Impact of ICE on Exercise Performance in the Heat

NCT04596618 | Completed

• 1 other identifier: H20-0092
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of intermittent forearm cooling on exercise performance in the heat.

Conditions

Hyperthermia

Outcome Measures

Primary Outcomes (16)

• Change in Rectal Temperature

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

  Measured continuously during the duration of the trial (total 150 minutes)

• Change in Mean Skin Temperature

  4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf)

  Measured continuously during the duration of the trial (total 150 minutes)

• Change in Heart Rate

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

  Measured continuously during the duration of the trial (total 150 minutes)

• Change in Esophageal Temperature

  An esophageal thermometer will be inserted by the researchers to assess participants esophageal temperature.

  Measured continuously during the duration of the trial (total 150 minutes)

• Change in Rating of Perceived Exertion (RPE)

  6-20 scale that indicates how hard the participant feels they are working. 6 represents rest and 20 represents maximal exertion. A high score indicates more perceived exertion.

  Measured every 5 minutes during the duration of the trial (total 150 minutes)

• Change in Thermal Sensation (TS)

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

  Measured every 5 minutes during the duration of the trial (total 150 minutes)

• Change in Perception of Fatigue

  0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).

  Measured every 5 minutes during the duration of the trial (total 150 minutes)

• Change in Perception of Thirst

  0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome.

  Measured every 5 minutes during the duration of the trial (total 150 minutes)

• Environmental Symptoms

  An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.

  Before the start of exercise block 1

• Environmental Symptoms

  An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.

  After completion of the performance battery, at time point 180min.

• Quick-Board Agility

  Agility will be assessed by number of foot taps within 10seconds and then number of hops within 10seconds.

  After the end of 3min cooling period block 6

• Broad Jump

  Participants will attempt to jump as far forward as they can 3 times, measured in centimeters.

  after the quick-board agility, at time point 153minutes

• Grip Strength

  Participants will squeeze a hand held dynamometer 3 times, measured in kilograms

  after the Broad jump test, at time point 155minutes

• Sprints

  On a non-motorized treadmill, participants will sprint for 6sec followed by 24sec of rest, repeat 3 times, belt revolutions will be measured.

  after the grip strength test, at time point 160minutes

• One Mile Timed Trial

  On a motorized treadmill, participants will run at a self-selected pace until they run a distance of 1-mile, time measured in minutes

  after the sprint test, at time point 170minutes

• Metabolic heat production

  Using a metabolic mask and metabolic cart, metabolic heat production will be collected.

  Measured during the last 5 minutes of each exercise block for a total of six measurements for a total of 36minutes.

Study Arms (2)

Forearm Cooling

ACTIVE COMPARATOR

Participants will be actively cooled during rest breaks.

Device: Forearm cooling

No Forearm Cooling

NO INTERVENTION

Participants will participant in "passive cooling" where they sit in a chair during rest.

Interventions

Forearm cooling DEVICE

forearm cooling will be performed for active cooling assessment.

Forearm Cooling

Eligibility Criteria

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

You may qualify if:

• Cisgender male between the ages of 18-30 years
• been cleared by the medical monitor for the study
• 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) 3. Fever or current illness at the time of testing 4. History of cardiovascular, metabolic, or respiratory disease 5. Current musculoskeletal injury that limits their physical activity 6. Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin) 7. Are a female 8. Have a history of heat related illness 9. Have any cold allergies or adverse reactions to the cold (i.e. cold urticaria, Raynaud's, cryoglobulinemia)

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

Gampel Pavilion

Storrs, Connecticut, 06269-1110, 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 Officials

• Douglas Casa, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

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: Professor

Model Details: Participants receive two cooling treatments on separate study visits: 1) passive cooling 2) forearm immersion cooling

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 22, 2020
• Study Start: October 20, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (1)