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

NCT ID: NCT05847712

Last Updated: 2024-08-06

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2024-07-12

Brief Summary

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

Workplaces rely on upper heat stress limits provided by the American Conference of Governmental Industrial Hygienists (ACGIH) to manage the health and safety of workers in hot environments. This is primarily achieved by interspersing work with rest periods, the length of which is dictated by environmental conditions and work intensity, to maintain core temperature at or below 38.0°C (equivalent to a 1°C increase in body core temperature above resting levels). However, these guidelines employ a "one size fits all" approach to exposure limits that does not consider individual variation between workers. Moreover, they fail to provide direction on the safe, initial stay times before these heat-mitigation controls should be employed (i.e., rest breaks) in conditions exceeding upper heat stress limits. While recent work has generated estimates of the initial stay times for young to older men before heat-mitigation controls are required for moderate-intensity work, this information is limited to a single work bout and does not consider a second work bout preceded by an extended rest period (e.g., lunch) or next day effects. This is a key consideration, as prolonged work in the heat has been shown to cause next-day impairments in heat dissipation in older men. Further, it remains unclear if the application of the prescribed ACGIH work-rest allocations thereafter would alleviate increases in core temperature for the duration of the work period (e.g., start of shift versus post-lunch period). This project will address these knowledge gaps by determining if refinements in initial stay times for moderate-intensity work (represents the average work effort of physically demanding occupations) in the heat (26°C wet-bulb globe temperature) may be required for young and older adults for i) a second work bout that is preceded by an extended rest period such as a lunch break, and ii) a work bout performed on the next day. This includes assessing the efficacy of the prescribed ACGIH work-rest allocations to mitigate increases in core temperature beyond safe limits (\>38.0°C, equivalent to a \>1°C increase in body core temperature above resting levels) during these work periods. Given the known sex-differences in heat loss that can modulate core temperature regulation during an exercise-heat stress, the investigators will conduct separate analysis to identify modulating effects of biological sex on the initial stay times and effectiveness of the work-rest allocation as a heat-alleviation control.

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.

Core Temperature Heat Stress, Exertional Heat Fatigue Exercise

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Data will be blinded prior to analysis

Study Groups

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

Younger adults

Adults aged 18-30 years with no pre-existing health conditions

Group Type EXPERIMENTAL

Simulated work in the heat

Intervention Type OTHER

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 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of \~240 min. The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).

Older adults

Adults aged 50-69 with no pre-existing health conditions

Group Type EXPERIMENTAL

Simulated work in the heat

Intervention Type OTHER

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 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of \~240 min. The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).

Interventions

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

Simulated work in the heat

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 3:1 work-rest allocation, starting with a 15 min rest break followed by a 45 min work bout for a total work duration of \~240 min. The work protocol is performed in the morning of day 1, and repeated in a post-lunch work period (i.e., afternoon of day 1) and on the morning of the next day (i.e., morning of day 2).

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

ALL

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, University Research Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Glen P Kenny, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

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 2023-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Work-To-Rest Ratios
NCT05327764 COMPLETED NA
S&B Heat Stress Pilot Protocols
NCT06094764 COMPLETED NA
Work Design Interventions for Heat Resilience
NCT06599788 NOT_YET_RECRUITING NA
Heat Acclimation in Females
NCT06551168 RECRUITING NA