NCT06670339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

October 28, 2024

Last Update Submit

June 13, 2025

Conditions

Keywords

Cold StressHeat StressHeat DissipationPhysical ActivityPerformanceAthletesWorkers

Outcome Measures

Primary Outcomes (14)

  • Evaporative heat loss at end exercise

    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

    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

    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

    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

    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

    Change in rectal temperature from baseline resting.

    Change over the 60-minute exercise bout

  • Heart rate at end 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

    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

    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

    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

    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

    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

    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

    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 Outcomes (1)

  • Heart rate variability at end of exercise

    Final 15 minutes of exercise

Study Arms (2)

No Cooling

ACTIVE COMPARATOR

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.

Other: No Cooling

Pre-Cooling

EXPERIMENTAL

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).

Other: Pre-Cooling

Interventions

Participants will not be pre-cooled prior to completing a 60-minute moderate-intensity exercise bout in the heat.

No Cooling

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.

Pre-Cooling

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young males (18-30 years)
  • Non-smoking
  • English or French speaking
  • Ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

MeSH Terms

Conditions

Heat Stress DisordersMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2024

First Posted

November 1, 2024

Study Start

October 24, 2024

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available with approved analysis plan and signed access agreement

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following publication of the main study report(s)
Access Criteria
Approved analysis plan and signed access agreement

Locations