The researcher is required to verify compliance with the CPHS approved exercise protocol that is planned for use in a research study upon submission of the CPHS application.
There are certain types of studies that require the PI to submit specific information to the CPHS. These studies include, but are not limited to exercise testing, genetic testing, testing of non-FDA approved substances, studies conducted over the Internet and studies involving women of child-bearing potential.
Note: Any medical information received from a subject must be maintained (handled) in compliance with HIPAA regulations.
Tests routinely conducted in exercise research protocols are reviewed by the CPHS for standardized procedures, appropriate risk management techniques and required training. Researchers who plan to collect data that involve maximal aerobic power (VO2max), endurance test protocols, strength and power test protocols, hydrostatic weighing, venipuncture, bone mineral density (DXA scan), lactate threshold, or exercise in the heat must incorporate the appropriate exercise testing protocol within their research protocol reviewed by the CPHS.
The exercise protocols also provide text to include within the informed consent document about the test procedures, associated risks and risk management strategies. This content may be edited if several tests are planned for use that, for example, have similar risks and/or risk management procedures. Researchers should note that guidelines from organizations such as the American College of Sports Medicine (ACSM), the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and the National Strength and Conditioning Association (NSCA) serve as key sources of information on procedure and safety of exercise testing. As the science related to the safety and efficacy of exercise testing advances, and new guidelines are published, the CPHS will review protocols based on these updated national guidelines.
Appropriate Applications
The testing of maximal aerobic power through direct measurement of maximal oxygen consumption (VO2max) is considered the best measure of cardiovascular fitness. VO2max has been assessed in a wide range of subjects, from children to the elderly, both fit and unfit, including cardiac patients. It is often used in studies to determine the effects of exercise training on fitness, both from short-term training, e.g., several weeks to longitudinal studies of a year or longer.
For older subjects (i.e., men >45 years; women >55 years), a standard three-channel ECG will be used where adequate monitoring and recording of the heart activity can be attained.* The use of ECG with other individuals will be restricted to studies that require quantification and qualification of heart rate, including any abnormal beats. For the majority of testing conditions requiring an ECG, a single lead will be used for monitoring and recording the ECG.
*Exception: ECG monitoring is not necessary for male and female endurance athletes up to age 59 years who are currently (within at least the past 12 months) training at maximal or near-maximal intensity, and who have no major cardiovascular risk factors.
Risk Stratification [ACSM Guidelines for Exercise Testing & Exercise Prescription, 2006, pg 27]
Low risk
1. Men <45, women < 55 years of age who are asymptomatic (as screened by the PAR-Q) and who self-report no more than one of the following risk factors for cardiovascular disease (CVD): current cigarette smoker; hypertension (SBP >140 mm Hg or DBP >90 mm Hg); obesity (BMI >30); sedentary; diabetes (Type 1 or 2); hypercholesterolemia; family history of CVD (cardiac death or event before age 55 years in father or other male first-degree relative, or before age 65 years in mother or other female first-degree relative. In addition, to be considered low risk, individuals must not be taking any medications prescribed to lower blood pressure or reduce serum cholesterol.
2. Endurance athletes <60 years of age (male and female). Must be currently (and for a minimum of the past 12 months) training and competing in endurance events, e.g., running, cycling, swimming, etc., including maximal or near-maximal bouts of exercise, AND have no known risk factors listed in #1 above (other than age). Moderate risk Men >45 and women >55 years of age (except athletes listed in #2 above), or any individual who has two or more risk factors mentioned above.
High risk
1. Individuals with known cardiovascular or pulmonary disease, or one or more signs/symptoms as screened with the PAR-Q.
Exception:
Persons with asymptomatic coronary heart disease with good exercise capacity (greater than or equal to 8 METS), good left ventricular ejection fraction (greater than 50%), and no evidence of ischemia may be considered at moderate risk, according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines. Persons with a previous diagnosis, signs or symptoms of cardiac disease will be required to see their cardiologist yearly and receive a letter of clearance, and return a completed and signed copy of Form A, which is a document produced by the AACVPR (see attached). Form A asks the participant's cardiologist to determine the participant's risk according to the AACVPR. If an individual meets the above criteria AND has written consent of their cardiologist, he/she may be categorized as moderate, rather than high risk.
Physician supervision of maximal exercise tests is based on risk categories.
Test Description
VO2max assessments are conducted in the CSUMB Exercise Physiology Laboratory located in the Stadium Complex Field House (emergency responder building index number: 902). Each subject will be screened for cardiovascular disease using the Physical Activity Readiness Questionnaire (PAR-Q). Any individual who answers “yes” to any of the PAR-Q questions will be excluded from the test. Subjects who meet specific study criteria and who do not report cardiovascular disease or its symptomology will undergo a maximal graded exercise test on a selected ergometer (treadmill, cycle, rowing machine, hand-crank cycle). Guidelines of the American College of Sports Medicine (ACSM) are adhered to regarding physician supervision of tests (see above).
To determine VO2max, subjects undergo a maximal graded exercise test to voluntary exhaustion. This means that the subject makes the decision when the test is over. On a cycle ergometer, the test is terminated when the subject can no longer turn the cranks at the desired frequency; on the treadmill, the test is terminated when the subject can no longer run at the treadmill speed and stands straddling the treadmill belt while holding on the railing. In addition, the subject is spotted at his/her side to prevent a possible fall.
When testing an athlete, in particular, he/she is coached to proceed as long as possible. Untrained individuals, older subjects, and children are encouraged to “give a hard effort,” but not coached to continue to their absolute physical limits. Following a test, the subject goes through a cool-down at a self-selected intensity until recovered.
Test protocols vary somewhat in terms of duration of each stage (1-3 minutes) and increments in intensity, but all begin with a 5-10 minute warm-up followed by a gradual increase in work effort until volitional exhaustion. Typically, a graded exercise test takes 8-12 minutes, excluding warm-up and cool-down. Throughout the test, the subject breathes through a rubber mouthpiece on a two-way re-breathing valve that is connected by low-resistance tubing to a metabolic measurement system. A computer permits analysis of the expired air for oxygen consumption and carbon dioxide production. Heart rates are monitored continuously, usually with a heart rate monitor that obtains a signal from a transmitter strapped around the chest. Older, inactive subjects are also monitored for heart arrhythmias and/or ischemic changes using a standard 3-lead ECG. Blood pressure is also monitored and recorded at each stage with older subjects. Only technicians trained in exercise ECG and blood pressure monitoring are permitted to test older and/or higher-risk subjects.
ECG assessment requires the placement of at least three electrodes, and possibly six, on the skin surface of the subject’s chest. Each electrode surface site is prepared to ensure that the electrode remains on the skin during exercise. The preparation process requires that the technician rub the electrode site with gauze until slightly red and to cleanse the area with alcohol prior to placing individual electrode pads. This process must be performed to remove natural body oil and dead skin that can interfere with the electrical signal and ECG assessment.
As follows ACSM guidelines, general indications that will be used for stopping an exercise test include:
Training/Supervision Required
Technicians or researchers need to be knowledgeable and trained in two specific areas: 1) administration of graded exercise tests, including ability to conduct pre-test health screenings, and knowledge and recognition of signs and symptoms of cardiovascular disease; and, 2) procedures for conducting metabolic measures. These procedures require academic preparation in exercise science.
Undergraduate students in the Kinesiology program in the Exercise Science concentration take coursework and have lab experiences to prepare them for these assessments. In addition, before they are allowed to collect data they must demonstrate to their faculty supervisor that they are competent in all these procedures.
All staff will be properly trained in application of electrodes and their respective monitoring and recording. Proper skin preparation is essential for good ECG tracings and staff will be trained. Once trained, minimal supervision will be necessary.
Risks
Maximal exercise testing may produce light-headedness, fatigue, nausea, and delayed-onset muscle soreness. These side effects are usually minimal in fit subjects. They are also minimized by having a gradual warm-up as well as cool-down (at least 5 minutes each) and by having the subject refrain from eating for at least 2-3 hours before their test. For treadmill testing, there is also a small risk of falling. This risk is managed by having at least one spotter at the subject’s side.
There is also a risk of a cardiac event, such as a heart attack, cardiac arrest, or dangerous arrhythmia. This risk is less than 1 occurrence in 12,000 tests of healthy subjects, and approximately 1-2 occurrences in 10,000 tests of higher risk and diseased subjects (ACSM Guidelines for Exercise Testing and Prescription, 2006).
There are minimal risks associated with an ECG. The most common is the debriding of the skin in preparation of ECG recording. In order to get a good ECG tracing, the skin must be properly prepared which will cause some reddening of the area where the electrodes are placed on the chest surface.
Risk Management
All test personnel are required to have current CPR certification and to be trained in emergency procedures for the particular lab. If possible, an AED (automated external defibrillator) is located within 10 ft of the test participant. A telephone (land line or cell phone) is located within 50 feet of the ergometers. Individuals with probable CVD, as screened with the PAR-Q, are not tested at CSUMB. Subjects are warmed up and cooled down gradually, which has been shown to decrease the incidence of cardiac arrhythmias during and after stress testing. In instances when ECG is monitored, only the necessary amount of skin preparation will be debrided, which minimizes perceived subject discomfort.
The mouthpiece and valves fall into the semi-critical device category. This device will come into contact with mucus membranes, but will not penetrate body surface. High-level disinfection using liquid glutaraldehyde disinfectants (e.g. Cidex) is acceptable according Center for Disease Control and Prevention recommendations. EPA-registered sterlants may also be used for this purpose in our laboratories.
Older is defined as men over 45 years and women over 55 years of age according to guidelines of the ACSM. Partial CVD risk is determined by the PAR-Q, i.e., subjects are asked about symptomology and whether they are hypertensive. Thus, a subject is screened out of studies if he/she reports symptoms indicative of CVD. However, if a subject reports high blood pressure, depending on the particular study, he/she would not necessarily be excluded from participating. The researcher will take BP of anyone self-reporting hypertension; if BP is >140/90, he/she will be excluded from studies involving high intensity or maximal exercise unless the study is specifically recruiting this population in which case a physician will monitor the exercise test.
ECG monitoring is normally conducted only in studies of older men (>45 yr) and women (>55) with diabetes or hypertension, who, in addition to their age, are at higher than average risk for cardiovascular complications during a maximal exercise test. The attending physician will be responsible for interpreting the ECG. Typically, the physician is accompanied by research assistants or faculty trained to recognize arrhythmias and possible ischemic responses. ECG monitoring is not necessary in studies of low risk individuals.
Exercise ECG will be used to determine possible ischemic responses to exercise, as well as dysrhythmias. Since, under most circumstances, a physician is supervising a maximal test in which ECG is being monitored, the physician will communicate test results to the subject. If an researcher is monitoring ECG without the presence of a physician, a suspected abnormal response will be criteria to terminate a test prematurely (see criteria for test termination on pg 106 of ACSM Guidelines, 2006). If this occurs, the subject will be told that the test was stopped “because your ECG response was not completely normal. I will make a copy of this test for you and I recommend that you show it to your physician. Since I am not a physician, I cannot answer specific questions about your test, therefore, it is best if you call your doctor to discuss this with him/her.”
All female subjects will be asked whether they are more than 3 months pregnant; if so, they will be excluded from maximal exercise testing.
Potential Benefits
Subjects receive a summary of their results. Measuring VO2max is a frequent request by athletes and coaches for they believe it will aid in planning and monitoring the athletes' training. Labs that conduct such testing often charge $150-300. In instances where an ECG is measured, it will provide the staff a better means of assessing the qualitative (rhythm) and quantitative (rate) heart function during and after exercise.
Consent Form Content (Description of the Study section)
Prior to undergoing a maximal exercise test, we will conduct a brief health screening to determine whether testing would put you at increased risk for an abnormal cardiac event such as a dangerous rhythm disturbance or a heart attack. If you are not at increased risk, you will be asked to report to the lab well rested; we recommend that you do no high-intensity exercise for 48 hours before your scheduled test. Also, please do not eat at least 2-3 hours before your test, but continue to drink water during this time.
For the VO2max test, you will be fitted with a mouthpiece and nose-clip, so that all of your expired air can be collected and analyzed for the amount of oxygen you consume and carbon dioxide you produce. You will be able to breathe normally through your mouth, but not through your nose. After a 5-10 minute warm-up, we will increase the work effort every 2-3 minutes until you no longer feel you can continue. Because you will not be able to talk through the mouthpiece, you will communicate with us using hand signals. Every 2-3 minutes during the test, we will ask you to rate your perceived exertion, on a scale of 1-10. This helps us determine when you are getting close to your maximal effort. Note: This last sentence can be deleted for athletes or physically conditioned subjects, as it becomes obvious when they are approaching maximum effort; also, having them attempt to rate their exertion distracts them from focusing on giving a true maximal effort.
If ECG is to be monitored: You will have specific sites on the surface of your chest prepared for electrode placement. During the preparation process, the technician will rub several sites with a gauze pad and then cleanse the area with alcohol prior to placing individual electrode pads on the area. This preparation process may be slightly uncomfortable. You will keep these electrodes on your skin until the end of the exercise, or until the technician indicates to you to remove them.
Consent Form Content (Risks and Discomforts section)
You are being asked to perform high-intensity maximal exercise that may lead to physical discomforts (e.g., fatigue and nausea). The risks associate with participating in this study may include muscle cramps, muscle strain and/or joint injury, delayed muscle soreness, lightheadedness, and fatigue. You may feel delayed muscle soreness (24-48 hours) after exercise. There is a risk of a cardiovascular event (approximately 1 in 12,000 people) such as a heart attack or rhythm disturbance, since the exercise will be very high intensity. To manage possible risks, there will be at least one CPR-certified researcher present at the testing, as well as a telephone available should an emergency arise.
If at any time during the test you want to stop, you can signal as instructed and we will stop the test. You will feel very tired at the end of the test, but should recover within a few minutes.
Compensation for Injury section (If injury is not covered by the study)
If any complications arise, we will assist you in obtaining appropriate attention. If you need treatment or hospitalization because of being in this study, you are responsible for payment of the cost for that care. If you have insurance, you may bill your insurance company. You will have to pay any costs not covered by your insurance. California State University Monterey Bay and the University Corporation at Monterey Bay, will not pay for any care, lost wages, or provide other financial compensation. However, if you feel you have a claim that you wish to file against the State or UCorp, please contact Sponsored Programs Office at (831) 582-5130 to obtain the appropriate claim forms.
Appropriate Applications
Endurance tests may be used to study cardiorespiratory and/or metabolic effects at various intensities of effort. They can also be used to collect data in thermoregulatory and altitude studies and in other studies examining the effects of endurance exercise on blood concentrations of hormones, electrolytes, etc. The exercise intensity used in a protocol is usually determined as a percent of one’s VO2max; if so, VO2max must be determined before the endurance test can be performed. These two procedures, under almost all circumstances, are not conducted on the same day. According to ACSM guidelines, three categories of intensity are suggested: 1) light/low (<50% VO2max); 2) moderate (60-75% VO2max); and 3) heavy/high (>80% VO2max). However, individual researchers may propose variations of these guidelines in their own protocols.
Test Description
After selection of the desired intensity, the subject warms up for 5-10 minutes, after which the ergometer is set to the selected intensity. For example, if the researcher selects 70% of VO2max as the intensity for a treadmill study, the speed and grade are adjusted until the subject reaches 70% of his/her VO2max. A variation that is frequently used for cycle ergometry testing is to conduct the endurance test at a given percent of each subject’s peak or maximum power output. For a test, the subject is asked to continue exercising either for a pre-determined time or until volitional exhaustion. Typically, heart rate is also monitored throughout the test using a heart rate monitor that takes its signal from a transmitter strapped around the chest with an elastic band.
Training/Supervision Required
Technicians or researchers need to be knowledgeable and trained in administering exercise tests, including the ability to conduct a pre-test health screening, and knowledge and recognition of possible signs and symptoms of cardiovascular disease. Technicians must also be familiar with the specific ergometer they propose to use in their study. If students are taking metabolic measures, i.e., collecting expired gases and analyzing for O2 consumption and CO2 production, they must first demonstrate this competency to the satisfaction of their faculty sponsor. These procedures require academic preparation in exercise science courses. Undergraduate students in the Kinesiology program in the Exercise Science concentration take coursework and have lab experiences to prepare them for these assessments.
Risks
The risk of a cardiac event is lower than it would be for maximal testing, however, the exact risk is not known. Any exercise bout may produce light-headedness, fatigue, possibly nausea, and delayed-onset muscle soreness. These side effects are usually minimal in fit subjects. They are also minimized by having a gradual warm-up as well as cool-down (at least 5 minutes each) and by having the subject refrain from eating for at least 2-3 hours before their test. For treadmill testing, there is also a small risk of falling. This risk is managed by having at least one spotter at the subject’s side.
Risk Management
Lactate threshold assessments are conducted in the CSUMB Exercise Physiology Laboratory located in the Stadium Complex Field House (emergency responder building index number: 902). All test personnel are required to have current CPR certification and trained in emergency procedures for the particular lab. A telephone is located within 50 feet of the ergometers. Individuals with probable cardiovascular disease, as screened with the PAR-Q, are not tested at CSUMB.
The mouthpiece and valves fall into the semi-critical device category. This device will come into contact with mucus membranes, but will not penetrate body surface. High-level disinfection using liquid glutaraldehyde disinfectants (e.g. Cidex) is acceptable according to CDC recommendations. EPA-registered sterlants may also be used for this purpose in our laboratory.
Potential Benefits
There may be no direct benefits to subjects. However, depending on the specific protocol, subjects may receive the results of their testing, which could possibly benefit them in their training.
Consent Form Content (Description of the Study section)
Prior to undergoing the exercise protocol, we will conduct a brief health screening to determine whether testing you would put you at risk for an abnormal cardiac event such as a dangerous rhythm disturbance or a heart attack. If you are not at risk, you will be asked to report to the lab well rested; we recommend that you do no high-intensity exercise for 48 hours before your scheduled test. Also, please do not eat at least 2-3 hours before your test, but continue to drink water during this time.
For this endurance test, you will run (walk) on the treadmill (or cycle ergometer) at a workload that is equal to (XX) percent of your VO2max. We want you to continue to exercise as long as you can (or for a specified time period).
Consent Form Content (Risks and Risks Management section)
For needle sticks or venipuncture: Procedures that require blood samples to be collected have the risk of soreness, bruising and/or swelling at the collection site. Prior to each finger stick, the area will be cleaned with an alcohol swab. After the stick, you will be instructed to maintain slight pressure on the area to minimize additional bleeding.
If high intensity exercise is included: If you are asked to perform high-intensity exercise you may experience physical discomforts that may include muscle cramps, muscle strain and/or joint injury, delayed muscle soreness, lightheadedness, and fatigue. It is likely that you will feel significant delayed muscle soreness (24-48 hours) after. There is also a risk of a cardiovascular event (less than that associated with maximal testing of 1 in 12,000 people) such as a heart attack or rhythm disturbance when participating in high intensity exercise. To manage possible risks, there will be at least one CPR-certified researcher present at the testing, as well as a cellular phone available should an emergency arise.
Appropriate Applications
This test is used to determine body density and estimate body composition.
Test Description
This procedure utilizes the difference in densities of the fat and non-fat masses to determine overall body density, which can be used to estimate body fat percent. Briefly, the subject is placed in a water tank and weighed after maximally exhaling. Differences in the dry and underwater weights are used to calculate body density. However, an allowance must be made for residual lung volume–the air that remains in the lungs after a maximal exhalation–as this air increases a subject's buoyancy. Residual lung volume can be either measured or estimated. In our laboratory, residual lung volume is usually indirectly measured using an oxygen-dilution technique (Wilmore et al., 1980). A 5-L Douglas re-breathing bag fitted with a two-way breathing valve is flushed and filled with 100% oxygen. While in a seated position and fitted with the mouthpiece on the Douglas bag and a nose clip, the subject takes several normal breaths of ambient air. Afterwards, the subject performs a maximal inhalation followed by a maximal exhalation and briefly holds his/her breath at the end of the exhalation. At this point, the mouthpiece valve is turned so that the subject begins rebreathing from the 100% oxygen. The subject takes 6-8 deep breaths after which the valve is closed and the subject removed from the Douglas bag. At least two, but sometimes three trials are performed with several minutes between trials.
The most accurate estimate of body composition by hydrostatic weighing requires residual lung volume to be measured. There are, however, situations because of expediency or lack of equipment in which residual lung volume is estimated. One way to estimate residual lung volume is from published tables that are based on age and weight. Another method is to estimate residual volume from the measured vital capacity. In this procedure, a seated subject, while fitted with a nose clip and connected to a spirometer, performs a maximal inhalation followed by a maximal exhalation. Vital capacity is the volume of the maximal exhalation from which residual lung volume is estimated based on gender, as a percentage of the vital capacity.
After having measured or estimated residual lung volume, the subject's dry weight is measured and then, wearing a swimming suit or running shorts, the subject climbs into the underwater weighing tank and sits in a seat that hangs from a force load-cell. The procedure involves the subject performing a maximal exhalation and slowly leaning forward in the chair until the top of his/her head is under water. After the underwater weight stabilizes (5-8 seconds), the subject is instructed, through yelling or pounding on the side of the tank, to return to an upright position. During a weighing, the subject is always free to stand up or return to the upright position. Four to eight trials are usually performed.
The non-skid steps up to the top of the tank where the subject enters are equipped with a handrail, and after climbing the steps, the subject climbs down a ladder into the water. Depth of the water is approximately 54 inches, which is maintained between 30 and 34 °C. While seated, the subject faces a clear plexiglas side to minimize feelings of claustrophobia. After each testing session, the water is drained and the tank allowed to dry.
Training/Supervision Needed
All test personnel are required to have current CPR certification and are trained in emergency procedures for the particular lab. A telephone is located within 30 feet of the underwater weighing tank.
Risks
Other than risks of falling while getting into or out of the underwater weighing tank, there are no physical risks associated with this protocol. Subjects not comfortable in water or in putting their head underwater may experience slight anxiety during the underwater weighing.
Risk Management
Subjects are encouraged to be careful while getting into or out of the underwater weighing tank. For individuals who experience anxiety during the underwater weighing, the test administrator will go more slowly with the subject and encourage him/her to stand up in the water should the anxiety become too strong.
The mouthpiece and valves used for the measure of residual volume fall into the semi-critical device category. This device will come into contact with mucus membranes, but will not penetrate body surface.
High-level disinfection using liquid glutaraldehyde disinfectants (e.g. Cidex) is acceptable according to CDC recommendations. EPA-registered sterilants may also be used for this purpose in a laboratory.
Potential Benefits
The subject obtains his/her body composition, which is an important component of overall personal fitness.
Consent Content (Description of the Study section)
There are two parts to this procedure. First, we will measure your residual volume, which is the amount of air that remains in your lungs after performing a maximal exhalation. Afterwards, we will weigh you underwater. Together, this information will be used to estimate your body fat percentage.
To measure your residual volume, you will perform 2-3 trials of breathing in and out of bag containing 100% oxygen. In a seated position and wearing a nose clip, you'll be connected to a breathing mouthpiece connected to the bag of oxygen. First, you will take several normal breaths from the outside air and then perform a maximal exhalation. At that time, a valve will be turned which will direct your breathing from the bag of oxygen. You'll take 6-8 deep breaths after which you'll be removed from the valve. After a couple of minutes, you will repeat this 1-2 times.
After you change into your bathing suit, you will climb into the underwater weighing tank. Briefly, you will sit quietly on the hanging seat in the tank, and when instructed, perform a maximal exhalation and then slowly lean forward just to the point that your head is completely underwater. You will remain motionless for 5-8 seconds until instructed by the technician to come back to the surface. It is very important that you blow all of the air out of your lungs and remain as motionless as possible while underwater. Should you develop any overpowering anxiety, you can always stand up before being instructed, as the depth of the water is only about 4½ feet. We will do at least four, but as many as eight, underwater weighings in all. Afterwards, you will climb out of the tank, dry off and change back into your street clothes.
Appropriate Applications
In various exercise studies, researchers may want to assess blood enzymes, blood lipids, hemoglobin, hormones, and serum parameters including glucose, electrolytes, or blood proteins that may be altered with physical exertion. The venipuncture may be taken prior to, during (with the subject stopped) and after exercise. For some studies that examine the graded effects of exercise on certain blood parameters, up to four blood samples may be taken via venipuncture (from different sites).
Test Description
Venipuncture (also known as phlebotomy) refers to a procedure in which venous blood is drawn into a small tube via needle insertion and aspiration. Steps taken by the phlebotomist to perform this procedure are to: wear safety (e.g. latex) gloves for reducing the likelihood of infection; position the subject in a seated position (unless blood is being taken from a subject standing on a treadmill stopped in the middle of an exercise protocol); clean the area (usually the antecubital fossa area) with alcohol and allow to air-dry; place an elastic band (tourniquet) around the upper arm to distend the veins; isolate the vein and insert the needle with a Vacutainer tube for aspiration. Upon removal of the needle, sterile gauze will be placed over the insertion site secured by tape. The subject will be encouraged to apply pressure to the site for several minutes to minimize bruising. The needle will be discarded into a hazardous waste (Sharps) container, which will be properly disposed.
Training/Supervision Needed
Only staff who are California-certified phlebotomists are allowed to perform blood draws. All certified phlebotomists will have had adequate experience to perform the blood draw without supervisory assistance; hence, no supervision will be necessary to perform a venipuncture.
Risks
Under normal conditions, there are minimal risks to the subject when performing venipuncture. These risks include: bruising; perforation of the vein leading to hematoma under skin; light-headedness or dizziness due to fear of needles; and infection.
Risk Management
Whenever blood is drawn, there is a small risk of bruising. Through this procedure, the risk for perforation of the vein is minimized. To minimize the risk of light-headedness or dizziness, each subject will have blood drawn in a seated position. Although infection is a risk with venipuncture, this is minimized by use of alcohol to cleanse the area prior to the blood draw, as well as the use of safety (latex) gloves by the phlebotomist, in accordance with the bloodborne pathogens standard of the Occupational Safety and Health Administration (OSHA). In the case of individuals with a latex allergy, the laboratories have non-latex gloves available for use. To minimize risk of injury due to fainting, the subject should be seated or supine, and a second party (able adult) should be within “shouting” distance.
Potential Benefits
From the blood analyses, we will be able to better understand the acute and/or chronic effects of exercise on hematological, enzymatic, and hormonal changes. This information will aid in our understanding of exercise programs that can favorably modify, or yield deleterious effects to specific blood parameters.
Consent Content (Description of the Study section)
You will be asked to submit to a (or multiple) venous blood draw(s). All blood draws will be performed by certified technicians and follow established standard procedures. Usually, the amount of a single blood draw is about 5-7 ml or ~1 tablespoon.
Consent Content (Risks and Discomforts section)
The risk in blood sampling is minimal, although there is the risk of soreness, bruising, and/or swelling at the collection site. Risks will be minimized by employing a trained and certified technician who will follow standard procedures for safely drawing blood.
Applications
Dual-energy x-ray absorptiometry (DXA) measurements are used to measure bone mineral density (BMD) and body composition. The National Osteoporosis Foundation recommends bone density scans for the following persons:
Additional populations that may be studied are athletes and children, as well as men. In addition, studies of body composition use the DXA technique as the new “gold standard” for determining lean tissue and fat mass.
Exclusion/Inclusion Criteria: Criteria specific to each new protocol will be provided by the researcher. The only general exclusion criterion is that pregnant women will not be scanned.
Test Description
Bone mineral density (BMD, will be assessed by dual-energy x-ray absorptiometry (DXA). The scan sites most often assessed include the spine (L1-L4), hip, and total body. The DXA total body scans will be used to determine both total body BMD as well as body composition and regional fat distribution. The average scan time for each of these is approximately 3, 4, and 10 minutes for the spine, hip, and total body, respectively. The total time required for subject positioning and scanning is approximately 5, 8, and 12 minutes for the spine, hip, and total body, respectively. A typical appointment, therefore, requires approximately 30 minutes per subject for all 3 scans, or approximately 20 minutes for spine and hip only.
Quality assurance (QA) tests will be performed each morning of use. QA will be conducted using a standard with tissue-equivalent material with three bone-simulating chambers of known bone mineral content. In vivo BMD precision is 0.6-1.2% for the spine, 0.6-1.7% for the femoral neck, 0.6-0.8% for total-body mineral, and less than 1.5% for total body soft tissue mass (Mazess, Br J Radiology 70:109-110, 1997).
Subjects are instructed, prior to the day of their scan, to dress with clothing free of any metal and not to wear jewelry. Women are encouraged to wear a halter-top or something similar. If subjects arrive with any metal on their clothing, they are asked to change into shorts and t-shirt. A supply of these are kept in the fitness lab and laundered as needed. The subject is shown the DXA machine and told that the scan arm will move above them while he/she lies on the table. They are instructed to lie still and not to talk while the machine is scanning. The following is a description of how the subject is positioned for each of the three scans:
Spine: The subject lies supine with his/her hands on their shoulders (to keep the arms away from the lumbar spine). The technician first straightens his/her body by gently pulling from the ankles (this is not done with older subjects or those who, when asked before proceeding, report back pain). The scan arm is then brought to the start position. The technician then asks the subject to bend his/her knees while a box is place beneath the lower legs. This is done to insure that the spine is positioned correctly and kept in contact with the table. The technician then locates the anatomical site for starting the scan, which is vertically aligned with the navel and 3-5 cm below it. Prior to touching the subject, the technician tells him/her to point to their navel. This is done to minimize the amount of palpation required by the technician. The subject is then asked to remain still while the machine scans.
Hip: The subject lies supine with his/her arms crossed over their chest. The feet are strapped to a plastic device such that the hip joints are medially rotated. The technician then locates the anatomical site for starting the scan, which is vertically aligned with the mid-thigh and approximately 7 inches below the anterior, superior iliac crest. The subject is then asked to remain still while the machine scans.
Total Body: The subject lies supine with his/her arms by their sides. Velcro straps are secured around the knees and ankles to hold the legs together. The subject is then asked to remain still while the machine scans.
Females who are minors will be accompanied by a parent or another adult when scanned by a male technician. The parent will sit just outside the door to the DXA room, but within clear view of the subject. California law does not permit anyone other than the technician and patient in the room during scanning.
Training/Supervision Needed
All scans will be conducted by experienced technicians certified by the state of California. California law requires all DXA facilities to be supervised by an M.D. serving as the medical advisor and licentiate. The M.D. has ultimate responsibility for insuring safe and effective procedures regarding bone densitometry testing and must be available to assist researchers in interpreting scans, should this be requested. The M.D. is not required to be present during the scanning procedures.
Technicians certified by the state of California will conduct all preliminary analyses of scans, unless the researcher of a particular project indicates that he/she wants to receive unanalyzed data. Some studies may have a designated reader at another site, but for analyses done at CSUMB any abnormal or questionable scans will be reviewed by both the M.D. and the technician, with the M.D. making the final interpretation.
Risks
Skin entrance dose of radiation is approximately 20 µSv for a spine and hip scan, and 0.2 µSv for total body. In practical terms, this is equivalent to the amount of radiation to which one is exposed during a cross-country airplane flight. Since the long-term effects of exposure to a fetus are not known, pregnant women will not be scanned. There are no other known risks associated with this procedure.
Risk Management
Only experienced and certified technicians are permitted to conduct scans. Given the extremely low dose of radiation, the benefits far outweigh the risks for any population tested. Young adults will have a baseline report for future comparison. Menopausal women and older adults will have objective data regarding their risk for osteoporosis, thus allowing them to discuss with their physicians possible preventive treatment. Since most insurance policies do not cover routine osteoporosis screening for persons younger than 65 years of age, participation in a research project in which BMD is assessed provides the participant with information that would otherwise cost between $150-300. For studies involving female subjects, the researcher will include relevant screening questions (see below) as part of the consent content.
Screening for Pregnancy. To insure that a pregnant woman is not scanned, a female will be scheduled for testing within 14 days of her last period. By including the following question in the screening process, relevant information can be obtained and used for scheduling without asking intrusive questions such as whether the subject is using birth control or whether she is sexually active.
Adult women (18 years and older) will be asked only the following question: “Are you pregnant or could you possibly be pregnant?” A negative answer will suffice for proceeding with the scan. If the participant is unsure, or if requested, a pregnancy test will be conducted. For studies of postmenopausal women, the technician will ask the participant to confirm that she is in menopause.
The use of a pregnancy test is also an option for screening purposes.
Potential Benefits
The primary benefit is for women, particularly postmenopausal women, to assess and monitor bone mineral density and their risk of osteoporosis. However, testing may also benefit males who are at risk. Moreover, testing can detect the presence of fractures and determine the severity of osteoporosis.
Confidentiality of Data and Room Security
When not in use, the room in which the DXA is located is kept locked. Other than the supervising M.D. and the researcher’s administrative assistant, only persons trained in DXA operation have keys to the room. Data collected each day are removed from the hard drive and stored on diskettes, which are kept in a locked file in each researcher’s office. Data transferred to a database for statistical analysis are coded; no identifying information will be used in data analysis.
Consent Content (Description of the Study section)
Dual-energy x-ray absorptiometry (DXA) measurements are used to measure bone mineral density (BMD) and body composition. For the DXA measurement, it is necessary to dress with clothing free of any metal and not to wear jewelry. We recommend that female participants wear a halter top or swim suit top, or something similar. If you forget and arrive with any metal on your clothing, we will have spare pairs of sweat pants and several t-shirts that you can wear while being scanned.
The DXA machine consists of a table with a scan arm that moves over your body while you lie on the table. The technician will position you for each scan. You will be asked to lie still and not talk while the machine is scanning. The entire procedure takes 10-20 minutes, depending on which scans are conducted.
Consent Content (Risks and Discomforts section)
The risk of harm from radiation with DXA machines is extremely small. The actual amount of radiation emitted for a total body scan is 0.2 uSv, which, in practical terms, is much less than the amount received during a cross-country airplane trip. However, the long-term effects of exposure to a fetus are not known, therefore, pregnant women are not scanned. For females: To ensure that you are not pregnant, we will ask you to schedule your appointment within two weeks of your last period. If you are unsure or cannot remember your last period, we will conduct a pregnancy test to confirm that you are not pregnant. For this we will have you collect a few drops of urine and we will use an over-the-counter test kit to determine pregnancy status.
Parental consent text if the subject is a minor female child: The assent form explicitly states that if your daughter is pregnant or could possibly be pregnant she cannot participate. To avoid embarrassing your child we have indicated on the assent form that she should simply tell us she does not want to participate, without giving us a reason. If your daughter qualifies for the study, we will ask her to tell us the date of her last menstrual period (if she has begun menstruating). We will then schedule her for her scan and other measurements within 2 weeks of her last period, thus ensuring that she could not possibly be pregnant when she is scanned.
Consent Content (Confidentiality of Data and Room Security section)
When not in use, the room in which the DXA is located is kept locked. Other than the supervising M.D., and the researcher’s administrative assistant, only persons trained in DXA operation have keys to the room. Data collected each day are removed from the hard drive and stored on diskettes, which are kept in a locked file in each researcher’s office. Data transferred to a database for statistical analysis are coded; no identifying information will be used in data analysis.
Appropriate Applications
There are multiple reasons why the lactate threshold might want to be determined. Identification of the lactate threshold is the best predictor of performance over a range of endurance distances. Furthermore, training causes a shift in the exercise intensity at which the lactate threshold occurs, thus this test can be used to monitor training /detraining progression. In addition, laboratory protocols may use an exercise intensity based that is relative to above or below the lactate threshold.
Test Description
Briefly, the subject will perform a series of incremental exercise bouts during which ~50 μL of blood from a finger stick is analyzed for lactate concentration at the end of each bout. As exercise intensity increases, blood lactate concentration increases in a curvilinear fashion, and the intent of this test is to identify the workload at which blood lactate concentration begins rising exponentially. A brief (5-10 minutes) warm-up and cool-down are performed before and after a test. The initial bout begins at a very low intensity, which progresses to a near-maximal intensity. Each bout is usually 3-5 minutes in length, and depending upon the exercise mode, may be continuous or discontinuous. During treadmill testing, subjects must be stopped in order to sample blood (a discontinuous protocol); with cycling protocols, however, blood can be sampled while a subject is exercising, thus the bouts could be continuous. The number of bouts varies, but usually 5-8 bouts are performed.
Blood is sampled from a finger stick that has been cleaned with an alcohol swab. After allowing the finger to dry, a fingertip is lanced and the blood collected in one or two 50 μL heparin-coated capillary tubes. The blood is transferred via a pipette to a lactate analyzer for determination of lactate concentration.
Sterile gauze is applied to the fingertip, and the subject instructed to maintain pressure for several minutes. As multiple samples are required for this test, for subsequent samples, the fingertip is squeezed to determine whether blood can still be sampled from the same stick, and if so, reduces the number of finger sticks that must be performed. Otherwise, additional finger sticks are performed on another site of the same finger or a different finger depending upon the subject's preferences. Total blood drawn during this test is less than 0.5 mL.
Training/Supervision Needed
Undergraduate students in the Kinesiology program in the Exercise Science concentration take coursework and have lab experiences to prepare them for these assessments.
Risks
The risk of a cardiac event is lower than it would be for maximal testing, however, the exact risk is not known. Any exercise bout may produce light-headedness, fatigue, possibly nausea, and delayed-onset muscle soreness. These side effects are usually minimized in fit subjects. They are also minimized by having a gradual warm-up as well as cool-down (at least 5 minutes each) and by having the subject refrain from eating for at least 2-3 hours before their test.
Under normal conditions, there are minimal risks to the subject when performing finger sticks that include: bruising; light-headedness or dizziness due to fear of needles; and infection.
Risk Management
Lactate threshold assessments are conducted in the CSUMB Exercise Physiology Laboratory located in the Stadium Complex Field House (emergency responder building index number: 902). Subjects who meet specific study criteria and who do not report cardiovascular disease or its symptomology, as screened with the Physical Activity Readiness Questionnaire (PAR-Q), will undergo an incremental exercise test on a selected ergometer (treadmill, cycle, rowing machine, hand-crank cycle). Mild exercise is used to warm-up and cool-down before and after exercise, which minimizes the risk of injury or a cardiac event from the exercise.
Whenever blood is drawn, there is a small risk of bruising. Although infection is a risk with finger sticks, this is minimized by use of alcohol to cleanse the area for the blood draw. Latex gloves are worn by the technician at all times, and all contaminated materials are deposited in a biohazard container, in accordance with the bloodborne pathogens standard of OSHA. In the case of individuals with a latex allergy, the laboratories have non-latex gloves available for use.
Potential Benefits
If the intent of the test were to determine fitness level or predict endurance performance, this test would provide extremely valuable information to the subject. However, if the test were used to determine exercise intensity of another exercise protocol, results of this test would likely be of little interest to the subject.
Consent Content (Description of the Study section)
You will first perform a 5-minute standardized warm-up at a low intensity. Afterwards, you will perform several bouts of (treadmill or cycling) exercise, which increase in intensity. Each intensity will be 3-5 minutes in length; the entire test will contain five to eight stages. After each exercise bout, a small amount of blood will be sampled from a finger stick. Prior to the finger stick, the fingertip will be cleaned with an alcohol swab. The amount of blood drawn will be equivalent to only a few drops, and the total volume of blood taken will be less than a teaspoon.
Consent Content (Risks and Risks Management section)
Procedures that require blood samples to be collected have the risk of soreness, bruising and/or swelling at the collection site. Prior to each finger stick, the area will be cleaned with an alcohol swab. After the stick, you will be instructed to maintain slight pressure on the area to minimize additional bleeding.
Appropriate Applications
Testing of subjects in a warm, humid environment can provide insight into the acute and chronic effects of exercising in the heat. Studies are performed to investigate the acute effects of exercise in the heat on the cardiovascular, metabolic, or thermoregulatory systems as well as the effects of acclimation on these systems to extreme environmental conditions.
Test Description
Subjects may exercise in the environmental chamber for up to 2 hours per day. In heat acclimation studies, subjects may perform up to 10 days of exercise in the heated chamber. Air temperature will range from 32 to 43 ºC (90 to 110 ºF) at a relative humidity of 30-80%. During a test, heart rate, sweat rate, skin blood flow, sweat gland density, and core body temperature may be followed. Heart rate is measured using a heart rate monitor received from a transmitter strapped around the chest. Sweat rate is determined by pre- and post-exercise body weights. Skin blood flow is estimated using either a laser Doppler technique or venous-occlusion plesmography. A laser Doppler probe is positioned on a forearm from which the signal is converted to units of blood flow. Venous-occlusion plesmography estimates blood flow from the tension measured from a strain gauge positioned around the forearm while applying a blood pressure cuff to the upper arm. Sweat gland density is calculated by applying iodine-impregnated paper to the skin. Core body temperature can be measured in a variety of ways: The three most commonly used methods in our laboratory are tympanic, rectal, and esophageal measurements. Tympanic temperatures are measured with an infrared sensor inserted into the ear. When tympanic temperatures are performed, though, the design of the sensor prevents it from being inserted too far and injuring the ear. Rectal temperature is measured from a sanitized temperature probe inserted by the subject approximately 10 cm past the anal sphincter. Esophageal temperature is measured using a single-use temperature probe inserted by the subject through a nostril to a length approximately 25% of the subject's height.
Training/Supervision Needed
Technicians must have coursework and lab experiences to prepare them for these assessments. These individuals will have been prepared for giving instructions to subjects for inserting probes.
Risks
The rectal or esophageal probe may produce mild discomfort while inserted. The risk of a cardiac event from exercising in the heat is lower than it would be for maximal testing, however, the exact risk is not known. Any exercise bout may produce light-headedness, fatigue, possibly nausea, and delayed-onset muscle soreness. These side effects are usually minimized in fit subjects. They are also minimized by having a gradual warm-up as well as cool-down (at least 5 minutes each) and by having the subject refrain from eating for at least 2-3 hours before their test.
Risk Management
Core body temperature will be monitored during the exercise test. If a subject's core temperature exceeds 39.5 ºC, the test will be terminated and the subject removed from the environmental chamber. Only single-use probes will be used to measure esophageal temperature.
A negative pregnancy test is required of all female subjects before beginning an exercise experiment in the heat. CSU/CSUMB students may have a urine pregnancy test at the CSUMB Campus Health Center; she will need to provide the researcher with a copy of the test results. If the subject is not a CSU/CSUMB student, we will provide a urine pregnancy test that will be administered and read in the lab.
Potential Benefits
In heat acclimation studies, subjects may be able to exercise longer and with less fatigue and discomfort after becoming acclimated.
Consent Content (Description of the Study section)
You are being asked to exercise in the environmental chamber, which will be set to XX ºF and a relative humidity of XX%, for XX minutes (and for XX consecutive days). In order to monitor that you are not becoming overly heated, your tympanic (or rectal or esophageal) temperature will be followed. Tympanic temperature is measured by inserting a temperature probe in the ear and holding it for a few seconds until the temperature is registered. (Rectal temperature is measured with a probe inserted in your rectum. You will do this yourself in the privacy of the changing room by inserting the probe to the mark indicated on the cable and/or esophageal temperature is measured with a probe inserted through a nostril into the esophagus to the point indicated on the cable.) Before and after the exercise, your weight will be recorded. To measure blood flow, a laser Doppler will be attached to your forearm and/or a strain gauge sensing devise will be placed around your forearm and a blood pressure cuff around the upper arm.
Consent Content (Risks and Discomforts section)
You may experience discomfort and briefly gag when you insert the esophageal probe. You may also experience mild irritation of the nose and throat both during and after the experiment. Should your temperature exceed 39.5 ºC, we will terminate the test and remove you from the chamber. If you feel uncomfortable during any part of this study, you may choose to terminate your participation.
Appropriate Applications
Strength, power, and endurance tests (e.g., one repetition maximum tests, vertical jump, bicycle sprint tests, repetitions to failure, etc.) may be used to assess muscular fitness and performance characteristics at various intensities of effort.
Test Description
A variety of protocols may be employed to assess characteristics of muscular fitness. Generally however, it is common that the subject warms up for 5-10 minutes (e.g. pedals a bike). Then the subject performs the specific movement (e.g. bench press) with progressively higher intensities until failure. Adequate rest is allowed between trials.
Training/Supervision Required
Technicians or researchers need to be knowledgeable and trained in administering exercise tests, including the ability to conduct a pre-test health screening, and knowledge and recognition of possible signs and symptoms of cardiovascular disease. Technicians must also be familiar with the specific assessment device they propose to use in their study. If students are taking muscular strength, power, or endurance measures, i.e., collecting performance data, they must first demonstrate this competency to the satisfaction of their faculty sponsor. These procedures require academic preparation in exercise science courses. Undergraduate students in the Kinesiology program in the Exercise Science concentration take coursework and have lab experiences to prepare them for these assessments.
Risks
Muscular strength, power, and endurance have been assessed safely in a variety of populations ranging from the elderly and those with chronic disease, to fit athletes. Any exercise bout may produce light-headedness, fatigue, possibly nausea, and delayed-onset muscle soreness. These side effects are usually minimal in fit subjects. They are also minimized by having a gradual warm-up as well as cool-down (at least 5 minutes each) and by having the subject refrain from eating for at least 2-3 hours before their test. Potential risks are further managed by having at least one spotter while the subject performs the assessment.
Risk Management
Muscular strength, power, and endurance assessments are conducted in the CSUMB Exercise Physiology Laboratory located in the Stadium Complex Field House (emergency responder building index number: 902), the Otter Sports Center (emergency responder building index number: 90), or the appropriate field setting (e.g. track). All test personnel are required to have current CPR certification and trained in emergency procedures for the particular lab. A telephone is located within 50 feet of the muscular testing equipment. Individuals with probable cardiovascular disease, as screened with the PAR-Q, are not tested at CSUMB.
Potential Benefits
There may be no direct benefits to subjects. However, depending on the specific protocol, subjects may receive the results of their testing, which could possibly benefit them in their training.
Consent Form Content (Description of the Study section)
Prior to undergoing the exercise protocol, we will conduct a brief health screening to determine whether testing you would put you at risk for an abnormal cardiac event such as a dangerous rhythm disturbance or a heart attack. If you are not at risk, you will be asked to report to the lab well rested; we recommend that you do no high-intensity exercise for 48 hours before your scheduled test. Also, please do not eat at least 2-3 hours before your test, but continue to drink water during this time.
For this test of muscular fitness, you will warm up for 5-10 minutes (e.g. pedal a bike). Then you will perform the specific movement (e.g. bench press) with progressively higher intensities until failure (i.e. your maximal effort).
Consent Form Content (Risks and Risks Management section)
If high intensity exercise is included: If you are asked to perform high-intensity exercise you may experience physical discomforts that may include muscle cramps, muscle strain and/or joint injury, delayed muscle soreness, lightheadedness, and fatigue. It is likely that you will feel significant delayed muscle soreness (24-48 hours) after. There is also a risk of a cardiovascular event (less than that associated with maximal testing of 1 in 12,000 people) such as a heart attack or rhythm disturbance when participating in high intensity exercise. To manage possible risks, there will be at least one CPR-certified researcher present at the testing, as well as a cellular phone available should an emergency arise.
Consent Content (Description of the Study section)
We will measure your forearm (or other body part) sweat rate using a Macroduct Sweat Collection System. This system works by stimulating sweat production in a small area (about 3 inches) of your forearm by using a small, nonshocking electrical current. You may feel a mild tingling sensation, but nothing more. Many individuals report that they cannot feel anything. A total of approximately 10 drops of sweat will be collected from your forearm using a collection pad. The entire procedure, including prep time, takes about 30 minutes.
If the study involves genetic testing, address issues pertaining to confidentiality of information collected. State whether or not the genetic information collected about the subject could pose a risk to them (e.g., denial of health insurance because of known predisposition to illness). State whether other genes will be studied in the DNA that may be shown at some point in the future to be related to illness. Describe how blood samples will be coded and stored. Explain whether or not any of the laboratory results will be made available to subjects, and whether the results will be added the subject’s medical record.
State whether the specimens collected will be made available for use in other genetic research and whether or not the discoveries will have significant therapeutic or commercial value. To protect subject privacy, all information that links the subject’s specimens and DNA to his/her identity must be removed prior to use in any research conducted outside of this specific study so that the sample provided to others for research purposes cannot be traced back to the individual subject.
Address safety and efficacy concerns for studies that involve non-FDA regulated botanical products. Provide evidence to suggest that the product being tested is safe for use with humans at the dose level planned for use in this study.
To insure that a pregnant woman is not included in research that may be harmful to her or her fetus, procedures to screen for pregnancy must be included in the protocol.
The CPHS has approved the following screening procedures: Prior to testing, ask female participants to disclose the start date of her last menstrual cycle. If she has not menstruated within the last 14 days, the participant will need to schedule testing to occur within 14 days of the start of her next cycle. The researcher can make a urine pregnancy test kit available to participants to use as confirmation of pregnancy status. If the pregnancy test indicates a negative result for pregnancy, the test may be conducted. If a positive pregnancy result is indicated, the subject is not eligible to participate in testing.