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Efficacy of Electric Fans for Mitigating Thermal Strain in Older Adults During Heat Waves

Primary Purpose

Hyperthermia, Weather; Heat, Heat Stress

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No cooling (control)
Electric fan (low airflow)
Electric fan (high airflow)
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 Heat wave, Cooling intervention, Electric fans, Cardiovascular strain, Extreme heat events

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female adults. Aged 65-85 years. Non-smoking. English or French speaking. Ability to provide informed consent. Exclusion Criteria: Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.). Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.) Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants). Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).

Sites / Locations

  • University of Ottawa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

No cooling intervention (control)

Fan generating low airflow

Fan generating high airflow

Arm Description

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension

Outcomes

Primary Outcome Measures

Core temperature (peak)
Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave.

Secondary Outcome Measures

Core temperature (AUC)
Area under the curve of rectal temperature (in degree-hours).
Core temperature (end-exposure)
Rectal temperature measured at hour 8 of the simulated heat wave exposure (15-min average)
Heart rate (peak)
Peak heart rate (15 min average) during exposure. Heart rate is measured continuously via 3-lead ECG throughout each simulated heat wave
Heart rate (AUC)
Area under the curve of rectal temperature (total beats).
Heart rate (end-exposure)
Heart rate measured at hour 8 of the simulated heat wave exposure via 3-lead ECG (15-min average)
Systolic blood pressure (end-exposure)
Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures)
Diastolic blood pressure (end-exposure)
Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures)
Rate pressure product (end-exposure)
Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.
Heart rate variability: SDNN (end-exposure)
Standard deviation of normal-to-normal RR intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Heart rate variability: RMSSD (end-exposure)
Root mean squared standard deviation of normal-to-normal RR intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Fluid consumption
Cumulative fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure.
Fluid loss
Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption)
Change in plasma volume
Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill.
Thermal comfort scale (end-exposure)
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "extremely uncomfortable" to "extremely comfortable"(midpoint: neutral).
Air movement scale (end-exposure)
Perception of air movement assessed via a visual analog scale ("How do you feel about the air movement in this room?") ranging from "much too still" to "much too breezy" (midpoint: neutral).

Full Information

First Posted
January 12, 2023
Last Updated
June 15, 2023
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05695079
Brief Title
Efficacy of Electric Fans for Mitigating Thermal Strain in Older Adults During Heat Waves
Official Title
Evaluating the Efficacy of Pedestal Fans for Limiting Heat Strain in Elderly Adults During Extreme Heat Events
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

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
With the increasing regularity and intensity of hot weather and heat waves, there is an urgent need to develop heat-alleviation strategies able to provide targeted protection for heat-vulnerable older adults. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals. Air-conditioning is also energy intensive, which can strain the electrical grid and, depending on the source of electricity generation, contribute to increasing green house gas emissions. For these reasons, recent guidance has advocated the use of electric fans as a simple and sustainable alternative to air-conditioning. To date, however, only one study has assessed the efficacy of fan use in older adults and demonstrated that fans accelerate increases in body temperature and heart rate in a short-duration (~2 hours) resting exposure to 42°C with increasing ambient humidity from 30-70%. While subsequent modelling has suggested that fans can improve heat loss via sweat evaporation in healthy older adults at air temperatures up to 38°C, there is currently no empirical data to support these claims. Further, that work assumed older adults were seated in front of a pedestal fan generating an airflow of 3·5-4·5 m/s at the front of the body. This airflow cannot be attained by most marketed pedestal fans. Studies are therefore needed to evaluate the efficacy of fans for preventing hyperthermia and the associated physiological burden in older adults in air temperatures below 38°C and determine whether the cooling effect of fans, if any, is evident at lower rates of airflow. To address these knowledge gaps, this randomized crossover trial will evaluate body core temperature, cardiovascular strain, dehydration, and thermal comfort in adults aged 65-85 years exposed for 8 hours to conditions experienced during hot weather and heat waves in North America simulated using a climate chamber (36°C, 45% relative humidity). Each participant will complete three randomized exposures that will differ only in the airflow generated at the front of the body via an electric pedestal fan: no airflow (control), low airflow (~2 m/s), and high airflow (~4 m/s). While participants will spend most of the 8-hour exposure seated in front of the fan, they will also complete 4 x 10 min periods of 'activities of daily living' (~2-2.5 METS, light stepping) at ~2 hour intervals to more accurately reflect activity patterns in the home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia, Weather; Heat, Heat Stress, Aging
Keywords
Heat wave, Cooling intervention, Electric fans, Cardiovascular strain, Extreme heat events

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will complete 3 simulated heat wave exposures in random order: i) no electric fan (control); ii) electric fan generating air flow of 2 m/s at the front of the body; and iii) electric fan generating air flow of 4 m/s at the front of the body.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be informed of the study interventions before providing informed consent but will be masked to the order of the arms until exposure (i.e., participants will not know the fan conditions). Data will be blinded prior to analysis.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No cooling intervention (control)
Arm Type
Active Comparator
Arm Description
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Arm Title
Fan generating low airflow
Arm Type
Experimental
Arm Description
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Arm Title
Fan generating high airflow
Arm Type
Experimental
Arm Description
Adults aged 65-85 years with or without type 2 diabetes and/or hypertension
Intervention Type
Other
Intervention Name(s)
No cooling (control)
Intervention Description
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling intervention (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7.
Intervention Type
Other
Intervention Name(s)
Electric fan (low airflow)
Intervention Description
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling interventions (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7. While participants are seated, an electric pedestal fan positioned 1 m away will deliver a continuous airflow of 2 m/s to the front of the body.
Intervention Type
Other
Intervention Name(s)
Electric fan (high airflow)
Intervention Description
Participants are exposed to 36°C, 45% relative humidity for 8 hours without cooling interventions (control condition). Drinking water is available ad libitum. Participants are seated throughout exposure, except for during 10 min periods of simulated activities of daily living (light stepping at 2-2.5 METS) performed at hours 1, 3, 5, and 7. While participants are seated, an electric pedestal fan positioned 1 m away will deliver a continuous airflow of 4 m/s to the front of the body.
Primary Outcome Measure Information:
Title
Core temperature (peak)
Description
Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave.
Time Frame
End of heat exposure (hour 8)
Secondary Outcome Measure Information:
Title
Core temperature (AUC)
Description
Area under the curve of rectal temperature (in degree-hours).
Time Frame
End of heat exposure (hour 8)
Title
Core temperature (end-exposure)
Description
Rectal temperature measured at hour 8 of the simulated heat wave exposure (15-min average)
Time Frame
End of heat exposure (hour 8)
Title
Heart rate (peak)
Description
Peak heart rate (15 min average) during exposure. Heart rate is measured continuously via 3-lead ECG throughout each simulated heat wave
Time Frame
End of heat exposure (hour 8)
Title
Heart rate (AUC)
Description
Area under the curve of rectal temperature (total beats).
Time Frame
End of heat exposure (hour 8)
Title
Heart rate (end-exposure)
Description
Heart rate measured at hour 8 of the simulated heat wave exposure via 3-lead ECG (15-min average)
Time Frame
End of heat exposure (hour 8)
Title
Systolic blood pressure (end-exposure)
Description
Systolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures)
Time Frame
End of heat exposure (hour 8)
Title
Diastolic blood pressure (end-exposure)
Description
Diastolic blood pressure measured in triplicate via automated oscillometry (~60 seconds between measures)
Time Frame
End of heat exposure (hour 8)
Title
Rate pressure product (end-exposure)
Description
Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate.
Time Frame
End of heat exposure (hour 8)
Title
Heart rate variability: SDNN (end-exposure)
Description
Standard deviation of normal-to-normal RR intervals (SDNN) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. SDNN will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Time Frame
End of heat exposure (hour 8)
Title
Heart rate variability: RMSSD (end-exposure)
Description
Root mean squared standard deviation of normal-to-normal RR intervals (RMSSD) measured during 5 minutes of paced breathing (15 breaths/min) with participants in the seated position. RMSSD will be evaluated twice, during two paced breathing periods (separated by 4 min of seated rest).
Time Frame
End of heat exposure (hour 8)
Title
Fluid consumption
Description
Cumulative fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure.
Time Frame
End of heat exposure (hour 8)
Title
Fluid loss
Description
Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for food consumption)
Time Frame
End of heat exposure (hour 8)
Title
Change in plasma volume
Description
Change in plasma volume from baseline values calculated from duplicate measurements of hemoglobin and hematocrit at the start and end of each exposure using the technique by Dill and Costill.
Time Frame
End of heat exposure (hour 8)
Title
Thermal comfort scale (end-exposure)
Description
Thermal comfort assessed via a visual analog scale ("How comfortable does your body temperature feel?") ranging from "extremely uncomfortable" to "extremely comfortable"(midpoint: neutral).
Time Frame
End of heat exposure (hour 8)
Title
Air movement scale (end-exposure)
Description
Perception of air movement assessed via a visual analog scale ("How do you feel about the air movement in this room?") ranging from "much too still" to "much too breezy" (midpoint: neutral).
Time Frame
End of heat exposure (hour 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female adults. Aged 65-85 years. Non-smoking. English or French speaking. Ability to provide informed consent. Exclusion Criteria: Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.). Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.) Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants). Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen P Kenny, PhD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald J Sigal, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University 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

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Efficacy of Electric Fans for Mitigating Thermal Strain in Older Adults During Heat Waves

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