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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05600452
Other study ID # 1017/MoDREC/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2020
Est. completion date January 4, 2023

Study information

Verified date December 2023
Source University of Portsmouth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 4, 2023
Est. primary completion date January 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Heat acclimation
Repeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C

Locations

Country Name City State
United Kingdom University of Portsmouth Portsmouth Hampshire

Sponsors (3)

Lead Sponsor Collaborator
University of Portsmouth Coventry University, Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in the peak deep body temperature 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 Reduction in the resting deep body temperature 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 Reduction in the peak mean body temperature 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)
Secondary Reduction in the resting mean body temperature 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)
Secondary Increased plasma volume Change in plasma volume calculated from resting haemoglobin and haematocrit prior to a heat stress test Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Increased sweating rate Sweating rate calculated from change in nude body mass and accounting for fluid consumption during a heat stress test Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Reduced sweat sodium concentration 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)
Secondary Reduced exercise heart rate Heart rate measured using chest telemetry during a heat stress test Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Increased resting intracellular heat shock protein 70 content Assessed in peripheral blood mononuclear cells obtained before a heat stress test Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Increased post heat stress intracellular heat shock protein 70 content 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)
Secondary Increased resting intracellular heat shock protein 90 alpha content 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)
Secondary Increased post heat stress intracellular heat shock protein 90 alpha content 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)
Secondary Maximal oxygen uptake Highest rate of oxygen uptake during graded cycling exercise Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Lactate threshold Power output at 4 mmol.L-1 blood lactate during graded cycling exercise Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Gross mechanical efficiency Percentage ratio of external work achieved compared to the total energy expenditure during graded cycling exercise below the lactate threshold Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Peak power output Highest power output achieved during exhaustive cycling exercise Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Peripheral oxygen saturation during exposure to hypoxia Assessed using ear or finger tip pulse oximetry during a hypoxic tolerance test Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)
Secondary Heart rate during exposure to hypoxia 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)
Secondary Minute ventilation during exposure to hypoxia 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)
Secondary Plasma neutrophil gelatinase-associated lipocalin 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)
Secondary Urine neutrophil gelatinase-associated lipocalin 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)
Secondary Plasma kidney injury molecule-1 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)
Secondary Urine kidney injury molecule-1 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)
Secondary Tissue inhibitor of metalloproteinase 2 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)
Secondary Insulin-like growth factor-binding protein 7 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)
Secondary Intestinal fatty acid binding protein Serum 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)
Secondary Soluble cluster of differentiation 14 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)
Secondary Lipopolysaccharide binding protein 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)
Secondary Interleukin-6 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)
Secondary Cortisol 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)
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