- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630832
Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress - Part III
June 13, 2025 updated by: Glen P. Kenny, University of Ottawa
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
23
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
-
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Ontario
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Ottawa, Ontario, Canada, K1N1A2
- University of Ottawa
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-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: No cooling
Participants 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.
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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).
|
|
Experimental: Partial cooling
Participants 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).
|
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).
|
|
Experimental: Full cooling
Participants 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
|
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
|
|
Average core temperature during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Average core temperature following initial stay time
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Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Heart rate at 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
|
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
|
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
|
|
Average heart rate during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Average heart rate following initial stay time
|
Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Skin temperature at 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
|
Skin temperature measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
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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
|
|
Average skin temperature during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Average heart rate following initial stay time
|
Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Thermal comfort scale at 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
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
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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
|
|
Thermal comfort scale during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
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Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Thirst sensation scale at 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
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
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
|
|
Thirst sensation scale during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Assessed via a visual analog scale ("How thirsty are you?")
(9: very, very thirsty to 1: Not thirsty at all)
|
Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Rating of Perceived Exertion at 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
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Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
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
|
|
Rating of Perceived Exertion during work-rest allocations
Time Frame: Period of work-rest allocations over a 180 minute following the initial stay time
|
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
|
Period of work-rest allocations over a 180 minute following the initial stay time
|
|
Orthostatic Intolerance Symptoms Assessment
Time Frame: At the end of the 180 minute work-rest allocations
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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"
|
At the end of the 180 minute work-rest allocations
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 27, 2024
Primary Completion (Actual)
March 29, 2025
Study Completion (Actual)
March 29, 2025
Study Registration Dates
First Submitted
October 4, 2024
First Submitted That Met QC Criteria
October 4, 2024
First Posted (Actual)
October 8, 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU-2024-09-B
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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