Furman University IRB Form Institutional Review Board for the Protection of Human Participants FORM A Project Description USE OF HUMAN PARTICIPANTS STATEMENT BY PRINCIPAL INVESTIGATOR OR ACTIVITY DIRECTOR A. Principal Investigator/Activity Director:___Dr. Scott Murr and Dr. Randolph E. Hutchison______________ B. Activity Title: The effect of cycling intensity on subsequent running performance C. Department: Health Sciences Telephone Ext: 864-294-3677 (Murr) and 864-294-3687 (Hutchison) D. Student Investigators:, Morgan Kuhar, Olivia “Livi” Tant, Maggie Grisell E. Sponsoring Agency (NIH, NSF, etc.): Funds Awarded: No none Funds Applied For: F. Date Submitted to Furman University IRB: No 01/11/2013 G. Furman IRB registration number of Activity Director: 0150 (Murr) and 1035 (Hutchison) ----------------------------------------------------------------Furman University adheres to the Code of Federal Regulation, Title 45 (Public Welfare) concerning research with human participants, Part 46 (Protection of Human Subjects). 1. TYPE OF SUBMISSION: X_ New Continuation (see section IX) Renewal (See Section IX) Please include copy of signed FUIRB approval from original submission. Modification (see section X & XIV-B1) Previous approval date: 2. TYPE OF REVIEW: Exempt – Form B (see section VIII-1) __X Expedited – Form C (see section VIII-2) ______ Full review – Form D (see section VIII-3) 3. DURATION OF INVESTIGATION: (Protocol must be reviewed annually or frequently if required by the FUIRB) Proposed Starting Date of Research Activity: January 2013 Expected Duration of Research Activity: _12 months Ending date: 12/31/2013________ 1 4. PARTICIPANTS: __X__Students Minors (students under 18) Patients as experimental subjects Patients as controls English Pregnant women or fetuses Mentally disabled Children/Infants (circle) 15 Prisoners, incarcerated subjects __X __Normal adult volunteers Persons whose first language is not Geriatrics Minority Other (please specify) TOTAL ANTICIPATED PARTICIPANTS 5. PROCEDURES: (check all that apply; ATTACH relevant materials, such as questionnaires, interview schedule, instruments, etc.) Survey, questionnaire(s) Drug trial/administration* Interview: phone/in-person Placebo Medical or other personal records X Filming, taping, recording(only markers, no personal ID) X Observation ______Ionizing Radiation (attach CURRENT approval) Participant observation ______Venipuncture, with IV ______Anthropological fieldwork Surgery Psychological Intervention Payment of Subjects Incomplete disclosure of purpose (blood lactate) Other body fluids, excreta _ Class project Other procedure ______________________ *FDA approval certification required (include IND# or IDE#)______________ 6. Location(s) where research will be conducted. Molnar Human Performance Laboratory, Furman University, 3300 Poinsett Highway, Greenville, SC 29613 Principal Investigator or Activity Director’s Signature* _________ Date Faculty Advisor’s Signature (if other than above)* Date Department Chairperson’s Signature** Date * By signing this document, the investigator acknowledges that he or she has received IRB certification from the FUIRB and has read and understood the Responsibilities of the Investigator Prior To and After Project Approval (section XII of the FUIRB). ** By signing this document, the Chair indicates that he or she has considered the ethical and empirical nature of the proposed investigation and can attest to its ethical and scientific merit. 2 FORM C Expedited Review (45 CFR 46.110) USE OF HUMAN PARTICIPANTS STATEMENT BY PRINCIPAL INVESTIGATOR OR ACTIVITY DIRECTOR Research activities that (1) present no more risk to human subjects, and (2) involves only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review process, as authorized by 45 CFR 46.110 and 21 CFR 56.110. Please refer to Section X of the Furman University IRB Guidebook to determine the criteria for expedited review prior to completing Form B. 1. Associate or Collaborating Investigator(s), excluding student assistants: Name Institution Address Tel.# Fax # Scott Murr Furman University, 3300 Poinsett Hwy, Greenville, SC 20613 (864)294-3677_(864)-294-2942 Randolph Hutchison Furman University, 3300 Poinsett Hwy, Greenville, SC 20613 (864)294-3687_(864)-294-2942 1. Describe the Nature of the Research Activity (Please use language that can be understood by reviewers outside of your discipline.). Provide enough detail to adequately and accurately represent the proposed investigation. Include description of each of the following concerns: A) The multidisciplinary sport of duathlon is composed of two different exercises in succession. It is proposed that, throughout a duathlon, the residual effect of prior exercise creates physiological responses that differ from performing the disciplines as individual events. Few multisport investigations have considered the interaction between the two activities with a performance based objective. Previous studies have not considered the effect that cycling effort may have on performance outcomes, thereby limiting their application. No investigation has explored performance outcome by specifically manipulating the cycling intensity before a run in female multisport athletes. The purpose of this study is to examine the effects of cycling intensity on subsequent running time and overall duathlon performance. (a) Relevant background research with bibliography No investigation has explored performance outcome by specifically manipulation the cycling intensity before a run in female multisport athletes. References Beidleman, Rock, Muza, Fulco, Forte, and Cymerman. "Exercise V˙e and Physical Performance at Altitude Are Not Affected by Menstrual Cycle Phase." Applied Physiology 86.5 (1998): Bernard, Vercruyssen, Grego, Hausswirth, Lepers, Vallier, and Brisswalter. "Effect of Cycling Cadence on Subsequent 3KM Running Performance in Well Trained Triathletes." Science and Medicine in Sport (2003): 154-58. Danner, and Plowman. "Running Economy Following an Intense Cycling Bout in Female Duathletes and Triathletes." Women in Sport & Physical Activity 4.1 (1995): 29-39. 3 Hausswirth, Christophe, Didier Leh Naff, Patrick Dr. Ano, and Kai Savonen. "Effects of Cycling Alone or in a Sheltered Position on Subsequent Running Performance during a Triathlon." Medicine & Science in Sports & Exercise 31.4 (1999): 599-604. Kishali, Necip, Osman Imamoglu, Dursun Katkat, Tulin Atan, and Pelin Akyol. "Effects Of Menstrual Cycle On Sports Performance." International Journal of Neuroscience 116.12 (2006): 1549-563. MacRae, Holden, Cindy Miller-Perrin, and Christine Tinberg. "Cycling with Video Feedback Improves Performance in Untrained, but Not in Trained Women." Research in Sports Medicine 11.4 (2003): 26176. Mauger, Jones, and Williams. "The Effect on Non-contingent and Accurate Performance Feedback on Pacing and Time Trial Performance in 4-km Track Cycling." Micklewright, Papadopoulou, Swart, and Noakes. "Previous Experience Influences Pacing during 20 Km Time Trial Cycling." 12 Apr. 2009. Peeling, P. D. "Effect of Swimming Intensity on Subsequent Cycling and Overall Triathlon Performance: Commentary." British Journal of Sports Medicine 39.12 (2005): 960-64. 17 May 2005. Peveler, Will W., and Matt Green. "The Effect of Extrinsic Factors on Simulated 20-km Time Trial Performance." Journal of Strength and Conditioning Research 24.12 (2010): 3265-269. 2010. Phillips. "Menstraul Myth Busting." Sports Coach 28.2 (2005): 1-3. Tew, Garra A. "The Effects of Cycling Cadence on Subsequent 10KM Running Performance in Welltrained Triathletes." Journal of Sports Science and Medicine (2005): 342-53. 01 Sept. 2005. Vercruyssen, Fabrice, Jeanick Brisswalter, Christophe Hausswirth, Thierry Bernard, Olivier Bernard, and Jean-Marc Vallier. "Influence of Cycling Cadence on Subsequent Running Performance in Triathletes." Medicine & Science in Sports & Exercise 34.3 (2002). (b) Purpose and methodology. The purpose of this study is to examine the effects of cycling intensity on running time and overall sprint distance duathlon performance. Fifteen trained and experienced female multisport athletes will complete six separate laboratory sessions comprising of a max cycling test, 20K cycling time trial, 5K run time trial, and three duathlons sessions. The max cycling test will be performed on the participant’s own bicycle on a stationary CompuTrainer. This testing session will be conducted in the Molnar Human Performance Laboratory. The 20K cycling time trial will be performed on a participant’s own bicycle on a stationary CompuTrainer. This testing session will be conducted in the Molnar Human Performance Laboratory. The 5K run time trial will be performed on the Furman track. 4 The cycling velocities of the three duathlon sessions will be 89-91% (DU90), 94-96% (DU95), and 98100% (DU100) of the 20K cycling time trial. For the duathlon sessions, the cycling component will be performed on the participant’s own bicycle on a stationary CompuTrainer. The subsequent running will be performed on the Furman track at a perceived maximal intensity. The max cycling test, RTT, and CTT will be completed first in randomized order. (c) Requirements for the participant population. Explain the rationale, if the population includes a special group such as prisoners, children, mentally disabled, or those whose ability to give informed consent may be in question. The sample population requirements will be females, age 18 to premenopausal, who have completed a multisport event, with current training of 5 or more hours per week. The athletes’ current training must include at least two (2) bike workouts and two (2) run workouts per week. The female participatns will be tested at Furman University in Greenville, SC. Subjects will be required to be aerobically trained. The study will include up to a maximum of 15 participants. (d) Identify those procedures in which a human participant is used which depart from common and established activities, or which increase the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service Considering our sample population is predisposed to the physical strain that one experience with physical activity, there are no procedures that divert from common activity. (e) Describe and assess any potential risks--physical, psychological, social, legal, etc., and assess the likelihood and seriousness of such risks. Potential risks include personal discomfort during vigorous exercise, muscle pain due to high intensity cycling and running, and in extremely rare situations cardiovascular complications. Investigators will closely monitor the subject’s heart rate while cycling and running and the participant has the authority to terminate the session at any point in the research process. In order to reduce the risks above, each participant will complete a lifestyle and training questionnaire prior to participation. If any of these risks are of concern to the participant, she can terminate her involvement at any time. (f) Anticipated statistical analyses to be conducted on the obtained data. Data will be analyzed upon completion of the study using SPSS statistical software. 2. Provide a copy of any and all Consent Forms to be used in this investigation. Subject Informed Consent Form – see pages 6 – 7 Subject Lifestyle and Training Questionnaire – see pages 8 - 10 3. Provide copies of any instruments or other documents that will be used in this investigation. CompuTrainer Testing Protocol – see page 11 Data Sheet – see page 12 For expedited review, submit the original plus Form A and other supporting materials to Ms. Pochard, Grants Administration Office. 5 Effect of Cycling Intensities on Subsequent Running Performance SUBJECT INFORMED CONSENT FORM Department of Health Sciences Molnar Human Performance Laboratory 1. Explanation of the Tests You will be asked to participate in various tests for a total of approximately 6 hours over 6-10 days that will enable the investigator (s) to assess your health status, cardio-respiratory fitness and maximal work capacity on a stationary bike ergometer. The procedures for conducting the tests are as follows: a. Standing Height - standing height will be measured as you stand erect, with shoes off, and with your back against a stadiometer. After you inhale deeply, a square edge will be brought in contact with the top of your head and your height will be recorded. b. Body Weight - body weight will be recorded as you stand on a weight scale, with your shoes off and clad in shorts. c. Maximal Bike Test: You will be asked to perform one maximal bike test to fatigue. During the test, workload will be progressed by 25-30 watts every 1 minute until you reach fatigue. The test should last between 10-15 minutes. This test is important to establish your maximal workload. Heart rate will be monitored during this test. The max cycling test will be performed on the participant’s own bicycle on a stationary CompuTrainer. This testing session will be conducted in the Molnar Human Performance Laboratory. e. Run Time Trial: You will be asked to perform one run time trial. During this test, you will run a 5K at your race pace. During the run, your heart rate, time, and pacing will be recorded. This test will be important in order to determine threshold running performance. The 5K run time trial will be performed on the Furman track. f. Cycling Time Trial: You will be asked to complete one 20 kilometer cycling time trial. The 20K cycling time trial will be performed on a participant’s own bicycle on a stationary CompuTrainer. This will be to determine threshold cycling performance. This testing session will be conducted in the Molnar Human Performance Laboratory. g. Duathlon Sessions: You will be asked to complete three sessions of a 20 kilometer bike followed by a 5K run. During each of these sessions you will be asked to cycle at a certain velocity (intensity), based on your cycling time trial. For these sessions, the cycling component will be performed on the participant’s own bicycle on a stationary CompuTrainer. The subsequent running will be performed on the Furman track at a perceived maximal intensity. h. Cardio-respiratory measures: A heart rate strap will be applied around your chest to record heart rates during all sessions of this investigation. 6 2. Risks and Discomforts The workouts during this study will be similar to the ones a multisport athletes completes as part of their typical training. There exists the possibility of certain changes occurring during the bike and run sessions. They include local muscle pain and fatigue. Potential risks include personal discomfort during vigorous exercise, muscle pain due to high intensity cycling and running, and in extremely rare situations cardiovascular complications. Investigators will closely monitor the subject’s heart rate while cycling and running and the participant has the authority to terminate the session at any point in the research process. In order to reduce the risks above, each participant will complete a complete a lifestyle and training questionnaire prior to participation. If any of these risks are of a concern to the participant, she can terminate her involvement at any time. 3. Responsibilities of the Participant You are responsible for fully disclosing requested information regarding your health status, pertinent lifestyle behaviors (usage of medications, caffeine, and tobacco, exercise habits) and psychological or physical feelings/symptoms accompanying physical exertion. 4. Benefits to be Expected The results from the exercise tests will be used to evaluate your physiological capacity and fitness. 5. Freedom of Consent Please ask for further explanations if you have any doubts or concerns. Your permission to participate in these exercise tests is entirely voluntary. You may freely choose to deny consent or to withdraw from the testing at any time. I __________________________________ acknowledge that I have thoroughly informed of and understand the procedures to be administered in this study. I am fully aware of any possible risk or discomfort that I may experience by participating in this study. My participation in this study is purely voluntary and I understand that I may withdraw from the study at any time without incurring coercion or prejudice. I acknowledge that I have no history of cardiovascular problems, especially diseases related to hypertension. I understand that a copy of this consent form and my results will be available to me upon request. I consent to participate in these tests. ____________________________________ Signature of Subject ___________________ Date ____________________________________ Signature of Witness If any questions or problems arise related to your participation in this study, contact Dr. Scott Murr at PAC 4J and 864.294.3677 or Randy Hutchison at PAC 4F and 864-884-7162. 7 Effects of Cycling Velocity in Duathlon Performance Lifestyle and Training Questionnaire Please complete the questionnaire to the best of your knowledge. Taking the time to provide as accurate answers as possible will allow the staff to better evaluate your fitness. All responses will be held in the strictest of confidence. I. Personal Information First Name Middle Preferred Name Weight __________ lbs. Last Gender ______________ Age _______________yrs. Height __________ inches Technical Shirt Size S M L XL Address City Telephone No. State Zip E-mail address _______________________________________ Occupation: _______________________________________________________________________________ Approximately how many hours do you work a week? __________________________________________hrs. Emergency Contact Telephone No. Physician Name Telephone No. II. Medical Background: Are you currently under physician’s care? Please list any medications you are presently taking: Do you have diabetes? Yes No ______________ Have you ever had a stroke? Yes No ______________ Has your doctor ever said you have heart trouble? Yes No ______________ Do you take asthma medication? Yes No ______________ Are you, or do you have any reason to believe, you may be pregnant? Yes No ______________ Has your doctor ever told you that you have a heart murmur? Yes No _____________ Is there any other physical reason that prevents you from participating in an exercise program (e.g. cancer, osteoporosis, severe arthritis, mental illness, thyroid, kidney, or liver disease)? Yes No ______________ Yes No ______________ ____________________________________________ 8 III. Current Fitness What do you consider to be your ideal running weight? ____________________________________________ If known, Maximal Heart Rate: _______________ bpm Method: ________________________________ If known, VO2 MAX: ____________________ ml/kg/min Method: ________________________________ If known, Lactate Threshold: ___________________ Method: ________________________________ If known, percent body fat: ____________________ % Method: ________________________________ Do you monitor your morning heart rate? Yes No if “yes,” please describe___________ Do you train with a heart rate monitor? Yes No ______________________________ Please indicate on the scale your perceived current level of fitness | | | | | | | Unfit | | | | Average Fitness | | | | | | Most Fit Please describe your previous training and racing (years, races, etc.) ____________________________________________________________________________________________ ____________________________________________________________________________________________ ____________________________________________________________________________________________ IV. Current Racing If “Yes,” give most recent race, date and finish time. No ______________________________________ Have you ever done a 5K race? Yes Have you ever done a 8K race? Yes No ______________________________________ Have you ever done a bike time trial? Yes No ______________________________________ Have you ever done a duathlon? Yes No ______________________________________ Have you ever done a triathlon? Yes No ______________________________________ Do you do any other exercise? Yes No ______________________________________ Do you have/use a heart rate monitor? Yes No ______________________________________ Do you have any current physical injuries? Yes No ______________________________________ 9 V. Current Training Please describe your current exercise/training program. Try to give an example of a typical current week (not an ideal or best training week). Please provide as much detail as possible. Indicate time, distance, effort, etc. Day Activity Distance Time Effort Comments Monday Tuesday Wed. Thurs Friday Saturday Sunday Approximately how many hours a week do you exercise? ___________________________________________ How often do you take a day off from training? ___________________________________________________ 10 CompuTrainer – Testing Protocol Name_______________________________ Age __________________yrs Body Weight ___________________kg Average Days Bike Per Week 1 – 3 1.5W x body weight (kg) = __________ Mount bike to CompuTrainer 4–7 3.0W x body weight (kg) = __________ □ inflate rear tire □ check / adjust press-on force Ride 10 minutes to warm-up tire Complete rolling resistance calibration 3 times to set rolling resistance Rider Warm-Up Warm-Up 0:00 – 1:00 1:01 – 2:00 2:01 – 3:00 3:01 – 4:00 4:01 - 5:00 5:01 – 6:00 6:01 – 7:00 7:01 – 8:00 8:01 – 9:00 9:01 – 10:00 Duration: 10 minutes Power Output: 1.5W x body weight (kg) Other: 1 minute sprints at the 4th & 7th minutes; watts = 3.0W x body weight (kg) Watts 1 minute sprint @ 3.0W x body weight (kg) 1 minute sprint @ 3.0W x body weight (kg) Test Protocol Test cadence: preferred cadence between 70 and 120 rpm Test termination: exhaustion; cadence drops below 70 rpm athlete bikes 1 – 3 days/week athlete bikes 4 – 7 days/week output increases 25 Watts each minute output increases 30 Watts each minute Test Time Watts HR (bpm) RPE Test Time Watts HR (bpm) RPE 0:00 – 1:00 50 0:00 – 1:00 50 1:01 – 2:00 75 1:01 – 2:00 80 2:01 – 3:00 100 2:01 – 3:00 110 3:01 – 4:00 125 3:01 – 4:00 140 4:01 - 5:00 150 4:01 - 5:00 170 5:01 – 6:00 175 5:01 – 6:00 200 6:01 – 7:00 200 6:01 – 7:00 230 7:01 – 8:00 225 7:01 – 8:00 260 8:01 – 9:00 250 8:01 – 9:00 290 9:01 – 10:00 275 9:01 – 10:00 320 10:01 – 11:00 300 10:01 – 11:00 350 11:01 – 12:00 325 11:01 – 12:00 380 12:01 – 13:00 350 12:01 – 13:00 410 13:01 – 14:00 375 13:01 – 14:00 440 14:01 – 15:00 400 14:01 – 15:00 470 11 Effect of Cycling Intensities on Subsequent Running Performance Data Sheet Name_______________________________________ Test / Session Bike Max 20K Bike TT 5K Run Duathlon #1 Duathlon #2 Duathlon #3 89 – 91% 94 – 96% 98 – 100% Date Time of day Temperature Humidity Bike Intensity maximum Avatar wattage 20K Bike Time Bike Heart Rate 5K Run Time Run Heart Rate Bike+Run Time 12