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Body Temperature ChangesNCT07847437

Progressive Heat Exposure and Physiological Strain

A study testing Constant Heat Exposure and Progressively Increasing Heat Exposure in people with Body Temperature Changes and Heat Stress, run by University of Ottawa at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Occupational heat-stress guidelines are commonly based on the level of environmental heat exposure and are largely derived from studies conducted under constant environmental conditions. Read more about this study

Who is it for?
Ages 45 to 65 years, men onlyHealthy volunteers can take part
What is being tested?
Constant Heat Exposure and Progressively Increasing Heat Exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
1 Oct 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are male.
  • Do not smoke or have been smoke free for at least 5 years.
  • English or French speaking.
  • Ability to provide informed consent.
  • Are physically active (engage in exercise at least 2 times per week for ≥30 minutes)

Who cannot join

  • Are regularly exposed to hot environments (e.g., occupational heat exposure)
  • Experience claustrophobia or discomfort in enclosed environments
  • Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
  • Serious complications related to diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
  • Uncontrolled hypertension - BP >150 mmHg systolic or >95 mmHg diastolic in a sitting position.
  • Restrictions in physical activity due to disease (e.g. intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable.
  • Cardiac abnormalities identified during screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Glen P Kenny, PhD contact

6135625800 ext. 4282

gkenny@uottawa.ca

Canada1 site
  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

    Glen P Kenny, PhD, 613-562-5800 ext. 4282, gkenny@uottawa.ca

Other trials in Canada

About this study

Official title: Does a Progressively Warming Workday Alter Work Performed and Physiological Heat Strain in Middle-Aged and Older Men?

Occupational heat-stress guidelines are commonly based on the level of environmental heat exposure and are largely derived from studies conducted under constant environmental conditions. However, outdoor workers are typically exposed to dynamic conditions, with environmental heat often increasing progressively from morning to afternoon. Consequently, workers may experience substantially different patterns of heat exposure across the workday even when average daily heat exposure is equivalent. It remains unclear whether the temporal pattern of heat exposure influences the amount of work that can be performed or the physiological strain experienced during a workday. Understanding these responses is important for determining whether occupational heat-stress guidelines developed under constant laboratory conditions adequately protect workers exposed to progressively changing environmental conditions.

The primary objective of this study is to determine whether the temporal pattern of heat exposure influences work performed and physiological heat strain during a simulated occupational workday in healthy middle-aged and older men. Participants will complete two 9-hour simulated workdays consisting of a 4-hour morning work period, a 1-hour lunch break, and a 4-hour afternoon work period. During one trial, wet-bulb globe temperature (WBGT) will remain constant at 28°C throughout the workday, whereas during the other trial, WBGT will progressively increase from morning to afternoon to simulate the changing environmental conditions of a typical hot summer workday. Both trials will have the same mean daily WBGT of 28°C. Participants will perform moderate-intensity treadmill exercise, and measures including total work performed, core temperature, heart rate, and time to the initial stay-time threshold will be assessed to determine whether constant and progressively increasing heat exposures produce different physiological and work-performance responses across the workday.

Being tested
Constant Heat Exposure, Progressively Increasing Heat Exposure
Keywords
Heat Strain, Thermoregulation, Core Temperature, Occupational Heat Stress, Physical Activity, Hyperthermia
Medical subject headings
Body Temperature Changes, Heat Stress Disorders, Occupational Stress, Motor Activity, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Constant Heat ExposureOther

    Participants complete a simulated occupational workday under constant environmental conditions, with WBGT maintained at 28°C throughout the morning and afternoon work periods.

  • Progressively Increasing Heat ExposureOther

    Participants complete a simulated occupational workday in which WBGT progressively increases from morning to afternoon while maintaining a mean daily WBGT of 28°C.

Study groups in NCT07847437
Study groupRoleWhat they receive
Constant Heat ExposureExperimentalParticipants will complete a 9-hour simulated occupational workday consisting of a 4-hour morning work period, a 1-hour seated lunch-recovery period, and a 4-hour afternoon work period. Wet-bulb globe temperature (WBGT) will remain constant at 28°C throughout the workday. During each work period, participants will perform moderate-intensity treadmill walking at a metabolic heat production of approximately 200 W·m-2. Participants will initially work continuously until reaching the initial stay-time threshold, defined as a core temperature of 38.0°C or an increase of 1.0°C above pre-work baseline, whichever occurs first. Thereafter, participants will complete 45-min work and 15-min seated rest cycles for the remainder of the work period.
Receives: Other: Constant Heat Exposure
Progressively Increasing Heat ExposureExperimentalParticipants will complete a 9-hour simulated occupational workday consisting of a 4-hour morning work period, a 1-hour seated lunch-recovery period, and a 4-hour afternoon work period. WBGT will progressively increase from morning to afternoon to simulate the changing environmental conditions of a hot summer workday, while maintaining a mean daily WBGT of 28°C. During each work period, participants will perform moderate-intensity treadmill walking at a metabolic heat production of approximately 200 W·m-2. Participants will initially work continuously until reaching the initial stay-time threshold, defined as a core temperature of 38.0°C or an increase of 1.0°C above pre-work baseline, whichever occurs first. Thereafter, participants will complete 45-min work and 15-min seated rest cycles for the remainder of the work period.
Receives: Other: Progressively Increasing Heat Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total work performed

    Total work completed during each 240-minute morning and afternoon work period, expressed as cumulative minutes of treadmill walking. Each work period consists of an initial continuous walking phase until core temperature reaches 38.0°C or increases by 1.0°C above the pre-work baseline, whichever occurs first, followed by intermittent 45-min work and 15-min seated rest cycles.

    Measured: From the start to the end of the morning and afternoon work periods during each experimental trial (0-4 hours and 5-9 hours after the start of the trial, respectively).

Secondary outcomes (22)
  1. Initial stay time

    Time, in minutes, from the start of continuous treadmill walking until the initial stay-time threshold is reached, defined as a core temperature of 38.0°C or an increase of 1.0°C above the pre-work baseline, whichever occurs first. Participants who do not reach the threshold during the 240-minute work period will be identified as not having reached the threshold within 240 min.

    Measured: During the initial continuous walking phase of each morning and afternoon work period.

  2. Core temperature

    Core temperature measured continuously using a rectal thermocouple temperature probe to assess thermoregulatory strain throughout the simulated workday.

    Measured: Continuously throughout each experimental trial, including the morning work period, lunch recovery, and afternoon work period.

  3. Average core temperature during work-rest cycles

    Average core temperature during the intermittent 45-min work and 15-min seated rest cycles following attainment of the initial stay-time threshold.

    Measured: During the work-rest cycles of each morning and afternoon work period.

  4. Mean skin temperature

    Mean skin temperature calculated from temperatures measured at eight body sites using ISO 9886 weighting factors.

    Measured: Assessed throughout each experimental trial, including the morning work period, lunch recovery, and afternoon work period.

  5. Heart rate

    Heart rate measured continuously using a chest-strap heart rate monitor and expressed as absolute heart rate.

    Measured: Continuously throughout each experimental trial, including the morning work period, lunch recovery, and afternoon work period.

  6. Percentage of heart rate reserve

    Heart rate expressed as a percentage of the participant's heart rate reserve to assess relative cardiovascular strain during heat exposure.

    Measured: Throughout each experimental trial, including the morning work period, lunch recovery, and afternoon work period.

  7. Systolic blood pressure

    Systolic blood pressure measured at the brachial artery using automated oscillometry. Three measurements obtained at approximately 1-min intervals will be averaged for analysis.

    Measured: Assessed at predetermined intervals throughout each experimental trial.

  8. Diastolic blood pressure

    Diastolic blood pressure measured at the brachial artery using automated oscillometry. Three measurements obtained at approximately 1-min intervals will be averaged for analysis.

    Measured: Assessed at predetermined intervals throughout each experimental trial.

  9. Heart rate variability: standard deviation of normal R-R intervals (SDNN)

    Cardiac autonomic modulation assessed from consecutive R-R intervals obtained using a 5-lead Holter electrocardiogram to calculate the standard deviation of normal R-R intervals (SDNN), expressed in milliseconds.

    Measured: Throughout each experimental trial.

  10. Heart rate variability: root mean square of successive differences (RMSSD)

    Cardiac autonomic modulation assessed from consecutive R-R intervals obtained using a 5-lead Holter electrocardiogram to calculate the root mean square of successive differences between adjacent normal R-R intervals (RMSSD), expressed in milliseconds.

    Measured: Throughout each experimental trial.

  11. Urine specific gravity

    Urine specific gravity measured to assess hydration status upon arrival at the laboratory. Higher values indicate greater urine concentration, whereas lower values indicate lower urine concentration.

    Measured: Assessed upon arrival before each experimental trial.

  12. Fluid consumption

    Cumulative fluid consumption determined from all fluid consumed during each experimental session.

    Measured: Throughout each experimental trial.

  13. Fluid loss from body mass change

    Fluid loss calculated from changes in body mass during each daytime work exposure, corrected for food and fluid intake.

    Measured: Assessed at the end of each 240-minute morning and afternoon work period of each experimental trial.

  14. Thermal sensation

    Thermal sensation assessed using an 8-point scale ranging from 0 (neutral) to 7 (extremely hot). Higher scores indicate a greater sensation of heat.

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, at the end of the work and recovery components of each work-rest cycle, and at the beginning and end of lunch recovery.

  15. Thermal comfort

    Thermal comfort assessed using the ISO 10551 scale ranging from 1 (comfortable) to 4 (very uncomfortable). Higher scores indicate greater thermal discomfort.

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, at the end of the work and recovery components of each work-rest cycle, and at the beginning and end of lunch recovery.

  16. Thirst sensation

    Thirst sensation assessed using a 9-point scale ranging from 1 (not thirsty at all) to 9 (very, very thirsty). Higher scores indicate greater perceived thirst

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, at the end of the work and recovery components of each work-rest cycle, and at the beginning and end of lunch recovery.

  17. Affective state

    Affective state will be assessed using the 11-point Feeling Scale ranging from -5 (very bad) to +5 (very good), with 0 representing neutral. Higher scores indicate more positive affective state.

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, at the end of the work and recovery components of each work-rest cycle, and at the beginning and end of lunch recovery.

  18. Perceived arousal

    Perceived arousal assessed using a 7-point scale ranging from 1 (low arousal) to 7 (high arousal). Higher scores indicate greater perceived arousal.

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, at the end of the work and recovery components of each work-rest cycle, and at the beginning and end of lunch recovery.

  19. Rating of perceived exertion

    Perceived exertion assessed using the Borg Rating of Perceived Exertion scale ranging from 6 (no exertion at all) to 20 (maximal exertion). Higher scores indicate greater perceived exertion.

    Measured: Assessed at baseline, every 10 min during initial continuous work, at attainment of the initial stay-time threshold, and at the end of the work and recovery components of each work-rest cycle.

  20. Environmental Symptoms Questionnaire-IV (ESQ-IV) total symptom score

    Symptoms associated with heat exposure will be assessed using the Environmental Symptoms Questionnaire-IV (ESQ-IV). Responses will be combined to generate a total symptom score, with higher scores indicating greater environmental symptom burden.

    Measured: Assessed at baseline and following completion of each experimental trial.

  21. Profile of Mood States-40 (POMS-40) total mood disturbance score

    Mood state will be assessed using the abbreviated 40-item Profile of Mood States questionnaire (POMS-40). Responses will be used to calculate a total mood disturbance score, with higher scores indicating greater overall mood disturbance.

    Measured: Assessed at baseline and following completion of each experimental trial.

  22. Changes in plasma volume

    Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill.

    Measured: Assessed as baseline, and following each 240-minute morning and afternoon work period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07847437
Sponsor's protocol ID
HEPRU-2026-09-A
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Constant Heat Exposure and Progressively Increasing Heat Exposure in people with Body Temperature Changes and Heat Stress, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Glen P Kenny, PhD (6135625800 ext. 4282, gkenny@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total work performed (time frame: From the start to the end of the morning and afternoon work periods during each experimental trial (0-4 hours and 5-9 hours after the start of the trial, respectively).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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