Impact of Neck Cooling Collar on Exercise Performance in the Heat

Hyperthermia Clinical Trial

Official title:

Impact of Neck Cooling Collar on Exercise Performance in the Heat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135117
• Other study ID #: H21-0053
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: February 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Physically active (at least 30 minutes of exercise 3-5 days per week) male

2. been cleared by the medical monitor for this study

3. Have a VO2max >45ml/kg/min

Exclusion Criteria:

1. Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.

2. Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally)

3. Fever or current illness at the time of testing

4. History of cardiovascular, metabolic, or respiratory disease

5. A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50

6. Current musculoskeletal injury that limits their physical activity

7. Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)

8. 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.

9. Have a history of heat related illness

10. Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing

11. Have any allergies or adverse reactions to the cold (e.g. Cold Urticaria, Raynauds Phenomenon/Disease, or cryoglobulinaemia)

12. 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.

13. Participant with clinical diagnosis of COVID-19 infection or positive result on a COVID-19 test due to concern about cardiac complications.

Related Conditions & MeSH terms

• Hyperthermia

Intervention

Other:
• NeuroRescue Cooling Collar
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
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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	NeuroRescue Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal Temperature Change	Esophageal Temperature Change	Up to 4 weeks
Secondary	Rectal Temperature Change	Rectal Temperature Change	Up to 4 weeks
Secondary	Heart Rate Change	Heart rate as beats per minute Change	Up to 4 weeks
Secondary	Performance Test Change	Reaction Time Test	Up to 4 weeks
Secondary	Performance Test Change	Broad jump	Up to 4 weeks
Secondary	Performance Test Change	Agility test	Up to 4 weeks
Secondary	Performance Test Change	15-min time trial	Up to 4 weeks
Secondary	Perceptual Scale Change	Rating of Perceived Exertion (6-20, lower exertion indicated by lower number)	Up to 4 weeks
Secondary	Perceptual Scale Change	Thermal Sensation Scale (0-8, lower number indicates cooler, higher number indicates hotter sensations)	Up to 4 weeks
Secondary	Perceptual Scale Change	Thirst Scale (1-9, 1 indicates not thirst, 9 indicates very very thirsty)	Up to 4 weeks
Secondary	Perceptual Scale Change	Fatigue Scale (0-10, 0 indicates no fatigue, 10 indicates extreme fatigue)	Up to 4 weeks
Secondary	Perceptual Scale Change	Environmental Symptoms questionnaire (0-70, 0 indicates no heat stress)	Up to 4 weeks
Secondary	Perceptual Scale Change	Profile of mood states (0-260, 0 indicates lower mood disturbance)	Up to 4 weeks
Secondary	Cognitive Functioning Change - Automated Neuropsychological Assessment Metrics (ANAM) Test System	Go/No Go (0-infinity, lower number indicates faster and more accurate response)	Up to 4 weeks
Secondary	Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System	Spatial Processing (0-infinity, lower number indicates faster and more accurate response)	Up to 4 weeks
Secondary	Cognitive Functioning Change- Automated Neuropsychological Assessment Metrics (ANAM) Test System	Stroop (0-infinity, lower number indicates faster and more accurate response)	Up to 4 weeks