- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257266
Cryo Pack Cooling After Exercise-induced Hyperthermia
The Effect of 5-site Ice Pack Cooling on Body Temperature, Skin Temperature, and Heart Rate After Exercise-induced Hyperthermia
Study Overview
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:
- Ice Pack Cooling
- 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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryo Cooling Pack
Cryo cooling pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
|
5 ice packs (Cryo cooling pack or commercial ice pack) will be placed on the subject for 30 mins after exercise-induced hyperthermia
|
Active Comparator: Commerical Ice Pack
The commercial ice pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
|
5 ice packs (Cryo cooling pack or commercial ice pack) will be placed on the subject for 30 mins after exercise-induced hyperthermia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Rectal Temperature
Time Frame: Measured continuously for 2-3 hours during exercise and cooling period
|
Rectal thermometer will be self-inserted by participant to assess core temperature
|
Measured continuously for 2-3 hours during exercise and cooling period
|
Change in Esophageal Temperature
Time Frame: Measured continuously for 2-3 hours during exercise and cooling period
|
Esophageal thermometer will be inserted by trained personnel to assess core temperature
|
Measured continuously for 2-3 hours during exercise and cooling period
|
Change in Heart rate
Time Frame: Measured continuously for 2-3 hours during exercise and cooling period
|
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
|
Measured continuously for 2-3 hours during exercise and cooling period
|
Change in Skin Temperature
Time Frame: Measured continuously for 2-3 hours during exercise and cooling period
|
4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf) during exercise and the cooling intervention
|
Measured continuously for 2-3 hours during exercise and cooling period
|
Change in Rating of Perceived Exertion
Time Frame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
6-20 scale that indicates how hard the participant feels they are working
|
Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
Change in Perception of Fatigue
Time Frame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels
|
Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
Change in Perception of Thirst
Time Frame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
0-9 (no thirst to very,very thirsty) Scale that indicates how thirsty the participant is
|
Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
Change in Thermal Sensation
Time Frame: Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels
|
Collected every 5 minutes during 2-3 hour exercise and cool down period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of Mood States
Time Frame: Immediately before exercise
|
Questionnaire that indicates the current mood of the participant
|
Immediately before exercise
|
Profile of Mood States
Time Frame: immediately following exercise
|
Questionnaire that indicates the current mood of the participant
|
immediately following exercise
|
Profile of Mood States
Time Frame: immediately following cooling intervention
|
Questionnaire that indicates the current mood of the participant
|
immediately following cooling intervention
|
Reaction time test
Time Frame: immediately before exercise
|
A ruler drop test to test reaction time
|
immediately before exercise
|
Reaction time test
Time Frame: immediately after exercise
|
A ruler drop test to test reaction time
|
immediately after exercise
|
Reaction time test
Time Frame: immediately after cooling intervention
|
A ruler drop test to test reaction time
|
immediately after cooling intervention
|
Digits Backwards
Time Frame: immediately before exercise
|
A test where participants are asked to repeat digits backwards to examine memory
|
immediately before exercise
|
Digits Backwards
Time Frame: immediately after exercise
|
A test where participants are asked to repeat digits backwards to examine memory
|
immediately after exercise
|
Digits Backwards
Time Frame: immediately after cooling intervention
|
A test where participants are asked to repeat digits backwards to examine memory
|
immediately after cooling intervention
|
1 Mile run
Time Frame: immediately following Cooling
|
A treadmill test where participants run as fast they can for 1 mile
|
immediately following Cooling
|
Grip strength: Hand Grip Dynamometer
Time Frame: immediately following cooling
|
Participant will squeeze a hand drip dynamometer (one hand at a time) for 3 trials to estimate grip strength
|
immediately following cooling
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19-168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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