HyperthermiaNCT06475339
Predicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat
A study testing 30/30 work/rest cycle, 30/20 work/rest cycle and 40/30 work/rest cycle in people with Hyperthermia and Fatigue; Heat, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Fatigue; Heat
- What is being tested?
- 30/30 work/rest cycle, 30/20 work/rest cycle and 40/30 work/rest cycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Physically active
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Research and Education in Special Environments
Buffalo, New York, 14214
Riana R Pryor, PhD, ATC, 716-829-5456, RPryor@buffalo.edu
About this study
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.
- Conditions
- Hyperthermia, Fatigue; Heat
- Being tested
- 30/30 work/rest cycle, 30/20 work/rest cycle, 40/30 work/rest cycle, 20/12 work/rest cycle
- Medical subject headings
- Hyperthermia, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30/30 work/rest cycleOther
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 cycleOther
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 cycleOther
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 cycleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 30/30 work/rest cycle first | Active comparator | Participants will first complete the 30/30 work/rest cycle, and then complete the other three conditions in a randomized fashion Receives: Other: 30/30 work/rest cycle; Other: 30/20 work/rest cycle; Other: 40/30 work/rest cycle; Other: 20/12 work/rest cycle |
| 30/20 work/rest cycle first | Experimental | Participants will first complete the 30/20 work/rest cycle, and then complete the other three conditions in a randomized fashion Receives: Other: 30/30 work/rest cycle; Other: 30/20 work/rest cycle; Other: 40/30 work/rest cycle; Other: 20/12 work/rest cycle |
| 40/30 work/rest cycle first | Experimental | Participants will first complete the 40/30 work/rest cycle, and then complete the other three conditions in a randomized fashion Receives: Other: 30/30 work/rest cycle; Other: 30/20 work/rest cycle; Other: 40/30 work/rest cycle; Other: 20/12 work/rest cycle |
| 20/12 work/rest cycle first | Experimental | Participants will first complete the 20/12 work/rest cycle, and then complete the other three conditions in a randomized fashion Receives: Other: 30/30 work/rest cycle; Other: 30/20 work/rest cycle; Other: 40/30 work/rest cycle; Other: 20/12 work/rest cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Maximum gastrointestinal temperature reached during the work protocol
Measured: 180 minutes of work
Isometric mid-thigh pull strength
Maximum voluntary contraction strength assessed using a force plate
Measured: 180 minutes of work
Secondary outcomes (4)
Metabolic cost
Collected expired air using a one-way mask will be analyzed using a metabolic cart to calculate metabolic heat production
Measured: 180 minutes of work
Heart rate
Maximum heart rate measured using a telemetry strap throughout the work protocol
Measured: 180 minutes of work
Mean skin temperature
Maximum skin temperature measured using buttons at four skin sites
Measured: 180 minutes of work
Vastus lateralis electromyography
Wireless electromyography electrodes placed lengthwise over the vastus lateralis muscle belly
Measured: 180 minutes of work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
- Investigators
- Riana R Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475339
- Sponsor's protocol ID
- STUDY00007981
- Other IDs
- CDMRP-BA230031
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate results will be shared via publications and/or presentations. De-identified data may be shared and reviewed by the Department of Defense and as part of our Cooperative Research \& Development Agreement with the United States Army Research Institute of Environmental Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat
- ClinicalTrials.gov ID
- NCT06475339
- Acronym / sponsor ID
- STUDY00007981
- Conditions
- Hyperthermia, Fatigue; Heat
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30/30 work/rest cycle first | Active comparator | Other: 30/30 work/rest cycle, Other: 30/20 work/rest cycle, Other: 40/30 work/rest cycle, Other: 20/12 work/rest cycleParticipants will first complete the 30/30 work/rest cycle, and then complete the other three conditions in a randomized fashion |
| 30/20 work/rest cycle first | Experimental | Other: 30/30 work/rest cycle, Other: 30/20 work/rest cycle, Other: 40/30 work/rest cycle, Other: 20/12 work/rest cycleParticipants will first complete the 30/20 work/rest cycle, and then complete the other three conditions in a randomized fashion |
| 40/30 work/rest cycle first | Experimental | Other: 30/30 work/rest cycle, Other: 30/20 work/rest cycle, Other: 40/30 work/rest cycle, Other: 20/12 work/rest cycleParticipants will first complete the 40/30 work/rest cycle, and then complete the other three conditions in a randomized fashion |
| 20/12 work/rest cycle first | Experimental | Other: 30/30 work/rest cycle, Other: 30/20 work/rest cycle, Other: 40/30 work/rest cycle, Other: 20/12 work/rest cycleParticipants will first complete the 20/12 work/rest cycle, and then complete the other three conditions in a randomized fashion |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Physically active
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30/30 work/rest cycleParticipants 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. | Other | 20/12 work/rest cycle first, 30/20 work/rest cycle first, 30/30 work/rest cycle first, 40/30 work/rest cycle first |
| 30/20 work/rest cycleParticipants 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. | Other | 20/12 work/rest cycle first, 30/20 work/rest cycle first, 30/30 work/rest cycle first, 40/30 work/rest cycle first |
| 40/30 work/rest cycleParticipants 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. | Other | 20/12 work/rest cycle first, 30/20 work/rest cycle first, 30/30 work/rest cycle first, 40/30 work/rest cycle first |
| 20/12 work/rest cycleParticipants 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. | Other | 20/12 work/rest cycle first, 30/20 work/rest cycle first, 30/30 work/rest cycle first, 40/30 work/rest cycle first |
Primary outcome
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
4 secondary outcomes
Metabolic cost
Time frame: 180 minutes of work
Heart rate
Time frame: 180 minutes of work
Mean skin temperature
Time frame: 180 minutes of work
Vastus lateralis electromyography
Time frame: 180 minutes of work
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Aggregate results will be shared via publications and/or presentations. De-identified data may be shared and reviewed by the Department of Defense and as part of our Cooperative Research \& Development Agreement with the United States Army Research Institute of Environmental Medicine.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riana R Pryor, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30/30 work/rest cycle, 30/20 work/rest cycle and 40/30 work/rest cycle in people with Hyperthermia and Fatigue; Heat, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riana R Pryor, PhD (7168295456, rpryor@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: 180 minutes of work). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.