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CompletedNCT05600452Updated Dec 6, 2023

Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme

An interventional study of Heat acclimation in Heat Stress, sponsored by University of Portsmouth. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by University of Portsmouth · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jan 2020, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Heat Stress

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03

In context

Heat Stress Disorders

111 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 37 is above the median of 24 across 97 interventional studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

University of Portsmouth is the lead sponsor of 32 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Traditional heat acclimation

    The traditional heat acclimation programme will consist of daily 75-minute heat exposures for eight consecutive days

    Other: Heat acclimation

  • 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

    Other: Heat acclimation

Interventions

  • OtherHeat acclimation

    Repeated heat exposures with light exercise sufficient to elevate deep body temperature to \~ 38.5C

06

What researchers measure

Primary outcomes

  1. Reduction in the peak deep body temperature

    Rectal temperature measurement during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

Secondary outcomes

  1. Reduction in the resting deep body temperature

    Rectal temperature measurement during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  2. Reduction in the peak mean body temperature

    Weighted rectal and mean skin temperature measurement during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  3. Reduction in the resting mean body temperature

    Weighted rectal and mean skin temperature measurement during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  4. Increased plasma volume

    Change in plasma volume calculated from resting haemoglobin and haematocrit prior to a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  5. Increased sweating rate

    Sweating rate calculated from change in nude body mass and accounting for fluid consumption during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  6. Reduced sweat sodium concentration

    Sweating sodium concentration assessed from sweat collected in a custom sweat patch on the back during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  7. Reduced exercise heart rate

    Heart rate measured using chest telemetry during a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  8. Increased resting intracellular heat shock protein 70 content

    Assessed in peripheral blood mononuclear cells obtained before a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  9. Increased post heat stress intracellular heat shock protein 70 content

    Assessed in peripheral blood mononuclear cells obtained after a heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  10. Increased resting intracellular heat shock protein 90 alpha content

    Assessed in peripheral blood mononuclear cells obtained before a heat stress tests

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  11. Increased post heat stress intracellular heat shock protein 90 alpha content

    Assessed in peripheral blood mononuclear cells obtained after a heat stress tests

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  12. Maximal oxygen uptake

    Highest rate of oxygen uptake during graded cycling exercise

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  13. Lactate threshold

    Power output at 4 mmol.L-1 blood lactate during graded cycling exercise

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  14. Gross mechanical efficiency

    Percentage ratio of external work achieved compared to the total energy expenditure during graded cycling exercise below the lactate threshold

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  15. Peak power output

    Highest power output achieved during exhaustive cycling exercise

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  16. Peripheral oxygen saturation during exposure to hypoxia

    Assessed using ear or finger tip pulse oximetry during a hypoxic tolerance test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  17. Heart rate during exposure to hypoxia

    Assessed using chest telemetry during a hypoxic tolerance test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  18. Minute ventilation during exposure to hypoxia

    Expire volume of air per minute during a hypoxic tolerance test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  19. Plasma neutrophil gelatinase-associated lipocalin

    Concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  20. Urine neutrophil gelatinase-associated lipocalin

    Concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  21. Plasma kidney injury molecule-1

    Concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  22. Urine kidney injury molecule-1

    Concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  23. Tissue inhibitor of metalloproteinase 2

    Urine concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  24. Insulin-like growth factor-binding protein 7

    Urine concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  25. Intestinal fatty acid binding protein

    Serum concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  26. Soluble cluster of differentiation 14

    Plasma concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  27. Lipopolysaccharide binding protein

    Plasma concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  28. Interleukin-6

    Plasma concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  29. Cortisol

    Plasma concentration change pre to post heat stress test

    Time frame: Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

07

Study locations

1 site
  • University of Portsmouth
    Portsmouth, Hampshire PO1 2ER, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — Data will be published as measures of central tendency and dispersion (e.g. Mean and Standard deviation)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05600452
Lead sponsor
University of Portsmouth
Collaborators
Coventry University, Teesside University
Responsible party
Jo Corbett (Reader in Environmental Physiology, University of Portsmouth) — Principal investigator
First posted
Oct 31, 2022
Start date
Jan 17, 2020
Primary completion
Jan 4, 2023
Completion
Jan 4, 2023
Last update
Dec 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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