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HyperthermiaNCT05838612

Hot Water Immersion as a Heat Acclimation Strategy in Older Adults

A study testing Heat acclimation in people with Hyperthermia and Heat Exposure, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aging is associated with impairments in heat loss responses of skin blood flow and sweating leading to reductions in whole-body heat loss. Consequently, older adults store more body heat and experience greater elevations in core temperature during heat exposure at rest and during exercise. Read more about this study

Who is it for?
Ages 60 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hyperthermia, Heat Exposure, Heat Stress
What is being tested?
Heat acclimation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
29 Apr 2022to 16 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Elderly (60-80 years), non-smoking adults.
  • Not engaged in regular physical activity (>2 sessions/week for ≥20 minutes per session).
  • Willing to provide informed consent.
  • Healthy, no diagnosed health conditions.
  • Body Mass index (BMI) <35 kg/m2.

Who cannot join

  • Heat adapted due to repeated exposure to hot environments within the last 3 weeks (use sauna, recent travel to hot climates, other).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Univerisity of Ottawa

    Ottawa, Ontario, K1N6N5

Other trials in Canada

About this study

Official title: Short-term Warm Water Immersion as a Heat Acclimation Strategy to Enhance Heat Dissipation in Older Adults: An Exploratory Study

Aging is associated with impairments in heat loss responses of skin blood flow and sweating leading to reductions in whole-body heat loss. Consequently, older adults store more body heat and experience greater elevations in core temperature during heat exposure at rest and during exercise. This maladaptive response occurs in adults as young as 40 years of age. Recently, heat acclimation associated with repeated bouts of exercise in the heat performed over 7 successive days has been shown to enhance whole-body heat loss in older adults, leading to a reduction in body heat storage. However, performing exercise in the heat may not be well tolerated or feasible for many older adults. Passive heat acclimation, such as the use of warm-water immersion may be an effective, alternative method to enhance heat-loss capacity in older adults. Thus, the following study aims to assess the effectiveness of a 7-day warm-water immersion (~40°C) protocol in enhancing whole-body heat loss in older adults. Warm-water immersion will consist of a one-hour immersion in warm water with core temperature clamped at 38.5°C. Improvements in whole-body heat loss will be assessed during an incremental exercise protocol performed in dry heat (i.e., 40°C, ~15% relative humidity) prior to and following the 7-day passive heat acclimation protocol. The incremental exercise protocol will consist of three 30 minute exercise bouts performed at increasing fixed rates of metabolic heat production (i.e., 150, 200, and 250 W/m2), each separated by 15-minutes of recovery, with exception final recovery will be 1-hour in duration) performed in a direct calorimeter (a device that provides a precise measurement of the heat dissipated by the human body).

Being tested
Heat acclimation
Keywords
Thermoregulation, Warm-water immersion, Heat acclimation, Aging
Medical subject headings
Hyperthermia, Heat Stress Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heat acclimationOther

    Participants will complete a 7-day passive heat acclimation protocol consisting of immersion in warm water (~40°C) for 1 hour over 7 consecutive days.

Study groups in NCT05838612
Study groupRoleWhat they receive
Heat AcclimationExperimentalParticipants will undergo an exercise heat stress test prior to and following seven consecutive days of warm-water immersion (~40°C) of 1-hour duration with core temperature clamped at 38.5°C. During the exercise-heat stress test participants will perform three, successive 30-minute bouts of semi-recumbent cycling performed at increasing fixed loads of metabolic heat production of 150, 200 and 250 W/m2 (i.e., exercise bout 1, exercise bout 2 and exercise bout 3, respectively), each separated by 15-minute of rest break with the final recovery extended to 1-hour.
Receives: Other: Heat acclimation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  2. Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  3. Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute bout 3 (average of last 5 minutes).

  4. Whole-body heat loss

    The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  5. Whole-body heat loss

    The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  6. Whole-body heat loss

    The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

Secondary outcomes (33)
  1. Body heat storage

    Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.

    Measured: Change from start to end of 30 minute exercise bout 1

  2. Body heat content

    Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.

    Measured: Change from start to end of 30 minute exercise bout 2

  3. Body heat storage

    Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.

    Measured: Change from start to end of 30 minute exercise bout 3

  4. Cumulative body heat storage

    Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.

    Measured: Change from baseline resting to end of exercise bout 3

  5. Dry heat loss

    Dry heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  6. Dry heat loss

    Dry heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  7. Dry heat loss

    Dry heat loss as assessed using a direct air calorimeter.

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  8. Core temperature

    Core temperature indexed by rectal/visceral temperature

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  9. Core temperature

    Core temperature indexed by rectal/visceral temperature

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  10. Core temperature

    Core temperature indexed by rectal/visceral temperature

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  11. Change in core temperature

    Core temperature indexed by rectal/visceral temperature

    Measured: Change from baseline resting to end of end of 30 minute exercise bout 3.

  12. Skin temperature

    Skin temperature measured at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - upper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%.

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  13. Skin temperature

    Skin temperature measured at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - upper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%.

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  14. Skin temperature

    Skin temperature measured at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - upper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%.

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  15. Change in skin temperature

    Skin temperature measured at 4-sites (chest, upper arm, thigh, calf) with mean value calculated as weighted value of 4 sites - upper arm, 30%; chest, 30%; thigh, 20%; and calf, 20%.

    Measured: Change from baseline resting to end of end of 30 minute exercise bout 3.

  16. Heart rate

    Measured continuously with chest-band device

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  17. Heart rate

    Measured continuously with chest-band device

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  18. Heart rate

    Measured continuously with chest-band device

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  19. Heart rate variability

    Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  20. Heart rate variability

    Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  21. Heart rate variability

    Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  22. Thermal comfort scale

    Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  23. Thermal comfort scale

    Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  24. Thermal comfort scale

    Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  25. Thermal sensation scale

    Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  26. Thermal sensation scale

    Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  27. Thermal sensation scale

    Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  28. Thirst sensation scale

    Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  29. Thirst sensation scale

    Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  30. Thirst sensation scale

    Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

  31. Rating of perceived exertion

    Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")

    Measured: End of 30 minute exercise bout 1 (average of last 5 minutes).

  32. Rating of perceived exertion

    Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")

    Measured: End of 30 minute exercise bout 2 (average of last 5 minutes).

  33. Rating of perceived exertion

    Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")

    Measured: End of 30 minute exercise bout 3 (average of last 5 minutes).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start29 Apr 2022
  3. Primary completion16 Feb 2023
  4. Study completion16 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Each participant will complete seven consecutive experimental sessions consisting of a passive heat acclimation involving a one hour immersion in warm water (\~40°C) with core temperature clamped at 38.5°C. Prior to and following the passive heat acclimation protocol, study participants will perform an exercise-heat stress test (Days 0 and 8) to assess whole-body heat loss in a hot-dry environment (40°C, 15% relative humidity). The exercise protocol will consist of three successive 30-minute bouts of exercise performed at increasing rates of metabolic heat production (i.e., 150, 200 and 250 W/m2), each separated by a 15-minute rest break, with the final recovery 1-hour in duration.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838612
Sponsor's protocol ID
HEPRU-2023-02
Status last verified
Jul 2024
First submitted
19 Apr 2023
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified participant data will be made available with approved analysis plan and signed access agreement

Publications

  • Carrillo AE, Luomala RA, Janetos KT, McCormick JJ, O'Connor FK, Kirby NV, Herry CL, Seely AJE, Kenny GP. Heart Rate Variability During Exercise-Heat Stress Following Seven Days of Passive Heat Acclimation in Older Males: A Secondary Analysis. Med Sci Sports Exerc. 2026 Nov 1;58(11):2549-2557. doi: 10.1249/MSS.0000000000004079. Epub 2026 Jul 7.

    PubMed 42406578
  • Janetos K, O'Connor F, Morris N, Kenny G. The influence of heat acclimation on the relation and agreement between perceptual and physiological strain in older males during exercise-heat stress. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-11. doi: 10.1139/apnm-2025-0360.

    PubMed 41549363
  • Janetos KT, O'Connor FK, Meade RD, Richards BJ, Koetje NJ, Kirby NV, McCormick JJ, Flouris AD, Kenny GP. Short-Term Warm Water Immersion for Improving Whole-Body Heat Loss in Older Men. Med Sci Sports Exerc. 2025 Jun 1;57(6):1137-1147. doi: 10.1249/MSS.0000000000003649. Epub 2025 Jan 17.

    PubMed 39820413

Questions about this trial

What is this clinical trial studying?

A study testing Heat acclimation in people with Hyperthermia and Heat Exposure, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaporative heat loss (time frame: End of 30 minute exercise bout 1 (average of last 5 minutes).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05838612, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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