF REPORT CHECKLIST:
Past Health Problems:
[ ] Rheumatic Fever
[ ] Epilepsy
[ ] Heart Murmur
[ ] Emphysema, Pneumonia, Asthma, Bronchitis
[ ] High Blood Pressure
[ ] Disease of the Arteries
[ ] Congenital Heart Disease [ ] High Cholesterol
[ ] Heart Attack
[ ] Heart Operation
[ ] Kidney and liver disease
[ ] Back Injuries
[ ] Diabetes (diet or insulin)
[ ] Varicose Veins
[ ] Heartburn
[ ] Enteritis/Colitis/Diverticulitis
[ ] Ulcers
[ ] Bleeding from Intestinal Tract
[ ] Bleeding Disorders
Present Health:
List current problems:
1.
2.
List medications taken now or in last 3 months:
1.
2.
For Females: Pregnant ________ Nursing ________
List Symptoms:
[ ] Irregular Heart Beat
[ ] Fatigue
[ ] Chest Pain
[ ] Cough up blood
[ ] Shortness of Breath
[ ] Back Pain/Injury
[ ] Persistent Cough
[ ] Leg Pain/Injury
[ ] Wheezing (Asthma)
[ ] Dizziness
Current Physical Training Status:
I consider my physical training status to be: High [ ], Average [ ], Low [ ]
List the types of physical activities that you do on a regular basis:
Habits:
Smoking:
Never [ ] Ex-smoker [ ] Regular [ ] Average # cigarettes/day ______
___________________________________________________
Signature of Participant