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

Study Overview
=================
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.

Official Title
-----------------
Evaluating the Efficacy of Pedestal Fans for Limiting Heat Strain in Elderly Adults During Extreme Heat Events

Conditions
-----------------
Hyperthermia, Weather; Heat, Heat Stress, Aging

Intervention / Treatment
-----------------
* Other: No cooling (control)
* Other: Electric fan (low airflow)
* Other: Electric fan (high airflow)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No cooling intervention (control)<br>Adults aged 65-85 years with or without type 2 diabetes and/or hypertension | Other: No cooling (control)<br>* 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.<br>|
| Experimental: Fan generating low airflow<br>Adults aged 65-85 years with or without type 2 diabetes and/or hypertension | Other: Electric fan (low airflow)<br>* 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.<br>|
| Experimental: Fan generating high airflow<br>Adults aged 65-85 years with or without type 2 diabetes and/or hypertension | Other: Electric fan (high airflow)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature (peak) | Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave. | End of heat exposure (hour 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature (AUC) | Area under the curve of rectal temperature (in degree-hours). | End of heat exposure (hour 8) | 
| Core temperature (end-exposure) | Rectal temperature measured at hour 8 of the simulated heat wave exposure (15-min average) | End of heat exposure (hour 8) | 
| 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 | End of heat exposure (hour 8) | 
| Heart rate (AUC) | Area under the curve of rectal temperature (total beats). | End of heat exposure (hour 8) | 
| Heart rate (end-exposure) | Heart rate measured at hour 8 of the simulated heat wave exposure via 3-lead ECG (15-min average) | End of heat exposure (hour 8) | 
| Systolic blood pressure (end-exposure) | Systolic blood pressure measured in triplicate via automated oscillometry ( 60 seconds between measures) | End of heat exposure (hour 8) | 
| Diastolic blood pressure (end-exposure) | Diastolic blood pressure measured in triplicate via automated oscillometry ( 60 seconds between measures) | End of heat exposure (hour 8) | 
| Rate pressure product (end-exposure) | Rate pressure product, an index of myocardial work and strain, calculated as systolic blood pressure x heart rate. | End of heat exposure (hour 8) | 
| 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). | End of heat exposure (hour 8) | 
| 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). | End of heat exposure (hour 8) | 
| Fluid consumption | Cumulative fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure. | End of heat exposure (hour 8) | 
| 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) | End of heat exposure (hour 8) | 
| 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. | End of heat exposure (hour 8) | 
| 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). | End of heat exposure (hour 8) | 
| 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). | End of heat exposure (hour 8) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heat wave, Cooling intervention, Electric fans, Cardiovascular strain, Extreme heat events