search
Back to results

Hot Water Immersion as a Heat Acclimation Strategy in Older Adults

Primary Purpose

Hyperthermia, Heat Exposure, Heat Stress

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Heat acclimation
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperthermia focused on measuring Thermoregulation, Warm-water immersion, Heat acclimation, Aging

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Univerisity of Ottawa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heat Acclimation

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaporative heat loss
Evaporative heat loss as assessed using a direct air calorimeter.
Evaporative heat loss
Evaporative heat loss as assessed using a direct air calorimeter.
Evaporative heat loss
Evaporative heat loss as assessed using a direct air calorimeter.
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).
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).
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).

Secondary Outcome Measures

Body heat storage
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Body heat content
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Body heat storage
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
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.
Dry heat loss
Dry heat loss as assessed using a direct air calorimeter.
Dry heat loss
Dry heat loss as assessed using a direct air calorimeter.
Dry heat loss
Dry heat loss as assessed using a direct air calorimeter.
Core temperature
Core temperature indexed by rectal/visceral temperature
Core temperature
Core temperature indexed by rectal/visceral temperature
Core temperature
Core temperature indexed by rectal/visceral temperature
Change in core temperature
Core temperature indexed by rectal/visceral temperature
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%.
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%.
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%.
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%.
Heart rate
Measured continuously with chest-band device
Heart rate
Measured continuously with chest-band device
Heart rate
Measured continuously with chest-band device
Heart rate variability
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Heart rate variability
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Heart rate variability
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Thermal comfort scale
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Thermal comfort scale
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Thermal comfort scale
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Thermal sensation scale
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Thermal sensation scale
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Thermal sensation scale
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Thirst sensation scale
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
Thirst sensation scale
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
Thirst sensation scale
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
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")
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")
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")

Full Information

First Posted
April 19, 2023
Last Updated
April 29, 2023
Sponsor
University of Ottawa
search

1. Study Identification

Unique Protocol Identification Number
NCT05838612
Brief Title
Hot Water Immersion as a Heat Acclimation Strategy in Older Adults
Official Title
Short-term Warm Water Immersion as a Heat Acclimation Strategy to Enhance Heat Dissipation in Older Adults: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia, Heat Exposure, Heat Stress, Thermoregulation, Aging
Keywords
Thermoregulation, Warm-water immersion, Heat acclimation, Aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
Data will be blinded prior to analysis.
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heat Acclimation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Heat acclimation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaporative heat loss
Description
Evaporative heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Evaporative heat loss
Description
Evaporative heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Evaporative heat loss
Description
Evaporative heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute bout 3 (average of last 5 minutes).
Title
Whole-body heat loss
Description
The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Whole-body heat loss
Description
The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Whole-body heat loss
Description
The sum of evaporative and dry heat exchange will be quantified during each exercise period (i.e., 150, 200 and 250 W/m2).
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Outcome Measure Information:
Title
Body heat storage
Description
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Time Frame
Change from start to end of 30 minute exercise bout 1
Title
Body heat content
Description
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Time Frame
Change from start to end of 30 minute exercise bout 2
Title
Body heat storage
Description
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Time Frame
Change from start to end of 30 minute exercise bout 3
Title
Cumulative body heat storage
Description
Cumulative amount of heat stored within the body calculated as the temporal summation of metabolic heat production and net heat loss.
Time Frame
Change from baseline resting to end of exercise bout 3
Title
Dry heat loss
Description
Dry heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Dry heat loss
Description
Dry heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Dry heat loss
Description
Dry heat loss as assessed using a direct air calorimeter.
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Core temperature
Description
Core temperature indexed by rectal/visceral temperature
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Core temperature
Description
Core temperature indexed by rectal/visceral temperature
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Core temperature
Description
Core temperature indexed by rectal/visceral temperature
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Change in core temperature
Description
Core temperature indexed by rectal/visceral temperature
Time Frame
Change from baseline resting to end of end of 30 minute exercise bout 3.
Title
Skin temperature
Description
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%.
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Skin temperature
Description
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%.
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Skin temperature
Description
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%.
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Change in skin temperature
Description
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%.
Time Frame
Change from baseline resting to end of end of 30 minute exercise bout 3.
Title
Heart rate
Description
Measured continuously with chest-band device
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Heart rate
Description
Measured continuously with chest-band device
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Heart rate
Description
Measured continuously with chest-band device
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Heart rate variability
Description
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Heart rate variability
Description
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Heart rate variability
Description
Measures of variability computed from the time, frequency, time-frequency, scale-invariant, entropy, and other nonlinear domains
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Thermal comfort scale
Description
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Thermal comfort scale
Description
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Thermal comfort scale
Description
Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable")
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Thermal sensation scale
Description
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Thermal sensation scale
Description
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Thermal sensation scale
Description
Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot")
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Thirst sensation scale
Description
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Thirst sensation scale
Description
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Thirst sensation scale
Description
Thirst sensation will be quantified using a 9-point scale ("1=not thirsty at all to 9=very, very thirsty")
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).
Title
Rating of perceived exertion
Description
Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
Time Frame
End of 30 minute exercise bout 1 (average of last 5 minutes).
Title
Rating of perceived exertion
Description
Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
Time Frame
End of 30 minute exercise bout 2 (average of last 5 minutes).
Title
Rating of perceived exertion
Description
Rating of perceived exertion will be quantified using a 14-point scale ("6=no exertion at all to 20=maximal exertion")
Time Frame
End of 30 minute exercise bout 3 (average of last 5 minutes).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD.
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univerisity of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N6N5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Hot Water Immersion as a Heat Acclimation Strategy in Older Adults

We'll reach out to this number within 24 hrs