- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600452
Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme
December 5, 2023 updated by: Jo Corbett, University of Portsmouth
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO1 2ER
- University of Portsmouth
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional heat acclimation
The traditional heat acclimation programme will consist of daily 75-minute heat exposures for eight consecutive days
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Repeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C
|
|
Experimental: Condensed heat acclimation
The condensed heat acclimation programme will consist of two consecutive days with four, 75-minute heat exposures undertaken on each day
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Repeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Rectal temperature measurement during a heat stress test
|
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)
|
Weighted rectal and mean skin temperature measurement during a heat stress test
|
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)
|
Weighted rectal and mean skin temperature measurement during a heat stress test
|
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)
|
Change in plasma volume calculated from resting haemoglobin and haematocrit prior to a heat stress test
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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)
|
Sweating rate calculated from change in nude body mass and accounting for fluid consumption during a heat stress test
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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)
|
Sweating sodium concentration assessed from sweat collected in a custom sweat patch on the back during a heat stress test
|
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)
|
Heart rate measured using chest telemetry during a heat stress test
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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)
|
Assessed in peripheral blood mononuclear cells obtained before a heat stress test
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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)
|
Assessed in peripheral blood mononuclear cells obtained after a heat stress test
|
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)
|
Assessed in peripheral blood mononuclear cells obtained before a heat stress tests
|
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)
|
Assessed in peripheral blood mononuclear cells obtained after a heat stress tests
|
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)
|
Highest rate of oxygen uptake during graded cycling exercise
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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)
|
Power output at 4 mmol.L-1 blood lactate during graded cycling exercise
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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)
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Percentage ratio of external work achieved compared to the total energy expenditure during graded cycling exercise below the lactate threshold
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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)
|
Highest power output achieved during exhaustive cycling exercise
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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)
|
Assessed using ear or finger tip pulse oximetry during a hypoxic tolerance test
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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)
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Assessed using chest telemetry during a hypoxic tolerance test
|
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)
|
Expire volume of air per minute during a hypoxic tolerance test
|
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)
|
Concentration change pre to post heat stress test
|
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)
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Concentration change pre to post heat stress test
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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)
|
Concentration change pre to post heat stress test
|
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)
|
Concentration change pre to post heat stress test
|
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)
|
Urine concentration change pre to post heat stress test
|
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)
|
Urine concentration change pre to post heat stress test
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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)
|
Serum concentration change pre to post heat stress test
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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)
|
Plasma concentration change pre to post heat stress test
|
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)
|
Plasma concentration change pre to post heat stress test
|
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)
|
Plasma concentration change pre to post heat stress test
|
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)
|
Plasma concentration change pre to post heat stress test
|
Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2020
Primary Completion (Actual)
January 4, 2023
Study Completion (Actual)
January 4, 2023
Study Registration Dates
First Submitted
October 21, 2022
First Submitted That Met QC Criteria
October 26, 2022
First Posted (Actual)
October 31, 2022
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1017/MoDREC/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be published as measures of central tendency and dispersion (e.g.
Mean and Standard deviation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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