NCT05600452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

October 21, 2022

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (29)

  • Reduction in the resting deep body temperature

    Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  • Reduction in the peak mean body temperature

    Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  • Reduction in the resting mean body temperature

    Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  • Increased plasma volume

    Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  • Increased sweating rate

    Pre heat acclimation intervention (up to 1 week) to post heat acclimation intervention (up to 1 week)

  • +24 more secondary outcomes

Study Arms (2)

Traditional heat acclimation

ACTIVE COMPARATOR

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

Other: Heat acclimation

Condensed heat acclimation

EXPERIMENTAL

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

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

Condensed heat acclimationTraditional heat acclimation

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Portsmouth

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel groups design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Environmental Physiology

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 31, 2022

Study Start

January 17, 2020

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Data will be published as measures of central tendency and dispersion (e.g. Mean and Standard deviation)

Locations