Cryo Pack Cooling After Exercise-induced Hyperthermia

NCT04257266 | Withdrawn FDA Device

• 1 other identifier: H19-168
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (8)

• Change in Rectal Temperature

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (11)

• Profile of Mood States

  Immediately before exercise

• Profile of Mood States

  immediately following exercise

• Profile of Mood States

  immediately following cooling intervention

• Reaction time test

  immediately before exercise

• Reaction time test

  immediately after exercise

Study Arms (2)

Cryo Cooling Pack

EXPERIMENTAL

Cryo cooling pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.

Device: Ice Pack Cooling

Commerical Ice Pack

ACTIVE COMPARATOR

The commercial ice pack will be placed on subjects for 30 mins after exercise-induced hyperthermia is achieved.

Device: Ice Pack Cooling

Interventions

Ice Pack Cooling DEVICE

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

Commerical Ice Pack; Cryo Cooling Pack

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Douglas Casa, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be blinded to which ice pack will be used during the intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants receive two alternative interventions: 1) cryothermic cooling pack and 2) commercially available ice pack.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: February 6, 2020
• Study Start: February 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: July 15, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share