Heat StressNCT05600452
Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme
A study testing Heat acclimation in people with Heat Stress, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
Repeated exposure to heat in a laboratory setting (acclimation) elicits a range of adaptations, which reduce heat illness risk and increase work capacity in the heat. Traditional approaches to heat acclimation require daily heat exposures of 1 to 2 hours over ~7 to 10 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stress
- What is being tested?
- Heat acclimation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2020to 4 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Physically active and healthy as determined by pre-participation health screening questionnaire.
- Free of COVID-19 symptoms (loss or change in sense of smell or taste, fever and new, continuous cough) as determined by pre-screening questionnaire.
- Resting diastolic blood pressure between 60 and 90 mmHg; resting systolic blood pressure between 90 and 150 mmHg A resting ECG is required if: individuals are over 30 years of age; they are unfamiliar with exercise of a maximal nature; they have a family history of adverse cardiac events. The ECG is to be reviewed by the Independent Medical Officer.
Who cannot join
- Current smokers
- Recent (< 3 months) participation in a formal heat acclimation regimen, or regular frequent heat exposures that may render the participant partially heat acclimated (other than regular exercise)
- Recent (< 3 months) high altitude (>1 500m ) sojourn that may render the participant partially altitude acclimated
- Diagnosed cardiovascular, metabolic or respiratory conditions (excluding asthma)
- Prior history of heat illness
- Prior history of collapse or intolerance with exposure to altitude
Show all 11Show fewer
- Recent blood donation (within 3 months of commencing study)
- Baseline serum sodium level <135 mmol.L-1
- Any other extant medical condition which may be exacerbated by participation
- Participants with inadequate understanding of English.
- Any volunteers who are currently participating in any other research studies which may influence their responses or the results obtained
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Portsmouth
Portsmouth, Hampshire, PO1 2ER
About this study
Repeated exposure to heat in a laboratory setting (acclimation) elicits a range of adaptations, which reduce heat illness risk and increase work capacity in the heat. Traditional approaches to heat acclimation require daily heat exposures of 1 to 2 hours over ~7 to 10 consecutive days. Heat acclimation approaches which reduce the number of days to achieve acclimation may have utility. The primary purpose of the proposed research is to determine whether it is possible to achieve a similar degree of heat acclimation to that seen with a traditional longer-term heat acclimation approach by increasing the frequency of heat exposure, utilising multiple daily heat exposures over a smaller number of days. Secondary aims of the research are to examine whether heat acclimation provides cross-adaptation to a hypoxic stressor and whether heat acclimation improves aerobic fitness.
Read the detailed description
Individuals are often required to operate in adverse conditions and may be exposed to prolonged periods of high ambient heat and humidity. High environmental temperatures impair work capacity and increase heat-illness risk. Repeated exposure to heat in a laboratory setting (acclimation) elicits a range of adaptations, which reduce heat illness risk and increase work capacity in the heat. However, traditional approaches to heat acclimation are time consuming, typically requiring daily heat exposures of 1 to 2 hours over ~7 to 10 consecutive days. This can be logistically difficult to implement and impractical, particularly in situations where an individual must be rapidly deployed. Therefore, heat acclimation approaches which reduce the number of days to achieve acclimation may have utility. In addition, recent research studies have suggested that adaptation to heat may improve tolerance to hypoxia (cross-adaptation) and improve aerobic fitness; these effects may also be beneficial in a military context. Therefore, the primary purpose of the proposed research is to determine whether it is possible to achieve a similar degree of heat acclimation to that seen with a traditional longer-term heat acclimation approach by increasing the frequency of heat exposure, utilising multiple daily heat exposures over a smaller number of days. Secondary aims of the research are to examine whether heat acclimation provides cross-adaptation to a hypoxic stressor and whether heat acclimation improves aerobic fitness. Heat acclimation will be evaluated using a range of whole-body (cardiovascular, thermoregulatory, psychophysiological) and biochemical markers.
- Conditions
- Heat Stress
- Being tested
- Heat acclimation
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat acclimationOther
Repeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C
| Study group | Role | What they receive |
|---|---|---|
| Traditional heat acclimation | Active comparator | The traditional heat acclimation programme will consist of daily 75-minute heat exposures for eight consecutive days Receives: Other: Heat acclimation |
| Condensed heat acclimation | Experimental | The condensed heat acclimation programme will consist of two consecutive days with four, 75-minute heat exposures undertaken on each day Receives: Other: Heat acclimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the peak deep body temperature
Rectal temperature measurement during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary outcomes (29)
Reduction in the resting deep body temperature
Rectal temperature measurement during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduction in the peak mean body temperature
Weighted rectal and mean skin temperature measurement during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduction in the resting mean body temperature
Weighted rectal and mean skin temperature measurement during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased plasma volume
Change in plasma volume calculated from resting haemoglobin and haematocrit prior to a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased sweating rate
Sweating rate calculated from change in nude body mass and accounting for fluid consumption during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduced sweat sodium concentration
Sweating sodium concentration assessed from sweat collected in a custom sweat patch on the back during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduced exercise heart rate
Heart rate measured using chest telemetry during a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased resting intracellular heat shock protein 70 content
Assessed in peripheral blood mononuclear cells obtained before a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased post heat stress intracellular heat shock protein 70 content
Assessed in peripheral blood mononuclear cells obtained after a heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased resting intracellular heat shock protein 90 alpha content
Assessed in peripheral blood mononuclear cells obtained before a heat stress tests
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased post heat stress intracellular heat shock protein 90 alpha content
Assessed in peripheral blood mononuclear cells obtained after a heat stress tests
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Maximal oxygen uptake
Highest rate of oxygen uptake during graded cycling exercise
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Lactate threshold
Power output at 4 mmol.L-1 blood lactate during graded cycling exercise
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Gross mechanical efficiency
Percentage ratio of external work achieved compared to the total energy expenditure during graded cycling exercise below the lactate threshold
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Peak power output
Highest power output achieved during exhaustive cycling exercise
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Peripheral oxygen saturation during exposure to hypoxia
Assessed using ear or finger tip pulse oximetry during a hypoxic tolerance test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Heart rate during exposure to hypoxia
Assessed using chest telemetry during a hypoxic tolerance test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Minute ventilation during exposure to hypoxia
Expire volume of air per minute during a hypoxic tolerance test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Plasma neutrophil gelatinase-associated lipocalin
Concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Urine neutrophil gelatinase-associated lipocalin
Concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Plasma kidney injury molecule-1
Concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Urine kidney injury molecule-1
Concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Tissue inhibitor of metalloproteinase 2
Urine concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Insulin-like growth factor-binding protein 7
Urine concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Intestinal fatty acid binding protein
Serum concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Soluble cluster of differentiation 14
Plasma concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Lipopolysaccharide binding protein
Plasma concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Interleukin-6
Plasma concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Cortisol
Plasma concentration change pre to post heat stress test
Measured: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start17 Jan 2020
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies 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
- Parallel groups
- Model description
- Parallel groups design
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Coventry University, Teesside University
- Responsible party
- Principal investigator, Jo Corbett, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600452
- Sponsor's protocol ID
- 1017/MoDREC/19
- Status last verified
- Dec 2023
- First submitted
- 21 Oct 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published as measures of central tendency and dispersion (e.g. Mean and Standard deviation)
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme
- ClinicalTrials.gov ID
- NCT05600452
- Acronym / sponsor ID
- 1017/MoDREC/19
- Conditions
- Heat Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Coventry University, Teesside University
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 31 Oct 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.
Repeated exposure to heat in a laboratory setting (acclimation) elicits a range of adaptations, which reduce heat illness risk and increase work capacity in the heat. Traditional approaches to heat acclimation require daily heat exposures of 1 to 2 hours over ~7 to 10 consecutive days. Heat acclimation approaches which reduce the number of days to achieve acclimation may have utility. The primary purpose of the proposed research is to determine whether it is possible to achieve a similar degree of heat acclimation to that seen with a traditional longer-term heat acclimation approach by increasing the frequency of heat exposure, utilising multiple daily heat exposures over a smaller number of days. Secondary aims of the research are to examine whether heat acclimation provides cross-adaptation to a hypoxic stressor and whether heat acclimation improves aerobic fitness.
Detailed description
Individuals are often required to operate in adverse conditions and may be exposed to prolonged periods of high ambient heat and humidity. High environmental temperatures impair work capacity and increase heat-illness risk. Repeated exposure to heat in a laboratory setting (acclimation) elicits a range of adaptations, which reduce heat illness risk and increase work capacity in the heat. However, traditional approaches to heat acclimation are time consuming, typically requiring daily heat exposures of 1 to 2 hours over ~7 to 10 consecutive days. This can be logistically difficult to implement and impractical, particularly in situations where an individual must be rapidly deployed. Therefore, heat acclimation approaches which reduce the number of days to achieve acclimation may have utility. In addition, recent research studies have suggested that adaptation to heat may improve tolerance to hypoxia (cross-adaptation) and improve aerobic fitness; these effects may also be beneficial in a military context. Therefore, the primary purpose of the proposed research is to determine whether it is possible to achieve a similar degree of heat acclimation to that seen with a traditional longer-term heat acclimation approach by increasing the frequency of heat exposure, utilising multiple daily heat exposures over a smaller number of days. Secondary aims of the research are to examine whether heat acclimation provides cross-adaptation to a hypoxic stressor and whether heat acclimation improves aerobic fitness. Heat acclimation will be evaluated using a range of whole-body (cardiovascular, thermoregulatory, psychophysiological) and biochemical markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel groups design
| Arm | Type | Receives |
|---|---|---|
| Traditional heat acclimation | Active comparator | Other: Heat acclimationThe traditional heat acclimation programme will consist of daily 75-minute heat exposures for eight consecutive days |
| Condensed heat acclimation | Experimental | Other: Heat acclimationThe condensed heat acclimation programme will consist of two consecutive days with four, 75-minute heat exposures undertaken on each day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Physically active and healthy as determined by pre-participation health screening questionnaire.
- Free of COVID-19 symptoms (loss or change in sense of smell or taste, fever and new, continuous cough) as determined by pre-screening questionnaire.
- Resting diastolic blood pressure between 60 and 90 mmHg; resting systolic blood pressure between 90 and 150 mmHg A resting ECG is required if: individuals are over 30 years of age; they are unfamiliar with exercise of a maximal nature; they have a family history of adverse cardiac events. The ECG is to be reviewed by the Independent Medical Officer.
Key exclusion criteria (11 listed)
- Current smokers
- Recent (< 3 months) participation in a formal heat acclimation regimen, or regular frequent heat exposures that may render the participant partially heat acclimated (other than regular exercise)
- Recent (< 3 months) high altitude (>1 500m ) sojourn that may render the participant partially altitude acclimated
- Diagnosed cardiovascular, metabolic or respiratory conditions (excluding asthma)
- Prior history of heat illness
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 |
|---|---|---|
| Heat acclimationRepeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C | Other | Condensed heat acclimation, Traditional heat acclimation |
Primary outcome
Reduction in the peak deep body temperature
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Rectal temperature measurement during a heat stress test
29 secondary outcomes
Reduction in the resting deep body temperature
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduction in the peak mean body temperature
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduction in the resting mean body temperature
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased plasma volume
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased sweating rate
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduced sweat sodium concentration
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Reduced exercise heart rate
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased resting intracellular heat shock protein 70 content
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased post heat stress intracellular heat shock protein 70 content
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased resting intracellular heat shock protein 90 alpha content
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Increased post heat stress intracellular heat shock protein 90 alpha content
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Maximal oxygen uptake
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Lactate threshold
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Gross mechanical efficiency
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Peak power output
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Peripheral oxygen saturation during exposure to hypoxia
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Heart rate during exposure to hypoxia
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Minute ventilation during exposure to hypoxia
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Plasma neutrophil gelatinase-associated lipocalin
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Urine neutrophil gelatinase-associated lipocalin
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Plasma kidney injury molecule-1
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Urine kidney injury molecule-1
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Tissue inhibitor of metalloproteinase 2
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Insulin-like growth factor-binding protein 7
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Intestinal fatty acid binding protein
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Soluble cluster of differentiation 14
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Lipopolysaccharide binding protein
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Interleukin-6
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Cortisol
Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
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 6 Dec 2023.
- Individual participant dataSharing planned: No. Data will be published as measures of central tendency and dispersion (e.g. Mean and Standard deviation)
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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 Heat acclimation in people with Heat Stress, run by University of Portsmouth at 1 site in United Kingdom.
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 11 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 6 Dec 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 Kingdom. 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?
Reduction in the peak deep body temperature (time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)). 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 6 Dec 2023.