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OpenTrials
Completed

NCT Number: NCT05600452

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Portsmouth

Portsmouth, Hampshire, PO1 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat acclimation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Gross mechanical efficiency

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

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

  15. 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

  16. 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

  17. 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)

    Assessed using chest telemetry during a hypoxic tolerance test

  18. 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

  19. 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

  20. Urine 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Collaborators

  • Coventry University
  • Teesside University

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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