Study 2: Blood Pressure And 15 Weeks Of Walking Study
(PDF version of consent form)

1. GENERAL INFORMATION

The Institutional Review Board for Human Subject Research at the University of Michigan Medical School (IRBMED) reviewed this research project from the standpoint of the protection of human research subjects. The IRBMED found the project to be in compliance with the regulations of the United States Government and of the University of Michigan.

1.1 This version of the consent document was prepared on: 2001/05/29.

1.2 This version of the consent document was approved by the IRBMED on: 2001/07/12.

1.3 This project's approval by the IRBMED will expire on: 2002/07/12.

1.4 The archive number assigned by the IRBMED to this project is: 1999-498

1.5 Names of the investigators responsible for this project: Katarina BORER, Ph.D., Robert BROOK, M.D., William FAY, M.D.

1.6 The title of this research project is: Effects of training intensity on the heart-rate and blood-pressure variability in postmenopausal women

1.7 The protocol number assigned to this study is: 1647

1.8 This research is funded by: M01-RR00042 (GCRC)

2. INFORMATION ON THE RESEARCH STUDY

2.1 What is the purpose of this research study?

The purpose of this research is to find out whether training at different exercise intensities reduces the risk of developing coronary heart disease (CHD) to a different extent. Heart attacks and stroke are the leading cause of death in older women. Reduced variability of the heart rate and increased dips and swings in blood pressure are risks factors that predict the chance of developing CHD as are increased levels of clotting protein fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol (>160 mg/dl). CHD risk is further increased when plasma cholesterol which travels in blood in the form of lipoproteins becomes oxidized, reduces the capacity of blood vessels to dilate , and contributes to atherosclerosis. We will be measuring these risk factors and your body fat level before you start training and after 15 weeks of training in the form of walking. At the present time the effects of exercise intensity on these factors are not well understood. This study will add to the basic understanding of these issues and allow us to recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce the risk of developing CHD.

2.2 Who can take part in this study?

The study group will be composed of forty women. In case more subjects may wish to participate than the study can accommodate, we will accept participants in the order in which they apply except for two Afro-American and two Asian women who will be given priority in order to meet the desirable ethnic composition of the group.

2.3 Why should I consider joining this study as a research subject?

Direct benefits to you include probable decrease in health risks for cardiovascular morbidity and mortality and for development of diabetes and cancer of the colon, improved cardiovascular fitness, and expected fat loss and lean mass increase. You also will receive useful information about your cardiovascular risks, beneficial effects of exercise, and any body fat changes.

2.4 Do I have to become a subject in this study? If I joined the study, can I change my mind and drop out before it ends?

Your becoming a subject in this study is entirely by your own free choice. You may refuse to enroll in the study, or drop out of the study at any time without any penalty even after having agreed to become a subject. By doing so, you will not lose any benefits that you may be entitled to up to that point in the study.

In case you withdraw from the study, you will not be harmed in any way but you will not receive the expected health benefits from walking exercise: fat loss, lean mass increase, improved cardiovascular fitness, probable decrease in health risks for cardiovascular morbidity and mortality and for development of diabetes and cancer.

The investigators of this study may have to end your taking part in this study as a subject, if any of the following conditions came up:

2.5 What exactly will be done to me, and what kinds of treatments or procedures will I receive, if I agree to be a research subject in this study?

This study will involve a walking program at different walking speeds for a period of 15 weeks. We will first ask several general questions about your health, and ask for your doctor's approval to participate in the study. If you have no health conditions that would preclude your participation in the study, we will arrange for a blood draw for determination of plasma lipids and clotting factors. We will also provide you with a container in which you should collect urine over 24 hours for measurement of adrenalin. After emptying your bladder, you should record the time and the date on the container. You should collect all urine up to the same time the next day at which time you should attempt to empty the bladder for the last collection. we will determine your body fat and aerobic fitness. Body fat will be assessed by measuring skinfold thickness and circumference of different parts of your body . This will be done in the CCRB and each measurement will take approximately 10 minutes. We will also measure total body fat by bioimpedance in the General Clinical Research Center (GCRC). This is done by measuring your body water by undetectable, low-level electric current. These procedures will allow us to accurately determine how much fat there is in your body, where it is distributed, and how it changes with exercise training. Your aerobic fitness will be assessed by having you breathe through a mouth piece as you walk on a treadmill at different speeds. We will be measuring your aerobic capacity from the breathing rate and the amount of oxygen you consume as the effort increases.

On the basis of the body fat and aerobic fitness, we will match you with other women of similar body composition and aerobic capacity and assign you to a slow or fast-walking group. Walking will be carried out five days a week (at 6:45 am). You will start with one mile per day, and increase distance by one half mile each week until you attain 3/miles per day. You will keep walking 3 miles/day five days a week until the end of week 30. The same measurements (aerobic capacity and body composition) will be repeated after 15 and 30 weeks of training.

Heart-rate (HR) and blood-pressure (BP) variability will be measured before training and after 15 weeks of walking. This will consist of your wearing an automated HR and BP arm cuff continuously for 7 days except for the times when you are taking a bath or a shower. During those times the monitor will be taken off and its battery will need to be recharged. During the seven days of HR and BP monitoring you will be expected to keep a diary in which you should record times and durations of sleep and major physical activities. This will take about 10 to 15 minutes each time.

The function of your blood vessels will be measured during a test at the GCRC. You will be asked to arrive to GCRC (floor 7B of the University of Michigan Hospital) without having anything to eat for 8 hours. The test will consist of your lying quietly for 30 minutes before a blood-pressure cuff is inflated for 5 minutes over your dominant arm. Immediately upon cuff deflation, an ultrasound image will be taken of the blood flow in this arm.

We will share with you all the health information we obtain through measurements. All of your records will be kept confidential.

2.6 What kinds of harm can I experience in this study, and what will the investigators do to reduce the chances of harm?

Wearing a HR-BP cuff for 7 days at a time may be slightly inconvenient in that it may affect the type of clothing you may wear over the cuff on the arm. Inflation of the blood pressure cuff at the GCRC will cut off circulation to your forearm for a few minutes and this may produce some discomfort or pain. A small chance of muscle soreness is possible upon initiation of walking program. As in everyday locomotion, injuries of the ankle, and knee could occur.

The risks of participating in this study are minimal. Risks of joint injuries will be prevented or minimized by inclusion of a warm up and cool down, recommendations to wear appropriate walking shoes and by walking on a level surface. You should be given clearance from your personal physician attesting that no conditions exist that would make exercise potentially hazardous to your health. Healthy people should experience no cardiac distress with any level of walking in this study. Your answers in Physical Activity Readiness Questionnaire also will help us identify conditions that would make exercise potentially hazardous. If at any time any subject develops chest pains or shortness of breath, exercise will be discontinued and a physician consulted. As an additional risk management measure, at least one person at each walking session will have minimal training in American Red Cross Adult CPR and Standard First Aid.

Taking part in more than one research study may be harmful to you. If you are already taking part in another study, please let us know. You should not take part in more than one study at the same time, unless you and the investigators agree that you are not likely to be harmed, and the outcome of the study will not be disturbed. This is particularly important if you are receiving in another research study any investigational or non-investigational drugs. If taken at the same time, some drugs may change each other's effects on the body, so that one drug may become harmful because of another drug.

2.7 What will the investigators do to make sure that the information they will collect on me will not get in wrong hands?

We shall put the information collected about you during the study into a research record. This research record will not show your name, but will have codes entered in it that will allow the information to be linked to you. However, we shall keep your research record confidential, to the extent provided by federal, state and local law. We shall not allow anyone to see your record, other than people who have a right to see it . You will not be identified in any reports on this study.

2.8 What kinds of benefit can I expect personally from taking part in this study?

Direct benefits to you include expected fat loss, lean mass increase, improved cardiovascular fitness, probable decrease in health risks for cardiovascular morbidity and mortality and useful information about your health.

2.9 What kinds of benefit to others can come out of this study?

Indirect benefit from this study are the chance further the understanding of how exercise intensity affects heart-rate and blood-pressure variability, several other risk factors of CHD, and fat loss. The findings may eventually be of value in developing recommendations for optimal exercise intensities to reduce risks of developing cardiovascular disease.

2.10 What will the investigators do, if I get injured in the study?

Should you get physically injured as a result of research-related treatments or procedures, the University of Michigan will provide first-aid medical treatment. Additional medical treatment will be provided, if the University determines that it is responsible to provide such treatment. However, the University does not provide compensation to a person injured while taking part as a subject in research.

2.11 Will I get paid for taking part in this study? No.

2.12 Will I or my health insurance company be charged for any of the costs of this study? No.

2.13 Once I start in this study as a subject, what do I do if I want to find out more about the study, or to complain about the way I get treated?

If you have any questions or concerns about your rights as a research subject, or any grievance, you may also contact the Institutional Review Board for Human Subject Research (IRBMED), University of Michigan, 4558 Kresge Medical Research Building I, 200 Zina Pitcher Street, Ann Arbor, MI 48109-0570; telephone 734 763 4768.

2.14 If I decide not to become a subject in this study, what may happen to me, or what other choices do I have if I need treatment?

Participation in this study is voluntary. You are free to participate in, or withdraw from the study at any time. The investigators may terminate your participation under the following circumstances: failure to (1) follow agreed-upon walking routine and participate in agreed-upon measurements, (2) start smoking, dieting, or (3) discontinue hormone replacement therapy or start taking medications that will affect physiological responses to exercise.

3. DOCUMENTATION OF CONSENT

3.1 Who gets to keep this document, once I sign it?

One copy of this document will be kept together with the investigators' research records on this study. A second copy will be given to you to keep. A third copy will be placed in your University of Michigan Health System Medical Record.

3.2 Research subject's statement of consent to participate in this study

I have read the information given above. The investigators personally discussed with me and told me more about the study, and answered my questions. I understand the meaning of this information. I am aware that, like in any research, the investigators cannot always predict what may happen or possibly go wrong. I have been given sufficient time to consider if I should join this study. I hereby consent by my own free choice to take part in the study as a research subject.

3.3 Research subject's identity, and the identity and dated signatures of the subject and/or legal representative of the subject, affirming that consent was given

Subject's Name:

Subject's Birth Date:

Subject's UMHS Case Number:

Consenting Signature of the Subject: Date:

3.4 Investigators' confirming statement

I have given this research subject information on the study, which in my opinion is accurate and sufficient for the subject to understand fully the nature, risks and benefits of the study, and the rights of a research subject. There has been no coercion or undue influence. I have witnessed the signing of this document by the subject.

Investigator's Name: Katarina T. Borer

Investigator's Signature _______________________________Date:

For any additional information about this study, you can reach the investigators of this study as follows:

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