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Body Surface Cooling MethodsNCT05890261

Cooling During Exercise in the Heat

A study testing Cold water-perfused cooling garment in people with Body Surface Cooling Methods, run by University of Manitoba at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to compare the effectiveness of upper-body surface cooling with whole-body surface cooling on exercise performance while wearing firefighter clothing in the heat. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Body Surface Cooling Methods
What is being tested?
Cold water-perfused cooling garment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteCanada
Study dates
15 May 2023to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-49 years.
  • Meet the criteria on the CSEP Get Active Questionnaire
  • Answer 'no' to questions in the Screening Questionnaire.

Who cannot join

  • Outside the accepted age bracket.
  • Not meeting the criteria on the CSEP Get Active Questionnaire or the Screening Questionnaire.

Trial locations and contacts

1 site in 1 country.

Gordon Giesbrecht, PhD contact

2049956599

gordon.giesbrecht@umanitoba.ca

Canada1 site, 1 recruiting
  • 211 Max Bell Centre, University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

    Gordon Giesbrecht, PhD, 205 474 8646, Gordon.Giesbrecht@ad.umanitoba.ca

    Gordon G Giesbrecht, PhD

    Recruiting

Other trials in Canada

About this study

The goal of this clinical trial is to compare the effectiveness of upper-body surface cooling with whole-body surface cooling on exercise performance while wearing firefighter clothing in the heat. The main question it aims to answer is:

  • which cooling protocol best prevents an increase in core temperature during exercise in the heat?
Read more

Participants will be asked to participate three times in a 60-minute exposure (to 40 degrees C, 40% relative humidity) in which they conduct three work/rest periods including 15 minutes of stepping exercise (20 steps/minute) and 5 minutes of rest. The following three conditions will include:

  • Control: no cooling garments
  • Upper-body cooling: cold water-perfused cooling vest
  • Whole-body cooling: cold water-perfused cooling pants and cooling vest
Read the detailed description

The objectives are to determine thermoregulatory stress (e.g., change in skin and core temperature), physiologic stress (e.g., heart rate and metabolism), cognitive function (Mini-Cog; includes clock drawing and three-word recall), and subjective responses (e.g., thermal comfort, heat sensation, rating of perceived exertion, subjective wetness, breathing comfort) during three conditions while exercising in the heat while wearing thermal protective clothing. The conditions are control (no cooling), upper-body cooling, and whole-body cooling.

Physiologic measures:

Core temperature. Core temperature (°C) will be monitored with e-Celsius, an ingestible pill that continuously monitors, records, and wirelessly transmits core temperature.

Skin temperature. Mean skin temperature (ºC) will be measured with small metal discs (iButton, EDS) taped to the skin at the following 7 sites: forehead, chest, abdomen, upper arm, lower arm, anterior thigh, and anterior calf.

Heart rate and respiration. A Hexoskin shirt will be worn. Sensors in the shirt measure heart rate and chest expansion for breathing indicators.

Metabolism. Subjects will wear a face mask and oxygen consumption, VCO2 and minute ventilation is going to be continuously monitored with a metabolic cart.

Sweat loss. Will be determined from differences in body and clothing weight measured before and after the exercise trials.

Subjective measures:

Every 20 minutes during the exercise test (see below), participants will be asked to rate the following: thermal comfort, heat sensation, rating of perceived exertion (RPE), breathing comfort, and skin wetness.

This will be followed by a test of cognitive function. This involves two components: a three-item recall test and a clock-drawing task. Investigators will ask the subject to repeat three unrelated words (e.g., apple, table, penny) and then will ask them to recall those words after a few minutes. While the subject is trying to recall the words, investigators will ask them to draw a clock face including all of the numbers, and the hands showing a specific time (e.g., 10 minutes past 11). Then the subjects will then be asked to repeat the original 3 words in order.

Cooling procedures:

Cooling will be applied through a liquid-perfused shirt and pants. Each garment has small tubes sewn into the interior of the garment. Cold water (3-8 degrees C) will be perfused through the garments at 5 l/min. The garments will be worn over the Hexoskin shirt and shorts.

Exercise test:

This 60-minute test involves 3 sets of 15 minutes of stepping exercises (20 steps per minute) followed by 5 minutes of sitting rest. During the rest periods, They will be asked to give their subjective evaluations of thermal comfort, heat sensation, rating of perceived exertion, breathing comfort, skin wetness, and cognitive function.

The exercise test will be stopped and the subject will exit the chamber if: the core temperature reaches 39 degrees C; the subject feels light-headed, or nausea; the subject indicates a wish to stop for any reason; or a researcher feels the subject should stop for any reason.

Protocol:

Once subjects have been instrumented they will sit for 10 minutes of baseline measurements in the laboratory (~20 degrees C). They will then enter a climatic chamber (40 degrees C, 40% humidity) and complete the 60-minute exercise/rest protocol. They will then exit the chamber and sit for another 10 minutes of post-exercise measurements.

Being tested
Cold water-perfused cooling garment
Keywords
hyperthermia prevention, liquid-perfused cooling garments, mental performance, physical performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold water-perfused cooling garmentDevice

    Two types of cooling garments will be used. One is a cooling vest and the other includes cooling pants.

Study groups in NCT05890261
Study groupRoleWhat they receive
Young healthy subjectsExperimentalYoung healthy subjects
Receives: Device: Cold water-perfused cooling garment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Core temperature

    Core temperature will be measured with a radio pill that is ingested 2 hours pre-trial.

    Measured: Times 0, 30, 50, 70 and 85 min

Secondary outcomes (1)
  1. Change in Mental performance

    Mini-Cog test for recall and cognition

    Measured: Times 0, 30, 50, 70 and 85 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start15 May 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Repeated measures design
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890261
Sponsor's protocol ID
HE2023-0101
Status last verified
May 2023
First submitted
17 May 2023
Last updated
6 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cold water-perfused cooling garment in people with Body Surface Cooling Methods, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gordon Giesbrecht, PhD (2049956599, gordon.giesbrecht@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Core temperature (time frame: Times 0, 30, 50, 70 and 85 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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