NCT05838612

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

April 19, 2023

Last Update Submit

July 9, 2024

Conditions

Keywords

ThermoregulationWarm-water immersionHeat acclimationAging

Outcome Measures

Primary Outcomes (6)

  • Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

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

  • Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

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

  • Evaporative heat loss

    Evaporative heat loss as assessed using a direct air calorimeter.

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

  • 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).

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

  • 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).

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

  • 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).

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

Secondary Outcomes (33)

  • Body heat storage

    Change from start to end of 30 minute exercise bout 1

  • Body heat content

    Change from start to end of 30 minute exercise bout 2

  • Body heat storage

    Change from start to end of 30 minute exercise bout 3

  • Cumulative body heat storage

    Change from baseline resting to end of exercise bout 3

  • Dry heat loss

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

  • +28 more secondary outcomes

Study Arms (1)

Heat Acclimation

EXPERIMENTAL

Participants 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.

Other: Heat acclimation

Interventions

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.

Heat Acclimation

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (2)

  • Janetos KT, O'Connor F, Morris N, Kenny GP. 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 16. doi: 10.1139/apnm-2025-0360. Online ahead of print.

  • 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.

MeSH Terms

Conditions

HyperthermiaHeat Stress Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Glen P Kenny, PhD.

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data will be blinded prior to analysis.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, University Research Chair, Principal Investigator

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

April 29, 2022

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available with approved analysis plan and signed access agreement

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following publication of the main study report(s)
Access Criteria
Approved analysis plan and signed access agreement

Locations