- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05838612
Hot Water Immersion as a Heat Acclimation Strategy in Older Adults
July 9, 2024 updated by: Glen P. Kenny, University of Ottawa
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1N6N5
- Univerisity of Ottawa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Heat adapted due to repeated exposure to hot environments within the last 3 weeks (use sauna, recent travel to hot climates, other).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Heat Acclimation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaporative heat loss
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
|
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
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
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
Time Frame: End of 30 minute bout 3 (average of last 5 minutes).
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Evaporative heat loss as assessed using a direct air calorimeter.
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End of 30 minute bout 3 (average of last 5 minutes).
|
|
Whole-body heat loss
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
|
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
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
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
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body heat storage
Time Frame: Change from start to end of 30 minute exercise bout 1
|
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
|
Change from start to end of 30 minute exercise bout 1
|
|
Body heat content
Time Frame: Change from start to end of 30 minute exercise bout 2
|
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
|
Change from start to end of 30 minute exercise bout 2
|
|
Body heat storage
Time Frame: Change from start to end of 30 minute exercise bout 3
|
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
|
Change from start to end of 30 minute exercise bout 3
|
|
Cumulative body heat storage
Time Frame: Change from baseline resting to end of exercise bout 3
|
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
|
Change from baseline resting to end of exercise bout 3
|
|
Dry heat loss
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
|
Dry heat loss as assessed using a direct air calorimeter.
|
End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Dry heat loss
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
Dry heat loss as assessed using a direct air calorimeter.
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Dry heat loss
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Dry heat loss as assessed using a direct air calorimeter.
|
End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Core temperature
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
|
Core temperature indexed by rectal/visceral temperature
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End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Core temperature
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
Core temperature indexed by rectal/visceral temperature
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End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Core temperature
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Core temperature indexed by rectal/visceral temperature
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End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Change in core temperature
Time Frame: Change from baseline resting to end of end of 30 minute exercise bout 3.
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Core temperature indexed by rectal/visceral temperature
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Change from baseline resting to end of end of 30 minute exercise bout 3.
|
|
Skin temperature
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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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%.
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End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Skin temperature
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
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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%.
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Skin temperature
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
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%.
|
End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Change in skin temperature
Time Frame: Change from baseline resting to end of end of 30 minute exercise bout 3.
|
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%.
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Change from baseline resting to end of end of 30 minute exercise bout 3.
|
|
Heart rate
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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Measured continuously with chest-band device
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End of 30 minute exercise bout 1 (average of last 5 minutes).
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|
Heart rate
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
Measured continuously with chest-band device
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Heart rate
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Measured continuously with chest-band device
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End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Heart rate variability
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
|
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
|
End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Heart rate variability
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Heart rate variability
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
|
End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Thermal comfort scale
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
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End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Thermal comfort scale
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
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Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
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End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Thermal comfort scale
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
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End of 30 minute exercise bout 3 (average of last 5 minutes).
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|
Thermal sensation scale
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
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End of 30 minute exercise bout 1 (average of last 5 minutes).
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|
Thermal sensation scale
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
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Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
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End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Thermal sensation scale
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
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Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
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End of 30 minute exercise bout 3 (average of last 5 minutes).
|
|
Thirst sensation scale
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
|
End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Thirst sensation scale
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
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Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Thirst sensation scale
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
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End of 30 minute exercise bout 3 (average of last 5 minutes).
|
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Rating of perceived exertion
Time Frame: End of 30 minute exercise bout 1 (average of last 5 minutes).
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Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
|
End of 30 minute exercise bout 1 (average of last 5 minutes).
|
|
Rating of perceived exertion
Time Frame: End of 30 minute exercise bout 2 (average of last 5 minutes).
|
Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
|
End of 30 minute exercise bout 2 (average of last 5 minutes).
|
|
Rating of perceived exertion
Time Frame: End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
|
End of 30 minute exercise bout 3 (average of last 5 minutes).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glen P Kenny, PhD., University of Ottawa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2022
Primary Completion (Actual)
February 16, 2023
Study Completion (Actual)
February 16, 2023
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
April 29, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2024
Last Update Submitted That Met QC Criteria
July 9, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEPRU-2023-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified participant data will be made available with approved analysis plan and signed access agreement
IPD Sharing Time Frame
Following publication of the main study report(s)
IPD Sharing Access Criteria
Approved analysis plan and signed access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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