Trial · NCT07656519
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 45
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total work volume. | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Total work completed during the 240-minute work protocol performed in the morning and afternoon work periods, expressed as cumulative minutes of work performed over the two consecutive work days. The work period consists of an initial continuous walking phase to a core temperature 38.0°C or 1°C increase above baseline resting (as measured prior to the start of the 2-day work protocol), followed by intermittent work-rest cycles. The morning and afternoon work periods are separated by a 1-hour recovery period. |
| Secondary | Time to core temperature of 38.0°C | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Time, in minutes, from the start of continuous walking to the point at which core temperature reaches 38.0°C. Participants who do not reach 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking will have their time recorded at termination or completion. |
| Secondary | Time to 1.0°C increase in rectal temperature | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Time, in minutes, from the start of continuous walking to the point at which rectal temperature increases by 1.0°C above baseline. For participant safety, continuous walking will not continue beyond a rectal temperature of 38.5°C. Therefore, for participants who reach 38.5°C before attaining a 1.0°C increase in rectal temperature, the time at which 38.5°C is reached will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their time recorded at termination or completion. |
| Secondary | Average core temperature during work/rest cycles | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Average core temperature measured during the intermittent work-rest cycles following the initial continuous work period. |
| Secondary | Heart rate at core temperature of 38.0°C | Each morning and afternoon work bout on Day 1 and Day 2. | Heart rate measured at the time a participant reaches a rectal temperature of 38.0°C during the initial continuous walking period. For participants who do not reach a rectal temperature of 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking, heart rate at termination or completion will be recorded. |
| Secondary | Heart rate at 1.0°C increase in core temperature | Each morning and afternoon work bout on Day 1 and Day 2. | Heart rate measured at the time a participant achieves a 1.0°C increase in core temperature above baseline during the initial continuous walking period. For participant safety, continuous walking will not continue beyond a core temperature of 38.5°C. Therefore, for participants who reach a core temperature of 38.5°C before attaining a 1.0°C increase above baseline, the heart rate at 38.5°C will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their final recorded heart rate used. |
| Secondary | Average heart rate during work/rest cycles | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Average heart rate measured during the intermittent work-rest cycles following the initial continuous work period. |
| Secondary | Mean skin temperature at core temperature of 38.0°C | Each morning and afternoon work bout on Day 1 and Day 2. | Mean skin temperature measured at the time a participant reaches a core temperature of 38.0°C during the initial continuous walking period. For participants who do not reach a core temperature of 38.0°C before voluntary termination, reaching the applicable stopping criterion, or completing 240 minutes of continuous walking, mean skin temperature at termination or completion will be recorded. |
| Secondary | Mean skin temperature at 1.0°C increase in core temperature | Each morning and afternoon work bout on Day 1 and Day 2. | Mean skin temperature measured at the time a participant achieves a 1.0°C increase in core temperature above baseline during the initial continuous walking period. For participant safety, continuous walking will not continue beyond a core temperature of 38.5°C. Therefore, for participants who reach a core temperature of 38.5°C before attaining a 1.0°C increase above baseline, the mean skin temperature at 38.5°C will be recorded. Participants who voluntarily terminate exercise or complete 240 minutes of continuous walking before reaching either endpoint will have their final recorded mean skin temperature used. |
| Secondary | Average mean skin temperature during work/rest cycles | During each 240-minute morning and afternoon work bout on Day 1 and Day 2. | Average mean skin temperature measured during the intermittent work-rest cycles following the initial continuous work period. |
| Secondary | Overnight heart rate | Overnight recovery periods (18:30-08:00) on Night 1 and Night 2. | Average heart rate during the overnight recovery period. Heart rate will be measured continuously throughout each overnight exposure. |
| Secondary | Overnight mean skin temperature | Overnight recovery periods (18:30-08:00) on Night 1 and Night 2. | Average mean skin temperature during the overnight recovery period. Mean skin temperature will be measured continuously throughout each overnight exposure. |
| Secondary | Overnight core temperature | Overnight recovery periods (18:30-08:00) on Night 1 and Night 2. | Average core temperature during the overnight recovery period. Core temperature will be measured continuously throughout each overnight exposure. |
| Secondary | Metabolic workload | During morning and afternoon work bouts on Day 1 and Day 2. | Metabolic workload during simulated occupational work will be assessed using indirect calorimetry. Oxygen consumption (VO₂) and respiratory exchange ratio (RER) will be measured and used to calculate metabolic workload, expressed in watts per square meter (W/m²). Higher values indicate greater metabolic heat production and physiological work demand. |
| Secondary | Whole-body evaporative heat loss | Baseline approximately 7 days before exposure and post-exposure on the morning of Day 3. | Change in whole-body evaporative heat loss from baseline to post-exposure, assessed using direct air calorimetry during standardized exercise at three work intensities. |
| Secondary | Whole-body dry heat exchange | Baseline approximately 7 days before exposure and post-exposure on the morning of Day 3. | Change in whole-body dry heat exchange from baseline to post-exposure, assessed using direct air calorimetry during standardized exercise at three work intensities. |
| Secondary | Whole-body total heat loss | Baseline approximately 7 days before exposure and post-exposure on the morning of Day 3. | Change in whole-body total heat loss from baseline to post-exposure, assessed using direct air calorimetry during standardized exercise at three work intensities. |
| Secondary | Urine specific gravity | Assessed at baseline and throughout Day 1, Day 2, and Day 3. | Urine specific gravity will be measured to assess hydration status. Higher values indicate greater urine concentration and therefore poorer hydration status, whereas lower values indicate lower urine concentration and therefore better hydration status. |
| Secondary | Fluid loss from body mass change | Assessed at baseline and throughout Day 1, Day 2, and Day 3. | Fluid loss calculated from changes in body mass during each daytime work exposure, corrected for food and fluid intake. |
| Secondary | Changes in plasma volume | Assessed at baseline and throughout Day 1, Day 2, and Day 3. | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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