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.
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.
Canada1 site, 1 recruiting
- 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
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.
- Conditions
- Body Surface Cooling Methods
- 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 group | Role | What they receive |
|---|---|---|
| Young healthy subjects | Experimental | Young 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.
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)
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.
- First posted6 Jun 2023
- Study start15 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Surface Cooling MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon Giesbrecht, PhD, Principal investigator, University of Manitoba
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooling During Exercise in the Heat
- ClinicalTrials.gov ID
- NCT05890261
- Acronym / sponsor ID
- HE2023-0101
- Conditions
- Body Surface Cooling Methods
- Keywords
- hyperthermia prevention, liquid-perfused cooling garments, mental performance, physical performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Young healthy subjects | Experimental | Device: Cold water-perfused cooling garmentYoung healthy subjects |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-49 years.
- Meet the criteria on the CSEP Get Active Questionnaire
- Answer 'no' to questions in the Screening Questionnaire.
Key exclusion criteria (2 listed)
- Outside the accepted age bracket.
- Not meeting the criteria on the CSEP Get Active Questionnaire or the Screening Questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water-perfused cooling garmentTwo types of cooling garments will be used. One is a cooling vest and the other includes cooling pants. | Device | Young healthy subjects |
Primary outcome
Change in Core temperature
Time frame: Times 0, 30, 50, 70 and 85 min
Core temperature will be measured with a radio pill that is ingested 2 hours pre-trial.
1 secondary outcome
Change in Mental performance
Time frame: Times 0, 30, 50, 70 and 85 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Giesbrecht, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
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.