The College name……………
The Relationship Between Heart Rate Variability and Aerobic Capacity
Informed Consent
You are invited to participate in a research study investigating heart rate variability (i.e., time between individual heart beats) and aerobic capacity. This study is being conducted by (Principle Investigator), graduate student in the Department of (Department) under the supervision of (faculty mentor’s name). You were selected as a possible participant because you are a student at the —————————- aged 18-24 years and are either: 1) a member of the xxx cross country skiing team or the xxxxx cross country running team or 2) an apparently healthy student who currently meets national recommendations for physical activity (moderate intensity aerobic physical activity for a minimum of 30 minutes five days per week, or vigorous activity for a minimum of 20 minutes three days per week), but are not considered a “trained” aerobic individual (i.e., more than 4 hours of moderate aerobic physical activity a week for the purpose of this study). We ask that you read this form and ask any questions you may have before agreeing to be in the study.
Study Purpose
The purpose of this study is to explore the relationship between heart rate variability at rest and maximal oxygen consumption (i.e., maximal aerobic capacity). Heart rate variability is the measurement of time between heart beats and varies from person to person. The majority of research involving heart rate variability up until now has focused on the relationship between heart rate variability and clinical outcomes; relatively little research has investigated how (or if) heart rate variability is related to aerobic exercise performance.
Study Procedure
If you agree to participate in this study, we will ask you to make two visits to the exercise physiology laboratory in the Burns Wellness Commons. On the first visit, you will fill out a medical history questionnaire and you will have measurements taken of your height, weight, and resting heart rate. Resting heart rate will be assessed by having you lie down in a dark room for 20 minutes in a relaxed state. You will be fitted with three skin sensors (below the right and left collar bone and to the left belly button) in order to precisely obtain beat-to-beat measurements utilizing an electrocardiogram. On the second visit, you will be asked to perform a maximal graded exercise test on a treadmill. If you are in the athlete/trained group, your test protocol will involve a starting treadmill speed between 6.0 and 12.5 mph and an inclination between 2.5 and 8%; the grade will be increased 2.5% every 3 minutes until you reach a level a maximal exertion. If you are in the nonathlete/untrained group, your test protocol will involve a starting treadmill speed of 1.7 mph and an inclination of 10%; the speed and grade will gradually be increased (0.5-0.9mph and 2%) every 3 minutes until you reach a level a maximal exertion. You are free to discontinue the test at any time for any reason. You will be monitored by study personnel for the entirety of the test. You will be monitored following the test and you will be allowed to leave once your heart rate and blood pressure have returned to normal post-exercise levels. For the 12 hours preceding each visit, we ask that you: 1) not consume any food or drink that contains caffeine or other stimulants and 2) refrain from moderate or vigorous exercise or physical activity. If you agree to be in this study, your time commitment will be approximately 1.5 hours for each visit for a total of 3 hours.
Risk of Study Participation
There are risks and discomforts associated with exercise tests. Certain changes in body function take place when any person exercises. Some of these changes are normal and others are abnormal. Abnormal changes may occur in blood pressure. A very rapid or very low heart rate may occur. Exercise carries a small risk of musculoskeletal injury, heart attack and, in rare instances, even death. Every effort will be made to minimize possible problems by the preliminary examination and constant surveillance during testing. Equipment and trained personnel are available to deal with unusual situations should they arise. In the event of an injury, first aid will be provided. A cardiac defibrillator is available in the Burns Wellness Commons building and an emergency response team generally takes less than 10 minutes to reach the location. If additional medical care is necessary, payment must be provided by you or your third party payer (such as your health insurance provider).
Benefits of Study Participation
You will not directly benefit from your participation in this study. The information you will receive about health and fitness including an accurate assessment of your cardiovascular fitness, resting heart rate, resting heart rate variability, and resting heart rhythm (i.e., electrocardiogram-ECG) may be useful to your health, but this is not guaranteed.
Alternative to Participation
While you may learn useful information about your cardiac fitness from participating in this study, you can obtain this information by making an appointment with your health care provider.
Research Related Injury
In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner to you or your insurance company. If you think that you have suffered a research related injury, let the researcher know right away.
Confidentiality
The records of this study will be kept private. In any publication or presentations, we will not include any information that will make it possible to identify you as a subject. Your record for the study may, however, be reviewed by individuals at xxxx with appropriate regulatory oversight. All data collected will be stored in a locked filling cabinet and/or on a password protected computer. To these extents, confidentiality is not absolute. Your consent form and data will be retained securely for five years after which time it will be destroyed.
Voluntary Nature of the Study
Participation in this study is voluntary. Your decision whether or not to participate in this study will not affect your current or future relations with xxx, the Department of Exercise Physiology, or the Athletics Department (including your specific sport team and coaches). If you decide to participate, you are free to withdraw at any time without affecting those relationships.
Contact and Questions
The researcher conducting this study is (Principle Investigator). You may ask any questions you have now, or if you have questions later, you are encouraged to contact the principle investigator at (Phone) or by email at (Email).
If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher, you are encouraged to contact the following individuals:
Research Advisor – Phone
Department Chair – Phone
School Dean – Phone
You may also contact any of the above-named individuals in writing or in person at The College xxxxxxxxxxxxx, address xxxxxxxxxxxx.
You will be given a copy of this form to keep for your records.
Your signature below indicates that you have you have read and understand the information in this consent form. You signature indicates that you want to participate in this study.
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Printed Name of Participant
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Signature of Participant Date Signed
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Signature of Investigator Date Signed
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