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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05838612
Other study ID # HEPRU-2023-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 29, 2022
Est. completion date June 30, 2023

Study information

Verified date April 2023
Source University of Ottawa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date June 30, 2023
Est. primary completion date February 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Heat acclimation
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.

Locations

Country Name City State
Canada Univerisity of Ottawa Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary Evaporative heat loss Evaporative heat loss as assessed using a direct air calorimeter. End of 30 minute bout 3 (average of last 5 minutes).
Primary 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).
Primary 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).
Primary 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 Body heat storage 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
Secondary Body heat content 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
Secondary Body heat storage 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
Secondary 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. Change from baseline resting to end of exercise bout 3
Secondary Dry heat loss Dry heat loss as assessed using a direct air calorimeter. End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary Dry heat loss Dry heat loss as assessed using a direct air calorimeter. End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary Dry heat loss Dry heat loss as assessed using a direct air calorimeter. End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Core temperature Core temperature indexed by rectal/visceral temperature End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary Core temperature Core temperature indexed by rectal/visceral temperature End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary Core temperature Core temperature indexed by rectal/visceral temperature End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Change in core temperature Core temperature indexed by rectal/visceral temperature Change from baseline resting to end of end of 30 minute exercise bout 3.
Secondary 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%. End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary 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%. End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary 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%. End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary 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%. Change from baseline resting to end of end of 30 minute exercise bout 3.
Secondary Heart rate Measured continuously with chest-band device End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary Heart rate Measured continuously with chest-band device End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary Heart rate Measured continuously with chest-band device End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Heart rate variability 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).
Secondary Heart rate variability 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).
Secondary Heart rate variability 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).
Secondary Thermal comfort scale Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable") End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary Thermal comfort scale Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable") End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary Thermal comfort scale Thermal comfort assessed via a questionnaire using the ASHRAE 4-point scale ("1=comfortable to 4=very uncomfortable") End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Thermal sensation scale Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot") End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary Thermal sensation scale Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot") End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary Thermal sensation scale Thermal sensation will be assessed using the ASHRAE 7-point scale ("0=neutral to 7=extremely hot") End of 30 minute exercise bout 3 (average of last 5 minutes).
Secondary Thirst sensation scale 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).
Secondary Thirst sensation scale 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).
Secondary Thirst sensation scale 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 3 (average of last 5 minutes).
Secondary 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") End of 30 minute exercise bout 1 (average of last 5 minutes).
Secondary 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") End of 30 minute exercise bout 2 (average of last 5 minutes).
Secondary 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") End of 30 minute exercise bout 3 (average of last 5 minutes).
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