HyperthermiaNCT06599788
Work Design Interventions for Heat Resilience
A study testing Standard work pace, Reduced-pace work and Increased-pace work in people with Hyperthermia and Fatigue; Heat, run by State University of New York at Buffalo.
Trial summary
The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles. Participants will come to the lab a total of six times. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Fatigue; Heat, Work-Related Condition
- What is being tested?
- Standard work pace, Reduced-pace work and Increased-pace work
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Sep 2029
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
- 18-29 years old and 40-65 years old
- Completes at least 120 minutes of moderate to vigorous physical activity each week for at least the past 4 weeks
- Resistance trained or have recently held a job involving box carrying or a similar task
Who cannot join
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg) or tachycardic (resting heart rate > 100 bpm) during the screening visit
- Current nicotine use or previous use within the past 6 months
- Current of previous musculoskeletal injury limiting physical activity
- A positive pregnancy test at any point during the study
- Currently breastfeeding
- Study physician discretion based on any other medical condition or medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles.
Participants will come to the lab a total of six times. During four of the visits participants will complete a box carrying task, simulating unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.
- Conditions
- Hyperthermia, Fatigue; Heat, Work-Related Condition
- Being tested
- Standard work pace, Reduced-pace work, Increased-pace work, Additional rest breaks
- Keywords
- hyperthermia, worker, fatigue
- Medical subject headings
- Hyperthermia, Heat Stress Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard work paceBehavioural
Participants will work at a standard pace of one box per minute during the box carrying protocol
Reduced-pace workBehavioural
Participants will work at a slower pace than the standard work pace of the box carrying protocol
Increased-pace workBehavioural
Participants will work at a faster pace than the standard work pace of the box carrying protocol
Additional rest breaksBehavioural
Participants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard work pace first | Active comparator | The order of the interventions is standard work pace first, followed by the other interventions in a permuted block randomization design. Receives: Behavioral: Standard work pace; Behavioral: Reduced-pace work; Behavioral: Increased-pace work; Behavioral: Additional rest breaks |
| Reduced-pace work first | Experimental | The order of the interventions is reduced-pace work first, followed by the other interventions in a permuted block randomization design. Receives: Behavioral: Standard work pace; Behavioral: Reduced-pace work; Behavioral: Increased-pace work; Behavioral: Additional rest breaks |
| Increase-paced work first | Experimental | The order of the interventions is increased-pace work first, followed by the other interventions in a permuted block randomization design. Receives: Behavioral: Standard work pace; Behavioral: Reduced-pace work; Behavioral: Increased-pace work; Behavioral: Additional rest breaks |
| Additional rest breaks first | Experimental | The order of the interventions is additional rest breaks first, followed by the other interventions in a permuted block randomization design. Receives: Behavioral: Standard work pace; Behavioral: Reduced-pace work; Behavioral: Increased-pace work; Behavioral: Additional rest breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Troponin
Serum cardiac troponin concentration
Measured: 2 hours following work protocol, approximately 6 hours into the trial
Maximum Core Temperature
Highest core temperature attained during the work protocol
Measured: End of work protocol, approximately 4 hours into the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startSep 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599788
- Sponsor's protocol ID
- STUDY00112233
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A spreadsheet of the cleaned, de-identified individual data for all variables will be shared on at clinicaltrials.gov without restriction to ensure public availability. Individual data will be identified using unique participant identifier numbers. In addition to the datasets, a study protocol, data dictionary defining and describing all variables, and data collection instruments will be shared and associated with the relevant datasets.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Design Interventions for Heat Resilience
- ClinicalTrials.gov ID
- NCT06599788
- Acronym / sponsor ID
- STUDY00112233
- Conditions
- Hyperthermia, Fatigue; Heat, Work-Related Condition
- Keywords
- hyperthermia, worker, fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 19 Sep 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 goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles.
Participants will come to the lab a total of six times. During four of the visits participants will complete a box carrying task, simulating unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard work pace first | Active comparator | Behavioral: Standard work pace, Behavioral: Reduced-pace work, Behavioral: Increased-pace work, Behavioral: Additional rest breaksThe order of the interventions is standard work pace first, followed by the other interventions in a permuted block randomization design. |
| Reduced-pace work first | Experimental | Behavioral: Standard work pace, Behavioral: Reduced-pace work, Behavioral: Increased-pace work, Behavioral: Additional rest breaksThe order of the interventions is reduced-pace work first, followed by the other interventions in a permuted block randomization design. |
| Increase-paced work first | Experimental | Behavioral: Standard work pace, Behavioral: Reduced-pace work, Behavioral: Increased-pace work, Behavioral: Additional rest breaksThe order of the interventions is increased-pace work first, followed by the other interventions in a permuted block randomization design. |
| Additional rest breaks first | Experimental | Behavioral: Standard work pace, Behavioral: Reduced-pace work, Behavioral: Increased-pace work, Behavioral: Additional rest breaksThe order of the interventions is additional rest breaks first, followed by the other interventions in a permuted block randomization design. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy individuals
- 18-29 years old and 40-65 years old
- Completes at least 120 minutes of moderate to vigorous physical activity each week for at least the past 4 weeks
- Resistance trained or have recently held a job involving box carrying or a similar task
Key exclusion criteria (7 listed)
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg) or tachycardic (resting heart rate > 100 bpm) during the screening visit
- Current nicotine use or previous use within the past 6 months
- Current of previous musculoskeletal injury limiting physical activity
- A positive pregnancy test at any point during the study
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 |
|---|---|---|
| Standard work paceParticipants will work at a standard pace of one box per minute during the box carrying protocol | Behavioural | Additional rest breaks first, Increase-paced work first, Reduced-pace work first, Standard work pace first |
| Reduced-pace workParticipants will work at a slower pace than the standard work pace of the box carrying protocol | Behavioural | Additional rest breaks first, Increase-paced work first, Reduced-pace work first, Standard work pace first |
| Increased-pace workParticipants will work at a faster pace than the standard work pace of the box carrying protocol | Behavioural | Additional rest breaks first, Increase-paced work first, Reduced-pace work first, Standard work pace first |
| Additional rest breaksParticipants will work at the standard work pace during the box carrying protocol and have superimposed 5 minutes of rest every 30 minutes. | Behavioural | Additional rest breaks first, Increase-paced work first, Reduced-pace work first, Standard work pace first |
Primary outcome
Cardiac Troponin
Time frame: 2 hours following work protocol, approximately 6 hours into the trial
Serum cardiac troponin concentration
Maximum Core Temperature
Time frame: End of work protocol, approximately 4 hours into the trial
Highest core temperature attained during the work protocol
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. A spreadsheet of the cleaned, de-identified individual data for all variables will be shared on at clinicaltrials.gov without restriction to ensure public availability. Individual data will be identified using unique participant identifier numbers. In addition to the datasets, a study protocol, data dictionary defining and describing all variables, and data collection instruments will be shared and associated with the relevant datasets.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard work pace, Reduced-pace work and Increased-pace work in people with Hyperthermia and Fatigue; Heat, run by State University of New York at Buffalo.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Pryor (716-829-5456, rpryor@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Troponin (time frame: 2 hours following work protocol, approximately 6 hours into the trial). 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 30 Jun 2026.