NCT05847712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

First Submitted

Initial submission to the registry

April 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

April 27, 2023

Last Update Submit

August 4, 2024

Conditions

Keywords

Heat exposureHeat strainBody temperatureThermoregulationOccupational heat stressUncompensable heat stressAgingSex

Outcome Measures

Primary Outcomes (6)

  • 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 first (morning day 1) continuous work bout

  • 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 second (afternoon day 1) continuous work bout

  • 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 third (morning day 2) continuous work bout

  • Average core temperature

    Average core temperature over final 2-hours of each work bout

    Period of work-rest allocations following initial stay time for morning day 1

  • Average core temperature

    Average core temperature following initial stay time

    Period of work-rest allocations following initial stay time for afternoon day 1

  • Average core temperature

    Average core temperature following initial stay time

    Period of work-rest allocations following initial stay time for morning day 2

Secondary Outcomes (57)

  • Heart rate at initial stay time

    End of first (morning day 1) continuous work bout

  • Heart rate at initial stay time

    End of second (afternoon day 1) continuous work bout

  • Heart rate at initial stay time

    End of third (morning day 2) continuous work bout

  • Average heart rate

    Period of work-rest allocations following initial stay time for morning day 1

  • Average heart rate

    Period of work-rest allocations following initial stay time for afternoon day 1

  • +52 more secondary outcomes

Study Arms (2)

Younger adults

EXPERIMENTAL

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

Other: Simulated work in the heat

Older adults

EXPERIMENTAL

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

Other: Simulated work in the heat

Interventions

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 adultsYounger adults

Eligibility Criteria

Age18 Years - 69 Years
Sexall
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, K1N6N5, Canada

Location

MeSH Terms

Conditions

Heat Stress DisordersMotor ActivityCoitus

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehaviorSexual Behavior

Study Officials

  • Glen P Kenny, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data will be blinded prior to analysis
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 8, 2023

Study Start

June 8, 2023

Primary Completion

July 12, 2024

Study Completion

July 12, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available with approved analysis plan and signed access agreement

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following publication of the main study report(s)
Access Criteria
Approved analysis plan and signed access agreement

Locations