HyperthermiaNCT05327764
Work-To-Rest Ratios
A study testing Work to rest cycles of 40:20 minutes and Work to rest cycles of 20:10 minutes in people with Hyperthermia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Work to rest cycles of 40:20 minutes and Work to rest cycles of 20:10 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18-39 year old individuals
- Physically active
Who cannot join
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm)
- Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin)
- Any form of tobacco or nicotine use in the past six months
- Current musculoskeletal injury impacting physical activity
- A positive pregnancy test at any point in the study
- Study physician discretion based on any other medical condition or medication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.
- Conditions
- Hyperthermia
- Being tested
- Work to rest cycles of 40:20 minutes, Work to rest cycles of 20:10 minutes
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work to rest cycles of 40:20 minutesOther
Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest
Work to rest cycles of 20:10 minutesOther
Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest
| Study group | Role | What they receive |
|---|---|---|
| 40:20 | Active comparator | Walking for 40 minutes, resting for 20 Receives: Other: Work to rest cycles of 40:20 minutes |
| 20:10 | Experimental | Walking for 40 minutes, resting for 20 Receives: Other: Work to rest cycles of 20:10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in core body temperature
Core body temperature is measured using a rectal thermistor
Measured: Upon completion of 2 hours of the work protocol
Change in heart rate
Heart rate is measured using a telemetry strap
Measured: Upon completion of 80 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 posted14 Apr 2022
- Study start21 Mar 2022
- Primary completion5 Nov 2023
- Study completion5 Nov 2023
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.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Model description
- Randomized counterbalanced study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
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
- Investigators
- Riana Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327764
- Sponsor's protocol ID
- STUDY00006115
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share these data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-To-Rest Ratios
- ClinicalTrials.gov ID
- NCT05327764
- Acronym / sponsor ID
- STUDY00006115
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 14 Apr 2022 (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 purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized counterbalanced study
| Arm | Type | Receives |
|---|---|---|
| 40:20 | Active comparator | Other: Work to rest cycles of 40:20 minutesWalking for 40 minutes, resting for 20 |
| 20:10 | Experimental | Other: Work to rest cycles of 20:10 minutesWalking for 40 minutes, resting for 20 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy 18-39 year old individuals
- Physically active
Key exclusion criteria (7 listed)
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm)
- Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin)
- Any form of tobacco or nicotine use in the past six months
- Current musculoskeletal injury impacting physical activity
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 |
|---|---|---|
| Work to rest cycles of 40:20 minutesWalking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest | Other | 40:20 |
| Work to rest cycles of 20:10 minutesWalking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest | Other | 20:10 |
Primary outcome
Change in core body temperature
Time frame: Upon completion of 2 hours of the work protocol
Core body temperature is measured using a rectal thermistor
Change in heart rate
Time frame: Upon completion of 80 minutes of work
Heart rate is measured using a telemetry strap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No. We do not plan to share these data with other researchers.
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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. This study is not recruiting at the moment.
Riana 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 Work to rest cycles of 40:20 minutes and Work to rest cycles of 20:10 minutes in people with Hyperthermia, 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 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: finished, as of the sponsor's last update on 9 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in core body temperature (time frame: Upon completion of 2 hours of the work protocol). 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 9 Nov 2023.