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Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress

Primary Purpose

Core Temperature, Heat Stress, Exertional, Heat Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Simulated work in the heat
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Core Temperature focused on measuring Heat exposure, Heat strain, Body temperature, Thermoregulation, Occupational heat stress, Uncompensable heat stress, Aging, Sex

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of OttawaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Younger adults

Older adults

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
Average heart rate
Average heart rate over final 2-hours of each work bout
Average heart rate
Average heart rate over final 2-hours of each work bout
Average heart rate
Average heart rate over final 2-hours of each work bout
Skin temperature at initial stay time
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Skin temperature at initial stay time
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Skin temperature at initial stay time
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Average skin temperature
Average skin temperature over final 2-hours of each work bout
Average skin temperature
Average skin temperature over final 2-hours of each work bout
Average skin temperature
Average skin temperature over final 2-hours of each work bout
Systolic blood pressure
Arterial blood pressure measured via automated oscillometry
Systolic blood pressure
Arterial blood pressure measured via automated oscillometry
Systolic blood pressure
Arterial blood pressure measured via automated oscillometry
Diastolic blood pressure
Arterial blood pressure measured via automated oscillometry
Diastolic blood pressure
Arterial blood pressure measured via automated oscillometry
Diastolic blood pressure
Arterial blood pressure measured via automated oscillometry
Mean arterial blood pressure
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Mean arterial blood pressure
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Mean arterial blood pressure
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Rate pressure product
Calculated as systolic blood pressure * heart rate
Rate pressure product
Calculated as systolic blood pressure * heart rate
Rate pressure product
Calculated as systolic blood pressure * heart rate
Fluid consumption
Cumulative fluid consumption calculated by weighing the participant's water intake
Fluid consumption
Cumulative fluid consumption calculated by weighing the participant's water intake
Fluid consumption
Cumulative fluid consumption calculated by weighing the participant's water intake
Fluid loss
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Fluid loss
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Fluid loss
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Change in plasma volume
Determined from venous blood samples
Change in plasma volume
Determined from venous blood samples
Change in plasma volume
Determined from venous blood samples
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thermal comfort scale
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Thirst sensation scale
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Rating of Perceived Exertion
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
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".
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".
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".
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".
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".
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".

Full Information

First Posted
April 27, 2023
Last Updated
June 15, 2023
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05847712
Brief Title
Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress
Official Title
Safe Maximum Work Times and the Effectiveness of Work-rest Allocations in Mitigating Increases in Core Temperature During and on the Day Following Prolonged Work in the Heat in Young and Older Workers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Core Temperature, Heat Stress, Exertional, Heat Fatigue, Exercise
Keywords
Heat exposure, Heat strain, Body temperature, Thermoregulation, Occupational heat stress, Uncompensable heat stress, Aging, Sex

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Data will be blinded prior to analysis
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Younger adults
Arm Type
Experimental
Arm Description
Adults aged 18-30 years with no pre-existing health conditions
Arm Title
Older adults
Arm Type
Experimental
Arm Description
Adults aged 50-69 with no pre-existing health conditions
Intervention Type
Other
Intervention Name(s)
Simulated work in the heat
Intervention Description
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).
Primary Outcome Measure Information:
Title
Initial stay time
Description
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).
Time Frame
End of first (morning day 1) continuous work bout
Title
Initial stay time
Description
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).
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Initial stay time
Description
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).
Time Frame
End of third (morning day 2) continuous work bout
Title
Average core temperature
Description
Average core temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the first (morning day 1) work period
Title
Average core temperature
Description
Average core temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the second (afternoon day 1) work period
Title
Average core temperature
Description
Average core temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the third (morning day 2) work period
Secondary Outcome Measure Information:
Title
Heart rate at initial stay time
Description
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of first (morning day 1) continuous work bout
Title
Heart rate at initial stay time
Description
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Heart rate at initial stay time
Description
Heart rate at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of third (morning day 2) continuous work bout
Title
Average heart rate
Description
Average heart rate over final 2-hours of each work bout
Time Frame
Final 2-hours of the first (morning day 1) work period
Title
Average heart rate
Description
Average heart rate over final 2-hours of each work bout
Time Frame
Final 2-hours of the second (afternoon day 1) work period
Title
Average heart rate
Description
Average heart rate over final 2-hours of each work bout
Time Frame
Final 2-hours of the third (morning day 2) work period
Title
Skin temperature at initial stay time
Description
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of first (morning day 1) continuous work bout
Title
Skin temperature at initial stay time
Description
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Skin temperature at initial stay time
Description
Skin temperature (4 sites) measured at the initial increase in absolute core temperature of 38°C (or relative increase of 1°C)
Time Frame
End of third (morning day 2) continuous work bout
Title
Average skin temperature
Description
Average skin temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the first (morning day 1) work period
Title
Average skin temperature
Description
Average skin temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the second (afternoon day 1) work period
Title
Average skin temperature
Description
Average skin temperature over final 2-hours of each work bout
Time Frame
Final 2-hours of the third (morning day 2) work period
Title
Systolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of first (morning day 1) work period
Title
Systolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of second (afternoon day 1) work period
Title
Systolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of third (morning day 2) work period
Title
Diastolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of first (morning day 1) work period
Title
Diastolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of second (afternoon day 1) work period
Title
Diastolic blood pressure
Description
Arterial blood pressure measured via automated oscillometry
Time Frame
End of third (morning day 2) work period
Title
Mean arterial blood pressure
Description
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Time Frame
End of first (morning day 1) work period
Title
Mean arterial blood pressure
Description
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Time Frame
End of second (afternoon day 1) work period
Title
Mean arterial blood pressure
Description
Calculated as 1/3 * systolic blood pressure + 2/3 * diastolic blood pressure
Time Frame
End of third (morning day 2) work period
Title
Rate pressure product
Description
Calculated as systolic blood pressure * heart rate
Time Frame
End of first (morning day 1) work period
Title
Rate pressure product
Description
Calculated as systolic blood pressure * heart rate
Time Frame
End of second (afternoon day 1) work period
Title
Rate pressure product
Description
Calculated as systolic blood pressure * heart rate
Time Frame
End of third (morning day 2) work period
Title
Fluid consumption
Description
Cumulative fluid consumption calculated by weighing the participant's water intake
Time Frame
End of first (morning day 1) work period
Title
Fluid consumption
Description
Cumulative fluid consumption calculated by weighing the participant's water intake
Time Frame
End of second (afternoon day 1) work period
Title
Fluid consumption
Description
Cumulative fluid consumption calculated by weighing the participant's water intake
Time Frame
End of third (morning day 2) work period
Title
Fluid loss
Description
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Time Frame
End of first (morning day 1) work period
Title
Fluid loss
Description
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Time Frame
End of second (afternoon day 1) work period
Title
Fluid loss
Description
Fluid loss calculated as the change in body mass (corrected for food/fluid consumption).
Time Frame
End of third (morning day 2) work period
Title
Change in plasma volume
Description
Determined from venous blood samples
Time Frame
End of first (morning day 1) work period
Title
Change in plasma volume
Description
Determined from venous blood samples
Time Frame
End of second (afternoon day 1) work period
Title
Change in plasma volume
Description
Determined from venous blood samples
Time Frame
End of third (morning day 2) work period
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of first (morning day 1) continuous work bout
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of third (morning day 2) continuous work bout
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of first (morning day 1) work period
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of second (afternoon day 1) work period
Title
Thermal comfort scale
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") (4: very uncomfortable to 1: comfortable)
Time Frame
End of third (morning day 2) work period
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of first (morning day 1) continuous work bout
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of third (morning day 2) continuous work bout
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of first (morning day 1) work period
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of second (afternoon day 1) work period
Title
Thirst sensation scale
Description
Assessed via a visual analog scale ("How thirsty are you?") (9: very, very thirsty to 1: Not thirsty at all)
Time Frame
End of third (morning day 2) work period
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
End of first (morning day 1) continuous work bout
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
End of third (morning day 2) continuous work bout
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
Final minute of exercise for the end of the first (morning day 1) work period
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
Final minute of exercise for the end of the second (afternoon day 1) work period
Title
Rating of Perceived Exertion
Description
Perceived exertion assessed via a self-report questionnaire upon verbal prompting (6: no exertion at all to 20: maximal exertion).
Time Frame
Final minute of exercise for the end of the first (morning day 2) work period
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of first (morning day 1) continuous work bout
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of second (afternoon day 1) continuous work bout
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of third (morning day 2) continuous work bout
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of first (morning day 1) work period
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of second (afternoon day 1) work period
Title
Orthostatic Intolerance Symptoms Assessment
Description
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".
Time Frame
End of third (morning day 2) work period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen P Kenny, PhD
Phone
613-562-5800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Fergus O'Connor, PhD
Phone
6136178682
Email
foconnor@uottawa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N6N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Phone
6135625800
Ext
4282
Email
gkenny@uottawa.ca
First Name & Middle Initial & Last Name & Degree
Fergus K O'Connor, PhD
Phone
6136178682
Email
foconnor@uottawa.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be made available with approved analysis plan and signed access agreement
IPD Sharing Time Frame
Following publication of the main study report(s)
IPD Sharing Access Criteria
Approved analysis plan and signed access agreement

Learn more about this trial

Initial Stay Times and Heat Mitigation Controls for Uncompensable Occupational Heat Stress

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