Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
Effects of Normobaric Hypoxia on Initial Stay Time and Physiological Strain During Moderate-Intensity Work in the Heat in Young and Older Males
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2026
CompletedStudy Start
First participant enrolled
June 17, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
July 14, 2026
July 1, 2026
7 months
June 17, 2026
July 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total work volume
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.
During the 240-minute work period
Secondary Outcomes (30)
Time to core temperature of 38.0°C
During the 240-minute work period
Time to 1.0°C increase in core temperature
During the 240-minute work period
Average core temperature during work/rest cycles
During the 240-minute work period
Heart rate at core temperature of 38.0°C
During the 240-minute work period
Heart rate at 1.0°C increase in core temperature
During the 240-minute work period
- +25 more secondary outcomes
Study Arms (2)
Normoxic exposure
EXPERIMENTALParticipants 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.
Hypoxic exposure
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa
Ottawa, Ontario, K1N 6N5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glen P Kenny, PhD
University of Ottawa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor, University Research Chair
Study Record Dates
First Submitted
June 17, 2026
First Posted
June 24, 2026
Study Start
June 17, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
July 14, 2026
Record last verified: 2026-07