CUIDADOS AUXILIARES DE ENFERMERÍA D EPARTAMENTO DE S ANIDAD
CALIFICACIÓN A15. Cuestionario tipo test, ejercicios a completar de conceptos
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APPENDIX A
UNIVERSITY OF TENNESSEE, KNOXVILLE INFORMED CONSENT
University of Tennessee
Department of Exercise, Sport, and Leisure Studies ADULT CONSENT FORM
Study Title: Development of an Integrated Measurement System to Assess Physical Activity
Principal Investigator: David R. Bassett, Jr.
Institution: The University of Tennessee, Knoxville
This information is provided to tell you about the research project. Please read this form carefully and ask any questions you may have about this study. Your questions will be answered before we ask you to sign it. Also, you will be given a copy of this consent form to take home.
INTRODUCTION
The purpose of this study is to test a new device that measures breathing, motion, and environmental light intensity to improve the assessment of the physical activity in a daily living situation. The improved accuracy will be useful to researchers who study physical activity.
ELIGIBILITY
To be in this study, you must be between 18 and 60 years of age, in good physical health (no diagnosed cardiovascular, pulmonary, metabolic, joint, or chronic diseases).
GENERAL TESTING SCHEDULE
Visit 1, Informed Consent Document (30 minutes)
During today’s visit to the Applied Physiology Laboratory, you will be asked to review this informed consent document. In addition to the written details provided in this document, you will be given a verbal explanation of the study. You will be given ample time to review this informed consent form and to inquire about the study and the procedures. You will be provided with a copy of the informed consent form, and your blood pressure will be measured during this visit. You will also be given a health and physical activity questionnaire to complete.
If you have never walked on a treadmill or have limited experience walking on a treadmill, you will be asked to complete a short treadmill test before enrolling in the study. We will provide instructions and then you will be given time to walk on the treadmill. You will begin at a slow speed and progress to a moderate pace (2.5-3.5 mph). If you are either uncomfortable with walking on the treadmill or if it is determined that you cannot complete the protocol(s) satisfactorily, you will not be asked to continue with the study.
You should not eat or drink (anything but water) for 3 hours before coming to the lab. Before any exercise testing takes place, your height and weight will be measured and your resting metabolic rate and resting blood pressure will be assessed. We will measure your resting metabolic rate using the MedGem analyzer. The MedGem is a portable device that will provide an estimate of your
resting energy expenditure based on the difference in the volume of oxygen between the air that you inhale and exhale. You will be asked to lie motionless on your back on a dormitory bed. After 10-15 minutes a nose clip will be placed on your nose and you will breathe into the mouthpiece of the MedGem analyzer for approximately 10 minutes.
Next, you will be asked to complete approximately 6-8 activities and each activity will be performed continuously for approximately 7 minutes. These activities will be chosen from a broad range of behaviors in the sport, leisure, recreation, occupation, and household areas. Activities may include tasks such as walking or jogging on a flat or inclined treadmill, walking carrying a box, climbing and descending stairs, playing tennis or basketball, doing household tasks such as laundry, sweeping, vacuuming, dusting, lawn mowing, raking, and gardening, or other common activities of daily living. You will be given a 3-5 minute rest period between activities.
Prior to performing the activities, you will be fitted with the Integrated Measurement System (IMS) which comprises a chest strap aimed to measure your breathing frequency, a hip strap with a device that measures your physical motion, and a wrist strap with a light intensity sensor designed to detect if the activity is taking place indoor or outdoor. Thin wires will connect these 3 straps to each other and they should not bother you while you are performing the activities. You will also wear several different activity monitors and a heart rate monitor and transmitter belt when you perform the activities. The activity monitors will be worn on the hip and the wrist and fastened with elastic belts. The heart rate transmitter will be fastened around the chest with an elastic belt, and the monitor will be worn on the wrist.
In addition, you will be fitted with a respiratory gas analysis system, which will be used to measure calorie expenditure. You will be also fitted with a facemask to allow collection of expired air. Instructions on how to complete the activities will be provided as you become accustomed to breathing while wearing the facemask. At the end of the testing session, all the devices will be removed. Attempts will be made to try to fit in all of the 6-8 activities during the same visit. If they cannot be completed during the same visit, a second visit will be scheduled to complete the protocol.
RISKS
During any type of exercise, especially strenuous exercise, there are health risks, including abnormal blood pressures, fainting, muscle or skeletal injuries, and heart attack, but the risk of these things happening is remote. However, the possibility of serious events is low in people who have no prior history of heart, respiratory, or muscular diseases or injuries. In order to minimize the risks, we will attempt to screen out individuals with pre-existing health problems. In addition, in the unlikely event of an injury, laboratory personnel trained in CPR will be available to assist you.
BENEFITS
Participation in this study will give scientists insights into improved methods of measuring physical activity and this may lead to new knowledge about physical activity that would
benefit many individuals. CONFIDENTIALITY
The information obtained from this study will be treated as confidential. Confidentiality will be maintained in the analysis and presentation of the data. You will be assigned an ID number, and this is this is the only way you will be identified in published reports. Your name and ID number will be recorded at the beginning of the study and this information will be placed in a file cabinet that will be locked and only accessible to study investigators. COMPENSATION
Compensation for completing the study will be $75. Full payment will be received only if participants complete the designated protocol. However, if an individual completes part of the study, he or she will receive partial payment that reflects the number of activities performed. Full payment will be received only if you finish the protocol that you are asked to complete for the study. However, if you finish part of the study, you will still receive partial payment that reflects the number of activities you performed. Payment will be received by check within 6-8 weeks of completing all testing.
EMERGENCY MEDICAL TREATMENT
The University of Tennessee does not have a program for automatically compensating subjects for injury or complications related to human subject research, but in the unlikely event of injury resulting directly from participation in this study, investigators will assist you in every way to ensure that you get proper medical treatment. Medical treatment will be available to you through the University of Tennessee Medical Center for a fee.
CONTACT INFORMATION
If you have questions at any time about the study or the procedures, (or you experience an adverse event while participating in this study,) you may contact the researcher, Dr. David R. Bassett, Jr., at 1914 Andy Holt Ave., 325 HPER Bldg., Knoxville, TN, and (865) 974-8766. If you have questions about your rights as a participant, contact the Office of Research
Compliance Officer at (865) 974-3466.
PARTICIPATION
Your participation in this study is voluntary; you may decline to participate. If you decide to participate, you may withdraw from the study at anytime without penalty and without loss of benefits to which you are otherwise entitled.
______________________________________________________________________________ _____
CONSENT
I have read the above information, and I have received a copy of this form. I agree to participate in this study.
Participant's signature ______________________________ Date __________
APPENDIX B
Physical Activity Readiness Questionnaire (PAR-Q)
Name ______________________________ Date of Birth ______________________
Home Phone _________________________ Work Phone _______________________ For most people physical activity should not pose any problem or hazard. The PAR- Q has been designed to identify the small number of adults for whom physical
activity might be inappropriate or those who should have medical advice concerning the type of activity most suitable for them.
Common sense is your best guide in answering these questions. Please read them carefully and check YES or NO opposite the question if it applies to you. If a
question is answered YES, please use the available space to explain your answer and give additional details.
1) Has a doctor ever said that you have a heart condition and that YES NO
you should only do physical activity recommended by a doctor?
2) Do you feel pain in your chest when you do physical activity? YES NO 3) In the past month, have you had chest pain when you were not YES NO doing physical activity?
4) Do you lose your balance because of dizziness or do you ever lose YES NO consciousness?
5) Do you have a bone or joint problem that could be made worse by YES NO a change in your physical activity?
6) Is your doctor currently prescribing drugs (for example, water pills) YES NO
for your blood pressure or heart condition?
7) Do you know of any other reason why you should not do physical YES NO activity?
8) Do you currently participate in any regular activity program YES NO