Does the subject group include healthy volunteers? _X_yes ___no
Does the subject group include ill persons? __yes _X_no
Are subject groups excluded for medical reasons? _X_yes ___no
Are there vulnerable subject groups? ___yes _X_no
If yes, is the exclusion criteria for the study specified? ___yes ___no
Are any subjects under the age of 18? ___yes _X_no
Are any subjects under the age of 12? ___yes X__no
Are any subjects over the age of 70? ___yes _X_no 

Yasmen Simonian_____________________ __CLS____________

PRINCIPAL INVESTIGATOR'S NAME (faculty)        DEPARTMENT

Leah Albornoz, Jackie Kofoed, Curtis Gapinski, Rob Johnson  CLS

STUDENT RESEARCHER'S NAME                         DEPARTMENT

3905 University Circle                                        Ogden, UT 84408-3905                              

MAILING ADDRESS/MAIL CODE                        CITY, STATE, ZIP

_________________________________________ __801-626-705-80___

PRINCIPAL INVESTIGATOR'S SIGNATURE          TELEPHONE

_________________________________________ _801-626-7080____

DEPARTMENT CHAIR'S SIGNATURE                 TELEPHONE

___________________________________

DATE

A. APPLICATION FORM

1. TITLE

Effects of Exercise on White Blood Cells

2. DESCRIPTION OF THE STUDY

The study will determine the effects of exercise on circulating white blood cells (WBC). This will include the percentages and the types of white blood cells (differential counts) on blood smear preparations, in addition to total WBC counts from anticoagulated blood samples.  It has been proposed that an individual’s immunity can increase through exercise.  We are proposing to select students from WSU Aerobics classes and students enrolled in ROTC to participate.  The participants will then be divided into two groups.  The aerobic classes will be the cardiovascular group and the ROTC students will be the cardio/strength training group. A questionnaire will be given to the volunteers to identify any obstacles that may affect the results and will disqualify participation. The individuals will then have their blood drawn a total of three times, one pre and two post draws. After all the participants have been identified, data will be gathered, values will be analyzed and a conclusion will be determined.

3. DURATION OF THE STUDY

This project will take approximately two semesters to complete. The gathering of research information and finalizing the test procedures will take place during the first semester. The second semester will include five weeks of conducting the research to give some leeway in case some students become ill and need to be drawn the following week. It will then be followed by data collection, along with a number of weeks of the data analysis.

4. MULTICENTER STUDY

Not applicable.

5. NUMBER OF SUBJECTS

A total number of 60-80 healthy subjects will be studied.

6. HEALTH STATUS OF THE SUBJECTS

Normal healthy individuals will be studied.

7. SUBJECT GROUPS EXCLUDED

Individuals with known chronic illnesses such as long term infections, asthma, allergies, or known malignancies will be excluded from the study.

8. AGES OF SUBJECTS

Healthy individual between ages 18-60 years.

9. DESIGN OF THE STUDY

Methods:

• The study will start with distributing questionnaires to at least 60 (30 in each group) volunteer participants regarding factors that may alter or influence the results, such as medications, infections, illnesses, food and health conditions. Numbers will be assigned to each participant to maintain confidentiality.
• Two to three days prior to their workout, the participants’ blood will be drawn to create baseline values of their WBC, differential tests, along with the pulse and temperature.
• Both groups blood will be drawn 5 minutes after exercise every other week for a total of two draws in a five week period.
• Both groups will wear a heart rate monitor to measure the degree and length of peaks in heart activity of each individual during exercise comparing it to the white blood cell count.
• Immediately upon receiving the samples, differentials and complete blood counts (CBC) will be performed.
• Once data (heart rate, pulse, temperature, white blood counts and differentials) has been collected it will be compared to baseline values, taking into consideration the interfering factors from the questionnaire. Proper statistical analyses will be performed.  Charts and graphs will be designed to illustrate shifts, trends or any other changes.
• Upon gathering all samples, participants will receive compensation for their time.

10. RISKS TO SUBJECTS

Risks include those related to phlebotomy (blood draws). Such may include anxiety to needle sticks or fainting of which these individuals should not participate and infection if ante-cubital area is not properly cleaned before the stick. There may also be risks involving transmission of pathogens through improper handling of needles. However, certified/trained phlebotomists who are aware of the safety precautions will be drawing the participants. Yet, participants are free to withdraw at any time during the experiment.

11. BENEFITS TO SUBJECTS AND OTHERS

Participants will receive a small compensation such as an item related to fitness, yet to be determined, as well as refreshments after phlebotomy. If study proves that indeed there is an increase in white blood cells due to exercise it will benefit participants to continue exercising to reduce infection.

12. COSTS TO BE BORNE BY SUBJECTS

Participants will not be charged for any portion of the experiment.

13. IS CONFIDENTIALITY ASSURED

Each participant will be assigned a number in place of their name to maintain anonymity and confidentiality.

14. CONTRACT OR GRANT NUMBER

A proposal for continuation of this project will be submitted to the Dumke College of Health Professions Marriott Research Committee.

15. NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

Dr. Yasmen Simonian, the Chair of Clinical Laboratory Sciences (CLS) Department is the principal investigator of the study. The senior students assisting with the study are Jackie Kofoed, Leah Albornoz, Curtis Gapinski, and Robert Johnson.

B. DESCRIPTION OF THE STUDY

Introduction:

It has been noted that people who exercise become ill less often than those who do not. According to previous studies, avoiding the common cold can be as simple as taking a daily walk[1]. Research has shown that there is an increase in WBC with moderate exercise. During exercise the white blood cells tend to demarginate, stay in the blood vessels instead of moving out into surrounding tissues. For this reason, there should be an increase in the amount of white cells in the circulation.  Therefore causing the white cells to more effectively identify and eliminate the pathogens. According to the British Journal of Sports Medicine, natural killer cells, a type of WBC, increased in number[2]. However, researchers commented that white blood cell counts alone were not evidence of improved immunity2.

Objective:

The intent is to show that after moderate exercise WBC increase in the circulation, therefore, possibly reducing the risk of infections. In particular, the expectation is to see an increase in the neutrophils (white cells that increase in bacterial infections) and natural killer cells (present in both viral and bacterial infections), which are some of the key components of fighting infection and general immunity.

Through the questionnaire and the results of the laboratory tests, significant variables that may influence the baseline (pre-test values) and post-test values will be identified. The heart rate during exercise and the pulse rate will be taken.   Additionally, blood will be taken pre/baseline and post exercise to identify a possible trend to find a correlation with increased white blood cells and intensity or level of exercise. From the two different groups involved, one will be strictly cardiovascular, while the other group will be cardiovascular and strength training.

Methods:

The study will start with distributing questionnaires to at least 60 (30 in each group) volunteer participants regarding factors that may alter or influence the results, such as medications, infections, allergies, illnesses, food and health conditions. Numbers will be assigned to each participant to maintain confidentiality.

Two to three days prior to their workout, the participants’ blood will be drawn to create baseline values of their WBC, differential tests, along with the pulse and temperature.

Both groups blood will be drawn five minutes after exercise every other week for a total of three draws in a five week period.

Both groups will wear a heart rate monitor to measure the degree and length of peaks in heart activity of each individual during exercise comparing it to the white blood cell count.

Immediately upon sample collection, blood smears will be made for the manual differentials and complete blood counts (CBC) will be performed for obtaining WBC and automated five-part differentials using the Coulter Max M blood analyzer.

Once data (heart rate, pulse, temperature, white blood counts and differentials) has been collected it will be compared to baseline values, taking into consideration the interfering factors from the questionnaire. Proper statistical analyses will be performed.  Charts and graphs will be designed to illustrate shifts, trends or any other changes.

Materials:

Ø      $110.00 – Butterfly drawing needles: 2 packs of 23 gauge by ¾ with 12 inch tubing needles

Ø      $28.80 –EDTA blood collection tubes: 4 packs of 4ml, 13x75 mm each packaging 50

Ø      $84.91 - Co-flex NL Cohesive Bandages, assorted colors, 2 inch, pack of 36 rolls

Ø      $400.00 – Incentives

Ø      $200.00 – Granola bars, orange juice, etc.

TOTAL:    $823.71

Questionnaire:

Are you currently taking any medications prescribed or otherwise? (i.e. corticosteroids, any other form of steroids, lithium or beta agonists, hormone pills, antibiotics, etc.) 

No ___, Yes ___ If yes, what and how often? __________________________________

Do you regularly take any vitamins or supplements? No____, Yes_____

If yes, what and how often? _________________________________________________

Do you participate in holistic medicine (i.e. herbs, alternative forms of medicine)? No___, Yes___ If yes, explain_______________________________________________

Have you eaten anything within the last hour? No ___, Yes __

If so what? ______________________________________________________________

Have you consumed any liquids within the last hour? No __, Yes____ Volume? _____

How often do you exercise during a week and how long is each workout? __________________________________

How many days has it been since you last exercised? ____________________________

What does your exercise routine consist of?  Strength____     aerobic____    

Other, explain____________________________________________________________

How would you rate the intensity of your workout? Light __   Moderate __ Vigorous __

Do you experience any pain following exercise? No___, Yes___

If yes, explain___________________________________________________________

How long has it been since you have been sick? Explain________________________________________________________________

Have you had any viral/bacterial/fungal infections within the last 24 hours? (i.e. Infectious Mononucleosis, TB, Malaria, Ingrown toenail, etc.)______________________

How many times would you say that you get sick per year? Explain_________________________________________________________________

Did you get a flu shot this winter? No__  Yes____

Do you have any chronic or abnormal health conditions?  (i.e. Anemia, Rheumatoid Arthritis, etc.) No __, Yes ___ Please explain ___________________________________

Have you had any seizures? No__ If yes, when? _________________________________

Have you had any allergic reaction in the last 24 hours? __________________________

How would you rate the amount of stress in your life? (1 being the least amount, 5 being the extreme). Circle one:  1      2      3       4       5

Females:  Are you currently menstruating? No ___, Yes ___

Females: Are you pregnant? No ___, Yes ___

Do you feel that when you exercise you become ill less often? 

Please explain___________________________________________________________.

Are there any other relevant issues to the study that you may want to discuss?  No ___,

If yes, please explain_____________________________________________________.

Thank you kindly for your time and participation…..

Date: _______________________

Participant Reference #:____________

Class number and time: _____________________________

Contact information:

Dr. Marjukka Ollilainen, IRB Chair – 801-626-6238

Dr. Yasmen Simonian, Chair of CLS Department – 801-626-7080

C. INFORMED CONSENT

Title: Effects of Exercise on White Blood Cells

Investigators: Dr. Yasmen Simonian (801-626-7080 or 801-557-1320), Jackie Kofoed, Leah Albornoz, Curtis Gapinski, Robert Johnson

WSU - IRB Chair Dr. Marjukka Ollilainen 801-626-6238

Purpose of the Study:

The intent is to show that after moderate exercise white blood cells increase in the circulation, therefore, possibly reducing the risk of infections. In particular, to see if there is an increase in the neutrophils (white cells that increase in bacterial infections) and natural killer cells (present in both viral and bacterial infections), which are some of the key components of fighting infection and general immunity. Your voluntary participation is requested to complete this study.

Study Procedure:

Volunteers must be over 18 and not have any significant chronic illnesses. A questionnaire will be distributed to each participant to determine their qualification to participate. The collection of data will take place during a six week period, which consists of a total of four blood draws (one 5 ml, EDTA tube), every other week.

1. The baseline sample will be drawn the first week
2. The second blood sample will be taken the second week following exercise
3. The third blood sample will be taken the fourth week following exercise
4. The fourth blood sample will be taken the sixth week following exercise
5. A short questionnaire will be handed out to be filled each week following the blood draws.

Risks:

Risks include those related to phlebotomy (blood draws). Such may include anxiety to needle sticks or fainting of which these individuals should not participate and infection if ante-cubital area is not properly cleaned before the stick. There may also be risks involving transmission of pathogens through improper handling of needles. However, certified/trained phlebotomists who are aware of the safety precautions will be drawing the participants. Yet, participants are free to withdraw at any time during the experiment.

Confidentiality:

You have the right to privacy. Any personal information obtained from the study will be kept confidential. The results of this study may be used for publications but the participants will remain anonymous.

Voluntary Participation:

Your participation in this study is entirely voluntary. You may withdraw at any time during the study with no penalty given.

Cost of Subjects:

There will be no cost to participate in the study.

Consent:

In signing this consent, I have given permission for the Investigators to use any results obtained during the test process with the understanding that all efforts will be made to keep my identity confidential.

My signature below indicates that I have read the above information and I have had a chance to ask questions to help me understand what my participation will involve. I agree to participate in this study. I also acknowledge having received a copy of this agreement. I understand that by signing this form, I have not waived any of the legal rights which I other wise would have as a participant in a research study.

Name of Participant (Print):­_________________________________________________

Participant’s Signature                                                                                      Date

Witness’s Signature                                                                                                      Date

Class number and time                                                              Participant #