Center for Research and Education in Special Environments
Buffalo, New York, 14214, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06475339
Predicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat
The overall goal of this project is to identify a work/rest cycle that allows for faster mission completion needed in emergency situations, compared to current Army heat guidance, while mitigating heat strain and neuromuscular fatigue. This project will determine the trade-off between faster mission completion and risk of heat strain and physical performance decrements. Completion of this project will allow military leaders to make informed decisions by understanding the impact of their choices on the magnitude of physical performance decrements and expected heat casualties, setting up hot weather missions for success.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–39 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy individuals
- Physically active
Exclusion criteria
- History of cardiovascular, metabolic (such as clinical thyroid disease), respiratory, neural, or renal disease
- Hypertensive (systolic blood pressure > 139 mmHg, diastolic blood pressure > 89 mmHg) or tachycardic (heart rate > 100 bpm) during the screening visit
- Taking medications or supplements known to effect physiologic responses to exercise or thermoregulation (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)
- Tobacco or nicotine use currently or in the past six months
- Musculoskeletal injury expected to impact exercise in the protocol
- A positive pregnancy test at any point in the study
- Study physician discretion based on any other medical condition or medication
- Inability to understand or follow instructions or the protocol
- Gastrointestinal disease or previous surgery prohibiting core temperature capsule use. Participants with a contraindication can opt to insert the pill rectally as a suppository.
Treatment and study plan
30/30 work/rest cycle
OtherParticipants will walk on a treadmill while wearing a weighted backpack to a work/rest cycle of 30 minutes of work followed by 30 minutes of rest.
30/20 work/rest cycle
OtherParticipants will walk on a treadmill while wearing a weighted backpack to a work/rest cycle of 30 minutes of work followed by 20 minutes of rest.
40/30 work/rest cycle
OtherParticipants will walk on a treadmill while wearing a weighted backpack to a work/rest cycle of 40 minutes of work followed by 30 minutes of rest.
20/12 work/rest cycle
OtherParticipants will walk on a treadmill while wearing a weighted backpack to a work/rest cycle of 20 minutes of work followed by 12 minutes of rest.
Primary outcomes
-
Core temperature
Time frame: 180 minutes of work
Maximum gastrointestinal temperature reached during the work protocol
-
Isometric mid-thigh pull strength
Time frame: 180 minutes of work
Maximum voluntary contraction strength assessed using a force plate
Secondary outcomes
-
Metabolic cost
Time frame: 180 minutes of work
Collected expired air using a one-way mask will be analyzed using a metabolic cart to calculate metabolic heat production
-
Heart rate
Time frame: 180 minutes of work
Maximum heart rate measured using a telemetry strap throughout the work protocol
-
Mean skin temperature
Time frame: 180 minutes of work
Maximum skin temperature measured using buttons at four skin sites
-
Vastus lateralis electromyography
Time frame: 180 minutes of work
Wireless electromyography electrodes placed lengthwise over the vastus lateralis muscle belly
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
State University of New York at Buffalo
Other
Collaborators
- United States Department of Defense
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 26, 2024
- Registry last updated
- Jan 26, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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