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CCSU Human Studies Council

APPROVAL FORM

PRINCIPAL INVESTIGATOR: JENNIFER BOSSI PHONE: 860-681-5940

IF CCSU STUDENT, PLEASE ENTER CCSU ID#: 30301488

INVESTIGATOR'S MAILING ADDRESS: 114 BRENTWOOD DR.

CITY, STATE AND ZIP: BRISTOL, CT 06010

TITLE OF PRINCIPAL INVESTIGATOR: GRADUATE INTERN ATHLETIC TRAINER

EMAIL: st_bossij@ccsu.edu

ACADEMIC DEPARTMENT OF PRINCIPAL INVESTIGATOR: PHYSICAL EDUCATION AND HUMAN

PERFORMANCE

TITLE OF PROJECT: EFFECTS ON MENSTRUAL CYCLE PHASE ON EXERCISE PERFORMANCE IN

FEMALE COLLEGIATE STUDENT-ATHLETES

PROPOSED PROJECT START DATE: SEPTEMBER, 2011

IS THIS A CONTINUATION OF PREVIOUSLY APPROVED STUDY Yes___ No_x__

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ A. STUDENTS ONLY

1. Please indicate (check) which of the following best describes your project:

____ Dissertation

x____ Thesis

____ Special Project (graduate level capstone other than thesis or dissertation)

____ Class project: specify CCSU DEPT/CLASS:________________________

____ Other undergraduate research project

2. Who is your supervising professor? Dr. Kimberly Kostelis

3. What is your professor’s academic department? Physical Education and Human Performance

4. Student submissions cannot be reviewed until an email is received by the project’s supervising professor.

Professors are asked to send an email to HSC@ccsu.edu indicating that they have reviewed and approved* the

student’s proposal for submission to the HSC.

* APPROVAL means that the supervising professor has reviewed all material to be submitted by the student

researcher and has determined that the submission is 1) complete, 2) consistent with relevant ethical

principles and procedures, 3) free of typographical and other errors, and 4) the quality of the material is

deemed to be suitable for human studies review and distribution to potential participants

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ B. FOR ALL RESEARCHERS:

1. Per Federal mandate, every researcher is required to complete an ethics educational component when submitting

research proposals to the HSC.

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I have completed the NIH Human Subjects Tutorial* Yes_x__ No___

I have met this requirement through other means Yes___ No___ How? __________________

*Click here to access the NIH Human Subjects Tutorial or go to http://phrp.nihtraining.com/users/login.php

2. Will your research be conducted in a school or other external agency? Yes x___ No ___

If you answered 'Yes' to the question above, you must attach written "gatekeeper" approval with this

application. (For example, if you are conducting a study in a school or other external agency, you must obtain

written permission from the principal/superintendent of the school or the director of the agency. Letter should be on

official letterhead. Gatekeeper must indicate familiarity with the goals and methods of the study and state

permission/support for the project).

SPONSORING AGENCY (if applicable): Central Connecticut State University Athletics

C. PLEASE COMPLETE ALL PARTS OF THIS FORM

1. SUMMARIZE YOUR PROPOSED RESEARCH: (OUTLINE OBJECTIVES AND METHODS)

(Do not exceed 150 words) See #2 on Checklist

This study is designed to examine the effects of menstrual cycle phase on exercise performance among

collegiate female student-athletes. Menstrual cycle phases will be estimated using self reported tracking of previous

periods for three months (See attached p.9). Subjects will first complete a basic questionnaire assessing exercise and

menstrual cycle history (See attached pp. 10-11). Subjects will then undergo 3 treadmill exercise to exhaustion tests

(Bruce, 1974; See attached p. 12 ). The first test will be a practice trial to get subjects familiarized with the testing

procedures. The second and third tests will be conducted during the midfollicular and midluteal phases of one

menstrual cycle. Heart rate and blood lactate levels will be taken pre and post exercise, while respiratory exchange

ratio, Rate of Perceived Exertion (Borg, 1984; See attached p. 13), and VO2 values will be recorded throughout and

after the test. To measure blood lactate accumulation, blood samples will be collected from the tip of the finger at 3

and 30 minutes into recovery following exercises.

2. SUMMARIZE ALL INVOLVEMENT OF HUMANS IN THIS PROJECT: (WHO, HOW MANY, AGE, SEX,

LENGTH OF INVOLVEMENT, FREQUENCY, ETC.)

Subjects will be approximately 10 female student-athletes at Central Connecticut State University ages 18-

24 with regular menstrual cycles. They will be recruited from varsity athletic teams on a volunteer basis. All

participants will be medically healthy and will not have taken any oral contraceptives in the past year. They will be

involved in the study for a total of 4 months, with 3 months of self tracking their menstrual cycle for baseline data

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and 1 month of exercise testing. They will have to report to the exercise physiology laboratory 3 times during the

exercise testing portion.

3. INDICATE WHETHER ANY SUBJECT OF YOUR RESEARCH WILL BE SELECTED FROM THE

FOLLOWING CATEGORIES:

( ) Minors ( ) Pregnant women ( ) Prisoners ( ) Addicts ( ) Parolees ( ) Fetuses

( ) Mental retardation or intellectual disability ( ) Mental disability or psychiatric illness

( ) Physically disabled

( x ) none of the above

4. CHECK ALL RISKS TO HUMANS INVOLVED IN YOUR PROJECT: (See #3C Checklist)

______ No risks

______ Deception

x_____ Personal material (interviews, opinions, test scores)

______ Stress or emotional arousal

______ Loss of privacy

x_____ Embarrassment, disappointment, or other disagreeable emotion

x_____ Alteration of self-concept (e.g. through knowledge of test scores)

x_____ Physical or psychological trauma or pain

______ Loss of legal rights

x_____ Experimental diagnostic procedures

______ Side effects of medications

x_____ Experimental treatment procedures

______ Contraction of disease

______ Worsening of illness

BRIEFLY EXPLAIN ANY OF THE ABOVE YOU CHECKED

Subjects will be asked to run on a treadmill until they cannot go any longer which may cause physical

injury or psychological damage from embarrassment. In the blood lactate measurements, blood will be drawn to

measure lactate levels post exercise which could lead to other medical risks. Lastly, subjects will be asked to reveal

personal information about their menstrual cycle which can cause embarrassment for some participants.

5. INDICATE PROCEDURES TO PROTECT HUMAN PARTICIPANTS FROM RISKS

(Check all that are appropriate)

______ Precautions in uses of stressors or emotional material (explain below)

______ When deception is used, subjects are fully informed of the nature of the research at a

feasible time (explain below)

x_____ Procedures to minimize changes in self-concept (explain below)

_____ Data from protected sources

x_____ Code numbers will be used

x_____ Individual data submerged in results

x_____ No unauthorized use of data

x_____ Data confidentiality will be used

______ Debriefing on experimental purposes

______ Clinical trial (describe data monitoring below)

x_____ Sterile equipment

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x_____ M.D. or other appropriately trained individual in attendance

OTHER AND EXPLAINATIONS

A registered nurse will be present to supervise blood lactate measurements. The finger prick used for this

measurement will be conducted using a specific approved protocol (See attached p. 13). A certified athletic trainer

will be present during all exercise tests in case of physical injury. Subjects will be self- monitoring their menstrual

cycles and only researchers will be able to see this information. All participants will be tested individually when

performing the VO2max test to exhaustion to reduce feelings of embarrassment or pressure from others. Results from

individual tests will be used but will be grouped when analyzed.

6. INDICATE HOW YOU WILL OBTAIN INFORMED CONSENT (Click to see sample consent form).

x______ Subject or parent/guardian reads information on consent form and signs. (Please attach a copy of the

consent form used)

______ Subject receives ORAL briefing (from principle investigator or project personnel) and then gives ORAL

consent. (Please attach copy of the text of briefing and consent)

______ Other (please explain)

7. BRIEFLY DESCRIBE THE SOCIAL AND SCIENTIFIC BENEFITS THAT WILL ACCRUE TO EACH

HUMAN SUBJECT, OR TO HUMAN BEINGS IN GENERAL, AS A RESULT OF THE INDIVIDUAL’S

PARTICIPATION IN THE PROJECT.

Participants will learn how their bodies respond to exercise during different phases of their menstrual cycle.

This study may also benefit participants by making them more aware of their fitness level through the VO2max test.

* If applicable, please submit the following attachments:

a. Consent document(s) (written and/or verbal text). (Click to see sample consent form).

b. Copies of all questionnaires, surveys, tests and other relevant material used.

c. Copy of gatekeeper letter.

DRUG FREE CERTIFICATION: As a condition of approval of this research, I certify that I will not engage in

the unlawful manufacturing, distribution, dispensing, possession or use of a controlled substance in conducting any

activity associated with this research. (45 CFR 620, subpart F, Appendix C)

Investigator check here to certify x___ Date 7/18/11_

SCIENTIFIC MISCONDUCT STATEMENT: I certify that I am aware that Central Connecticut State University

does not tolerate scientific misconduct. The following PHS definition (NPRM) is accepted by the University:

"'Misconduct' or 'misconduct in science' as used herein is defined as plagiarism, deception or other practices that

seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting

or reporting research; or (2) material failure to comply with federal requirements that uniquely relate to the conduct

of research."

Investigator check here to certify x___ Date 7/18/11___

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CENTRAL CONNECTICUT STATE UNIVERSITY

Department of Physical Education and Human Performance

1615 Stanley Street

New Britain, CT 06050

Jennifer Bossi Dr. Kimberly Kostelis

Graduate Intern Associate Professor

st_bossij@ccsu.edu kostelisk@ccsu.edu

860-832-3086 860-832-2791

EFFECTS OF MENSTRUAL CYCLE PHASE ON EXERCISE PERFORMANCE

AMONG FEMALE COLLEGIATE STUDENT-ATHLETES

INFORMED CONSENT STATEMENT

1. Invitation to Participate and Description of the Project. You are being asked to

participate in our study examining menstrual cycle phase and blood lactate levels during

exercise. We are investigating this topic in order to further our understanding of how the

menstrual cycle affects exercise. You were recruited for this study because you are a female

varsity athlete at Central Connecticut University, have a regular menstrual cycle, and have not

been on any type of birth control or other medication that would affect your menstrual cycle in

the past year. Your participation in the research study is voluntary. Before agreeing to be part of

this study, please read and/or listen to the following information carefully. Feel free to ask

questions if you do not understand something.

2. Description of Procedure. If you participate in this study, you will be asked to report

information on your menstrual cycle history and birth control use. You will then be asked to

complete 3 VO2max tests to exhaustion on a treadmill, including a practice test, and tests during

the follicular phase (6-9 days after menses) and luteal phase (6-9 days after ovulation) of your

menstrual cycle. The phase of the menstrual cycle will be determined by using self reported

tracking of the menstrual cycle each month for 3 months. Blood samples will be collected from

the tip of the finger at before exercise and 3 minutes and 30 minutes into post exercise. VO2max,

heart rate, respiratory exchange ratio, and Rate of Perceived Exertion values will also be taken

throughout and after each test.

3. Risks and Inconveniences. Risks that may be presented in this study include chance of

physical injury resulting from the VO2max test to exhaustion and chance of feeling sick resulting

from drawing blood for blood lactate accumulation measurements. You will be asked to run on

the treadmill with progressing speed and incline until you feel like you cannot go any longer.

Injuries may include but are not limited to: muscle strains, shin splints, and fatigue. There are

also cardiovascular risks from the exercise tests. An athletic trainer will be present at all times to

treat any injury and/or medical condition that may occur. If you have any preexisting injuries

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and/or medical conditions, you should not participate in this study. Also, blood will be drawn to

measure blood lactate accumulation pre and post exercise. Risks that may occur include but are

not limited to: lightheadedness, headache, nausea, and fainting. An athletic trainer and registered

nurse will be present to draw the blood safely and treat any condition they may occur. The blood

will be drawn from a finger prick using a specific approved protocol.

4. Benefits. From this study, you will learn how your body responds to exercise during different

phases of your menstrual cycle. Also, this study might also be beneficial by making you more

physically fit through the VO2max test.

5. Financial (or other) considerations: There are no financial and/or other considerations to

this study.

6. Confidentiality. Any and all information obtained from you during the study will be

confidential. Your privacy will be protected at all times. You will not be identified individually

in any way as a result of your participation in this research. The data collected however, may be

used as part of publications and papers related to the effects of the menstrual cycle on exercise.

7. Voluntary Participation. Your participation in this study is entirely voluntary. You may

refuse to participate in this research. Such refusal will not have any negative consequences for

you. If you begin to participate in the research, you may at any time, for any reason, discontinue

your participation without any negative consequences.

8. Other considerations and questions. Please feel free to ask any questions about anything

that seems unclear to you and to consider this research and consent form carefully before you

sign.

Authorization: I have read or listened to the above information and I have decided that I will participate in the project described above. The researcher has explained the study to me and answered my questions. I know what will be asked of me. I understand that the purpose of the study is to determine the effects of menstrual cycle phase on exercise performance. If I don't participate, there will be no penalty or loss of rights. I can stop participating at any time, even after I have started.

I agree to participate in the study. My signature below also indicates that I have received a copy of this

consent form.

Participant’s signature: ________________________________

Name (please print); _________________________________ Date: ________________

If you have further questions about this research project, please contact the principal investigator, Jennifer Bossi, at

(860) 681-5940 or e-mail st_bossij@ccsu.edu or faculty supervisor , Dr. Kimberly Kostelis, at (860) 832-2791 or

e-mail kostelisk@ccsu.edu. If you have questions about your rights as a research participant or if you have a

research- related complaint please contact Dr. Bradley Waite, Chair, CCSU Human Studies Council at (860) 832-

3115, e-mail Waite@ccsu.edu or Kim DeMichele, Administrator, CCSU Human Studies Council at (860) 832-2366,

email kim.demichele@ccsu.edu.

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MENSTRUAL CYCLE SELF-TRACKING SHEET

Code Number: ______

Directions: Starting with this month, please circle the days that you have your period for the

next 3 consecutive months.

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EXERCISE AND MENSTRUAL CYCLE HISTORY QUESTIONNAIRE

Code Number: _____

Age: _____

Height : _____ Weight: _____

In Season Exercise History (Please circle your response.)

1. How many hours of exercise do you complete per day as part of your sport (practice,

games, lift, etc)?

0-1 2-3 4-5 >5

2. How many days per week do you compete (practice and games)?

0-1 2-3 4-5 >5

3. How would you rate your average intensity of play (1 lowest; 5 highest)?

1 2 3 4 5

4. How many hours of exercise do you perform outside of your sport per week?

0-1 2-3 4-5 >5

Out of Season Exercise History (Non-competitive season. Please circle your response).

5. How many hours of exercise do you complete per day as part of your sport (practice,

games, lift, etc)?

0-2 2-3 4-5 >5

6. How many days per week do you compete (practice and games)?

0-1 2-3 4-5 >5

7. How would you rate your average intensity of play (1 lowest; 5 highest)?

1 2 3 4 5

8. How many hours of exercise do you perform outside of your sport per week?

0-1 2-3 4-5 >5

Medical History:

Please list any injury/ medical condition that you have sustained within the last 5 years

that kept you from practice or play for more than one week. (Continue on back if

necessary.)

Injury: Length of time until return to activity.

1.

2.

3

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Menstrual Cycle History (Please circle or write your response.)

1. Age you started your period: __________

2. Your menstrual cycle is:

Regular (comes consistently every month) Irregular

3. Date of most recent menstrual period: __________

4. Frequency of Menstrual Cycle:

<21 days 21-28 days 28-35 days >35 days

5. Number of skipped/missed periods during that last 12 months:

0-1 2-3 4-5 6-7 8-9 >10

6. PMS symptoms: (circle all that apply.)

Cravings Cramps Headaches Drowsiness Mood swings

7. Intensity of menstrual flow (on average):

Very light Light Medium Heavy Very Heavy

8. Longest period of time without menstruation (if applicable):

2 months 3 months 4 months >4 months

9. Are you on birth control or any other medication that would affect your menstrual

cycle?

YES NO

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BRUCE VO2MAX TREADMILL TEST

Stage Time (min) km/hr Incline

1 0 2.74 10%

2 3 4.02 12%

3 6 5.47 14%

4 9 6.76 16%

5 12 8.05 18%

6 15 8.85 20%

7 18 9.65 22%

8 21 10.46 24%

9 24 11.26 26%

10 27 12.07 28%

(Bruce, 1994)

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BORG SCALE (RATE OF PRECIEVED EXERTION)

6 No exertion

7 Very Very Light

8

9 Very Light

10

11 Light

12

13 Somewhat Difficult

14

15 Difficult

16

17 Very Difficult

18

19 Very Very Difficult

20 Maximal Exertion

(Borg, 1982)

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Central Connecticut State University

Athletic Training

Protocol for Finger Stick Capillary Blood

Skill Level Certified Athletic Trainer

Indications Unresponsive patients of unknown etiology, patients with suspected diabetic emergencies

Contraindications Cold, cyanotic, swollen, scarred, or rash covered finger

Procedure 1. Apply powder free gloves.

2. Patient should be seated or lying supine with arm in hyperextension.

3. Turn patient’s hand upward.

4. Massage patient’s hand and lower part of finger to increase blood flow.

5. Scrub the patient’s 3rd or 4th finger of non-dominant hand with an alcohol pad

and dry with gauze.

6. Hold finger in an upward position, press lancet firmly just off the center of the

finger pad on the palm-side surface of the finger with a sterile lancet making a

puncture.

7. Puncture should be made perpendicular to the ridges of the fingerprint.

8. Apply slight pressure to start blood flow.

9. Blot the first drop of blood on a gauze pad and discard pad in appropriate

biohazard container.

10. Keep the finger in a downward position and gently massage it to maintain blood

flow. Avoid excessive pressure.

11. Collect drop of blood on collection device.

12. Provide patient with small gauze pad over the puncture site for a couple of

minutes to stop bleeding.

13. Apply a sterile bandage over the puncture site.

14. Dispose of contaminated materials in designated biohazard containers.

Complications NONE

Remarks Normal blood glucose levels are from 60 to 110.

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NIH CERTIFICATE

Certificate of Completion

The National Institutes of Health (NIH) Office of Extramural Research certifies that Jennifer Bossi successfully completed the NIH Web-based training course “Protecting Human Research Participants”.

Date of completion: 07/18/2011

Certification Number: 711213

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