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HyperthermiaNCT04257266

Cryo Pack Cooling After Exercise-induced Hyperthermia

A study testing Ice Pack Cooling in people with Hyperthermia, run by University of Connecticut.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hyperthermia
What is being tested?
Ice Pack Cooling
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Feb 2021to 15 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • Are a female
  • Have a history of heat related illness
  • Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing

About this study

Official title: The Effect of 5-site Ice Pack Cooling on Body Temperature, Skin Temperature, and Heart Rate After Exercise-induced Hyperthermia

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.

Read the 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.

Conditions
Hyperthermia
Being tested
Ice Pack Cooling
Medical subject headings
Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ice Pack CoolingDevice

    5 ice packs (Cryo cooling pack or commercial ice pack) will be placed on the subject for 30 mins after exercise-induced hyperthermia

Study groups in NCT04257266
Study groupRoleWhat they receive
Cryo Cooling PackExperimentalCryo cooling pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
Receives: Device: Ice Pack Cooling
Commerical Ice PackActive comparatorThe commercial ice pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.
Receives: Device: Ice Pack Cooling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Rectal Temperature

    Rectal thermometer will be self-inserted by participant to assess core temperature

    Measured: Measured continuously for 2-3 hours during exercise and cooling period

  2. Change in Esophageal Temperature

    Esophageal thermometer will be inserted by trained personnel to assess core temperature

    Measured: Measured continuously for 2-3 hours during exercise and cooling period

  3. Change in Heart rate

    A heart rate monitor will be worn by participant throughout exercise/cooling protocol

    Measured: Measured continuously for 2-3 hours during exercise and cooling period

  4. Change in Skin Temperature

    4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf) during exercise and the cooling intervention

    Measured: Measured continuously for 2-3 hours during exercise and cooling period

  5. Change in Rating of Perceived Exertion

    6-20 scale that indicates how hard the participant feels they are working

    Measured: Collected every 5 minutes during 2-3 hour exercise and cool down period.

  6. Change in Perception of Fatigue

    0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels

    Measured: Collected every 5 minutes during 2-3 hour exercise and cool down period.

  7. Change in Perception of Thirst

    0-9 (no thirst to very,very thirsty) Scale that indicates how thirsty the participant is

    Measured: Collected every 5 minutes during 2-3 hour exercise and cool down period.

  8. Change in Thermal Sensation

    0-8 Scale (cold to hot) that indicated how cold or hot the participate feels

    Measured: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Secondary outcomes (11)
  1. Profile of Mood States

    Questionnaire that indicates the current mood of the participant

    Measured: Immediately before exercise

  2. Profile of Mood States

    Questionnaire that indicates the current mood of the participant

    Measured: immediately following exercise

  3. Profile of Mood States

    Questionnaire that indicates the current mood of the participant

    Measured: immediately following cooling intervention

  4. Reaction time test

    A ruler drop test to test reaction time

    Measured: immediately before exercise

  5. Reaction time test

    A ruler drop test to test reaction time

    Measured: immediately after exercise

  6. Reaction time test

    A ruler drop test to test reaction time

    Measured: immediately after cooling intervention

  7. Digits Backwards

    A test where participants are asked to repeat digits backwards to examine memory

    Measured: immediately before exercise

  8. Digits Backwards

    A test where participants are asked to repeat digits backwards to examine memory

    Measured: immediately after exercise

  9. Digits Backwards

    A test where participants are asked to repeat digits backwards to examine memory

    Measured: immediately after cooling intervention

  10. 1 Mile run

    A treadmill test where participants run as fast they can for 1 mile

    Measured: immediately following Cooling

  11. Grip strength: Hand Grip Dynamometer

    Participant will squeeze a hand drip dynamometer (one hand at a time) for 3 trials to estimate grip strength

    Measured: immediately following cooling

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start1 Feb 2021
  3. Primary completion15 May 2021
  4. Study completion15 Jul 2021

Why it stopped: The funding was never received and the study was terminated in the IRB

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Participants receive two alternative interventions: 1) cryothermic cooling pack and 2) commercially available ice pack.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04257266
Sponsor's protocol ID
H19-168
Status last verified
Sep 2021
First submitted
10 Dec 2019
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Analyzed and summary data will be shared through publication in a journal article

Questions about this trial

What is this clinical trial studying?

A study testing Ice Pack Cooling in people with Hyperthermia, run by University of Connecticut.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Rectal Temperature (time frame: Measured continuously for 2-3 hours during exercise and cooling period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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