Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
11 июля 2026 г. обновлено: Glen P. Kenny, University of Ottawa
Effects of Normobaric Hypoxia on Initial Stay Time and Physiological Strain During Moderate-Intensity Work in the Heat in Young and Older Males
Extreme heat events are becoming more frequent, intense, and prolonged, increasing the risk of heat-related illness among workers performing physically demanding work in hot environments. Occupational heat-stress guidelines use work-rest schedules to limit increases in core temperature and physiological strain, but they do not clearly define the safe maximum duration of continuous work before heat-mitigation controls should begin, known as the initial stay time. Recent work has generated initial stay time recommendations for young and older workers performing moderate-intensity work in the heat; however, these recommendations were developed under normoxic conditions. In many workplaces, heat may occur alongside additional stressors such as hypoxia, including work at altitude or in oxygen-reduced environments. Hypoxia can increase cardiovascular strain, reduce arterial oxygen saturation, and impair exercise tolerance, potentially compromising heat-stress guidance developed under normal oxygen conditions. Older workers may be especially vulnerable because of age-related reductions in thermoregulatory and cardiovascular function. It remains unclear whether hypoxia increases physiological strain during work in the heat or whether current initial stay time and recovery recommendations remain protective under combined heat and hypoxic stress.
The primary objective of this study is to determine whether hypoxia increases physiological strain during moderate-intensity work in the heat in young and older males. Specifically, the study will assess whether normoxia-derived initial stay times and recovery recommendations for work at 29°C wet-bulb globe temperature (37.5°C, 35% RH) remain effective during exposure to 14% inspired oxygen, simulating approximately 3000 m altitude. Healthy young and older males will complete two simulated occupational heat exposures: heat alone and heat plus hypoxia. Participants will perform moderate-intensity treadmill work based on age-specific initial stay times, followed by prescribed work-rest cycles and seated recovery. Core temperature, cardiovascular strain, oxygen saturation, skin temperature, hydration status, perceptual responses, mood, environmental stress symptoms, and cognitive function will be assessed to determine whether hypoxia modifies responses to work in the heat. Findings will help determine whether occupational heat-stress guidance requires refinement for workers exposed to combined heat and hypoxic stress.
Обзор исследования
Статус
Рекрутинг
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Glen P Kenny, PhD
- Номер телефона: 4282 6135625800
- Электронная почта: gkenny@uottawa.ca
Места учебы
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Ontario
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Ottawa, Ontario, Канада, K1N 6N5
- Рекрутинг
- University of Ottawa
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Контакт:
- Glen P Kenny, PhD
- Номер телефона: 4282 613-562-5800
- Электронная почта: gkenny@uottawa.ca
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Are regularly exposed to hot environments (e.g., occupational heat exposure)
- Are regularly exposed to hypoxic environments (e.g., high altitudes)
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Normoxic exposure
Participants complete a simulated moderate-intensity occupational heat exposure protocol in a hot environment (37.5°C, 35% RH) under normoxic conditions.
Participants walk on a treadmill until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
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Participants complete a simulated moderate-intensity occupational heat exposure protocol involving treadmill walking in a hot environment (37.5°C, 35% RH) under normoxic conditions (~20.9% inspired oxygen).
Participants walk until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
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Экспериментальный: Hypoxic exposure
Participants complete a simulated moderate-intensity occupational heat exposure protocol in a hot environment (37.5°C, 35% RH) with an added hypoxic exposure equivalent to 14% inspired oxygen.
Participants walk on a treadmill until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
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Participants complete a simulated moderate-intensity occupational heat exposure protocol involving treadmill walking in a hot environment (37.5°C, 35% RH) with an added hypoxic exposure equivalent to 14% inspired oxygen.
Participants walk until they reach their initial stay time, followed by prescribed work-rest cycles and seated recovery.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total work volume
Временное ограничение: During the 240-minute work period
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Total work completed during the 240-minute work bout.
The work period consists of an initial continuous walking phase to a core temperature 38.0°C or 1°C increase above baseline resting, followed by intermittent work-rest cycles.
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During the 240-minute work period
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time to core temperature of 38.0°C
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Time to 1.0°C increase in core temperature
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Average core temperature during work/rest cycles
Временное ограничение: During the 240-minute work period
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Average core temperature measured during the intermittent work-rest cycles following the initial continuous work period.
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During the 240-minute work period
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Heart rate at core temperature of 38.0°C
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Heart rate at 1.0°C increase in core temperature
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Average heart rate during work/rest cycles
Временное ограничение: During the 240-minute work period
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Average heart rate measured during the intermittent work-rest cycles following the initial continuous work period.
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During the 240-minute work period
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Mean skin temperature at core temperature of 38.0°C
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Mean skin temperature at 1.0°C increase in core temperature
Временное ограничение: During the 240-minute work period
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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.
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During the 240-minute work period
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Average mean skin temperature during work/rest cycles
Временное ограничение: During the 240-minute work period
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Average mean skin temperature measured during the intermittent work-rest cycles following the initial continuous work period.
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During the 240-minute work period
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Recovery core temperature
Временное ограничение: During 1 hour recovery following the 240-minute work period
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Average core temperature during the recovery period.
Core temperature will be measured continuously throughout recovery.
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During 1 hour recovery following the 240-minute work period
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Recovery heart rate
Временное ограничение: During 1 hour recovery following the 240-minute work period
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Average heart rate during the recovery period.
Heart rate will be measured continuously throughout recovery.
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During 1 hour recovery following the 240-minute work period
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Recovery mean skin temperature
Временное ограничение: During 1 hour recovery following the 240-minute work period
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Average mean skin temperature during the recovery period.
Skin temperature will be measured continuously throughout recovery.
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During 1 hour recovery following the 240-minute work period
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Tissue oxygenation
Временное ограничение: During 240-minute work bout and subsequent 1 hour recovery
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Functional near-infrared spectroscopy will be used to continuously assess changes in cerebral and skeletal muscle oxygenation
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During 240-minute work bout and subsequent 1 hour recovery
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Peripheral oxygen saturation
Временное ограничение: During 240-minute work bout and subsequent 1 hour recovery
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Peripheral oxygen saturation will be continuously monitored using pulse oximetry to assess the level of arterial oxygen saturation during work and recovery; indicates the degree of hypoxemia and helps determine whether reduced oxygen availability contributes to physiological strain during heat exposure
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During 240-minute work bout and subsequent 1 hour recovery
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Urine specific gravity
Временное ограничение: Assessed at baseline and after recovery
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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.
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Assessed at baseline and after recovery
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Fluid loss from body mass change
Временное ограничение: Assessed at baseline and throughout protocol
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Fluid loss calculated from changes in body mass during exposure, corrected for fluid intake.
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Assessed at baseline and throughout protocol
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Changes in plasma volume
Временное ограничение: Assessed at baseline and after recovery
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Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of exposure using the technique by Dill and Costill
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Assessed at baseline and after recovery
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Systolic blood pressure
Временное ограничение: Assessed at baseline and throughout protocol
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Systolic blood pressure measured in triplicate using automated oscillometry.
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Assessed at baseline and throughout protocol
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Diastolic blood pressure
Временное ограничение: Assessed at baseline and throughout protocol
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Diastolic blood pressure measured in triplicate using automated oscillometry.
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Assessed at baseline and throughout protocol
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Orthostatic hypotension questionnaire
Временное ограничение: Assessed at baseline and throughout protocol
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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"
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Assessed at baseline and throughout protocol
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Lake Louise Mountain Sickness Questionnaire
Временное ограничение: Assessed at baseline and throughout protocol
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Assess symptoms of acute mountain sickness, including headache, gastrointestinal discomfort, fatigue/weakness, dizziness/lightheadedness, and sleep disturbance.
Each symptom is scored from 0 - 3 and summed for a total score, with higher scores indicating greater symptom severity and acute mountain sickness typically defined as headache plus a total score ≥3.
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Assessed at baseline and throughout protocol
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Thermal sensation scale
Временное ограничение: Assessed at baseline and throughout protocol
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Thermal sensation will be assessed using a visual analog ASHRAE-based scale in response to the question "How hot do you feel?" Scores range from 0 (neutral) to 7 (extremely hot).
Higher scores indicate a greater sensation of heat and therefore a worse outcome, whereas lower scores indicate less perceived heat and therefore a better outcome.
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Assessed at baseline and throughout protocol
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Thermal comfort
Временное ограничение: Assessed at baseline and throughout protocol
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Thermal comfort will be assessed in response to the question "How comfortable does your body temperature feel?" using a visual analog scale ranging from 1 (comfortable) to 4 (very uncomfortable).
Higher scores indicate lower thermal comfort and therefore a worse outcome, whereas lower scores indicate greater thermal comfort and therefore a better outcome.
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Assessed at baseline and throughout protocol
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Thirst sensation
Временное ограничение: Assessed at baseline and throughout protocol
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Thirst sensation will be assessed in response to the question "How thirsty are you?" using a visual analog scale ranging from 1 (not thirsty at all) to 9 (very, very thirsty).
Higher scores indicate greater thirst and therefore a worse outcome, whereas lower scores indicate less thirst and therefore a better outcome.
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Assessed at baseline and throughout protocol
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Rating of Perceived Exertion (Borg 6-20 Scale)
Временное ограничение: Assessed during 240-minute work period
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Perceived exertion will be assessed using a visual analog scale in response to the question "How hard are you working?" Scores range from 6 (no exertion at all) to 20 (maximal exertion).
Higher scores indicate greater perceived effort and therefore a worse outcome, whereas lower scores indicate less perceived effort and therefore a better outcome.
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Assessed during 240-minute work period
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Feel-good scale
Временное ограничение: Assessed at baseline and throughout protocol
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Feelings of well-being will be assessed using a visual analog scale in response to the question "How good do you feel?" Scores range from -5 (very bad) to +5 (very good), with 0 representing neutral.
Higher scores indicate more positive feelings and therefore a better outcome, whereas lower scores indicate more negative feelings and therefore a worse outcome.
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Assessed at baseline and throughout protocol
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Profiles of Mood States (POMS-40) total mood disturbance score
Временное ограничение: Assessed at baseline and end of recovery
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Mood state will be assessed using the 40-item Profiles of Mood States (POMS-40) questionnaire.
Participants will rate how they feel at the time of assessment using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).
Responses will be summed to generate a total score.
Higher scores indicate greater overall mood disturbance and therefore a worse outcome, whereas lower scores indicate lower mood disturbance and therefore a better outcome.
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Assessed at baseline and end of recovery
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Environmental Symptoms Questionnaire-IV (ESQ-IV) total symptom score
Временное ограничение: Assessed at baseline and end of recovery
|
Environmental symptomatology associated with prolonged heat exposure will be assessed using the Environmental Symptoms Questionnaire-IV (ESQ-IV).
Participants will rate 68 symptoms using a 6-point Likert scale ranging from 0 (not at all) to 5 (extreme).
Responses are summed, with positive items reverse scored as appropriate, to generate a Total Symptom Score ranging from 0 to 340.
Higher scores indicate greater symptom burden and therefore a worse outcome, whereas lower scores indicate fewer symptoms and therefore a better outcome.
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Assessed at baseline and end of recovery
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Heart rate variability: standard deviation of normal R-R intervals (SDNN)
Временное ограничение: During 240-minute work bout and subsequent 1 hour recovery
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Cardiac autonomic modulation will be assessed using a 5-lead Holter electrocardiogram (ECG) monitor (DigiTrak XT, Philips Zymed, Andover, MA, USA).
Consecutive R-R intervals will be derived from the ECG recording to calculate the standard deviation of normal R-R intervals (SDNN), measured in milliseconds (ms).
Higher values indicate greater heart rate variability and cardiac autonomic modulation, whereas lower values indicate reduced heart rate variability and cardiac autonomic modulation.
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During 240-minute work bout and subsequent 1 hour recovery
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Heart rate variability: root mean square of successive differences (RMSSD)
Временное ограничение: During 240-minute work bout and subsequent 1 hour recovery
|
Cardiac autonomic modulation will be assessed using a 5-lead Holter electrocardiogram (ECG) monitor (DigiTrak XT, Philips Zymed, Andover, MA, USA).
Consecutive R-R intervals will be derived from the ECG recording to calculate the root mean square of successive differences between adjacent normal R-R intervals (RMSSD), measured in milliseconds (ms).
Higher values indicate greater parasympathetic modulation and heart rate variability, whereas lower values indicate reduced parasympathetic modulation and heart rate variability.
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During 240-minute work bout and subsequent 1 hour recovery
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Glen P Kenny, PhD, University of Ottawa
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
17 июня 2026 г.
Первичное завершение (Оцененный)
31 декабря 2026 г.
Завершение исследования (Оцененный)
28 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
17 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
17 июня 2026 г.
Первый опубликованный (Действительный)
24 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Раны и травмы
- Поведенческие симптомы
- Заболевания дыхательных путей
- Нарушения дыхания
- Признаки и симптомы, Респираторные
- Стресс, Психологический
- Профессиональные заболевания
- Патологические состояния, признаки и симптомы
- Поведение
- Признаки и симптомы
- Профессиональный стресс
- Гипертермия
- Гипоксия
- Нарушения теплового стресса
- Изменения температуры тела
- Высотная болезнь
- Двигательная активность
Другие идентификационные номера исследования
- HEPRU-2026-06-B
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .