Aging is associated with a decline in immune function. The immune response to influenza vaccine may not be as effective in the elderly compared to younger individuals. Approximately 25% of adults > age 70 do not develop protective immunity to the vaccine. Diet, physical activity and psychosocial factors may enhance immune response, thus improving the efficacy of influenza vaccination. The purpose of this investigation is to determine whether one year of participation in a moderate exercise program will enhance immune response to influenza vaccine.
At the beginning of the study, all participants will be asked to complete a medical history, physical exam if deemed necessary by the study physician, and a physician supervised maximal exercise test on a treadmill to determine whether it is safe for participants to exercise. As a participant in this study, you may be assigned to either an aerobic exercise group or a flexibility/toning group for a one-year period. You will not have a choice regarding group assignment. However, those individuals assigned to the flexibility/toning group for one year will have the option of participating in an aerobic exercise program (free of charge) for one year following completion of the study. Individuals in the aerobic exercise group will be asked to participate in supervised exercise sessions, using exercise bicycles, treadmills, rowing machines, and/or stair steppers, three times per week, approximately 30 – 40 minutes per session. Individuals in the flexibility/toning group will meet three times per week to participate in appropriate activities.
We ask all subjects to consider their participation as a one-year commitment to the research study (allowing some time off for vacation and sick days as necessary). We expect all participants to attend the scheduled exercise sessions 3 times per week. If you do not feel you will be able to meet these expectations, we ask that you withdraw from the study.
After assignment to a group, you will receive the Year One Influenza
Vaccine. Blood samples will be taken two times before this immunization and at 4 time points throughout the flu season after the immunization. After year one of exercise, the Second Influenza Vaccine will be administered.

Two blood samples will be taken before the immunization and again at 4 time points following the second vaccination. We ask that all participants continue to attend exercise sessions for up to 6 months following immunization number two.
As a participant, you will be asked to give a blood sample a total of 12 times in an 18-month period. Blood sample one and two will be taken in the month prior to receiving influenza vaccine (Fall 2003). Blood sample three will be taken 1 week after receiving the influenza vaccine. Blood sample four will be 1 month after the vaccine, and blood samples five and six will be taken 3 and 6 months after the first vaccine. After the one-year intervention period of exercise, blood samples seven and eight will be collected. Then, after immunization number two, (Fall 2004) blood samples nine through 12 will be taken following the same schedule as was used for immunization one. Approximately 40 ml of blood (less than 3 ounces) of blood will be drawn from a forearm vein each time. Your body contains approximately 5000 ml of blood, therefore we will be removing approximately 1% of your total blood volume with each sample.
As a participant you have the option of obtaining information regarding your blood chemistry / lipids (cholesterol, etc) free of charge. If you choose to have this testing performed, you will need to fast overnight before the one week post-immunization blood draw. The blood samples will be taken early in the morning (6:00- 7:00 am) and we will provide refreshments.
As a participant in this study, we will also ask you to complete a dietary questionnaire, medical history, psychosocial analysis, and we will ask you several questions about your exercise habits. This information will remain confidential.
You may withdraw your consent to participate at any time throughout the study. Such withdrawal can be for any reason you choose.
If an accident or complication occurs during the testing that requires emergency care, the emergency care procedure at the Des Moines University
Clinic will be activated. If an accident or complication occurs that is minor in nature, you will be referred to your family physician. If you have no physician, you will be referred to the Des Moines University Clinic Family
Practice Department. If an accident or injury occurs while exercising at

Fitness World West, the site emergency plan will be activated there.
Compensation for injuries resulting from participation in this research may or may not be paid by Iowa State University depending on the Iowa Tort
Claims Act. Claims for compensation will be handled by the Iowa State
University Vice President for Business and Finance.
Your questions on any aspect of this research are welcome. At the conclusion of this study, you will be informed of the results of this study.
Your results will be kept strictly confidential and should your data be used in publication of the results, your name or any identifying characteristic will not be used.
QUESTIONS OR PROBLEMS
You are encouraged to ask questions at any time during this study. For further information about the study contact Dr. Marian Kohut at 515 294-
8364. If you have any questions about the rights of research subjects or research-related injury, please contact the Human Subjects Research Office,
2810 Beardshear Hall, (515) 294-4566; austingr@iastate.edu
or the Research
Compliance Officer, Office of Research Compliance, 2810 Beardshear Hall,
(515) 294-3115; dament@iastate.edu
I have read the above form and understand the testing procedures. I voluntarily agree to participate in this research project and will allow the results to be used for research purposes.
Name______________________ Date_____________________
Witness____________________ Date_____________________

5)
1- 800-447-0060
Marian Kohut, Ph.D. (515) 294-8364
Principal Investigator
Del Konopka, RN,M.S. (515) 294-7349
Study Coordinator