Comparison of Bi-environmental Conditions During Occupational Related Activity

NCT05059730 | Completed

• 1 other identifier: H19-169
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and cold. Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and cold. Multiple cold ambient temperatures will be validated.

Conditions

Hyperthermia; Hypothermia

Outcome Measures

Primary Outcomes (7)

• Change in Rectal Temperature

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

  Measured continuously for rest block (1.5-2.5 hours) and exercise 2 hour).

• Change in esophageal temperature

  Esophageal thermometer will be inserted by researchers to assess core temperature

  Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).

• Change in Mean Skin temperature

  14 sites with Biopac sensors and 4 sites with iButtonsResearchers will apply the skin temperature sensors with medical tape to the participants' finger tip and base of finger, hand dorsum, forearm, thigh, calf, feet dorsum, big toe, nose, cheek, ear tip, chin, and forehead. The participant will also be instrumented with 4 iButton skin temp sensors (thigh, calf, chest, shoulder).

  Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).

• Change in Heart rate

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

  Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).

• Change in Blood Flow

  Blood flow will be measured using a portable Triplex ultrasound device using Doppler imaging (GE Logiq E, Soma Technology, Bloomfield, CT). Measurements will be taken at 6 predetermined locations (brachial, radial, ulnar, femoral, anterior tibial, and posterior tibial arteries) at distinct anatomical sites

  Measured 3 data collection points(every 10-15 min) every following each exercise block for all three exercise blocks (total of 3 recovery time points)

• Change in Blood Lactate

  a finger stick blood sample equivalent to 1 drop of blood (0.7μ1) will be taken to analyze lactate concentration with a portable analyzer at baseline, at predetermined intervals during exercise, and once during the post-exercise rest periods.

  Collected every 10 mins during last exercise block (exercise block 3) and post-exercise block (total for 4 time points)

• Change in Rating of Perceived Exertion

  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 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).

Secondary Outcomes (5)

• Oxygen saturation

  Measured 3 data collection points(every 10-15 min) every following each exercise block for all three exercise blocks (total of 3 recovery time points)

• Heart rate variability

  Measured continuously for rest block (1.5-2.5 hours) and exercise (1 hour).

• Change in Thermal Sensation

  Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).

• Change in Perception of Fatigue

  Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).

• Change in Perception of Thirst

  Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).

Study Arms (3)

Men

ACTIVE COMPARATOR

Men will belong to one arm

Other: Zero Degrees Cold Environment; Other: Eight Degrees Cold Environment; Other: Ten Degrees Cold Environment; Other: 40 degrees Hot Environment

Women (follicular phase)

ACTIVE COMPARATOR

Women will be allocated in this group during the follicular phase of their menstrual cycle.

Other: Zero Degrees Cold Environment; Other: 40 degrees Hot Environment

women (luteal phase)

ACTIVE COMPARATOR

Women will be allocated in this group during the luteal phase of their menstrual cycle.

Other: Zero Degrees Cold Environment; Other: 40 degrees Hot Environment

Interventions

Zero Degrees Cold Environment OTHER

Participants will be exposed to zero degrees celsius environment.

Men; Women (follicular phase); women (luteal phase)

Eight Degrees Cold Environment OTHER

Participants will be exposed to eight degrees celsius environment.

Men

Ten Degrees Cold Environment OTHER

Participants will be exposed to Ten degrees celsius environment.

Men

40 degrees Hot Environment OTHER

Participants will be exposed to 40 degrees celsius hot environment.

Men; Women (follicular phase); women (luteal phase)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 18-28 years
• been cleared by the medical monitor for this study
• Must perform aerobic exercise for 150 minutes per week.

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, respiratory disease, peripheral arterial disease, or coagulopathy
• Current musculoskeletal injury that limits their physical activity
• Currently taking a medication that is known to influence body temperature or blood flow (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin, vasoactive medications)
• Have a history of heat related illness
• Have a history of cold urticaria (i.e. allergy to the cold) and/or Raynaud's phenomenon \[disorder that causes decreased blood flow to peripheral body parts (e.g. fingers and toes)\]
• Currently smoking (cigarettes, vaporizers, e-cigarettes)

Sponsors & Collaborators

• University of Connecticut: lead
• BHSAI: collaborator
• Harvard-NIOSH Education and Research Center (ERC): collaborator

Study Sites (1)

Korey Stringer Institute, University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Hyperthermia; Hypothermia

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: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: men are exposed to four conditions (3 cold conditions at 0, 8, 10C and 40C heat) women are exposed to four conditions (2 cold conditions- follicular and luteal phase; 2 heat conditions follicular and luteal phase)

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: September 28, 2021
• Study Start: April 2, 2021
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)