Human Performance Laboratory

IRB Standard Operating Procedures

This document provides standard language for use in IRB consent forms for common Human Performance Laboratory procedures. In the Methods and Procedures section of the application, you may reference the appropriate section of this Standard Operating Procedures document. Procedures not included in this document must be described in detail in the Methods and Procedures section of the application and included in the consent form.

Note: The language in the application section should be written in the third person, e.g., “the participant”; in the consent form it should be the second person, i.e., “you” and “my.”

Anthropometric and Body Composition Measurements

Anthropometric Testing
1. Height –will be measured using a stadiometer. The participant will stand in bare feet with heels touching the wall while an adjustable level is placed on top of the head to record their height.
2. Mass –will be measured using an electronic scale. The participant will stand in bare feet and remain as still as possible for 15-20 seconds.
3. Circumferences – The participant will have arm and leg circumferences measured using a tape measure and subcutaneous (under skin) body fat measured with a Skinfold caliper to estimate total muscle mass. Circumferences and skinfolds will be measured at the mid-point of the upper arm, thigh and calf. Waist and hip circumferences will be measured using a tape measure to calculate the waist-to-hip ratio. Waist circumference will be measured at the narrowest or smallest girth observed between the xiphoid process (bottom of chest bone) and the navel (belly button). Hip circumference will be measured at the greatest protrusion of the gluteal muscles (buttocks).
4. Skinfold Thickness Test –Body composition is measured by skinfold calipers. The fat underlying the skin will be measured at sites taken on the back of the arm, upper back, chest, abdomen, hip, thigh and calf to determine percent body fat.
5. Heart Rate –The participant will wear a heart rate monitor attached by elastic band at the bottom of the breastbone (i.e., xyphoid process) that will transmit the heart rate to a watch.
6. Blood Pressure - The participant will have their blood pressure measured by an automated blood pressure machine commonly used in medical clinics.
7. Muscle Soreness - Lower body muscle soreness will be evaluated by placing a mark along a 10 cm scale that ranges from “no soreness” to “extreme soreness” after performing an unloaded (body weight only) parallel squat. Upper body muscle soreness will be evaluated by placing a mark along a 10 cm scale that ranges from “no soreness” to “extreme soreness” after performing an unloaded push-up.
Body Composition
1. Bioelectrical Impedance Analysis (BIA) - Body water will be measured using an EVOLT360 bioelectrical impedance analysis [BIA] machine (similar to a handheld BIA body fat analyzer). Participants will stand bare foot on the analyzer and hold on to the handles using their hands in a full but relaxed grip ensuring contact with electrodes. The device sends a low voltage/amperage current through the body and measures impedance of the current to determine total body water. The participant will not feel anything during this procedure which lasts about 1 minute.
2. Underwater Weighing Test (UWW, Hydrostatic weighing) - The participant will wear a bathing suit or tight-fitting exercise outfit during the test. Mass will be weighed in a water tank by the participant submerging themselves completely underwater while exhaling as much air as possible and remaining underwater for ~2-3 seconds. Five to ten trials will be completed in order to find the most precise measurements, three measured within .1kg will be used in the final body fat estimation. The data collected will be used to determine percent body fat.

Physiological Performance Assessments

Isokinetic Strength Testing
1. Biodex Testing – Three types of strength test measurements may be collected. Isometric strength (against a stationary dynamometer testing arm, 0 degrees/second), Isokinetic concentric strength (pushing the dynamometer testing arm away) at a designated degrees/second, and Isokinetic eccentric strength (controlling the dynamometer testing arm toward the body) at designated degrees/second.
  1. Participants will be allowed to warm-up and practice the motion with a designated percentage of their total strength for each position. After each of the practice sessions, 5 test repetitions (3 second contraction for isometric strength test) will be collected while maximally push against the dynamometer testing arm and the middle 3 repetitions will be used for analyses. A 30 second rest period will be provided between each test trial. Throughout all practice trials and during the test trials participants will be monitored for signs of fatigue or discomfort and will be questioned about their overall wellness. Testing will be discontinued if a participant verbally reports discomfort or fatigue and desires to discontinue testing.
Isotonic Muscular Testing
1. 1RM – Participants will perform a one-repetition maximum (1RM) bench press to measure upper body muscular strength and/or a 1 RM squat to determine lower-body muscular strength. Participants will warm up by completing 5-10 repetitions at 40-60% of estimated 1RM. This will be followed by a 1-minute rest period. Testing administrators will increase weight to 60-80% estimated 1RM, complete 3-5 repetition and then rest 3 minutes. Testing administrators will increase weight conservatively to ~90% estimated 1RM and have subject attempt 1RM. If the lift is successful, participants will wait 3 minutes then attempt the next weight increment. Follow this procedure until the subject fails to complete the lift. Trained personnel will be available to spot and supervise all lifts. Throughout all practice trials and during the test trials participants will be monitored for signs of fatigue or discomfort and will be questioned about their overall wellness. Testing will be discontinued if a participant verbally reports discomfort or fatigue and desires to discontinue testing.
2. Multiple-RM - Participants will perform multiple-repetition maximum bench press test to measure upper body muscular strength and leg press or squat test to measure lower body muscular strength. Subject will select challenging weight to be lifted for <10 repetitions (ideally). A warm-up consisting of 6 repetitions at 50% of the designated selected load, followed by a 3-minute rest. The load will be adjusted to 70% and participants will complete 6 repetitions, and rest 3 minutes. Final warm up set will be completed at 90% of 6 repetitions, followed again by a 3-minute rest. The load will then be adjusted to the predetermined weight, and participants will be asked to complete as many reps as possible. The resulting weight lifted and number of successfully completed full repetitions will account for the participant’s #RM test. Throughout all practice trials and during the test trials participants will be monitored for signs of fatigue or discomfort and will be questioned about their overall wellness. Testing will be discontinued if a participant verbally reports discomfort or fatigue and desires to discontinue testing. Trained personnel will be available to spot and supervise all lifts.
3. Muscular Power - Vertical Jump - From a standing, flat footed position the participant will attempt to jump up in the air as high as possible while tapping a measuring device with their fingers. This test will be repeated 3 to 5 times.
Balance
1. Static Balance - The Balance Error Scoring System (BESS) test is composed of three stances: double leg, single leg, and tandem (heel-to-toe). The participant will complete the three stances for 20 seconds each, first on firm ground and then repeated on a foam pad. Shoes will be removed prior to testing, but socks may be worn. Participants will be instructed to close their eyes and position hands on iliac crests (i.e., hips). In double leg stance, feet must be side by side (touching). In single leg stance, the participant will be instructed to balance on the non-dominant leg (i.e., the opposite of the preferred or natural kicking leg) with the hip flexed to about 30 degrees and knee flexed to about 45 degrees. In tandem stance, the participant will be instructed to place their non-dominant foot behind dominant foot, with the heel of the dominant foot touching the toes of the non-dominant foot. Any errors made will be recorded on the Balance Error Score Card following each of the tests. Errors include removal of hands from the iliac crests, opening of the eyes, any stepping, stumbling, or falling, abduction or flexion of the hip beyond 30 degrees, lifting of the heel or forefoot off of the surface, or remaining out of proper testing position in excess of five (5) seconds. If multiple errors are committed at one time, only one error will be recorded. If the participant is unable to maintain the stance for a minimum of five (5) seconds, maximum error score of 10 for that condition will be recorded.
2. Dynamic Balance - the Star Excursion Balance Test (SEBT). The SEBT evaluates dynamic balance of each leg while measuring maximal reach of the opposite leg. The participant will stand at the center of an eight-line grid, with each line separated by a 45-degree angle (i.e., anterior [forward], anteromedial, medial [side], posteromedial, posterior [behind], posterolateral, lateral [side], and anterolateral). Starting from a neutral position (both feet touching in the center of the grid), the participant will be asked to reach and lightly touch as far as possible for each of the eight lines. After each maximal reach, the participant will return the reach limb back to its original position and rest for 15 seconds before performing the next reach. A research assistant will mark and measure the distance from the center to the maximum excursion (distance) of the reach leg. A total of three trials for each direction and leg will be measured and averaged for data analysis. In a left-leg stance, the participant will begin the reach in the anterior (forward) direction and continue in a clockwise direction ending with the anterolateral direction. In a right-leg stance, the participant will begin to reach in the anterior direction and continue counterclockwise, ending with the anterolateral direction. Trials can be excluded or repeated if the participant uses the reaching leg for any substantial amount of support, remove the stance foot from the center of the grid, lose balance of the support leg, or do not remain in the start and return positions for at least one second.
Flexibility
1. Sit and Reach Test - The participant will sit on the floor with shoes removed and place feet against a Sit and Reach box that is placed against a wall. They then will place one hand on top of the other hand and, in a slow and controlled fashion, lean forward as far as possible and hold for two (2) seconds. A research assistant will measure the furthest distance reached.
2. Trunk Flexibility - This test will require the participant to lie prone on a mat on the floor and place their hands behind their back. The participant will raise their head up as high as possible in a slow and controlled manor. The test will be repeated three (3) times.
3. Knee Flexibility - The participant will lie down on their back (i.e., supine position) with hips and knees flexed to 90 degrees and will be instructed to actively extend the knee while keeping the hips flexed at 90 degrees. A research assistant will place a standard goniometer (i.e., a simple device used to measure joint angles – looks like a large protractor) against the lateral aspect (i.e., outside) of the testing knee and measure the active extension (i.e., how far they can straighten their knee). This test will be performed on both the right and left sides.
4. Shoulder Flexibility - The participant will lie down on their back (i.e., supine position) with hips and knees flexed and then attempt to flex their arm over their head. A research assistant will then measure active flexion by placing the stationary arm of the goniometer in line with the body and the movable arm in line with the humerus (bone of the upper arm). This test will be performed on both the right and left sides.
Muscular Endurance
1. Curl-up test - The participant will perform as many curl-ups as possible in one minute with knees bent and arms extended alongside the body.
2. Push-up or modified push-up test – The participant will perform as many (modified) push-ups as possible in one minute. The push-up test will be performed with toes and palms on the floor maintaining a straight body position. The modified push-up test will be performed with knees and palms on the floor maintaining a straight body position.
Metabolic Testing
1. Resting Metabolic Rate - The resting metabolic rate test (RMR) will be performed while the participant is lying on a padded table for 45 minutes. Oxygen uptake will be measured from expired air collected under a canopy (i.e., clear plastic enclosure similar in size to a beach ball) placed over their head. The canopy will allow unrestricted inhalation and exhalation throughout the entire test. Participants will rest quietly and remain as motionless as possible without fall asleep during the test. Heart rate will be measured through a telemetric heart rate monitor.
2. Submaximal Aerobic Step test – Participants will alternately step up and down on a 33 cm bench for five (5) minutes at a pace of 90 beats per minute. Post stepping heart rate will be measured using a Polar heart rate monitor attached by elastic band at the bottom of the breastbone (i.e., xyphoid process).
3. Maximal Oxygen Consumption (VO2 max) Test - Aerobic fitness will be determined by performing a maximal oxygen consumption test (VO2max) on a treadmill or cycle. To perform this test the participant will begin walking or cycling at a relatively easy workload which will become progressively more difficult every 2-3 minutes (depending on the testing protocol used) until maximal effort is reached. During this test oxygen consumption, rating of perceived exertion and heart rate are measured. Oxygen consumption will be measured using a computer that collects all of the air expelled during the exercise tests. In order to measure oxygen consumption, a mouthpiece attached to a head-gear harness will be used while exercising. Heart rate will be measured through a telemetric heart rate monitor. Rating of perceived exertion will be measured by pointing to a number on a scale.
4. Anaerobic Power - Wingate Lower Body – The participant will perform a maximal cycle test pedaling as fast as possible for 30 second against a resistance equal to 7.5% of the participant’s body mass while remaining in a seated position. The test will be preceded by a 5-minute cycling warm-up with three 5-second sprints against minimal resistance will occur at the top of the second, third, and forth minute. In the last 15 seconds of the warm-up period, the bike’s resistance will be loaded and the participant will then complete the 30-second all-out sprint. Throughout the warm-up and during the test, participants will be monitored for signs of fatigue or discomfort. Testing will be discontinued if a participant verbally reports discomfort or fatigue and desires to discontinue testing.

Body Fluid Collection

Blood
1. Capillary puncture - All blood collection procedures will be performed by trained personnel and will be performed using standard phlebotomy procedures. The amount of blood required per sample is one small drop. Blood samples will be collected using aseptic technique from either a finger or earlobe stick. Blood samples will be collected directly into capillary tubes or a glucose/lactate stick (similar to a glucometer routinely used by diabetic patients).
2. Venipuncture - All blood collection procedures will be performed by trained personnel and will be performed using standard phlebotomy procedures. (The amount of blood required per sample will depend on the biomarkers being measured for each specific study.) Following a 12 hour overnight fast, the participant will be asked to sit quietly for 20 minutes prior to blood being collected. Blood samples will be collected using a needle and aseptic technique. Blood samples will be collected directly into sterile blood collection tubes. The needle will be removed immediately after the blood sample has been collected.
3. Cannula with IV - All blood collection procedures will be performed by trained personnel and will be performed using standard phlebotomy procedures. (The amount of blood required per sample will depend on the biomarkers being measured for each specific study.) Following a 12 hour overnight fast, the participant will be asked to sit quietly for 20 minutes prior to blood being collected. Blood samples will be collected using aseptic technique from an indwelling needle. The needle will be placed in a superficial forearm vein and will remain there for approximately 20 min. To prevent blood from clotting an IV solution of sterile saline (salt water) will continuously flow (at the slowest rate possible) through the needle. Following removal of the sterile saline from the needle, blood samples will be collected with a 10 mL syringe, attached to the needle via a 3-way stop cock, and the IV line will be removed immediately after the last blood sample has been collected. This method allows for several blood samples to be collected with only one needle stick.
4. Cannula without IV - All blood collection procedures will be performed by trained personnel and will be performed using standard phlebotomy procedures. (The amount of blood required per sample will depend on the biomarkers being measured for each specific study.) Following a 12 hour overnight fast, the participant will be asked to sit quietly for 20 minutes prior to blood being collected. Blood samples will be collected using aseptic technique from an indwelling needle. The needle will be placed in a superficial forearm vein and will remain there for approximately 20 min. To prevent blood from clotting a solution of sterile saline (salt water) will be flushed through the needle. Following removal of the sterile saline from the needle, blood samples will be collected with a 10 mL syringe, attached to the indwelling needle, and the extension line will be removed immediately after the blood sample has been collected.
Urine
1. Immediate Measurement - The participant will provide a urine sample that will be immediately measured for urine specific gravity using a handheld refractometer. A urine specific gravity score of 1.020 or less indicates that the participant is in a euhydrated (i.e. normal) state.
2. Stored for Analysis – The participant will provide a urine sample that will be immediately stored for analysis. (Specific analyses depend on the particular study. Examples include potassium, sodium, magnesium, chloride, osmolality, glucose, protein, etc.)
Saliva - The participant will provide a saliva sample by passively drooling into a collection tube after sitting quietly for fifteen (15) minutes. Saliva will be measured for hormones (cortisol, testosterone), immune markers (immunoglobulin A) or enzyme levels (amylase).

Questionnaires

Health History
1. To ensure privacy the participant will complete all forms in a private area. The questionnaires will only be used as a screening tool to determine if the participant possesses any exclusionary criteria that would preclude them from safely participating in the study.
Physical Activity History
1. To ensure privacy the participant will complete all forms in a private area. The questionnaires will only be used as a screening tool to determine if the participant possesses any exclusionary criteria that would preclude them from safely participating in the study.

July 3, 2009, April 7, 2014, November 10, 2023