HyperthermiaNCT04624919
Comparison of Fatigue in Varying Hot Environments
A study testing Hot/Dry and Warm/Humid in people with Hyperthermia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work. 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?
- Hot/Dry and Warm/Humid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 30 Jun 2021
- 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
- 18-39 y old men and women
- Self-reported to be healthy
Who cannot join
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Current musculoskeletal injury
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- Currently pregnant or breastfeeding, or planning to become pregnant during the study
- Inability to follow the rules of the protocols or understand the consent form
- Contraindications of consuming a core temperature monitoring pill
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Exercise in Special Environments
Buffalo, New York, 14214
About this study
The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.
Read the detailed description
After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.
- Conditions
- Hyperthermia
- Being tested
- Hot/Dry, Warm/Humid
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot/DryOther
Work is completed in a hot/dry environment.
Warm/HumidOther
Work is completed in a warm/humid environment
| Study group | Role | What they receive |
|---|---|---|
| Hot/Dry | Active comparator | Not described Receives: Other: Hot/Dry |
| Warm/Humid | Experimental | Not described Receives: Other: Warm/Humid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoothness of movement
The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder.
Measured: 90 minutes
Energy Expenditure
The amount of energy the body is expending during work. This is measured using indirect calorimetry.
Measured: 90 minutes
Secondary outcomes (1)
Perceptual fatigue
The degree of fatigue that the subjects perceive during work. This is measured using a subjective likert 0-10 scale named the Fatigue Scale with 0 indicting "no fatigue at all" and 10 indicating "completely fatigued".
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start10 Dec 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, counterbalanced crossover design
- Masking
- None (open label)
- Enrolment
- 13 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624919
- Sponsor's protocol ID
- STUDY00004012
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data can be made available upon written request.
Publications
Bartman NE, Vargas NT, Cavuoto LA, Hostler D, Pryor RR. Heat strain differences walking in hot-dry and warm-wet environments of equivalent wet bulb globe temperature. Temperature (Austin). 2024 Aug 26;11(4):333-349. doi: 10.1080/23328940.2024.2384185. eCollection 2024.
PubMed 39583902
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fatigue in Varying Hot Environments
- ClinicalTrials.gov ID
- NCT04624919
- Acronym / sponsor ID
- STUDY00004012
- Conditions
- Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Nov 2020 (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 this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.
Detailed description
After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, counterbalanced crossover design
| Arm | Type | Receives |
|---|---|---|
| Hot/Dry | Active comparator | Other: Hot/Dry |
| Warm/Humid | Experimental | Other: Warm/Humid |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-39 y old men and women
- Self-reported to be healthy
Key exclusion criteria (7 listed)
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Current musculoskeletal injury
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- Currently pregnant or breastfeeding, or planning to become pregnant 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 |
|---|---|---|
| Hot/DryWork is completed in a hot/dry environment. | Other | Hot/Dry |
| Warm/HumidWork is completed in a warm/humid environment | Other | Warm/Humid |
Primary outcome
Smoothness of movement
Time frame: 90 minutes
The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder.
Energy Expenditure
Time frame: 90 minutes
The amount of energy the body is expending during work. This is measured using indirect calorimetry.
1 secondary outcome
Perceptual fatigue
Time frame: 90 minutes
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 14 Oct 2021.
- Derived from this study: PubMed 39583902Bartman NE, Vargas NT, Cavuoto LA, Hostler D, Pryor RR. Heat strain differences walking in hot-dry and warm-wet environments of equivalent wet bulb globe temperature. Temperature (Austin). 2024 Aug 26;11(4):333-349. doi: 10.1080/23328940.2024.2384185. eCollection 2024.
- Individual participant dataSharing planned: No. Individual participant data can be made available upon written request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot/Dry and Warm/Humid 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 14 Oct 2021. 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?
Smoothness of movement (time frame: 90 minutes). 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?
On the ClinicalTrials.gov record for NCT04624919, which also lists 1 linked publication.
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 14 Oct 2021.