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

Primary Purpose

Heat Stress

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Heat acclimation
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Stress

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of PortsmouthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional heat acclimation

Condensed heat acclimation

Arm Description

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

The condensed heat acclimation programme will consist of two consecutive days with four, 75-minute heat exposures undertaken on each day

Outcomes

Primary Outcome Measures

Reduction in the peak deep body temperature
Rectal temperature measurement during a heat stress test

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2022
Last Updated
October 26, 2022
Sponsor
University of Portsmouth
Collaborators
Coventry University, Teesside University
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1. Study Identification

Unique Protocol Identification Number
NCT05600452
Brief Title
Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme
Official Title
Comparison of a Novel Condensed Heat Acclimation Programme With a Traditional Longer-term Heat Acclimation Programme
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
Collaborators
Coventry University, Teesside University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional heat acclimation
Arm Type
Active Comparator
Arm Description
The traditional heat acclimation programme will consist of daily 75-minute heat exposures for eight consecutive days
Arm Title
Condensed heat acclimation
Arm Type
Experimental
Arm Description
The condensed heat acclimation programme will consist of two consecutive days with four, 75-minute heat exposures undertaken on each day
Intervention Type
Other
Intervention Name(s)
Heat acclimation
Intervention Description
Repeated heat exposures with light exercise sufficient to elevate deep body temperature to ~ 38.5C
Primary Outcome Measure Information:
Title
Reduction in the peak deep body temperature
Description
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 Outcome Measure Information:
Title
Reduction in the resting deep body temperature
Description
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)
Title
Reduction in the peak mean body temperature
Description
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)
Title
Reduction in the resting mean body temperature
Description
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)
Title
Increased plasma volume
Description
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)
Title
Increased sweating rate
Description
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)
Title
Reduced sweat sodium concentration
Description
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)
Title
Reduced exercise heart rate
Description
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)
Title
Increased resting intracellular heat shock protein 70 content
Description
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)
Title
Increased post heat stress intracellular heat shock protein 70 content
Description
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)
Title
Increased resting intracellular heat shock protein 90 alpha content
Description
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)
Title
Increased post heat stress intracellular heat shock protein 90 alpha content
Description
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)
Title
Maximal oxygen uptake
Description
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)
Title
Lactate threshold
Description
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)
Title
Gross mechanical efficiency
Description
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)
Title
Peak power output
Description
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)
Title
Peripheral oxygen saturation during exposure to hypoxia
Description
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)
Title
Heart rate during exposure to hypoxia
Description
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)
Title
Minute ventilation during exposure to hypoxia
Description
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)
Title
Plasma neutrophil gelatinase-associated lipocalin
Description
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)
Title
Urine neutrophil gelatinase-associated lipocalin
Description
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)
Title
Plasma kidney injury molecule-1
Description
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)
Title
Urine kidney injury molecule-1
Description
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)
Title
Tissue inhibitor of metalloproteinase 2
Description
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)
Title
Insulin-like growth factor-binding protein 7
Description
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)
Title
Intestinal fatty acid binding protein
Description
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)
Title
Soluble cluster of differentiation 14
Description
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)
Title
Lipopolysaccharide binding protein
Description
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)
Title
Interleukin-6
Description
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)
Title
Cortisol
Description
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Corbett, PhD
Phone
44 2392 84
Ext
3084
Email
jo.corbett@port.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph T Costello, PhD
Phone
44 2392 84
Ext
5366
Email
joe.costello@port.ac.uk
Facility Information:
Facility Name
University of Portsmouth
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO1 2ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Corbettt, PhD
Phone
44 2392 84
Ext
3084
Email
jo.corbett@port.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published as measures of central tendency and dispersion (e.g. Mean and Standard deviation)

Learn more about this trial

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

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