- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670339
Effect of Pre-cooling on Whole-body Heat Loss During Exercise-heat Stress
June 13, 2025 updated by: Glen P. Kenny, University of Ottawa
Effect of Pre-cooling the Body on Whole-body Heat Exchange in Young Males During Exercise in the Heat
Endurance exercise performance declines in hot environments as core body temperature increases.
To enhance performance, body pre-cooling strategies, such as cold-water immersion have been employed to lower resting core temperature thereby increasing the body's heat storage capacity.
In turn, the increase in body core temperature associated with exercise in the heat is blunted, allowing the individual to exercise at higher intensity and or for a longer period of time.
However, the mechanisms by which pre-cooling impacts heat exchange during exercise remain unclear.
While existing research has focused on the performance benefits of pre-cooling the body, relatively little is known about the impacts of pre-cooling on whole-body heat exchange during an exercise-heat stress.
Investigators will therefore evaluate whole-body heat exchange (dry ± evaporative heat loss as assessed using a direct air calorimeter) during a prolonged (1-hour) moderate-intensity cycling bout in the heat (wet-bulb globe temperature of 29°C; equivalent to 37.5°C, 35% relative humidity) performed with and without pre-cooling by cool-water (~17°C) immersion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy young males (18-30 years)
- Non-smoking
- English or French speaking
- Ability to provide informed consent
Exclusion Criteria:
- Presence of chronic diseases (e.g., hypertension, diabetes)
- Acute illness (e.g., flu, COVID-19)
- Physical restriction limiting physical activity
- Use of medication judged by the patient or investigators to make participation in this study inadvisable.
- Sedentary
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: No Cooling
Participants will complete 60 min of continuous semi-recumbent cycling at a fixed metabolic heat load (200 W/m2) in the heat (wet-bulb globe temperature of 29°C; 37.5°C and 35% relative humidity) (Control condition) without pre-cooling.
|
Participants will not be pre-cooled prior to completing a 60-minute moderate-intensity exercise bout in the heat.
|
|
Experimental: Pre-Cooling
Participants will undergo a cold-water immersion (~17°C) to elicit a decrease in rectal temperature by 0.5°C from baseline values.
Thereafter, once the target temperature is achieved, participants will complete 60 min of continuous moderate-intensity cycling (200 W/m2) in the heat (wet-bulb globe temperature of 29°C; 37.5°C and 35% relative humidity).
|
Participants will be immersed in cold (~17°C) water to elicit a decrease in rectal temperature by 0.5°C from baseline values prior to completing a 60-min moderate-intensity exercise bout in the heat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaporative heat loss at end exercise
Time Frame: Final 15 minutes of the 60 minutes exercise bout
|
Evaporative heat loss as assessed using a direct air calorimeter
|
Final 15 minutes of the 60 minutes exercise bout
|
|
Dry heat loss at end exercise
Time Frame: Final 15 minutes of the 60 minutes exercise bout
|
Total dry heat loss as assessed using a direct air calorimeter
|
Final 15 minutes of the 60 minutes exercise bout
|
|
Total heal loss at end exercise
Time Frame: Final 15 minutes of the 60 minutes exercise bout
|
Net heat loss (dry plus/minus evaporative heat exchange) as assessed using a direct air calorimeter
|
Final 15 minutes of the 60 minutes exercise bout
|
|
Body heat storage during the 60-minute exercise bout
Time Frame: Over the 60 minute exercise bout
|
Change in body heat storage (i.e., amount of heat stored in the body) calculated as the temporal summation of metabolic heat production and total heat loss
|
Over the 60 minute exercise bout
|
|
Core temperature at end of exercise
Time Frame: Final 15 minutes of exercise
|
Rectal temperature during final 15 minutes of exercise.
Rectal temperature is measured continuously throughout the intervention.
|
Final 15 minutes of exercise
|
|
Relative change in core temperature at end of exercise
Time Frame: Change over the 60-minute exercise bout
|
Change in rectal temperature from baseline resting.
|
Change over the 60-minute exercise bout
|
|
Heart rate at end exercise
Time Frame: Final 15 minutes of exercise
|
Heart rate during final 15 minutes of exercise.
Rectal temperature is measured continuously throughout the intervention.
|
Final 15 minutes of exercise
|
|
Mean skin temperature at end of exercise
Time Frame: Final 15 minutes of exercise
|
Skin temperature measured continuously at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - upper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%
|
Final 15 minutes of exercise
|
|
Relative change in skin temperature at end of exercise
Time Frame: Change over the 60-minute exercise bout
|
Change in skin temperature from baseline resting as assessed at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - uper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%
|
Change over the 60-minute exercise bout
|
|
Thermal sensation A at end exercise
Time Frame: Final 15 minutes of exercise
|
Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; -3: cold to +3: hot)
|
Final 15 minutes of exercise
|
|
Thermal sensation B at end exercise
Time Frame: Final 15 minutes of exercise
|
Thermal sensation assessed via a self-report questionnaire upon verbal prompting (7-point scale; 0: neutral to 7: extremely hot)
|
Final 15 minutes of exercise
|
|
Thermal comfort at end exercise
Time Frame: Final 15 minutes of exercise
|
Thermal comfort assessed via a self-report questionnaire upon verbal prompting (4-point scale; 1: comfortable to 4: very uncomfortable)
|
Final 15 minutes of exercise
|
|
Thirst sensation at end exercise
Time Frame: Final 15 minutes of exercise
|
Thirst sensation assessed via a self-report questionnaire upon verbal prompting (9-point scale; 1: not thirsty at all to 9: very, very thirsty)
|
Final 15 minutes of exercise
|
|
Rating of perceived exertion
Time Frame: Final 15 minutes of exercise
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion)
|
Final 15 minutes of exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability at end of exercise
Time Frame: Final 15 minutes of exercise
|
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains (R-R interval data extracted from the electrocardiogram).
Measured continuously using a holter monitor with Zymed placement
|
Final 15 minutes of exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glen P Kenny, PhD, University of Ottawa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2024
Primary Completion (Actual)
February 27, 2025
Study Completion (Actual)
February 27, 2025
Study Registration Dates
First Submitted
October 28, 2024
First Submitted That Met QC Criteria
October 30, 2024
First Posted (Actual)
November 1, 2024
Study Record Updates
Last Update Posted (Actual)
June 17, 2025
Last Update Submitted That Met QC Criteria
June 13, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU-2024-08-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified participant data will be made available with approved analysis plan and signed access agreement
IPD Sharing Time Frame
Following publication of the main study report(s)
IPD Sharing Access Criteria
Approved analysis plan and signed access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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