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

NCT ID: NCT06630832

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2025-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Body Temperature Changes Heat Stress Heat Exposure Heat Fatigue Work Related Stress Hyperthermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Simulated work in the heat with no cooling during rest breaks

Intervention Type OTHER

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).

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).

Group Type EXPERIMENTAL

Simulated work in the heat with partial cooling during rest breaks

Intervention Type OTHER

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).

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).

Group Type EXPERIMENTAL

Simulated work in the heat with full cooling during rest breaks

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simulated work in the heat with no cooling during rest breaks

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).

Intervention Type OTHER

Simulated work in the heat with partial cooling during rest breaks

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).

Intervention Type OTHER

Simulated work in the heat with full cooling during rest breaks

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Glen P. Kenny

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEPRU-2024-09-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Work Design Interventions for Heat Resilience
NCT06599788 NOT_YET_RECRUITING NA
S&B Heat Stress Pilot Protocols
NCT06094764 COMPLETED NA
Work-To-Rest Ratios
NCT05327764 COMPLETED NA
Cooling Solutions for Outdoor Workers
NCT06998667 ENROLLING_BY_INVITATION NA