Clinical trial NCT04257266: Cryo Pack Cooling After Exercise-induced Hyperthermia
Official title: The Effect of 5-site Ice Pack Cooling on Body Temperature, Skin Temperature, and Heart Rate After Exercise-induced Hyperthermia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyperthermia
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants receive two alternative interventions: 1) cryothermic cooling pack and 2) commercially available ice pack.
Primary purpose: TREATMENT

Brief summary: This research study aims to examine whether Cryo Cooling packs reduce thermal and cardiovascular strain after exercise-induced hyperthermia compared to a commercially available ice pack. Secondly, the effect of Cryo Cooling packs on cognitive and exercise performance will be examined. There is no current research examining the efficacy of Cryo Cooling packs in hyperthermic individuals and this information will be helpful to establish whether Cryo Cooling Packs can be used for performance enhancement or to prevent heat illness.

Detailed description: This study will consist of three study visits:

Visit 1: Baseline and VO2max Testing Visit 2-3: Trial 1 and 2.

Visit 1: Baseline and VO2max Testing

Participants who are approved to participate will be scheduled for a baseline and VO2max testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be recorded. Privacy will be afforded for each participant while obtaining body mass measures by taking measurements with the participant alone in a private room behind a solid, closed door, and the research reading the scale outside of the room. Participants will only be permitted to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG) ≤1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Height will be measured with a tape measure on Visit 1. Percent body fat will be calculated using a 3-site evaluation of skin fold thickness using skin fold calipers on one of the three baseline days. A researcher will use appropriate grasping technique to measure skin fold thickness on the chest, abdomen, and thigh. This will take less than \~5 minutes to complete. This information will be used to describe the subject demographics. Participants will also be asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral environment. This test will provide aerobic fitness levels of the participants.

Visit 2-3: Trials 1 and 2

This is a randomized, counter-balanced, cross over design. Participant numbers will be randomly assigned and trials will be ordered with a random number generator and assigned to a participant number. These orders will be counterbalanced between participants to ensure that there is not an order effect, and each participant will complete both trials as part of the study. Participants will be allowed to make-up trial visits if they are sick, suffer an injury or do not meet hydration requirements. Participants will be asked if they have a current illness or taking medications to determine whether they can complete the exercise trial. The participant's visit will be rescheduled if they have a fever, current illness or taking medications that influence body temperature.

Cooling Intervention:

1. Ice Pack Cooling
2. Commercially Available Ice Pack

The exercise protocol, performance testing, cognitive testing, and recovery portions of this study will be conducted in a climatic chamber with ambient temperature approximately 30-40°C and relative humidity at approximately 30-70%.

Upon arrival to the lab, participants will be asked to indicate if they have consumed alcohol or caffeine in the last 24 hours. They will not be asked to specify exactly what they have consumed, but if they provide a positive indication, their trial will be rescheduled for another day. Participants will provide a small urine sample in a clean urine cup, and a nude body mass will be measured. Upon arrival to the lab, hydration status will be assessed by urine specific gravity, nude body mass and urine color. Participants will only be permitted to continue to the exercise trial if the euhydrated criteria of a urine specific gravity (USG) ≤ 1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Participants will be given instructions at the prior visit about how to obtain desired hydration status for the upcoming trial. Key study personnel will insert an esophageal probe to measure esophageal temperature. Participants will then insert a rectal probe and wear a heart rate monitor strap. Additionally, participants will wear 4-site skin temperature sensors. The participants will also be asked to complete a subjective sleep questionnaire upon arriving to the lab. All perceptual measures, cognitive performance measures and physical performance tests will be administered to determine a baseline value at the beginning of each trial.

All participants will undergo a treadmill protocol involving approximately 90 minutes of jogging or walking. Cognitive and physical performance tests will be administered at various time points throughout the trial.

After exercise, participants will be cooled by either 5 cryothermic ice packs or 5 commercially available ice packs. Participants will be cooled for approximately 30 mins. All participants will be laying supine during cooling.

Cryothermic Cooling and Commercially Available Ice Pack Placement

Storage and Preparation:

Ice packs will be stored in a cooler at approximately 34°F for at least 6 hours prior to use and kept as dry as possible (35°F to 70°F). Ideally, Ice packs will be kept in tray or basket above ice or frozen gel packs, not in contact with the method of cooling the cooler. Refrigerator may be acceptable for storage before cooler use as well, but prefer cooler for real situations in field.

For cryo cooling elements: the cryo cooling packs will be shaken quickly and vigorously (10 seconds) and placed on subject (subject will be supine).

For commercially available ice pack: ice packs will be placed on subject (subject will be supine).

All ice packs will be placed on the following body segments:

* 1 ice pack on neck covering both carotid Triangle regions
* 2 ice packs in axilla region
* 2 ice packs in groin region

Cryo Cooling Elements and commercially available ice packs will be discarded after use.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-30 years
* been cleared by the medical monitor for this study

Exclusion Criteria:

* Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
* Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally)
* Fever or current illness at the time of testing
* History of cardiovascular, metabolic, or respiratory disease
* Current musculoskeletal injury that limits their physical activity
* Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
* Are a female
* Have a history of heat related illness
* Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing

Primary outcomes:
measure: Change in Rectal Temperature
timeFrame: Measured continuously for 2-3 hours during exercise and cooling period
measure: Change in Esophageal Temperature
timeFrame: Measured continuously for 2-3 hours during exercise and cooling period
measure: Change in Heart rate
timeFrame: Measured continuously for 2-3 hours during exercise and cooling period
measure: Change in Skin Temperature
timeFrame: Measured continuously for 2-3 hours during exercise and cooling period
measure: Change in Rating of Perceived Exertion
timeFrame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
measure: Change in Perception of Fatigue
timeFrame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
measure: Change in Perception of Thirst
timeFrame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
measure: Change in Thermal Sensation
timeFrame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
Secondary outcomes:
measure: Profile of Mood States
timeFrame: Immediately before exercise
measure: Profile of Mood States
timeFrame: immediately following exercise
measure: Profile of Mood States
timeFrame: immediately following cooling intervention
measure: Reaction time test
timeFrame: immediately before exercise
measure: Reaction time test
timeFrame: immediately after exercise
measure: Reaction time test
timeFrame: immediately after cooling intervention
measure: Digits Backwards
timeFrame: immediately before exercise
measure: Digits Backwards
timeFrame: immediately after exercise
measure: Digits Backwards
timeFrame: immediately after cooling intervention
measure: 1 Mile run
timeFrame: immediately following Cooling
measure: Grip strength: Hand Grip Dynamometer
timeFrame: immediately following cooling
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut
name: Douglas Casa, PhD
role: PRINCIPAL_INVESTIGATOR
References: