WHO IS CONDUCTING THE STUDY?
The study is being conducted by the University of British Columbia.
WHAT IS THE STUDY ABOUT?
Engaging in physical activity and exercise has many benefits for physical and mental health. Nevertheless, a lot of people do not exercise enough during their spare time. Research has found that people’s willingness to participate and engage in an active lifestyle depends on how in shape someone is, as well as how motivated they are. The type of workout, the amount of time engaging in it, and the intensity of the activity are also features that determine whether someone wants to engage in exercise. In our study, we hope to determine how the body and mind respond to exercise that is performed at different intensities. We plan to investigate the relationship between how you feel (i.e. your mood), how much effort you exert, and your physiology (i.e. how your heart functions and the amount of hormones you produce), during and after a single session of running on a treadmill.
WHAT WILL I BE ASKED TO DO IN THE STUDY?
This study takes place in the Medical Sciences Block C, 2176 Health Sciences Mall, Room #104 at the University of British Columbia in Vancouver. You will be asked to visit the laboratory on two occasions. If you agree to take part in this study, you can expect the procedures and visits to include the following:
First Assessment
After arriving at the FAST Lab, we will talk with you about the study, which you should already be familiar with. We will answer all additional questions that you might have. Once you have agreed to participate, we will ask you to sign the consent form. Once you have, we will ask you to fill out a few questionnaires on one of our lab computers. These should take no more than 15 minutes These questionnaires will ask you about your health and wellbeing. Next, you will perform a graded exercise test on a treadmill to determine your maximal oxygen consumption and your maximal power output. Throughout the whole assessment day there will be two experimenters present, and both will be highly trained in performing this protocol.
During exercise you will wear your own exercise clothing and a heart rate monitor that we will supply you with. The heart rate monitor is a simple strap that goes around your chest and monitors your heartbeat. One of the experimenters will place the heart rate monitor around your chest, in a secure and comfortable position. You will also wear a gas exchange mask that we will provide. An experimenter will place this on you as well. It measures your oxygen uptake during exercise. Your blood pressure will be taken at rest and several times throughout the exercise. The graded exercise test will start with a comfortable warm-up. Intensity will be increased every twenty seconds. You will be asked to run as long as you can until you feel you can work no harder. At that point the test is complete, and you will cool down during a 5-minute walking period on the treadmill. The total time for this test will be approximately 35 minutes.
Second Assessment
The second meeting will consist of a single thirty-minute bout of aerobic exercise. In a similar manner to flipping a coin, you will be randomly assigned to one of three exercise groups differing in exercise intensity: high, moderate or low exercise intensity on the treadmill. Your individual “high”, “moderate”, or “low” intensity level on the treadmill is based on your maximal oxygen consumption and maximal power output measured on Day 1. Just like on Day 1, you will wear your own exercise clothing and you will be asked to wear a heart rate monitor. However, no blood pressure cuff or gas exchange mask will be required. You will wear a heart rate monitor around your chest throughout the entire workout and recovery period. After a 20-minute rest period, you will begin the 30-minute exercise bout with a comfortable warm-up. The warm up will last 5 minutes, over which time you will be slowly ramped up to a fraction of your max performance from Study Visit Day 1 (either 75%, 55%, or 30% depending on whether you are randomized to vigorous, moderate, or light activity, respectively). You will terminate your workout with a 5-minute walking cool down, followed by a. 70-min recovery period, during which you will be asked to sit and relax.
Throughout the “Second Assessment Day”, we will collect a sample of your saliva at 11 different time points. This is a non-invasive, risk-free procedure. We will hand you a small cotton swab, and you will simply need to chew on it for 60 seconds. While chewing on this swab, we will ask you to rate your feelings and your arousal using pre-determined questionnaires. During exercise, we will also ask you to rate your perceived exertion. Before and after exercise and at the end of the recovery period you will be asked to fill out two more questionnaires concerning your current state of positive and negative feelings. The total time for the tests done on Day 2 will be approximately 125 minutes. Of course you will be allowed to drink as much water as you want to throughout the whole assessment day. We encourage that you at least drink a little bit following exercise.
WHAT ARE MY RESPONSIBILITIES?
In the days prior to and on the day of your appointments, you will be asked to hydrate well. You will also refrain from eating any large meals or drink caffeine 2 hours prior to visiting the laboratory on Day 1. Likewise, on the Second Assessment Day, please do not eat anything or drink caffeine 2 hours prior to your appointment. Also, please do not drink alcohol on the day of both appointments or drink more than two drinks the night before either assessment. Additionally, you should not exercise in the mornings before either visit. This is necessary to make sure that our measurements are not influenced by any physical activity prior to testing.
WHO CAN PARTICIPATE?
To participate, you must be a 20 to 40-year-old male and free of any heart or lung diseases. You should not have any health difficulties that prevent you from exercising, any current psychiatric disorder, or current use of exogenous steroid treatments.
WHO SHOULD NOT PARTICIPATE IN THE STUDY?
Individuals cannot participate in the study if they have a medical history or a current medical condition affecting their heart, lungs or capacity to exercise. If for any reason you are unable to perform high-intensity or strenuous exercise, you should not participate in this study.
WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY?
You will get a complementary graded exercise test which will give you an objective measure of your aerobic fitness. You will be given an honorarium to partially compensate for your time. If you are interested in becoming more active, we will be happy to offer you a list of tips for increasing and maintaining an active lifestyle. These tips have been assembled by graduate students of the School of Kinesiology at UBC and approved by the principal investigator. They are based on the most recent scientific findings. If you are interested in the results of the CAPE-study, we would be happy to send them to you via email, as soon as our study is finished and published.
WHAT ARE POTENTIAL RISKS OF PARTICIPATING IN THE STUDY?
The main risks in our exercise protocol are from running on a treadmill, especially on Day 1, where you will be working as hard as you can. According to the American College of Sports Medicine, there remains a small risk of complications requiring a hospital admission (≤0.20%), acute myocardial infarction (0.04%), or sudden cardiac death (0.01%). A recent review by Goodman, Thomas and Burr (2011) found that risk of death is actually markedly lower in apparently healthy individuals, between 0.2 and 0.8 per 10,000 test.
In the unlikely event of an emergency during exercise, all personnel involved will be trained in basic cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) use. Emergency equipment, including an AED, oxygen masks, blood pressure cuff and stethoscope, will be readily available and working properly. If a serious problem occurs during exercise testing, the study coordinator will decide whether to call for evacuation to the nearest hospital. In this case, emergency transportation to the closest hospital will be summoned immediately. UBC Hospital`s Emergency Wing is approximately 400 meters from the laboratory.
CAN I WITHDRAW FROM THE STUDY ONCE I BEGIN?
Your participation in this research is entirely voluntary. You may withdraw from this study at any time without providing any reason for your decision. Choosing to withdraw will have no impact on you care by health services.
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?
Your confidentiality will be respected. Individuals will be identified using a unique alphanumeric code on physical data collection sheets. Names will not be used in any publications. Your data will be analyzed and presented at an aggregate level with other participants. Data records will be kept on a computer hard disk; these files will be password protected and encrypted and kept on a password protected computer in a locked room at UBC. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, research records and medical records identifying you may be inspected in the presence of the Investigator or his or her designate the UBC Research Ethics Board for the purpose of monitoring the research. no records which identify you by name or initials will be allowed to leave the Investigators’ offices.
WHOM CAN I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY?
If you have any questions or desire further information about this study before or during participation, you can contact Adam Caplin or Franziska Orthuber at 604 827 2618 and also via email kin(DOT)fastlab(AT)ubc(DOT)ca. You may also contact the Principal Investigator, Dr. Eli Puterman, at 604.822.2854.
WHOM CAN I CONTACT IF I HAVE ANY CONCERNS OR COMPLAINTS ABOUT THE STUDY?
If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the UBC Office of Research Ethics at 604-822-8598 or via e-mail at RSIL(AT)ors(DOT)ubc(DOT)ca or call toll free at 1-877-822-8598.