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Body Temperature ChangesNCT06630832

Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress - Part III

A study testing Simulated work in the heat with no cooling during rest breaks, Simulated work in the heat with partial cooling during rest breaks and Simulated work in the heat with full cooling during rest breaks in people with Body Temperature Changes and Heat Stress, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Occupational heat stress directly threatens workers' ability to live healthy and productive lives. Heat exposed workers are at an elevated risk of experiencing impaired work performance and cognitive function leading to a greater risk of work-related injuries which includes traumatic injury and a myriad of… Read more about this study

Who is it for?
Ages 18 to 69 years, men onlyHealthy volunteers can take part
What is being tested?
Simulated work in the heat with no cooling during rest breaks, Simulated work in the heat with partial cooling during rest breaks and Simulated work in the heat with full cooling during rest breaks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteCanada
Study dates
27 Sep 2024to 29 Mar 2025
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 69 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • young (18-30 years) and older adults (50-69 years)
  • habitually active, not endurance trained (<2 sessions per week, <150 minutes per week)
  • non-smoking
  • English or French speaking
  • ability to provide informed consent

Who cannot join

  • pre-existing health conditions (e.g., diabetes, hypertension)
  • use of medication deemed to significantly modulate thermoregulatory function and heat tolerance (e.g., antidepressants, antihistamines, diuretics)
  • engaged in jobs and/or activities that involve frequent exposure to hot environments (e.g., regular sauna use)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Ottawa

    Ottawa, Ontario, K1N1A2

Other trials in Canada

About this study

Official title: Impact of Partial and Full Cooling Applied During Prescribed Rest Breaks to Mitigate Increases in Physiological Strain During Prolonged Work in Hot Environments.

Occupational heat stress directly threatens workers' ability to live healthy and productive lives. Heat exposed workers are at an elevated risk of experiencing impaired work performance and cognitive function leading to a greater risk of work-related injuries which includes traumatic injury and a myriad of pathophysiological conditions (e.g., heat stroke, acute kidney injury, adverse cardiovascular events). To mitigate the adverse health effects of occupational heat stress, safety organizations recommend upper limits for heat stress, typically defined by a worker's metabolic rate and the prevailing wet-bulb globe temperature (WBGT). In instances where the heat load created by the combination of work intensity, environment, and clothing worn exceed the upper heat stress limits (uncompensable heat stress), controls such as rest breaks are prescribed to limit increases in core temperature beyond recommended limits. While workers are encouraged to find shelter from the heat during a rest break, it is not always possible or feasible. Typically, workers may rest while remaining exposed to the heat, recover in a shaded area or rest in an air-conditioned room or vehicle. However, the effectiveness of these cooling strategies in mitigating the level of physiological strain experienced by the worker during prolonged work in a hot environment remains unclear. In this project, the investigators will assess the efficacy of the different cooling strategies in preventing excursions in core temperature beyond recommended limits (38.0°C) following the initial stay time for moderate-intensity work in hot ambient conditions (WBGT of 29°C; represents hot outdoor conditions experienced by workers in summers in Ontario, Canada) in context of the prescribed American Conference of Governmental Industrial Hygienists (ACGIH) work-to-rest allocation for unacclimated adults. On three separate days, participants will walk on a treadmill at a fixed metabolic rate of 200 W/m2 until core temperature reaches and/or exceeds 38.0°C or until volitional fatigue. Thereafter, participants will complete an additional 180 min work bout employing the recommended ACGIH work-to-rest allocation of 1:3 (starting with a 45 min rest break followed by a 15 min work bout, with the cycle repeated three times over the 180 min work simulation bout) without (Control) or with cooling mitigation during each 15-min break consisting of either: i) partial cooling equivalent to sitting in a shaded space (WBGT 24°C; 31.7°C and 35% RH) such as under a tree with a light breeze (simulated with pedestal fan fixed at ~2 m/s) or ii) full cooling equivalent to sitting in air-conditioned space (e.g., room or vehicle) maintained at 22°C and 35% RH (equivalent WBGT of 16°C).

Being tested
Simulated work in the heat with no cooling during rest breaks, Simulated work in the heat with partial cooling during rest breaks, Simulated work in the heat with full cooling during rest breaks
Keywords
Heat strain, Thermoregulation, Exercise, Core temperature, Occupational heat stress, Uncompensable heat stress, Aging
Medical subject headings
Body Temperature Changes, Heat Stress Disorders, Occupational Stress, Hyperthermia, Motor Activity

What participants receive

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

  • Simulated work in the heat with no cooling during rest breaksOther

    Young and older adults will not undergo cooling during rest breaks applied during the implementation of work-rest allocations over the duration of a 180-min work period following a continuous work bout to 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels).

  • Simulated work in the heat with partial cooling during rest breaksOther

    Young and older adults will not undergo partial cooling during rest breaks applied during the implementation of work-rest allocations over the duration of a 180-min work period following a continuous work bout to 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels).

  • Simulated work in the heat with full cooling during rest breaksOther

    Young and older adults will not undergo full cooling during rest breaks applied during the implementation of work-rest allocations over the duration of a 180-min work period following a continuous work bout to 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels).

Study groups in NCT06630832
Study groupRoleWhat they receive
No coolingActive comparatorParticipants perform a continuous moderate-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 1:3 work-rest allocation, starting with a 45 min rest break followed by a 15 min work bout for an additional 180-min of work without cooling.
Receives: Other: Simulated work in the heat with no cooling during rest breaks
Partial coolingExperimentalParticipants perform a continuous heavy-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 1:3 work-rest allocation, starting with a 45 min rest break followed by a 15 min work bout for an additional 180-min of work with partial cooling equivalent to sitting in a shaded space (WBGT 24°C; 31.7°C and 35% RH) such as under a tree with a light breeze (simulated with pedestal fan fixed at ~2 m/s).
Receives: Other: Simulated work in the heat with partial cooling during rest breaks
Full coolingExperimentalParticipants perform a continuous heavy-intensity work bout (metabolic rate of ~200 W/m2) until core temperature reaches 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels), which is immediately followed by intermittent work using a 1:3 work-rest allocation, starting with a 45 min rest break followed by a 15 min work bout for an additional 180-min of work with full cooling equivalent to sitting in air-conditioned space (e.g., room or vehicle) maintained at 22°C and 35% RH (equivalent WBGT of 16°C).
Receives: Other: Simulated work in the heat with full cooling during rest breaks

What is being measured

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

  1. Initial stay time

    Total continuous work time to achieve an initial absolute increase in core temperature of 38°C (equivalent to a 1°C increase in body core temperature above resting levels) (note: in instances where a participant voluntarily terminates work prematurely before the absolute core temperature of ≥38°C (or relative increase of ≥1°C) is achieved or the absolute core temperature is <38°C (or relative increase of <1°C), the time of termination or end of the work bout will be taken as the initial stay time respectively).

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  2. Average core temperature during work-rest allocations

    Average core temperature following initial stay time

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  3. Heart rate at initial stay time

    Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  4. Average heart rate during work-rest allocations

    Average heart rate following initial stay time

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  5. Skin temperature at initial stay time

    Skin temperature measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  6. Average skin temperature during work-rest allocations

    Average heart rate following initial stay time

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  7. Thermal comfort scale at initial stay time

    Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  8. Thermal comfort scale during work-rest allocations

    Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  9. Thirst sensation scale at initial stay time

    Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  10. Thirst sensation scale during work-rest allocations

    Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  11. Rating of Perceived Exertion at initial stay time

    Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).

    Measured: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved

  12. Rating of Perceived Exertion during work-rest allocations

    Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).

    Measured: Period of work-rest allocations over a 180 minute following the initial stay time

  13. Orthostatic Intolerance Symptoms Assessment

    Cumulative sum of scores on 6 questions asking participant to rank symptoms associated with orthostatic intolerance. All symptoms scored on a scale from 0 (none) to 10 (worst possible) and include feelings of: (1) "dizziness, lightheadedness, feeling faint, or feeling like you might black out"; (2) "Problems with vision (blurring, seeing spots, tunnel vision, etc.)"; (3) "Weakness"; (4) "Fatigue"; (5) "Trouble concentrating"; and (6) "Head and neck discomfort"

    Measured: At the end of the 180 minute work-rest allocations

Timeline

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

  1. First posted8 Oct 2024
  2. Study start27 Sep 2024
  3. Primary completion29 Mar 2025
  4. Study completion29 Mar 2025

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630832
Sponsor's protocol ID
HEPRU-2024-09-B
Status last verified
Jun 2025
First submitted
4 Oct 2024
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Simulated work in the heat with no cooling during rest breaks, Simulated work in the heat with partial cooling during rest breaks and Simulated work in the heat with full cooling during rest breaks in people with Body Temperature Changes and Heat Stress, run by University of Ottawa 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial stay time (time frame: End of continuous work bout as defined when core temperature reaches 38.0°C or when the maximum of 240 minutes of continuous exercise is achieved). The study lists 13 primary outcomes in all. 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 17 Jun 2025.

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