Cryo Pack Cooling After Exercise-induced Hyperthermia
Primary Purpose
Hyperthermia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ice Pack Cooling
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthermia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cryo Cooling Pack
Commerical Ice Pack
Arm Description
Cryo cooling pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
The commercial ice pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
Outcomes
Primary Outcome Measures
Change in Rectal Temperature
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in Esophageal Temperature
Esophageal thermometer will be inserted by trained personnel to assess core temperature
Change in Heart rate
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Change in Skin Temperature
4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf) during exercise and the cooling intervention
Change in Rating of Perceived Exertion
6-20 scale that indicates how hard the participant feels they are working
Change in Perception of Fatigue
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels
Change in Perception of Thirst
0-9 (no thirst to very,very thirsty) Scale that indicates how thirsty the participant is
Change in Thermal Sensation
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels
Secondary Outcome Measures
Profile of Mood States
Questionnaire that indicates the current mood of the participant
Profile of Mood States
Questionnaire that indicates the current mood of the participant
Profile of Mood States
Questionnaire that indicates the current mood of the participant
Reaction time test
A ruler drop test to test reaction time
Reaction time test
A ruler drop test to test reaction time
Reaction time test
A ruler drop test to test reaction time
Digits Backwards
A test where participants are asked to repeat digits backwards to examine memory
Digits Backwards
A test where participants are asked to repeat digits backwards to examine memory
Digits Backwards
A test where participants are asked to repeat digits backwards to examine memory
1 Mile run
A treadmill test where participants run as fast they can for 1 mile
Grip strength: Hand Grip Dynamometer
Participant will squeeze a hand drip dynamometer (one hand at a time) for 3 trials to estimate grip strength
Full Information
NCT ID
NCT04257266
First Posted
December 10, 2019
Last Updated
September 28, 2021
Sponsor
University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT04257266
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The funding was never received and the study was terminated in the IRB
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants receive two alternative interventions: 1) cryothermic cooling pack and 2) commercially available ice pack.
Masking
Participant
Masking Description
The participant will be blinded to which ice pack will be used during the intervention.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryo Cooling Pack
Arm Type
Experimental
Arm Description
Cryo cooling pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
Arm Title
Commerical Ice Pack
Arm Type
Active Comparator
Arm Description
The commercial ice pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
Intervention Type
Device
Intervention Name(s)
Ice Pack Cooling
Intervention Description
5 ice packs (Cryo cooling pack or commercial ice pack) will be placed on the subject for 30 mins after exercise-induced hyperthermia
Primary Outcome Measure Information:
Title
Change in Rectal Temperature
Description
Rectal thermometer will be self-inserted by participant to assess core temperature
Time Frame
Measured continuously for 2-3 hours during exercise and cooling period
Title
Change in Esophageal Temperature
Description
Esophageal thermometer will be inserted by trained personnel to assess core temperature
Time Frame
Measured continuously for 2-3 hours during exercise and cooling period
Title
Change in Heart rate
Description
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Time Frame
Measured continuously for 2-3 hours during exercise and cooling period
Title
Change in Skin Temperature
Description
4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf) during exercise and the cooling intervention
Time Frame
Measured continuously for 2-3 hours during exercise and cooling period
Title
Change in Rating of Perceived Exertion
Description
6-20 scale that indicates how hard the participant feels they are working
Time Frame
Collected every 5 minutes during 2-3 hour exercise and cool down period.
Title
Change in Perception of Fatigue
Description
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels
Time Frame
Collected every 5 minutes during 2-3 hour exercise and cool down period.
Title
Change in Perception of Thirst
Description
0-9 (no thirst to very,very thirsty) Scale that indicates how thirsty the participant is
Time Frame
Collected every 5 minutes during 2-3 hour exercise and cool down period.
Title
Change in Thermal Sensation
Description
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels
Time Frame
Collected every 5 minutes during 2-3 hour exercise and cool down period.
Secondary Outcome Measure Information:
Title
Profile of Mood States
Description
Questionnaire that indicates the current mood of the participant
Time Frame
Immediately before exercise
Title
Profile of Mood States
Description
Questionnaire that indicates the current mood of the participant
Time Frame
immediately following exercise
Title
Profile of Mood States
Description
Questionnaire that indicates the current mood of the participant
Time Frame
immediately following cooling intervention
Title
Reaction time test
Description
A ruler drop test to test reaction time
Time Frame
immediately before exercise
Title
Reaction time test
Description
A ruler drop test to test reaction time
Time Frame
immediately after exercise
Title
Reaction time test
Description
A ruler drop test to test reaction time
Time Frame
immediately after cooling intervention
Title
Digits Backwards
Description
A test where participants are asked to repeat digits backwards to examine memory
Time Frame
immediately before exercise
Title
Digits Backwards
Description
A test where participants are asked to repeat digits backwards to examine memory
Time Frame
immediately after exercise
Title
Digits Backwards
Description
A test where participants are asked to repeat digits backwards to examine memory
Time Frame
immediately after cooling intervention
Title
1 Mile run
Description
A treadmill test where participants run as fast they can for 1 mile
Time Frame
immediately following Cooling
Title
Grip strength: Hand Grip Dynamometer
Description
Participant will squeeze a hand drip dynamometer (one hand at a time) for 3 trials to estimate grip strength
Time Frame
immediately following cooling
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Casa, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Analyzed and summary data will be shared through publication in a journal article
Learn more about this trial
Cryo Pack Cooling After Exercise-induced Hyperthermia
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