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

NCT ID: NCT06475339

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperthermia Fatigue; Heat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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30/30 work/rest cycle first

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

Group Type ACTIVE_COMPARATOR

30/30 work/rest cycle

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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.

30/20 work/rest cycle first

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

Group Type EXPERIMENTAL

30/30 work/rest cycle

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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.

40/30 work/rest cycle first

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

Group Type EXPERIMENTAL

30/30 work/rest cycle

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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.

20/12 work/rest cycle first

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

Group Type EXPERIMENTAL

30/30 work/rest cycle

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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

Intervention Type OTHER

Participants 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.

Interventions

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30/30 work/rest cycle

Participants 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.

Intervention Type OTHER

30/20 work/rest cycle

Participants 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.

Intervention Type OTHER

40/30 work/rest cycle

Participants 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.

Intervention Type OTHER

20/12 work/rest cycle

Participants 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Riana Pryor

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riana R Pryor, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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Center for Research and Education in Special Environments

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Riana R Pryor, PhD

Role: CONTACT

Phone: 7168295456

Email: [email protected]

Facility Contacts

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Riana R Pryor, PhD, ATC

Role: primary

Other Identifiers

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CDMRP-BA230031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00007981

Identifier Type: -

Identifier Source: org_study_id