Predicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat

University at Buffalo (UB)

Status: Enrolling

Conditions: Hyperthermia; Fatigue; Heat

Treatments: Other: 30/20 work/rest cycle; Other: 40/30 work/rest cycle; Other: 20/12 work/rest cycle; Other: 30/30 work/rest cycle

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06475339

STUDY00007981

CDMRP-BA230031 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

30/30 work/rest cycle first

Active Comparator group

Description:

Participants will first complete the 30/30 work/rest cycle, and then complete the other three conditions in a randomized fashion

Treatment:

Other: 30/30 work/rest cycle

Other: 20/12 work/rest cycle

Other: 40/30 work/rest cycle

Other: 30/20 work/rest cycle

30/20 work/rest cycle first

Experimental group

Description:

Participants will first complete the 30/20 work/rest cycle, and then complete the other three conditions in a randomized fashion

Treatment:

Other: 30/30 work/rest cycle

Other: 20/12 work/rest cycle

Other: 40/30 work/rest cycle

Other: 30/20 work/rest cycle

40/30 work/rest cycle first

Experimental group

Description:

Participants will first complete the 40/30 work/rest cycle, and then complete the other three conditions in a randomized fashion

Treatment:

Other: 30/30 work/rest cycle

Other: 20/12 work/rest cycle

Other: 40/30 work/rest cycle

Other: 30/20 work/rest cycle

20/12 work/rest cycle first

Experimental group

Description:

Participants will first complete the 20/12 work/rest cycle, and then complete the other three conditions in a randomized fashion

Treatment:

Other: 30/30 work/rest cycle

Other: 20/12 work/rest cycle

Other: 40/30 work/rest cycle

Other: 30/20 work/rest cycle