Information for Interested Subjects

 

 

Purpose of Research Study

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 25-30% of adults > age 65 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 exercise and/or psychosocial factors will improve immune response to influenza vaccine.

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Qualifications for the Study

"Any male or female over the age of 65 that has not participated in a regular moderate-vigorous exercise program for the past 3 years and who does NOT suffer from

- any disease or condition that may impair their ability to safely perform exercise
(such as uncontrolled hypertension, orthopedic limitations, significant coronary heart disease, uncontrolled diabetes, severe chronic obstructive pulmonary disease, etc.)

OR

- any condition that may affect immune function
(such as cancer within the last 5 years, autoimmune disorders, Type 1 (insulin dependent) diabetes, fibromyalgia, chronic fatigue syndrome, transplant recipient currently treated with immunosuppressive medications).

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Brief Overview of the Research Study
Individuals that qualify for the study will be randomly assigned to either an aerobic exercise group or a strength/flexibility/balance exercise group. An influenza vaccine will be given to all subjects in fall 2003. Blood samples will be collected before the vaccine and at several time points after the vaccine. After receiving the vaccine, everyone will begin the exercise program in fall 2003 and continue exercising through fall 2004. Exercise sessions will be held 3 times per week. A certified exercise physiologist (M.S.) will supervise exercise sessions and individual instructions for exercise will be given to all participants. In fall, 2004, another influenza vaccine will be given. Blood samples will be taken before immunization and again at several time points after immunization. Subject participation will end Feb-March 2005.

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Location of the Study

Participants will exercise three days a week at Fitness World West, 3200 Westown Parkway, West Des Moines, next to Valley West Mall. The center is available during midday, a quieter time of facility usage. Classes will be led by Iowa State University study personnel who are experienced in working with senior citizens and exercise. See link for more information and the map: www.fitnessworldwest.com

For exercise testing and the blood sample collection, we will see you at Des Moines University at 3200 Grand Ave. Take I-235 to the 35th street exit. From there, go south to Grand Avenue. Make a left turn. The Medical Tower is the second building on your right, just past the construction.

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Requirements of Participants

At the beginning of the study, all participants will be asked to complete a medical history. A physical exam will be performed by the study physician, and a physician-supervised maximal exercise test on a treadmill will be administered 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/balance group for a one-year period. You will not have a choice regarding group assignment. However, those individuals assigned to the flexibility/balance 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, treadmill, rowing machines, and/or stair steppers, three times per week, approximately 30 - 40 minutes per session. Individuals in the flexibility/balance will meet three times per week to participate in appropriate activities.

As a participant, you will be asked to give a blood sample a total of 12 times in a 17-18 month period. 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. At the start of the study, you will receive the year 1 influenza immunization (fall 2002). 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 the second influenza immunization will be administered (fall 2004). Two blood samples will be taken before the year two immunization and again at 4 time points following the vaccination. We ask that all participants continue to attend exercise sessions for up to 6 months following immunization number two.

As a participant in this study, we will also ask you to complete a dietary questionnaire and psychosocial questionnaires. We will ask you several questions about your exercise habits and ask you to perform fitness tests for older adults. 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.

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.

To apply for the study or to request more information please mail or email your name and address to the Primary Investigator at:

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Further Information or to Apply for the Study
For further information, please call or email the Principal Investigator, Dr. Marian Kohut at:
Marian Kohut, Ph.D.
Assistant Professor, HHP & Immunobiology
Iowa State University
235 Forker Building
Ames, IA 50011
515 294-8364
mkohut@iastate.edu
Del Konopka, RNMS
Clinical Study Coordinator
Iowa State University
225 Forker Building
Ames, IA 50011
515-294-7349
dkonopka@iastate.edu
 


Toll free#: 1-800-447-0060
FAX: 515-294-8740 (attn. Dr. Kohut or Del Konopka)

If you would like to apply for the study, you can contact Dr. Marian Kohut or Del Konopka and we’ll mail the forms to you. If you would like to print off the forms, email or call us and we’ll send a postage paid envelop for your convenience. You can download these forms:

You will need Adobe® Acrobat® Reader to read the form.

Please complete the Medical History and Consent form. Ask your physician to complete the Physician Awareness Form. You may mail the forms to us at the address above. A FAX number is also available as an option for returning the forms.

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