NCT06630832

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 27, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

October 4, 2024

Last Update Submit

June 13, 2025

Conditions

Keywords

Heat strainThermoregulationExerciseCore temperatureOccupational heat stressUncompensable heat stressAging

Outcome Measures

Primary Outcomes (13)

  • 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).

    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

    Average core temperature following initial stay time

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

  • 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)

    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

    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

    Skin temperature measured 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 skin temperature during work-rest allocations

    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

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

    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

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

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

  • 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)

    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

    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

    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

    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

    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

Study Arms (3)

No cooling

ACTIVE COMPARATOR

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.

Other: Simulated work in the heat with no cooling during rest breaks

Partial cooling

EXPERIMENTAL

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).

Other: Simulated work in the heat with partial cooling during rest breaks

Full cooling

EXPERIMENTAL

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).

Other: Simulated work in the heat with full cooling during rest breaks

Interventions

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).

No cooling

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).

Partial cooling

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).

Full cooling

Eligibility Criteria

Age18 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N1A2, Canada

Location

MeSH Terms

Conditions

Body Temperature ChangesHeat Stress DisordersOccupational StressHyperthermiaMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

September 27, 2024

Primary Completion

March 29, 2025

Study Completion

March 29, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations