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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Withdrawn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
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperthermia

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    December 10, 2019
    Last Updated
    September 28, 2021
    Sponsor
    University of Connecticut
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    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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