Impact of Neck Cooling Collar on Exercise Performance in the Heat

NCT05135117 | Completed

• 1 other identifier: H21-0053
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (1)

• Esophageal Temperature Change

  Esophageal Temperature Change

  Up to 4 weeks

Secondary Outcomes (15)

• Rectal Temperature Change

  Up to 4 weeks

• Heart Rate Change

  Up to 4 weeks

• Performance Test Change

  Up to 4 weeks

• Performance Test Change

  Up to 4 weeks

• Performance Test Change

  Up to 4 weeks

Study Arms (3)

Control

NO INTERVENTION

Passive rest - no intervention provided

Ice towel cooling

ACTIVE COMPARATOR

About 6-12 cooling periods of ice towel lasting between 5-20 minutes will be done and equally distributed throughout the respective trials. Towels dipped in ice water will be placed on subjects necks during this time.

Other: Ice Towel

NeuroRescue Neck Cooling Collar

EXPERIMENTAL

About 6-12 cooling periods of neck cooling with the NeuroRescue collar lasting between 5-20 minutes will be done and equally distributed throughout the respective trials.

Other: NeuroRescue Cooling Collar

Interventions

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.

NeuroRescue Neck Cooling Collar

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.

Ice towel cooling

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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)
• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• NeuroRescue Inc.: collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigaator

Model Details: Crossover assignment

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: November 26, 2021
• Study Start: August 31, 2021
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)