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Completed

NCT Number: NCT05135117

Impact of Neck Cooling Collar on Exercise Performance in the Heat

During exercise in the heat, the thermoregulatory system impacts performance in an athletic population. Increased in core body temperature could lead to development of heat-related illnesses and impair physical performance. To facilitate heat loss and optimize performance during exercise in the heat, various cooling strategies, including cold water immersion and wearable cooling devices have been previously explored. Although whole body cooling by cold water immersion is considered to be the most effective way to reduce core body temperature, this cooling method would not be feasible for athletes during practice or competition. Therefore, previous studies strongly recommended neck cooling during exercise because of the rate of heat dissipation through the large blood vessel and accessibility compared to other body part. Furthermore, multiple studies reported that the neck cooling could improve aerobic performance (i.e. running distance and time). In addition to physiological changes, human prefer to be cool in the neck region as well as the face in hot environment. Thus, local cooling of the neck is efficient way to reduce thermal discomfort during heat exposure. The novel neck cooling collar device (NeuroRescue Inc., Lafayette, LA) used in the current study may be able to produce powerful effect of conductive cooling, which result in improving performance and also reduce thermal discomfort during exercise in the heat.

While this neck cooling collar would assist athletes in improving sports safety and performance by decreasing skin temperature around the neck, the effectiveness of this neck cooling collar on core temperature was not examined at this point. Moreover, other physiological and perceptual changes are important to assess along with changes in core body temperature. Therefore, this study aims to examine how internal body temperature, heart rate, perceptual measures, and athletic performance are affected by the novel neck cooling collar during exercise in the heat.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physically active (at least 30 minutes of exercise 3-5 days per week) male
  • been cleared by the medical monitor for this study
  • Have a VO2max >45ml/kg/min

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
  • A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50
  • 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. Due to the internal body temperature gradient that accompanies the menstrual cycle, inclusion of females may not provide the most controlled internal body temperature data for this study.
  • Have a history of heat related illness
  • Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing
  • Have any allergies or adverse reactions to the cold (e.g. Cold Urticaria, Raynauds Phenomenon/Disease, or cryoglobulinaemia)
  • Any COVID-19 related symptoms including fever, cough, shortness of breath or difficulty breathing, gastrointestinal discomfort (nausea, vomiting, and/or diarrhea), repeated shaking with chills, muscle pain (unrelated to exercise), headache, sore throat, new loss of taste or smell, congestion or runny nose.
  • Participant with clinical diagnosis of COVID-19 infection or positive result on a COVID-19 test due to concern about cardiac complications.

Treatment and study plan

NeuroRescue Cooling Collar

Other

Between bouts of exercise subjects will be provided cooling on the neck with the NeuroRescue Collar. The custom sized cooling collar has ice water (which is kept around 2 degrees celsius) that is circulated through a neoprene sleeve that is attached to their neck for the cooling period.

Ice Towel

Other

Between bouts of exercise subjects will be provided cooling on the neck with a towel. The towel will be kept in ice water (which is kept around 2 degrees celsius) and placed around the neck of the individual during the cooling intervention period.

Primary outcomes

  1. Esophageal Temperature Change

    Time frame: Up to 4 weeks

    Esophageal Temperature Change

Secondary outcomes

  1. Rectal Temperature Change

    Time frame: Up to 4 weeks

    Rectal Temperature Change

  2. Heart Rate Change

    Time frame: Up to 4 weeks

    Heart rate as beats per minute Change

  3. Performance Test Change

    Time frame: Up to 4 weeks

    Reaction Time Test

  4. Performance Test Change

    Time frame: Up to 4 weeks

    Broad jump

  5. Performance Test Change

    Time frame: Up to 4 weeks

    Agility test

  6. Performance Test Change

    Time frame: Up to 4 weeks

    15-min time trial

  7. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)

  8. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)

  9. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)

  10. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)

  11. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)

  12. Perceptual Scale Change

    Time frame: Up to 4 weeks

    Profile of mood states (0-260, 0 indicates lower mood disturbance)

  13. Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System

    Time frame: Up to 4 weeks

    Go/No Go (0-infinity, lower number indicates faster and more accurate response)

  14. Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System

    Time frame: Up to 4 weeks

    Spatial Processing (0-infinity, lower number indicates faster and more accurate response)

  15. Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System

    Time frame: Up to 4 weeks

    Stroop (0-infinity, lower number indicates faster and more accurate response)

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • NeuroRescue Inc.

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2021
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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